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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 2025
| INN | Trade Name | Type | Indication | Primary Target | Comments | Approval Sources |
| famitinib | Abit | sm | To treat recurrent or metastatic cervical cancer in combination with camrelizumab | multiple kinases | First approved in China May 2025 | China NMPA (2025) |
| sebetralstat | Ekterly | sm | To treat hereditary angioedema (HAE) attacks | plasma kallikrein (KLKB1) | Approved by FDA and UK MHRA in July 2025 | UK MHRA (2025) US FDA (2025) |
| tiratricol | Emcitate | sm | To treat peripheral thyrotoxicosis associated with MCT8 deficiency (Allan-Hernon-Dudley syndrome) | thyroid hormone receptor | EU EMA (2025) | |
| trastuzumab rezetecan | Avida | ADC | To treat unresectable locally advanced or metastatic NSCLC with HER2 activating mutations | HER2 with activating mutations | Approved by China NMPA in May 2025 | |
| lisaftoclax | n/a | sm | To treat chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL) | BCL2 | Approved in China in July 2025 | China NMPA (2025) |
| serplulimab | Hetronifly | mAb | To treat extensive-stage SCLC (and other solid tumours China) | PD-1 | China NMPA (2024) EU EMA (2025) | |
| onradivir | Anruiwei | sm | To treat uncomplicated influenza A infection | PB2 cap-binding domain of RNA polymerase | First approval in China, May 2025 | |
| ifupinostat | Betlin | sm | Relapsed/refractory diffuse large B-cell lymphoma | PI3kα/HDACs | First approved by China NMPA in June 2025 | China NMPA (2025) |
| ebdarokimab | unknown | mAb | To treat moderat-severe plaque psoriasis | IL-12B | China NMPA (2025) | |
| enavogliflozin | Envlo | sm | Type 2 diabetes mellitus | SGLT2 | First approval by S. Korea MFDS | Korea MFDS (2022) |
| luvometinib | Lynozyfic | sm | To treat paediatric neurofibromatosis type 1 (NF1) | MEK1/2 | 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 | mutated EGFR | Firts approved in China, in January 2025 | China NMPA (2025) |
| linvoseltamab | Lynozyfic | mAb | To treat multiple myeloma | BCMA/CD3e | US FDA (2025) EU EMA (2025) | |
| sipavibart | Kavigale | mAb | Pre-exposure prophylaxis for SARS-CoV-2 | SARS-CoV-2 spike protein | EU EMA (2025) | |
| palonosetron + fosrolapitant | Ritanine | sm | To prevent chemotherapy-induced nausea and vomiting | NK1 and 5-HT3 receptors | Fixed-dose combination; first approval in China, May 2025 | palonosetron: EU EMA (2009) US FDA (2003) fosrolapitant: China NMPA (2025) |
| mazdutide | Xinermei | peptide | Obesity | glucagon receptor/GLP1 receptor | First approved in China in June 2025 | China NMPA (2025) |
| vilobelimab | Gohibic | mAb | To treat COVID-19-related ARDS | C5a anaphylatoxin | EU EMA (2025) | |
| sunvozertinib | Zegfrovy | sm | To treat EGFR exon 20 insertion mutation +ve locally advanced/metastatic NSCLC | mutated 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 | RSV fusion protein | Viral target | |
| repotrectinib | Augtyro | sm | To treat locally advanced or metastatic ROS1-positive non-small cell lung cancer | ROS1/NTRK/ALK | 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 | TROP2 (TACSTD2) | EU EMA (2025) US FDA (2025) | |
| treosulfan | Grafapex | sm | Used with fludarabine as a preparative regimen for alloHSCT | DNA | 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 | MEK | US FDA (2025) | |
| vimseltinib | Romvimza | sm | To treat tenosynovial giant cell tumour | CSF1R | US FDA (2025) | |
| gepotidacin | Blujepa | sm | To treat uncomplicated urinary tract infections | bacterial DNA gyrase and topoisomerase IV | US FDA (2025) | |
| fitusiran | Qfitlia | nucleic acid | To treat hemophilia A/B | antithrombin (SERPINC1) | US FDA (2025) | |
