GtoPdb is requesting financial support from commercial users. Please see our sustainability page for more information.
Drug Approvals
Each year, the Guide to Pharmacology Curation Team puts together a list of the latest approved drugs from FDA, EMA and MHRA as well as first-time approvals from other agencies. The majority of these will be curated in the database, and they are hyperlinked to their respective summary pages from the INN in the tables below. There are some cases were we have listed an approved drug but it doesn't have a link because it will not have been curated.
Drug Approvals in 2026
| INN | Trade Name | Type | Indication | Therapeutic Target | Comments | Approval Sources |
| copper histidinate | Zycubo | sm | To treat Menkes disease | US FDA approval 12/01/2026: A copper-chelated drug that bypasses the defective ATP7A transporter-mediated copper absorption process in the gut of pediatric patients with Menkes disease | ||
| difamilast | Adquey | sm | To treat mild to moderate atopic dermatitis | phosphodiesterase 4D | US FDA (2026) Japan PMDA (2021) | |
| milsaperidone | Bysanti | sm | To treat schizophrenia and to treat manic or mixed episodes associated with bipolar I disorder | D2 receptor | 5-HT2A receptor | US FDA (2025) | |
| pegzilarginase-nbln | Loargys | peptide | Enzyme replacement therapy to treat hyperarginemia in adults and pediatric patients two years and older with arginase 1 deficiency, in conjunction with dietary protein restriction | US FDA approval 23/02/2026 |
Drug Approvals in 2025
| INN | Trade Name | Type | Indication | Therapeutic Target | Comments | Approval Sources |
| garadacimab | Andembry | mAb | To prevent attacks of hereditary angioedema | coagulation factor XII | US FDA (2025) UK MHRA (2025) EU EMA (2025) | |
| vilobelimab | Gohibic | mAb | To treat COVID-19-related ARDS | C5a1 receptor | EU EMA (2025) | |
| repotrectinib | Augtyro | sm | To treat locally advanced or metastatic ROS1-positive non-small cell lung cancer | TrkA | ALK | ROS | China NMPA (2024) EU EMA (2025) US FDA (2023) | |
| datopotamab deruxtecan | Datroway | ADC | To treat unresectable or metastatic hormone receptor (HR)-positive, HER2-negative breast cancer | tumor associated calcium signal transducer 2 | EU EMA (2025) China NMPA (2025) US FDA (2025) | |
| sipavibart | Kavigale | mAb | Pre-exposure prophylaxis for SARS-CoV-2 | CoV Spike glycoprotein | EU EMA (2025) | |
| treosulfan | Grafapex | sm | Used with fludarabine as a preparative regimen for alloHSCT | UK MHRA (1992) EU EMA (2019) US FDA (2025) | ||
| suzetrigine | Journavx | sm | To treat moderate-to-severe acute pain | Nav1.8 | US FDA (2025) | |
| mirdametinib | Gomekli | sm | To treat NF1 with unresectable symptomatic plexiform neurofibromas | STE7 family | EU EMA (2025) US FDA (2025) | |
| tiratricol | Emcitate | sm | To treat peripheral thyrotoxicosis associated with MCT8 deficiency (Allan-Hernon-Dudley syndrome) | 1A. Thyroid hormone receptors | EU EMA (2025) | |
| vimseltinib | Romvimza | sm | To treat tenosynovial giant cell tumour | CSFR | EU EMA (2025) US FDA (2025) | |
| serplulimab | Hetronifly | mAb | To treat extensive-stage SCLC (and other solid tumours China) | PD-1 | China NMPA (2024) EU EMA (2025) | |
| ebdarokimab | Aidaro | mAb | To treat moderat-severe plaque psoriasis | IL-12B | China approval 15/04/2025 | China NMPA (2025) |
| gepotidacin | Blujepa | sm | To treat uncomplicated urinary tract infections | DNA gyrase | DNA topoisomerase 4 | US FDA (2025) | |
| fitusiran | Qfitlia | nucleic acid | To treat hemophilia A/B | serpin family C member 1 | China NMPA (2025) US FDA (2025) | |
| penpulimab | Anike | mAb | In combination with either cisplatin or carboplatin and gemcitabine, to treat adults with recurrent or metastatic non-keratinizing nasopharyngeal carcinoma (NPC), or as a single agent while on or after platinum-based chemotherapy and at least one other prior line of therapy | PD-1 | Initially approved by China NMPA in 2021 | China NMPA (2021) US FDA (2025) |
| atrasentan | Vanrafia | sm | To reduce proteinuria in adults with primary immunoglobulin A nephropathy at risk of rapid disease progression | ETA receptor | China NMPA (2025) US FDA (2025) | |
| linvoseltamab | Lynozyfic | mAb | To treat multiple myeloma | BCMA | CD3e | US FDA (2025) EU EMA (2025) | |
| nipocalimab | Imaavy | mAb | To treat generalized myasthenia gravis | FcRn | EU EMA (2025) US FDA (2025) | |
| defactinib + avutometinib | Avmapki Fakzynja | sm | To treat KRAS-mutated recurrent low-grade serous ovarian cancer (LGSOC) after prior systemic therapy | MEK1 | FAK | c-Raf | defactinib: US FDA (2025) avutometinib: US FDA (2025) | |
| telisotuzumab vedotin | Emrelis | ADC | To treat locally advanced or metastatic, non-squamous non-small cell lung cancer (NSCLC) with high c-Met protein overexpression after prior systemic therapy | MET | US FDA (2025) | |
| acoltremon | Tryptyr | sm | To treat the signs and symptoms of dry eye disease | TRPM8 | US FDA (2025) | |
| taletrectinib | Ibtrozi | sm | ROS1 fusion-positive NSCLC | TrkA | ROS | First approved in China in 2024. | China NMPA (2024) US FDA (2025) |
| sunvozertinib | Zegfrovy | sm | To treat EGFR exon 20 insertion mutation +ve locally advanced/metastatic NSCLC | EGFR | First approved in China in 2023 | US FDA (2025) China NMPA (2023) |
| clesrovimab-cfor | Enflonsia | mAb | To prevent respiratory syncytial virus (RSV) lower respiratory tract disease in neonates and infants who are born during or entering their first RSV season | Viral target | ||
| sebetralstat | Ekterly | sm | To treat hereditary angioedema (HAE) attacks | kallikrein B1 | UK MHRA (2025) US FDA (2025) EU EMA (2025) | |
| delgocitinib | Anzupgo | sm | To treat moderate-to-severe chronic hand eczema when topical corticosteroids are not advisable or produce an inadequate response | Janus kinase (JakA) family | First approved in Japan in 2020, to treat atopic dermatitis | US FDA (2025) EU EMA (2024) Japan PMDA (2020) |
| sepiapterin | Sephience | sm | To treat hyperphenylalaninemia in patients with sepiapterin-responsive phenylketonuria | L-Phenylalanine hydroxylase | EU EMA (2025) US FDA (2025) | |
| dordaviprone | Modeyso | sm | To treat diffuse midline glioma harboring an H3 K27M mutation with progressive disease following prior therapy. | caseinolytic mitochondrial matrix peptidase proteolytic subunit | FDA accelerated approval | US FDA (2025) |
| aceclidine | Vizz | sm | To treat presbyopia | Acetylcholine receptors (muscarinic) | US FDA (2025) | |
| zongertinib | Hernexeos | sm | To treat unresectable/metastatic NSCLC with HER2-activating mutations in the tyrosine kinase domain. | HER2 | US FDA (2025) China NMPA (2025) | |
| brensocatib | Brinsupri | sm | To treat non-cystic fibrosis bronchiectasis (NCFB) | cathepsin C | First drug with disease-modifying potential, approved to treat NCFB | US FDA (2025) EU EMA (2025) |
| donidalorsen | Dawnzera | nucleic acid | To treat hereditary angioedema (HAE) | First RNA-targeted treatment for HAE | US FDA (2025) EU EMA (2026) | |
| rilzabrutinib | Wayrilz | sm | To treat immune thrombocytopenic purpura (ITP) | Btk | US FDA (2025) EU EMA (2025) | |
| luvometinib | Lynozyfic | sm | To treat paediatric neurofibromatosis type 1 (NF1) | MEK1 | MEK2 | First approved in China, in May 2025 | China NMPA (2025) |
| senaparib | Paishuning | sm | To treat advanced epithelial ovarian, fallopian tube or primary peritoneal cancer | PARP1 | Firts approved in China, January 2025 | China NMPA (2025) |
| limertinib | Aoyixin | sm | To treat NSCLC with EGFR mutations | EGFR | First approved in China, January 2025 | China NMPA (2025) |
| imlunestrant | Inluriyo | sm | To treat progressing advanced/metastatic ER+ve/HER2-ve breast cancer with ER mutations | Estrogen receptor-α | US FDA (2025) UK MHRA (2026) EU EMA (2026) | |
| elamipretide | Forzinity | peptide | To improve muscle strength in patients with Barth syndrome weighing at least 30 kg | Accelerated approval | US FDA (2025) Accelerated approval | |
| paltusotine | Palsonify | sm | To treat acromegaly | SST2 receptor | US FDA (2025) | |
| famitinib | Abit | sm | To treat recurrent or metastatic cervical cancer in combination with camrelizumab | PDGFRβ | Kit | VEGFR-2 | First approved in China May 2025 | China NMPA (2025) |
| palonosetron + fosrolapitant | Ritanine | sm | To prevent chemotherapy-induced nausea and vomiting | NK1 receptor 5-HT3 receptors | Fixed-dose combination; first approval in China, May 2025 | palonosetron: EU EMA (2009) US FDA (2003) fosrolapitant: China NMPA (2025) |
| onradivir | Anruiwei | sm | To treat uncomplicated influenza A infection | First approval in China, May 2025 | ||
| remibrutinib | Rhapsido | sm | To treat chronic, anti-histamine-resistant spontaneous urticaria | Btk | US FDA (2025) China NMPA (2025) | |
| nerandomilast | Jascayd | sm | To treat idiopathic pulmonary fibrosis | PDE4B | US FDA (2025) China NMPA (2025) | |
| ifupinostat | Betlin | sm | Relapsed/refractory diffuse large B-cell lymphoma | TAS2R30 3.5.1.- Histone deacetylases (HDACs) | First approved by China NMPA in June 2025 | China NMPA (2025) |
| mazdutide | Xinermei | peptide | Obesity | GLP-1 receptor | glucagon receptor | First approved in China in June 2025 | China NMPA (2025) |
| lisaftoclax | No established brand name | sm | To treat chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL) | Bcl-2 | Approved in China in July 2025 | China NMPA (2025) |
| elinzanetant | Lynkuet | sm | To treat moderate to severe menopausal hot flushes and night sweats | NK1 receptor | NK3 receptor | First approval granted by the UK MHRA in July 2025 | UK MHRA (2025) US FDA (2025) EU EMA (2025) |
| doxecitine + doxribtimine | Kygevvi | sm | To treat thymidine kinase 2 (TK2) deficiency in patients who start to show symptoms when they are 12 years old or younger | Fixed-dose mixture of exogenous pyrimidine nucleosides that act to bypass dysfunctional mitochondrial TK2 and improve mitochondrial DNA synthesis | ||
| ziftomenib | Komzifti | sm | To treat relapsed/refractory AML with a susceptible nucleophosmin 1 (NPM1) mutation | US FDA (2025) | ||
| plozasiran | Redemplo | sm | To reduce triglycerides in adults with familial chylomicronemia syndrome | US FDA (2025) | ||
| sevabertinib | Hyrnuo | sm | To treat locally advanced/metastatic NSCLC with confirmed HER2 activating mutations | EGFR | HER2 | Accelerated approval | US FDA (2025) |
| trastuzumab rezetecan | Avida | ADC | To treat unresectable locally advanced or metastatic NSCLC with HER2 activating mutations | HER2 | China approval 27/05/2025; an anti-HER2 ADC with a topoisomerase inhibitor payload | |
| sibeprenlimab | Voyxact | mAb | To reduce proteinuria in patients with primary immunoglobulin A nephropathy | APRIL | FDA accelerated approval; first-in-class APRIL-selective drug | US FDA (2025) |
| lerodalcibep | Lerochol | peptide | To reduce low-density lipoprotein cholesterol in adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia, as an adjunct to diet and exercise | proprotein convertase subtilisin/kexin type 9 | US FDA (2025) | |
| zoliflodacin | Nuzolvence | sm | To treat uncomplicated urogenital gonorrhea due to Neisseria gonorrhoeae | DNA gyrase | US FDA (2025) | |
| etripamil | Cardamyst | sm | To treat episodes of paroxysmal supraventricular tachycardia | Voltage-gated calcium channels (CaV) | US FDA (2025) | |
| depemokimab | Exdensur | mAb | To treat severe eosinophilic asthma as an add-on maintenance therapy | IL-5 | UK MHRA (2025) US FDA (2025) | |
| aficamten | Myqorzo | sm | To treat symptomatic obstructive hypertrophic cardiomyopathy | Myosin binding proteins | US FDA (2025) China NMPA (2025) EU EMA (2026) | |
| narsoplimab | Yartemlea | mAb | To treat hematopoietic stem cell transplant-associated thrombotic microangiopathy | MBL associated serine protease 2 | MASP2 is an enzyme in the lectin pathway of the complement system. Disrupting MASP2 reduces complement-mediated microvascular damage and clotting. | US FDA (2025) |
| tradipitant | Nereus | sm | To treat vomiting associated with motion | NK1 receptor | US FDA (2025) | |
| tolebrutinib | Cenrifki | sm | To treat and slow dosability progression in non-relapsing secondary progressive multiple sclerosis (nrSPMS) | Btk | United Arab Emirates (UAE) approval 26/08/2025 | UAE (2025) |
| zeprumetostat | Airijing | sm | To treat relapsed/refractory peripheral T-cell lymphoma following ≥1 line of systemic therapy | EZH2 | China NMPA- conditional approval August 2025 | China NMPA (2025) Conditional approval |
| culmerciclib | Sai Tamsin | sm | To treat hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer | cyclin dependent kinase 4 | cyclin dependent kinase 6 | China approval 09/12/2025 | China NMPA (2025) |
| dirozalkib | Xuan Feining | sm | To treat ALK+ve, locally advanced, or metastatic NSCLC | ALK receptor tyrosine kinase | China approval 19/08/2025 | China NMPA (2025) |
| fovinaciclib | Futuoning | sm | To treat hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative recurrent or metastatic breast cancer | cyclin dependent kinase 4 | cyclin dependent kinase 6 | China approval 27/05/2025 | China NMPA (2025) |
| becotatug vedotin | Tsune Miyu | ADC | To treat recurrent or metastatic nasopharyngeal cancer | epidermal growth factor receptor | China approval 28/10/2025 | China NMPA (2025) |
| lerociclib | Ru Jianing | sm | To treat HR-positive, HER2-negative locally advanced or metastatic breast cancer | cyclin dependent kinase 4 | cyclin dependent kinase 6 | China approval 27/05/2025 | China NMPA (2025) |
| mifanertinib | Mairuidong | sm | To treat locally advanced /metastatic NSCLC with EGFR exon 21 (L858R) substitution mutations | epidermal growth factor receptor | EGFRL858R | China approval 21/10/2025 | China NMPA (2025) |
| pimicotinib | Betimai | sm | To treat symptomatic tenosynovial giant cell tumor (TGCT) | colony stimulating factor 1 receptor | China approval 16/12/2025 | China NMPA (2025) |
| sonrotoclax | Baiyueda | sm | To treat chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) | BCL2 apoptosis regulator | China approval 30/12/2025 | China NMPA (2025) |
| tibremciclib | Comina | sm | To treat HR-positive, HER2-negative locally advanced or metastatic breast cancer, in combination with fulvestrant | cyclin dependent kinase 4 | cyclin dependent kinase 6 | China approval 30/06/2025 | China NMPA (2025) |
| tunodafil | Taituotuo | sm | To treat male erectile dysfunction | phosphodiesterase 5A | China approval 22/07/2025 | China NMPA (2025) |
| zurletrectinib | Yinuoxin | sm | To treat advanced solid tumors harboring NTRK gene fusions | Type VII RTKs: Neurotrophin receptor/Trk family | China approval 09/12/2025 | China NMPA (2025) |
| jaktinib | Zepuping | sm | To treat disease-related splenomegaly in myelofibrosis | Janus kinase (JakA) family | China approval 27/05/2025 | China NMPA (2025) |
| glecirasib | Erica | sm | To treat KRASG12C advanced NSCLC | KRAS | China approval 20/05/2025 | China NMPA (2025) |
| mufemilast | Momishin | sm | To treat moderate to severe plaque psoriasis | PDE4 | China approval 30/09/2025 | China NMPA (2025) |
| prusogliptin | Shan Zeping | sm | To improve glycemic control in type 2 diabetes mellitus | dipeptidyl peptidase 4 | China approval 08/01/2025 | China NMPA (2025) |
| simenafil | Envida | sm | To treat male erectile dysfunction | phosphodiesterase 5A | China approval 08/07/2025 | China NMPA (2025) |
| sitokiren | Xintuoan | sm | To treat primary hypertension | renin | China approval 03/12/2025 | China NMPA (2025) |
| firsekibart | Jin Beixin | mAb | To treat acute gouty arthritis | IL-1β | China approval 30/06/2025 | China NMPA (2025) |
| picankibart | Pecondle | mAb | To treat moderate-to-severe plaque psoriasis | IL-23A | China approval 25/11/2025 | China NMPA (2025) |
| finotonlimab | An Youping | mAb | To treat recurrent and/or metastatic squamous cell carcinoma of the head and neck | programmed cell death 1 (CD279) | China approval 08/02/2025 | China NMPA (2025) |
| deutenzalutamide | Hainaan | sm | To treat metastatic castration-resistant prostate cancer (mCRPC) | Androgen receptor | China approval 27/05/2025 | China NMPA (2025) |
| anrikefon | Si Shu Jing | sm | To treat mild‑to‑moderate pain after abdominal surgery | κ receptor | China approval 13/05/2025 | China NMPA (2025) |
| bireociclib | Xuan Yuening | sm | To treat HR+ve, HER2-ve advanced or metastatic breast cancer | cyclin dependent kinase 3 | cyclin dependent kinase 6 | China approval 13/05/2025 | China NMPA (2025) |
| trastuzumab botidotin | Suterai | ADC | To treat unresectable or metastatic HER2-positive breast cancer | erb-b2 receptor tyrosine kinase 2 | China approval 14/10/2025; an anti-HER2 ADC with a tubulin inhibitor payload | |
| velaglucerase beta | Ge Ruining | peptide | Enzyme replacement therapy (recombinant human glucocerebrosidase) for type I and type III Gaucher disease | China approval 13/05/2025; | ||
| relmapirazin | Lumitrace | sm | Fluorescent imaging reagent for real-time measurement of glomerular filtration rate | China approval 14/10/2025 | ||
| siltartoxatug | Sintetol | mAb | To treat tetanus; binds to the AB fragment of the tetanus toxin to prevent disease onset | China approval 11/02/2025 | ||
| albipagrastim alfa | Melisan | peptide | To decrease the incidence febrile neutropenia associated with myelosuppressive anti-cancer therapy | China approval 27/05/2025; a long-acting granulocyte colony-stimulating factor (G-CSF) ligand | ||
| efsubaglutide alfa | Yinuoqing | peptide | To treat type 2 diabetes mellitus | GLP-1 receptor | China approval 24/01/2025; a peptide GLP-1 receptor agonist | |
| inpegsomatropin | Pegpesen | peptide | To treat treat to growth hormone deficiency | Growth hormone receptor | China approval 27/05/2025; long-acting recombinant human growth hormone | |
| visepegenatide | Paidakan | peptide | To treat type 2 diabetes mellitus | GLP-1 receptor | China approval 12/11/2025; GLP-1 receptor agonist | |
| pixavir marboxil | unknown | sm | To treat influenza infection | China approval 09/12/2025; inflenza virus cap-dependent endonuclease inhibitor | ||
| sebaloxavir marboxil | Jikeshu | sm | To treat influenza infection | China approval 15/07/2025; influenza virus cap-dependent endonuclease inhibitor | ||
| suraxavir marboxil | Isuda | sm | To treat influenza infection | China approval 25/03/2025; inhibits influenza virus polymerase acidic protein (PA) of RNA polymerase | ||
| encofosbuvir | Dongying | sm | To treat chronic HCV infection | China approval 25/03/2025; HCV NS5B polymerase inhibitor | ||
| netanasvir | Dongweizhuo | sm | To treat chronic HCV infection | China approval 08/02/2025; HCV NS5A non-structural protein inhibitor | ||
| recaticimab | Ai Xin'an | mAb | To treat hypercholesteremia and mixed dyslipidemia | proprotein convertase subtilisin/kexin type 9 | China approval 08/01/2025 | China NMPA (2025) |
| vornorexant | Vorzzz | sm | To treat insomnia | OX1 receptor | OX2 receptor | Japan PMDA approval August 2025 | Japan PMDA (2025) |
Drug Approvals in 2024
| INN | Trade Name | Type | Indication | Therapeutic Target | Comments | Approval Sources |
| berdazimer | Zelsuvmi | sm | To treat molluscum contagiosum (a viral skin infection) | berdazimer has a complex mechanism of action that involves both direct NO-mediated killing of the infecting virus and immunomodulatory effects that target the virus and promote healing. | ||
| tegileridine | Asut | sm | To treat postoperative pain | μ receptor | First approved in China, Jan 2024 | China NMPA (2024) |
| cefepime + enmetazobactam | Exblifep | sm | To treat complicated urinary tract infections | cefepime: UK MHRA (2017) US FDA (1996) enmetazobactam: EU EMA (2024) US FDA (2024) | ||
| letibotulinumtoxinA-wlbg | Letybo | pep | To temporarily improve the appearance of moderate-to-severe glabellar lines | Another botulinum toxin for cosmtic use. These agents relax (paralyse) muscles locally by disrupting acetylcholine-mediated motor nerve signaling. | ||
| tislelizumab | Tevimbra | mAb | To treat unresectable or metastatic esophageal squamous cell carcinoma | PD-1 | China NMPA (2024) China NMPA (2019) | |
| resmetirom | Rezdiffra | sm | To treat noncirrhotic non-alcoholic steatohepatitis with moderate to advanced liver scarring | EU EMA (2025) US FDA (2024) | ||
| aprocitentan | Tryvio | sm | To treat hypertension | ETA receptor | US FDA (2024) | |
| givinostat | Duvyzat | sm | To treat Duchenne muscular dystrophy in individuals aged 6 years and older | 3.5.1.- Histone deacetylases (HDACs) | EU EMA (2025) US FDA (2024) | |
| tunlametinib | Kolupin | sm | To treat RAS/RAF mutated melanoma | MEK1 | MEK2 | First approval in China March 2024 | China NMPA (2024) |
| sotatercept | Winrevair | fusion protein | To treat pulmonary arterial hypertension (PAH) | ActR2 | US FDA (2024) | |
| vadadustat | Vafseo | sm | To treat anemia due to chronic kidney disease | Prolyl hydroxylases | First approval in Japan 2020 | Japan PMDA (2020) EU EMA (2023) |
| danicopan | Voydeya | sm | To treat extravascular hemolysis with paroxysmal nocturnal hemoglobinuria | complement factor D | First approval in Japan Jan 2024 | Japan PMDA (2024) EU EMA (2024) US FDA (2024) |
| zolbetuximab | Vyloy | mAb | To treat HER2-ve, CLDN18.2+ve unresectable, advanced/recurrent gastric cancer | claudin 18 | First approval in Japan Mar 2024 | China NMPA (2024) Japan PMDA (2024) EU EMA (2024) US FDA (2024) |
| ceftobiprole | Zevtera | sm | To treat certain bloodstream infections, bacterial skin and associated tissue infections, and community-acquired bacterial pneumonia | UK MHRA (2013) | ||
| pegulicianine | Lumisight | sm | To use as an optical imaging agent for the detection of cancerous tissue | Fluoresces when cleaved by MMPs and cathepsins in/around tumours. Not curated as it is not intended to elicit a pharmacodynamic response. | ||
| nogapendekin alfa inbakicept-pmln | Anktiva | pep | To treat bladder cancer | Interleukin-15 receptor | recombinant IL-15 superagonist complex | |
| tovorafenib | Ojemda | sm | To treat relapsed or refractory pediatric low-grade glioma | RAF family | US FDA (2024) | |
| mavorixafor | Xolremdi | sm | To treat WHIM syndrome | CXCR4 | US FDA (2024) | |
| tarlatamab | Imdelltra | mAb | To treat extensive stage small cell lung cancer | CD3e delta like canonical Notch ligand 3 | US FDA (2024) | |
| ivonescimab | Idafang | mAb | To treat advanced EGFR-mutated NSCLC | PD-1 VEGFA | First approved in China 2024 | China NMPA (2024) |
| imetelstat | Rytelo | nucleotide | To treat low- to intermediate-risk myelodysplastic syndromes | inhibits TERT function | EU EMA (2025) US FDA (2024) | |
| elafibranor | Iqirvo | sm | To treat primary biliary cholangitis in combination with ursodeoxycholic acid | Peroxisome proliferator-activated receptor-α | Peroxisome proliferator-activated receptor-β/δ | EU EMA (2024) US FDA (2024) | |
| sofpironium | Sofdra | sm | To treat primary axillary hyperhidrosis. | Acetylcholine receptors (muscarinic) | First approved in Japan Sep 2020 | Japan PMDA (2020) |
| crovalimab | Piasky | mAb | To treat paroxysmal nocturnal hemoglobinuria | complement C5 | China NMPA (2024) EU EMA (2024) US FDA (2024) | |
| ensifentrine | Ohtuvayre | sm | To treat COPD | PDE3A | PDE4A | US FDA (2024) | |
| zastaprazan | JAQBO | sm | To treat GERD | ATP4B | First approved in South Korea Apr 2024 | South Korea MFDS (2024) |
| enlonstobart | Enshuxing | mAb | To treat recurrent/metastatic PD-L1-positive cervical cancer | PD-1 | First approval in China Jun 2024 | China NMPA (2024) |
| golidocitinib | GaoRuizhe | sm | To treat r/r PTCL | JAK1 | First approval in China Jun 2024 | China NMPA (2024) |
| donanemab | Kisunla | mAb | To treat early symptomatic Alzheimer's disease | amyloid β | EU EMA (2025) China NMPA (2024) US FDA (2024) | |
| deuruxolitinib | Leqselvi | sm | To treat severe alopecia areata | JAK1 | JAK2 | US FDA (2024) | |
| benzgalantamine | Zunveyl | sm | To treat mild-to-moderate Alzheimer's disease | AChE | galantamine prodrug | US FDA (2024) |
| vorasidenib | Voranigo | sm | To treat IDH1/2 mutation positive astrocytoma or oligodendroglioma | isocitrate dehydrogenase (NADP(+)) 1 | isocitrate dehydrogenase (NADP(+)) 2 | EU EMA (2025) US FDA (2024) | |
| palopegteriparatide | Yorvipath | pep | To treat hypoparathyroidism | Parathyroid hormone receptors | EU EMA (2023) US FDA (2024) | |
| nemolizumab | Nemluvio | mAb | To treat prurigo nodularis | Interleukin-31 receptor, α subunit | First approval in Japan (March 2022) to treat atopic dermatitis | Japan PMDA (2022) EU EMA (2025) US FDA (2024) |
| seladelpar | Livdelzi | sm | To treat primary biliary cholangitis | Peroxisome proliferator-activated receptor-β/δ | US FDA (2024) | |
| axatilimab | Niktimvo | mAb | To treat chronic graft-versus-host disease | US FDA (2024) | ||
| vunakizumab | AnDajing | mAb | To treat moderate-to-severe plaque psoriasis | IL-17A | First approval in China Aug 2024 | China NMPA (2024) |
| lazertinib | Lazcluze | sm | To treat non-small cell lung cancer (EGFR mutation positive advanced NSCLC) | EGFR | First approval in S Korea 2021 | South Korea MFDS (2021) EU EMA (2025) US FDA (2025) |
| xeligekimab | Jinlixi | mAb | To treat plaque psoriasis | IL-17A | First approval in China Aug 2024 | China NMPA (2024) |
| fulzerasib | Dupert | sm | To treat KRAS G12C adv NSCLC | KRAS | First approval in China 2024 | China NMPA (2024) |
| lebrikizumab | Ebglyss | mAb | To treat moderate-to-severe atopic dermatitis | IL-13 | EU EMA (2023) | |
| arimoclomol | Miplyffa | sm | To treat Niemann-Pick disease type C | US FDA (2024) | ||
| levacetylleucine | Aqneursa | sm | To treat Niemann-Pick disease type C | N-Acetyl-L-Leucine (IB1001) is a prodrug for the delivery of l-leucine; approved since 1957 in France as a treatment for acute vertigo (Tanganil) | ||
| xanomeline + trospium | Cobenfy | sm | To treat schizophrenia | M1 receptor | M4 receptor | xanomeline: US FDA (2024) trospium: US FDA (2004) | |
| flurpiridaz F 18 | Flyrcado | sm | PET tracer for detection of coronary artery disease | |||
| inavolisib | Itovebi | sm | To treat locally advanced or metastatic breast cancer | PI3Kα | EU EMA (2025) China NMPA (2025) US FDA (2024) | |
| marstacimab | Hympavzi | mAb | To prevent or reduce bleeding episodes related to hemophilia A or B | tissue factor pathway inhibitor | China NMPA (2025) EU EMA (2024) US FDA (2024) | |
| foscarbidopa + foslevodopa | Vyalev | sm | To treat advanced Parkinson's disease motor fluctuations | carbidopa and levodopa prodrugs | foslevodopa: EU EMA (2022) | |
| sulopenem + probenecid | Orlynvah | sm | To treat uncomplicated UTIs | sulopenem: US FDA (2024) probenecid: US FDA (1951) | ||
| revumenib | Revuforj | sm | To treat acute r/r leukemia with KMT2A translocation | US FDA (2024) | ||
| zanidatamab | Ziihera | mAb | To treat unresectable or metastatic HER2-positive (IHC 3+) biliary tract cancer | HER2 | EMA OD gastric cancer 2020; FDA accelerated approval | EU EMA (2025) China NMPA (2025) US FDA (2024) |
| acoramidis | Attruby | sm | To treat cardiomyopathy of wild-type or variant transthyretin-mediated amyloidosis | TTR | TTR stabiliser | EU EMA (2025) US FDA (2024) |
| landiolol | Rapiblyk | sm | To treat supraventricular tachycardia | β1-adrenoceptor | Approved by individual EU countries, not EU-wide | Japan PMDA (2024) and some European countries US FDA (2024) |
| iomeprol | Iomervu | sm | For use as a radiographic contrast agent | Has been approved in the UK since early 1990s | ||
| zenocutuzumab | Bizengri | mAb | To treat advanced/metaststic pancreatic adenocarcinoma & NSCLC with NRG1 fusions | HER3 | HER2 | FDA accelerated approval | US FDA (2024) |
| cosibelimab | Unloxcyt | mAb | To treat cutaneous squamous cell carcinoma | programmed cell death 1 ligand 1 | US FDA (2024) | |
| crinecerfont | Crenessity | sm | To treat classic congenital adrenal hyperplasia | CRF1 receptor | US FDA (2024) | |
| ensartinib | Ensacove | sm | To treat non-small cell lung cancer | ALK | US FDA (2024) | |
| olezarsen | Tryngolza | nucleotide | To treat familial chylomicronemia syndrome | EMA OD familial chylomicronemia syndrome granted Aug 2024 | EU EMA (2025) US FDA (2024) | |
| vanzacaftor + tezacaftor + deutivacaftor | Alyftrek | sm | To treat cystic fibrosis | CFTR | vanzacaftor: UK MHRA (2025) EU EMA (2025) US FDA (2024) tezacaftor: EU EMA (2018) US FDA (2018) deutivacaftor: UK MHRA (2025) EU EMA (2025) US FDA (2024) | |
| concizumab | Alhemo | mAb | For routine prophylaxis to prevent bleeding episodes in hemophilia A and B | tissue factor pathway inhibitor | EMA CHMP positive opinion Oct 2024 | Canada HC (2023) EU EMA (2024) US FDA (2024) |
| ainuovirine | No trade name for the monotherapy | sm | To treat HIV type 1 infection | First approval in China Sep 2024. It was the domestically developed oral anti-HIV drug to receive approval in China. | China NMPA (2024) | |
| benmelstobart | Andervi | mAb | To treat extensive-stage small cell lung cancer | programmed cell death 1 ligand 1 | First approval in China May 2024 | China NMPA (2024) |
| cofrogliptin | Beichangping (China) | sm | To manage T2DM | dipeptidyl peptidase 4 | First approval in China Jun 2024 | China NMPA (2024) |
| crisugabalin | Simei Ning (China) | sm | To treat diabetic peripheral neuropathic pain, and postherpetic neuralgia | First approval in China May 2024 | China NMPA (2024) | |
| ebronucimab | Yixining | mAb | To treat primary hypercholesterolaemia and mixed hyperlipidaemia | proprotein convertase subtilisin/kexin type 9 | First approval in China Sep 2024 | China NMPA (2024) |
| entinostat | Zhuda | sm | To treat recurrent metastatic non-small cell lung cancer | histone deacetylase 2 | histone deacetylase 3 | histone deacetylase 8 | histone deacetylase 1 3.5.1.- Histone deacetylases (HDACs) | 3.5.1.- Histone deacetylases (HDACs) | 3.5.1.- Histone deacetylases (HDACs) | 3.5.1.- Histone deacetylases (HDACs) | First approval in China 2024 | China NMPA (2024) |
| envonalkib | Anrakuharu | sm | To treat ALK-positive non-small cell lung cancer | ALK | First approval in China 2024 | China NMPA (2024) |
| evocalcet | Orkedia | sm | To treat hyperparathyroidism secondary to chronic kidney disease | CaS receptor | First approval in China 2024 | China NMPA (2024) |
| garsorasib | AnFangning | sm | To treat KRAS G12C mutation positive NSCLC | KRAS | First approval in China Nov 2024 | China NMPA (2024) |
| iparomlimab + tuvonralimab | Zimbab | mAb | To treat recurrent or metastatic cervical cancer | CTLA-4 | PD-1 | First approval in China Oct 2024 | iparomlimab: China NMPA (2024) tuvonralimab: China NMPA (2024) |
| linaprazan | No widely used brand name | sm | To treat gastroesophageal reflux disease | ATP4B | First approval in China Dec 2024 | China NMPA (2024) |
| mirogabalin | Tarlige | sm | To treat diabetic peripheral neuropathy | First approval in China 2024 | China NMPA (2024) | |
| ongericimab | Junshida | mAb | To treat primary hypercholesterolemia (non-familial) and mixed dyslipidemia | proprotein convertase subtilisin/kexin type 9 | First approval in China 2024 | China NMPA (2024) |
| SH-1028 | Saint Rasa | sm | To treat EGFRT790M mutated NSCLC | EGFR | First approval in China Jun 2024 | China NMPA (2024) |
| rezivertinib | Rapida | sm | To treat EGFR T790M-positive NSCLC | EGFR | First approval in China 2024 | China NMPA (2024) |
| sacituzumab tirumotecan | Jiataile | ADC | To treat advanced triple-negative breast cancer | tumor associated calcium signal transducer 2 | First approval in China Nov 2024 | China NMPA (2024) |
| serplulimab | Hetronifly | mAb | To treat extensive-stage small-cell lung cancer (ES-SCLC) | PD-1 | First approval in China Dec 2024 | China NMPA (2024) EU EMA (2025) |
| stapokibart | Kangyueda | mAb | To treat moderate-to-severe atopic dermatitis | Interleukin-4 receptor subunit α | First approval in China Sep 2024 | China NMPA (2024) |
| sugemalimab | Cejemly | mAb | First line treatment for metastatic NSCLC without sensitising EGFR mutations, or ALK, ROS1 or RET genomic tumour aberrations | programmed cell death 1 ligand 1 | First approval in EU Jul 2024 | China NMPA (2021) |
| tagitanlimab | Cotelet | mAb | To treat recurrent/metastatic nasopharyngeal cancer | programmed cell death 1 ligand 1 | First approval in China Dec 2024 | China NMPA (2024) |
| taletrectinib | Dubbo | sm | To treat ROS1 fusion-positive non-small cell lung cancer (NSCLC) | Type XVII RTKs: ROS receptors | Type VII RTKs: Neurotrophin receptor/Trk family | First approval in China 2024 | China NMPA (2024) US FDA (2025) |
| tasurgratinib | Tasfygo | sm | To treat FGFR2 fusion-positive, unresectable biliary tract cancer | Type V RTKs: FGF (fibroblast growth factor) receptor family | First approval in Japan Sep 2024 | Japan PMDA (2024) |
| unecritinib | Ambani | sm | To treat ROS1 fusion-positive NSCLC | ALK | First approval in China Apr 2024 | China NMPA (2024) |
| zorifertinib | Zerini | sm | To treat NSCLC with EGFR exon 19 deletions or exon 21 EGFRL858R mutation | EGFR | First approval in China Nov 2024 | China NMPA (2024) |
| seniprutug | Tribuvia | mAb | To treat axial spondyloarthritis (ankylosing spondylitis) | First approved in Russia 2024 | Russia Minzdrav (2024) | |
| janagliflozin | Huiyoujing | sm | To treat type 2 diabetes mellitus (T2DM) in adults | SGLT2 | Approved by China NMPA in Jan 2024 | China NMPA (2024) |
| fotagliptin | Xinliting | sm | To treat T2DM, as an add-on therapy to metformin | dipeptidyl peptidase 4 | Approved by China NMPA in June 2024 | China NMPA (2024) |
| cetagliptin | No widely used brand name | sm | To treat type 2 diabetes mellitus (T2DM) | dipeptidyl peptidase 4 | Approved by China MNPA in 2024 | China NMPA (2024) |
| bevifibatide | Betagrin | peptide | Anti-thrombotic agent for use during percutaneous coronary intervention | integrin αIIbβ3 | integrin αVβ3 | Approved by the China NMPA in 2024 | China NMPA (2024) |
| ivarmacitinib | No established brand name | sm | To treat rheumatoid arthritis, atopic dermatitis and active ankylosing spondylitis | JAK1 | First approved by China NMPA in September 2024 | China NMPA (2024) |
Drug Approvals in 2023
| INN | Trade Name | Type | Indication | Therapeutic Target | Comments | Approval Sources |
| lecanemab | Leqembi | mAb | To treat Alzheimer’s disease | amyloid β | China NMPA (2024) EU EMA (2025) US FDA (2023) | |
| bexagliflozin | Brenzavvy | sm | To improve glycemic control in adults with type 2 diabetes mellitus as an adjunct to diet and exercise | SGLT2 | US FDA (2023) | |
| pirtobrutinib | Jaypirca | sm | To treat mantle cell lymphoma | Btk | EMA OD MCL June 2021 | China NMPA (2024) EU EMA (2023) US FDA (2023) |
| elacestrant | Orserdu | sm | To treat advanced/metastatic ER-positive, HER2-negative, ESR1 mutated breast cancer | Estrogen receptor-α | SERM/SERD hybrid (SSH) | EU EMA (2023) US FDA (2023) |
| daprodustat | Jesduvroq | sm | To treat anemia caused by chronic kidney disease for adults on dialysis for at least four months | Prolyl hydroxylases | Approved in Japan in 2020, EMA application withdrawn July 2023 | Japan PMDA (2020) US FDA (2023) |
| keverprazan | Beiwen/Keprason (China) | sm | To treat reflux oesophagitis and duodenal ulcer | ATP4B | 15/02/2023- China approval | China NMPA (2023) |
| velmanase alfa-tycv | Lamzede | pep | To treat non-central nervous system manifestations of alpha-mannosidosis | enzyme replacement therapy for alpha-mannosidase (MAN2B1) deficiency | ||
| sparsentan | Filspari | sm | To reduce proteinuria in adults with primary immunoglobulin A nephropathy at risk of rapid disease progression | AT1 receptor | ETA receptor | EMA OD primary IgA nephropathy Jan 2022 | US FDA (2023) |
| efanesoctocog alfa | Altuviiio | Fc fusion peptide | Routine prophylaxis and on-demand treatment to control bleeding episodes, as well as perioperative management (surgery) for adults and children with hemophilia A | factor VIII replacement therapy | US FDA (2023) | |
| omaveloxolone | Skyclarys | sm | To treat Friedreich’s ataxia in adults and adolescents aged 16 years and older | NRF2 | EMA OD June 2018, to treat Friedreich’s ataxia | US FDA (2023) |
| zavegepant | Zavzpret | sm | To treat migraine with or without aura in adults | CGRP receptor | US FDA (2023) | |
| trofinetide | Daybue | pep | To treat Rett syndrome | analogue of endogenous glycine-proline-glutamate tripeptide (GPE) | US FDA (2023) | |
| adebrelimab | Arelili, Ariely | mAb | To treat advanced small cell lung cancer | programmed cell death 1 ligand 1 | First approval in China in March 2023 | China NMPA (2023) |
| retifanlimab | Zynyz | mAb | To treat metastatic or recurrent locally advanced Merkel cell carcinoma | PD-1 | FDA & EMA ODs in 2020/21/23 anal cancer, Merkel cell carcinoma | US FDA (2023) |
| rezafungin | Rezzayo | sm | To treat candidemia and invasive candidiasis | antifungal; EMA OD invasive candidiasis June 2022 | ||
| leniolisib | Joenja | sm | To treat activated phosphoinositide 3-kinase delta syndrome (APDS) | PI3Kδ | EMA OD APDS Oct 2020 | US FDA (2023) |
| tofersen | Qalsody | nucleic acid | To treat amyotrophic lateral sclerosis in adults who have a SOD1 gene mutation | EMA OD for SOD1 ALS Aug 2016 | China NMPA (2024) EU EMA (2024) US FDA (2023) | |
| divozilimab | Ivlizi | mAb | To treat relapsing multiple sclerosis | CD20 (membrane-spanning 4-domains, subfamily A, member 1) | First approved in Russia April 2023 | Russia MinzDRAV (2023) |
| pegunigalsidase alfa-iwxj | Elfabrio | pep | To treat confirmed Fabry disease | Enzyme replacement therapy; EMA OD Fabry disease Dec 2017 (withdrawn when fully approved) | ||
| fezolinetant | Veozah | sm | To treat moderate to severe hot flashes caused by menopause | NK3 receptor | UK MHRA (2023) US FDA (2023) | |
| perfluorhexyloctane | Miebo | inert sm | To treat signs and symptoms of dry eye disease | Synonym NOV03 | ||
| epcoritamab | Epkinly/Tepkinly | mAb | To treat R/R DLBCL and HGBL | CD20 (membrane-spanning 4-domains, subfamily A, member 1) | CD3e | EMA OD DLBCL & FL 2022 | EU EMA (2023) US FDA (2023) |
| sulbactam + durlobactam | Xacduro | sm | To treat hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia caused by susceptible isolates of Acinetobacter baumannii-calcoaceticus complex | sulbactam: US FDA (1986) durlobactam: US FDA (2023) | ||
| nirmatrelvir + ritonavir | Paxlovid | sm | To treat mild-to-moderate COVID-19 in adults at high risk for progression to severe COVID-19 | CoV 3C-like (main) protease | MHRA approval 2021 | nirmatrelvir: UK MHRA (2021) EU EMA (2022) US FDA (2023) ritonavir: US FDA (1996) EU EMA (1996) |
| flotufolastat F 18 | Posluma | sm | To use with positron emission tomography imaging in certain patients with prostate cancer | Folate hydrolase (prostate-specific membrane antigen) 1 | ||
| sotagliflozin | Inpefa | sm | To treat heart failure | SGLT1 | SGLT2 | EU EMA (2019) US FDA (2023) | |
| sovateltide | Tycamzzi | pep | To treat acute cerebral ischemic stroke | ETB receptor | India approval 05/2023 | India CDSCO (2023) |
| befotertinib | Surmana | sm | To treat adv/met NSCLC with mutated EGFR | EGFR | China approval 05/2023 | China NMPA (2023) |
| glofitamab | Columvi | mAb | To treat DLBCL or LBCL | CD20 (membrane-spanning 4-domains, subfamily A, member 1) | CD3e | first approved in Canada in March 2023 | US FDA (2023) EU EMA (2023) |
| ritlecitinib | Litfulo | sm | To treat severely patchy hair loss (alopecia areata) | JAK3 | TEC | UK MHRA (2023) EU EMA (2023) US FDA (2023) | |
| rozanolixizumab | Rystiggo | mAb | To treat antibody positive generalized myasthenia gravis | EMA OD myasthenia gravis, 22/04/2020 | US FDA (2023) | |
| somatrogon | Ngenla | pep | To treat growth failure due to inadequate secretion of endogenous growth hormone | Growth hormone receptor | EU EMA (2022) US FDA (2023) | |
| iruplinalkib | Qixinke | sm | To treat advanced ALK+ve NSCLC | ALK | ROS | Approved in China June 2023 | China NMPA (2023) |
| nirsevimab-alip | Beyfortus | mAb | To prevent respiratory syncytial virus (RSV) lower respiratory tract disease in infants | |||
| concizumab | Alhemo | mAb | To treat hemophilia B | tissue factor pathway inhibitor | first approval Canada March 2023 | Canada HC (2023) EU EMA (2024) US FDA (2024) |
| quizartinib | Vanflyta | sm | To use as part of a treatment regimen for newly diagnosed acute myeloid leukemia that meets certain criteria (ie FLT3-ITD +ve) | PDGFRα | PDGFRβ | Kit | CSFR | FLT3 | first approval in Japan June 2019 | Japan PMDA (2019) US FDA (2023) |
| cantharidin | Ycanth | sm | To treat molluscum contagiosum | protein phosphatase 2 catalytic subunit alpha | US FDA (2023) | |
| lotilaner | Xdemvy | sm | To treat Demodex blepharitis | previously used in vet med for flea/tick infestations in cats & dogs (EMA approval 2017) | ||
| avacincaptad pegol | Izervay | nucleic acid | To treat geographic atrophy (secondary to AMD) | complement C5 | US FDA (2023) | |
| zuranolone | Zurzuvae | sm | To treat postpartum depression | GABAA receptors | US FDA (2023) | |
| talquetamab | Talvey | mAb | To treat adults with relapsed or refractory multiple myeloma who have received at least four prior therapies | GPRC5D | CD3e | EMA OD for MM 20/08/2021 | EU EMA (2023) US FDA (2023) |
| elranatamab | Elrexfio | mAb | To treat adults with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy | BCMA | CD3e | EMA OD for MM 19/07/2021 | US FDA (2023) |
| palovarotene | Sohonos | sm | To reduce the volume of new heterotopic ossification in adults and pediatric patients (aged 8 years and older for females and 10 years and older for males) with fibrodysplasia ossificans progressiva | RAR-related orphan receptor-γ | EMA & FDA OD for heterotopic ossification in FOP; Canada approval in 2022 | Canada HC (2022) US FDA (2023) |
| pozelimab | Veopoz | mAb | To treat patients 1 year old and older with CD55-deficient protein-losing enteropathy (PLE), also known as CHAPLE disease | complement C5 | US FDA (2023) | |
| sunvozertinib | Zegfrovy | sm | To treat EGFR exon20ins metastatic NSCLC | EGFR | First approved in China in Aug 2023 | US FDA (2025) China NMPA (2023) |
| tafolecimab | Sintbilo | mAb | To treat primary hyperlipidemia | proprotein convertase subtilisin/kexin type 9 | First approved in China in Aug 2023 | China NMPA (2023) |
| motixafortide | Aphexda | pep | To use with filgrastim (G-CSF) to mobilize hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in patients with multiple myeloma | CXCR4 | EMA OD pancreatic cancer 2020 | US FDA (2023) |
| momelotinib | Ojjaara | sm | To treat intermediate or high-risk myelofibrosis in adults with anemia | ALK2 | JAK1 | JAK2 | EMA OD primary myelofibrosis & post-polycythaemia vera myelofibrosis Aug 2022 | US FDA (2023) |
| gepirone | Exxua | sm | To treat major depressive disorder | 5-HT1A receptor | US FDA (2023) | |
| cipaglucosidase alfa-atga | Pombiliti | pep | To treat late-onset Pompe disease | alpha glucosidase | ERT used in combination with miglustat; replaces acid alpha-glucosidase (GAA) | |
| nedosiran | Rivfloza | nucleic acid | To lower urinary oxalate levels in patients 9 years and older with primary hyperoxaluria type 1 and relatively preserved kidney function | siRNA vs lactate dehydrogenase A mRNA | US FDA (2023) | |
| narlumosbart | Jinlitai | mAb | To treat giant cell tumor of bone | RANK | First approval in China in Sept 2023 | China NMPA (2023) |
| etrasimod | Velsipity | sm | To treat moderately to severely active ulcerative colitis in adults | S1P1 receptor | US FDA (2023) | |
| zilucoplan | Zilbrysq | pep | To treat generalized myasthenia gravis in adults who are anti-acetylcholine receptor (AChR) antibody positive | complement C5 | EMA OD for gMG 18/07/2022; earliest approval in Japan in Sept 2023 | EU EMA (2023) US FDA (2023) |
| bimekizumab | Bimzelx | mAb | To treat moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy | IL-17A | IL-17F | China NMPA (2024) EU EMA (2021) US FDA (2023) | |
| vamorolone | Agamree | sm | To treat Duchenne muscular dystrophy | EMA OD for DMD (4/09/2022) and negative opinion in Oct 2023 | China NMPA (2024) EU EMA (2023) US FDA (2023) | |
| mirikizumab | Omvoh | mAb | To treat ulcerative colitis | IL-23A | Japan PMDA (2023) US FDA (2023) EU EMA (2023) | |
| toripalimab | Loqtorzi | mAb | To treat advanced nasopharyngeal carcinoma | PD-1 | China NMPA (2024) US FDA (2023) | |
| fruquintinib | Fruzaqla | sm | To treat metastatic colorectal cancer. | Type IV RTKs: VEGF (vascular endothelial growth factor) receptor family | Approved in China 2018 | China NMPA (2018) US FDA (2023) |
| apadamtase alfa (recombinant ADAMTS13) | Adzynma | pep | To treat congenital thrombotic thrombocytopenic purpura | ADAMTS13 | EMA OD cTTP 2008 | |
| repotrectinib | Augtyro | sm | To treat locally advanced or metastatic ROS1-positive non-small cell lung cancer | TrkA | ALK | ROS | China NMPA (2024) EU EMA (2025) US FDA (2023) | |
| taurolidine + heparin | Defencath | mixture | To reduce the incidence of catheter-related bloodstream infections in adults with kidney failure receiving chronic hemodialysis through a central venous catheter | taurolidine: US FDA (2023) heparin: US FDA (1939) | ||
| capivasertib | Truqap | sm | To treat HR+ve, HER2-ve adv breast cancer with AKT pathway activating mutations | Akt (Protein kinase B, PKB) family | China NMPA (2025) UK MHRA (2024) EU EMA (2024) US FDA (2023) | |
| efbemalenograstim alfa-vuxw | Ryzneuta | Fc fusion peptide | To treat neutropenia | Granulocyte colony-stimulating factor receptor | long-acting hG-CSF fused to IgG2-Fc | |
| lebrikizumab | Ebglyss | mAb | To treat atopic dermatitis | IL-13 | EU EMA (2023) | |
| nirogacestat | Ogsiveo | sm | To treat progressing desmoid tumours | EU EMA (2025) US FDA (2023) | ||
| iptacopan | Fabhalta | sm | To treat paroxysmal nocturnal hemoglobinuria | complement factor B | China NMPA (2024) EU EMA (2024) US FDA (2023) | |
| birch triterpenes (birch bark extract) | Filsuvez | np | To treat wounds associated with dystrophic and junctional epidermolysis bullosa | EMA OD 23/02/2011 EB | ||
| eplontersen | Wainua | nucleic acid | To treat polyneuropathy of hereditary transthyretin-mediated amyloidosis | TTR | UK MHRA (2024) EU EMA (2025) US FDA (2023) | |
| dimdazenil | Junoenil | sm | To treat insomnia | GABAA receptor α1 subunit | GABAA receptor β2 subunit | GABAA receptor γ2 subunit | First approved in China, Nov 2023 | |
| aponermin | Shaite (China) | pep | To treat relapsed or refractory multiple myeloma | DR4 | DR5 | First approved in China, Nov 2023; Functions as a TRAIL mimetic that interacts with DR4/5 | China NMPA (2023) |
Drug Approvals in 2022
| INN | Trade Name | Type | Indication | Therapeutic Target | Comments | Approval Sources |
| daridorexant | Quviviq | sm | To treat insomnia | Orexin receptors | EU EMA (2022) US FDA (2022) | |
| abrocitinib | Cibinqo | sm | To treat refractory, moderate-to-severe atopic dermatitis | JAK1 | China NMPA (2024) UK MHRA (2021) Japan PMDA (2021) US FDA (2022) EU EMA (2021) | |
| tebentafusp | Kimmtrak | pep | To treat unresectable or metastatic uveal melanoma | CD3e | gp100-CD3 fusion protein (ImmTAC) | EU EMA (2022) US FDA (2022) |
| faricimab | Vabysmo | mAb | To treat wet AMD and diabetic macular edema (DME) | VEGFA | China NMPA (2024) EU EMA (2022) US FDA (2022) | |
| nirmatrelvir | Paxlovid (nirmatrelvir + ritonavir) | sm | To treat COVID-19 | CoV 3C-like (main) protease angiopoietin-2 | nirmatrelvir is the NME | UK MHRA (2021) EU EMA (2022) US FDA (2023) |
| palovarotene | Sohonos | sm | To reduce heterotopic ossification in fibrodysplasia ossificans progressiva | RAR-related orphan receptor-γ | Canada HC (2022) US FDA (2023) | |
| sutimlimab | Enjaymo | mAb | To decrease the need for red blood cell transfusion due to hemolysis in cold agglutinin disease | complement C1s | EMA ODs: autoimmune haemolytic anaemia (2016), ITP (2020) | EU EMA (2022) US FDA (2022) |
| somatrogon | Ngenla | pep | To treat growth hormone deficiency | Growth hormone receptor | EU EMA (2022) US FDA (2023) | |
| mitapivat | Pyrukynd | sm | To treat hemolytic anemia caused by PK deficiency | pyruvate kinase M1/2 | pyruvate kinase L/R | EMA OD 2020, for treatment of PK deficiency | EU EMA (2022) US FDA (2022) |
| pacritinib | Vonjo | sm | To treat intermediate or high-risk primary or secondary myelofibrosis in adults with low platelets | JAK2 | EMA OD since 2010 primary & secondary myelofibrosis | US FDA (2022) |
| ganaxolone | Ztalmy | sm | To treat seizures in cyclin-dependent kinase-like 5 deficiency disorder | GABAA receptors | EMA OD 2019 for treatment of CDKL5 deficiency disorder | China NMPA (2024) EU EMA (2023) US FDA (2022) |
| relatlimab | Opdualag | mAb | To treat unresectable or metastatic melanoma | LAG3 (CD223) | EU EMA (2022) US FDA (2022) | |
| lutetium (177Lu) vipivotide tetraxetan | Pluvicto | sm | To treat prostate-specific membrane antigen-positive metastatic castration-resistant prostate cancer following other therapies | Folate hydrolase (prostate-specific membrane antigen) 1 | radioligand- DOTA-conjugated PSMA inhibitor | |
| cilgavimab | Evusheld (tixagevimab + cilgavimab) | mAb fixed-dose combination | Pre-exposure prophylaxis of COVID-19 | CoV Spike glycoprotein | EU EMA (2022) | |
| tixagevimab | Evusheld (tixagevimab + cilgavimab) | mAb fixed-dose combination | Pre-exposure prophylaxis of COVID-19 | CoV Spike glycoprotein | EU EMA (2022) | |
| oteseconazole | Vivjoa | sm | To reduce the incidence of recurrent vulvovaginal candidiasis (RVVC) in females with a history of RVVC who are not of reproductive potential | |||
| mavacamten | Camzyos | sm | To treat class II-III obstructive hypertrophic cardiomyopathy | China NMPA (2024) EU EMA (2023) US FDA (2022) | ||
| vonoprazan + amoxicillin + clarithromycin | Voquezna | sm | To treat Helicobacter pylori infection | vonoprazan is the NME | vonoprazan: Japan PMDA (2014) US FDA (2022) amoxicillin: US FDA (1974) clarithromycin: US FDA (1991) | |
| tirzepatide | Mounjaro | pep | To improve blood sugar control in diabetes, in addition to diet and exercise | GIP receptor | GLP-1 receptor | China NMPA (2024) EU EMA (2022) US FDA (2022) | |
| tapinarof | Vtama | sm | To treat plaque psoriasis | Aryl hydrocarbon receptor | China NMPA (2024) US FDA (2022) | |
| vutrisiran | Amvuttra | nucleic acid | To treat polyneuropathy of hereditary transthyretin-mediated amyloidosis | TTR | UK MHRA (2022) EU EMA (2022) US FDA (2022) | |
| linzagolix | Yselty | sm | To treat uterine fibroids | GnRH1 receptor | EU EMA (2022) | |
| olipudase alfa | Xenpozyme | pep | To treat acid sphingomyelinase deficiency | enzyme replacement therapy | ||
| spesolimab | Spevigo | mAb | To treat generalized pustular psoriasis flares | Interleukin-1 receptor-like 2 | China NMPA (2024) EU EMA (2022) US FDA (2022) | |
| daxibotulinumtoixnA-lanm | Daxxify | pep | To treat moderate-to-severe glabellar lines associated with corrugator and/or procerus muscle activity | reduces acetylcholine release at cholinergic nerve terminals | ||
| deucravacitinib | Sotyktu | sm | To treat moderate-to-severe plaque psoriasis | Tyk2 | EU EMA (2023) US FDA (2022) | |
| eflapegrastim | Rolvedon | fusion protein | To decrease the incidence of infection in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with clinically significant incidence of febrile neutropenia | GM-CSF receptor, α subunit | Granulocyte colony-stimulating factor receptor | recombinant G-CSF | US FDA (2022) |
| terlipressin | Terlivaz | pep | To improve kidney function in adults with hepatorenal syndrome with rapid reduction in kidney function | vasopressin analogue; active form is lysine vasopressin (LVP) | UK MHRA (2001) US FDA (2022) | |
| gadopiclenol | Elucirem | sm | To detect and visualize lesions, together with MRI, with abnormal vascularity in the central nervous system and the body; macrocyclic gadolinium-based contrast agent | Vasopressin and oxytocin receptors | MRI contrast agent | |
| omidenepag | Omlonti | sm | To reduce elevated intraocular pressure in patients with open‑angle glaucoma or ocular hypertension | EP2 receptor | US FDA (2022) | |
| sodium phenylbutyrate + tauroursodeoxycholic acid | Relyvrio | sm | To treat amyotrophic lateral sclerosis (ALS)- discontinued in US and Canada in spring 2024 | mixture of components | tauroursodeoxycholic acid: US FDA (2022) | |
| futibatinib | Lytgobi | sm | To treat unresectable, locally advanced/metastatic intrahepatic cholangiocarcinoma (iCCA; with confirmed FGFR2 gene fusions or other rearrangements | Type V RTKs: FGF (fibroblast growth factor) receptor family | EMA OD 2019- cholangiocarcinoma | EU EMA (2023) US FDA (2022) |
| tremelimumab | Imjudo | mAb | To treat unresectable hepatocellular carcinoma In combination with durvalumab | CTLA-4 | EMA OD- 2020 HCC | EU EMA (2023) US FDA (2022) |
| teclistamab | Tecvayli | mAb | To treat relapsed or refractory multiple myeloma among adults who have received at least four specific lines of therapy | BCMA | CD3e | China NMPA (2024) EU EMA (2022) US FDA (2022) | |
| mirvetuximab soravtansine | Elahere | ADC | To treat patients with recurrent ovarian cancer that is resistant to platinum therapy | folate receptor alpha | cytotoxic payload is the maytansinoid DM4 microtubule toxin | China NMPA (2024) US FDA (2022) |
| teplizumab | Tzield | mAb | To delay the onset of stage 3 type 1 diabetes | CD3e | EU EMA (2026) US FDA (2022) | |
| olutasidenib | Rezlidhia | sm | To treat adults with relapsed or refractory acute myeloid leukemia with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation | isocitrate dehydrogenase (NADP(+)) 1 | US FDA (2022) | |
| adagrasib | Krazati | sm | To treat KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer in adults who have received at least one prior systemic therapy | KRAS | US FDA (2022) | |
| lenacapavir | Sunlenca | sm | To treat adults with HIV whose HIV infections cannot be successfully treated with other available treatments due to resistance, intolerance, or safety considerations | for the treatment of HIV-1 infection in heavily treatment-experienced adults with multi-drug resistant HIV-1 infection | China NMPA (2024) EU EMA (2022) US FDA (2022) | |
| mosunetuzumab | Lunsumio | mAb | To treat adults with relapsed or refractory follicular lymphoma, a type of non-Hodgkin lymphoma, after two or more lines of systemic therapy | CD20 (membrane-spanning 4-domains, subfamily A, member 1) | CD3e | CD20 × CD3 T-cell-engaging bispecific that redirects T cells to eliminate malignant B cells, accelerated approval | China NMPA (2024) EU EMA (2022) US FDA (2022) |
| hyperpolarized Xe 129 | Xenoview | inorganic | To evaluate pulmonary function and imaging | gaseous contrast agent for use with magnetic resonance imaging for evaluation of lung ventilation | ||
| ublituximab | Briumvi | mAb | To treat relapsing forms of multiple sclerosis | CD20 (membrane-spanning 4-domains, subfamily A, member 1) | EMA OD 2009- CLL | US FDA (2022) EU EMA (2023) |
| anacaulase-bcdb | NexoBrid | enzyme(s) | Removal of eschar in adults with deep partial-thickness and/or full-thickness thermal burns | botanical drug product containing proteolytic enzymes | ||
| olverembatinib | No widely recognised brand name | sm | To treat CLL, AML, ALL, GIST | Abl | BCR activator of RhoGEF and GTPase | China NMPA (2021) | |
| dorzagliatin | Sinogliatin | sm | To treat T2DM | Glucokinase | China NMPA (2022) | |
| chiglitazar | Bilessglu | sm | To treat T2DM | 1C. Peroxisome proliferator-activated receptors | China NMPA (2022) | |
| clazosentan | Pivlaz | sm | Prevention of cerebral vasospasm, cerebral infarction and cerebral ischaemia post-aneurysmal subarachnoid haemorrhage | ETA receptor | Japan PMDA (2022) | |
| valemetostat | Ezharmia | sm | To treat aggressive adult T-cell leukemia/lymphoma | EZH2 | EZH1 | Japan PMDA (2022) | |
| gefapixant | Lyfnua | sm | To treat refractory or unexplained chronic cough | P2X3 | Receptor antagonist with some selectivity for P2X3 | Japan PMDA (2022) |
| nemolizumab | Mitchga | mAb | To treat unresolved itch associated with atopic dermatitis | Interleukin-31 receptor | Japan PMDA (2022) EU EMA (2025) US FDA (2024) | |
| ensitrelvir | Xocova | sm | To treat COVID-19 | CoV 3C-like (main) protease | Japan PMDA (2022) | |
| rezvilutamide | Ariane | sm | To treat metastatic hormone-sensitive prostate cancer | Androgen receptor | China NMPA (2022) | |
| enavogliflozin | Envlo | sm | Type 2 diabetes mellitus | SGLT2 | First approval by S. Korea MFDS | Korea MFDS (2022) |
Drug Approvals in 2021
| INN | Trade Name | Type | Indication | Therapeutic Target | Comments | Approval Sources |
| vericiguat | Verquvo | sm | To treat chronic heart failure | Nitric oxide (NO)-sensitive (soluble) guanylyl cyclase | activator | US FDA (2021) EU EMA (2021) |
| cabotegravir + rilpivirine | Vocabria | sm | To treat HIV | cabotegravir: EU EMA (2020) US FDA (2021) rilpivirine: EU EMA (2011) US FDA (2011) | ||
| voclosporin | Lupkynis | pep | To treat lupus nephritis | EMA OD 2012 for non-infectious uveitis | EU EMA (2022) US FDA (2021) | |
| tepotinib | Tepmetko | sm | To treat metastatic NSCLC with MET exon 14 skipping alterations | MET | UK MHRA (2021) EU EMA (2021) US FDA (2021) | |
| umbralisib | Ukoniq | sm | For the treatment of certain patients with marginal zone lymphoma and follicular lymphoma | CK1-E | PI3Kδ | US FDA (2021) | |
| evinacumab | Evkeeza | mAb | For the treatment of homozygous familial hypercholesterolemia | angiopoietin-like 3 | US FDA (2021) EU EMA (2021) | |
| trilaciclib | Cosela | KI | Myelopreservation therapy for patients receiving chemotherapy for SCLC | CDK4 | CDK6 | US FDA (2021) | |
| casimersen | Amondys 45 | nucleic acid | For the treatment of Duchenne muscular dystrophy | US FDA (2021) | ||
| fosdenopterin | Nulibry | sm | Cyclic pyranopterin monophosphate (cPMP) replacement therapy, to treat patients with the rare genetic disease molybdenum cofactor deficiency Type A | EMA OD (2010) molybdenum-cofactor deficiency type A | ||
| melphalan flufenamide | Pepaxto | sm | To treat relapsed/refractory MM. | Prodrug that is hydrolysed to the DNA alkylating drug melphalan. Particularly active ctive in cancer cells with high expression of aminopeptidases. EMA OD (2015) plasma cell myeloma. | EU EMA (2022) US FDA (2021) | |
| serdexmethylphenidate + dexmethylphenidate | Azstarys | sm | To treat ADHD | NET | DAT | serdexmethylphenidate: US FDA (2021) dexmethylphenidate: US FDA (2001) | |
| tivozanib | Fotivda | KI | To treat advanced relapsed/refractory RCC | Type IV RTKs: VEGF (vascular endothelial growth factor) receptor family | US FDA (2021) EU EMA (2017) | |
| ponesimod | Ponvory | sm | To treat relapsing forms of multiple sclerosis | S1P1 receptor | EU EMA (2021) US FDA (2021) | |
| dasiglucagon | Zegalogue | sm | To treat severe hypoglycemia | glucagon receptor | ||
| viloxazine | Qelbree | sm | To treat ADHD | NET | 5-Hydroxytryptamine receptors | US FDA (2021) | |
| drospirenone + estetrol | Nextstellis (US), Lydisilka (EMA), Drovelis (EMA) | sm | To prevent pregnancy | Estrogen receptor-α | Progesterone receptor | drospirenone: estetrol: EU EMA (2021) US FDA (2021) | |
| dostarlimab | Jemperli | mAb | To treat endometrial cancer | PD-1 | EU EMA (2021) US FDA (2021) | |
| loncastuximab tesirine | Zynlonta | ADC | To treat relapsed or refractory B cell malignancies | CD19 | China NMPA (2024) EU EMA (2022) US FDA (2021) | |
| pegcetacoplan | Empaveli | pep | To treat paroxysmal nocturnal hemoglobinuria | complement C3 | EMA OD C3 glomerulopathy (2019) | |
| bimekizumab | Bimzelx | mAb | To treat moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy | IL-17A | IL-17F | China NMPA (2024) EU EMA (2021) US FDA (2023) | |
| amivantamab | Rybrevant | mAb | To treat NSCLC with EGFR exon 20 mutations | EGFR | MET | EU EMA (2021) US FDA (2021) | |
| piflufolastat F 18 injection | Pylarify | sm | For positron emission tomography imaging of prostate-specific membrane antigen-positive lesions in men with prostate cancer | Folate hydrolase (prostate-specific membrane antigen) 1 | ||
| infigratinib | Truseltiq | sm | To treat adults with cholangiocarcinoma whose disease meets certain criteria | Type V RTKs: FGF (fibroblast growth factor) receptor family | EMA OD 2020 cholangiocarcinoma | US FDA (2021) |
| samidorphan + olanzapine | Lybalvi | sm | To treat schizophrenia in adults and certain aspects of bipolar I disorder in adults | 5-HT2A receptor | 5-HT2C receptor | 5-HT6 receptor | μ receptor | Dopamine receptors | 5-HT3 receptors | samidorphan: US FDA (2021) olanzapine: US FDA (1996) EU EMA (1996) | |
| sotorasib | Lumakras | sm | To treat adults with non-small cell lung cancer whose disease meets certain criteria (KRAS G12C mutation +ve) | KRAS | EU EMA (2022) US FDA (2021) | |
| ibrexafungerp | Brexafemme | sm | To treat vulvovaginal candidiasis | |||
| aducanumab | Aduhelm | mAb | To treat Alzheimer's disease | amyloid β | US FDA (2021) | |
| asparaginase erwinia chrysanthemi (recombinant)-rywn | Rylaze | recombinant enzyme | As a component of a chemotherapy regimen to treat acute lymphoblastic leukemia and lymphoblastic lymphoma in patients who are allergic to E. coli-derived asparaginase products | |||
| finerenone | Kerendia | sm | To reduce the risk of kidney and heart complications in chronic kidney disease associated with type 2 diabetes | mGlu2 receptor | EU EMA (2022) US FDA (2021) | |
| belumosudil | Rezurock | sm | To treat chronic graft-versus-host disease after failure of at least two prior lines of systemic therapy | Rho kinase 2 | US FDA (2021) | |
| fexinidazole | fexinidazole | sm | To treat human African trypanosomiasis caused by the parasite Trypanosoma brucei gambiense | |||
| odevixibat | Bylvay | sm | To treat pruritus associated with progressive familial intrahepatic cholestasis (PFIC) | ASBT | EMA OD (2012) PFIC | China NMPA (2024) EU EMA (2021) US FDA (2021) |
| anifrolumab | Saphnelo | mAb | To treat moderate-to severe systemic lupus erythematousus along with standard therapy | interferon α/β receptor 1 | EU EMA (2022) US FDA (2021) | |
| avalglucosidase alfa-ngpt | Nexviazyme | pep | To treat late-onset Pompe disease | Enzyme replacement therapy | ||
| belzutifan | Welireg | sm | To treat VHL disease-associated cancers | HIF-2α | EU EMA (2025) US FDA (2021) | |
| difelikefalin | Korsuva | sm | To treat moderate-to-severe pruritus associated with chronic kidney disease in certain populations | κ receptor | EU EMA (2022) US FDA (2021) | |
| lonapegsomatropin-tcgd | Skytrofa | pep | To treat short stature due to inadequate secretion of endogenous growth hormone | GHRH receptor | EMA OD growth hormone deficiency (2019) | |
| mobocertinib | Exkivity | sm | To treat NSCLC with EGFR exon 20 mutations | EGFR | HER2 | US FDA (2021) | |
| tisotumab vedotin | Tivdak | mAb | To treat recurrent or metastatic cervical cancer with disease progression on or after chemotherapy | coagulation factor III, tissue factor | EU EMA (2025) US FDA (2021) | |
| atogepant | Qulipta | sm | For the preventive treatment of migraine | CGRP receptor | EU EMA (2023) US FDA (2021) | |
| maralixibat | Livmarli | sm | To treat cholestatic pruritus in patients with Alagille syndrome | ASBT | EMA OD for several cholestatic liver diseases (2014, 2020) | EU EMA (2022) US FDA (2021) |
| avacopan | Tavneos | sm | To treat severe active anti-neutrophil cytoplasmic autoantibody-associated vasculitis (granulomatosis with polyangiitis and microscopic polyangiitis) in combination with standard therapy, including glucocorticoids | C5a1 receptor | EMA for ANCA vasculitis & C3 glomerulopathy (2014, 2017) | EU EMA (2022) US FDA (2021) |
| asciminib | Scemblix | sm | To treat CML | Abl | BCR activator of RhoGEF and GTPase | EMA OD for CML (2020) | EU EMA (2022) US FDA (2021) |
| ropeginterferon alfa-2b-njft | Besremi | pep | To treat polycythemia vera, a blood disease that causes the overproduction of red blood cells | Interferon-α/β receptor | ||
| vosoritide | Voxzogo | pep | To improve growth in children five years of age and older with achondroplasia and open epiphyses | GC-B | EU EMA (2021) US FDA (2021) | |
| maribavir | Livtencity | sm | To treat post-transplant cytomegalovirus (CMV) infection/disease that does not respond (with or without genetic mutations that cause resistance) to available antiviral treatment for CMV | EMA OD 2007 to prevent CMV infection in patients with impaired cell-mediated immunity | ||
| pafolacianine | Cytalux | sm | To help identify ovarian cancer lesions (fluorescent imaging) | folate receptor alpha | ||
| efgartigimod alfa | Vyvgart | pep | To treat generalized myasthenia gravis | FcRn | EMA OD 2018 (MG), 2019 (ITP) | EU EMA (2022) US FDA (2021) |
| tezepelumab | Tezspire | mAb | To treat severe asthma as an add-on maintenance therapy | thymic stromal lymphopoietin | EU EMA (2022) US FDA (2021) | |
| inclisiran | Leqvio | nuc | To treat heterozygous familial hypercholesterolemia or clinical atherosclerotic cardiovascular disease as an add-on therapy | proprotein convertase subtilisin/kexin type 9 | UK MHRA (2021) EU EMA (2020) US FDA (2021) | |
| tralokinumab | Adbry | mAb | To treat moderate-to-severe atopic dermatitis | IL-13 | EU trade name is Adtralza | EU EMA (2021) US FDA (2021) |
| levoketoconazole | Recorlev | sm | To treat endogenous hypercortisolemia in adult patients with Cushing’s syndrome | CYP11B1 | CYP17A1 | CYP21A2 | US FDA (2021) | |
| pamiparib | Partruvix | sm | To treat recurrent/advanced ovarian, fallopian tube or primary peritoneal cancers with germline BRCA mutations | PARP1 | PARP2 | approved in China, April 2021 | China NMPA (2021) |
| sugemalimab | Cejemly | mAb | To treat EGFR gene mutation and anaplastic lymphoma kinase (ALK) negative metastatic NSCLC | programmed cell death 1 ligand 1 | approved in China, December 2021 | China NMPA (2021) |
| penpulimab | Anniko (China); penpulimab-kcqx (US) | mAb | To treat nasopharyngeal cancer and NSCLC | PD-1 | Approved in China, August 2021, and by US FDA in April 2025 | China NMPA (2021) US FDA (2025) |
| zimberelimab | Yu Tuo (China) | mAb | To treat cervical cancer, non-small cell lung cancer, classical Hodgkin's lymphoma | PD-1 | approved in China, August 2021 | China NMPA (2021) |
| nirmatrelvir + ritonavir | Paxlovid | sm | To treat mild or moderate COVID-19, in at-risk patients | CoV 3C-like (main) protease | SARS-CoV sm antivirals. Approved 31/12/2021 (MHRA). FDA EUA only | nirmatrelvir: UK MHRA (2021) EU EMA (2022) US FDA (2023) ritonavir: US FDA (1996) EU EMA (1996) |
| molnupiravir | Lagevrio | sm | To treat mild or moderate COVID-19, in at-risk patients | CoV RNA-dependent RNA polymerase | UK MHRA (2021) | |
| bamlanivimab + etesevimab | None widely used | mAb | FDA emergency use authorisation granted in early 2020, as treatment for mild or moderate COVID-19 cases. This was revoked in 2021. | CoV Spike glycoprotein | A mixture of anti-Spike mAbs from Eli Lilly | bamlanivimab: etesevimab: |
| casirivimab + imdevimab | Ronapreve | mAb | To treat COVID-19 | CoV Spike glycoprotein | anti-Spike mAbs. Regeneron/Roche anti-Spike mAb cocktail. FDA EUA only | casirivimab: Japan PMDA (2021) UK MHRA (2021) EU EMA (2021) imdevimab: Japan PMDA (2021) UK MHRA (2021) EU EMA (2021) |
| sotrovimab | Xevudy | mAb | To treat mild to moderate COVID-19 in patients with at least one risk factor for developing severe disease | CoV Spike glycoprotein | anti-Spike mAbs. GSK/Vir Biotechnology. FDA EUA only | UK MHRA (2021) EU EMA (2021) |
| tixagevimab + cilgavimab | Evusheld | mAb | Pre-exposure prophylaxis of COVID-19 (FDA EUA withdrawn in early 2023) | CoV Spike glycoprotein | anti-Spike mAbs. AZ. FDA EUA only | tixagevimab: EU EMA (2022) cilgavimab: EU EMA (2022) |
| tozinameran | Comirnaty | mRNA vaccine | pre-exposure prophylaxis of COVID-19 | Coronavirus vaccines. Pfizer/BioNtech. MHRA 02/12/2020; EMA 21/12/2020; FDA 23/08/2021 | ||
| elasomeran | Spikevax | mRNA vaccine | To reduce/prevent SARS-CoV-2 infection | Coronavirus vaccines. Moderna (CX-024414). FDA EUA 18/12/2020; EMA approval 06/01/2021; MHRA 08/01/2021 | ||
| lazertinib | Lazcluze | sm | To treat EGFR mutation positive advanced NSCLC | EGFR | First approval by South Korea's MFDS in 2021 | South Korea MFDS (2021) EU EMA (2025) US FDA (2025) |