| atrasentan | Vanrafia | sm | To reduce proteinuria in adults with primary immunoglobulin A nephropathy at risk of rapid disease progression | endothelin receptor type A (ETA) | 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) |
| nipocalimab | Imaavy | mAb | To treat generalized myasthenia gravis | FcRn (FCGRT) | US FDA (2025) | |
| defactinib + avutometinib | Avmapki Fakzynja | sm | To treat KRAS-mutated recurrent low-grade serous ovarian cancer (LGSOC) after prior systemic therapy | focal adhesion kinase (FAK) and c-RAF/MEK1 kinases | 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 | HGFR (c-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 | ROS1/NTRK | First approved in China in 2024. | China NMPA (2024) US FDA (2025) |
| garadacimab | Andembry | mAb | To prevent attacks of hereditary angioedema | FXIIa | US FDA (2025) UK MHRA (2025) EU EMA (2025) | |
| aceclidine | Vizz | sm | To treat presbyopia | acetylcholine receptors (muscarinic) | US FDA (2025) | |
| delgocitinib | Anzupgo | sm | To treat moderate-to-severe chronic hand eczema when topical corticosteroids are not advisable or produce an inadequate response | JAKs | 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 | phenylalanine hydroxylase (PAH) activator | 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. | mitochondrial caseinolytic protease P (ClpP) | FDA accelerated approval | US FDA (2025) |
| zongertinib | Hernexeos | sm | To treat unresectable/metastatic NSCLC with HER2-activating mutations in the tyrosine kinase domain. | matant HER2 | US FDA (2025) | |
| brensocatib | Brinsupri | sm | To treat non-cystic fibrosis bronchiectasis (NCFB) | dipeptidyl peptidase 1 (DPP1) | First drug with disease-modifying potential, approved to treat NCFB | US FDA (2025) |
| donidalorsen | Dawnzera | nucleic acid | To treat hereditary angioedema (HAE) | prekallikrein mRNA | First RNA-targeted treatment for HAE | US FDA (2025) |
| rilzabrutinib | Wayrilz | sm | To treat immune thrombocytopenic purpura (ITP) | Bruton's tyrosine kinase (BTK) | US FDA (2025) | |
| elamipretide | Forzinity | peptide | To improve muscle strength in patients with Barth syndrome weighing at least 30 kg | cardiolipin | Accelerated approval | US FDA (2025) Accelerated approval |
| paltusotine | Palsonify | sm | To treat acromegaly | somatostatin receptor type 2 (SST2) | US FDA (2025) | |
| imlunestrant | Inluriyo | sm | To treat progressing advanced/metastatic ER+ve/HER2-ve breast cancer with ER mutations | estrogen receptor (ER)- | US FDA (2025) | |
| remibrutinib | Rhapsido | sm | To treat chronic, anti-histamine-resistant spontaneous urticaria | Bruton's tyrosine kinase (BTK) | US FDA (2025) | |
| nerandomilast | Jascayd | sm | To treat idiopathic pulmonary fibrosis | PDE4B | US FDA (2025) | |
| elinzanetant | Lynkuet | sm | To treat moderate to severe menopausal hot flushes and night sweats | NK1/3 receptors | First approval granted by the UK MHRA in July 2025 | UK MHRA (2025) US FDA (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 | menin (MEN1) | US FDA (2025) | |
| plozasiran | Redemplo | sm | To reduce triglycerides in adults with familial chylomicronemia syndrome | apolipoprotein C-III (APOC3) | US FDA (2025) | |
| sevabertinib | Hyrnuo | sm | To treat locally advanced/metastatic NSCLC with confirmed HER2 activating mutations | mutated EGFR/HER2 | Accelerated approval | US FDA (2025) |
| sibeprenlimab | Voyxact | mAb | To reduce proteinuria in patients with primary immunoglobulin A nephropathy | APRIL (TNFSF13) | FDA accelerated approval; first-in-class APRIL-selective drug | US FDA (2025) |
Drug Approvals in 2024
| INN | Trade Name | Type | Indication | Primary Target | Comments | Approval Sources |
| rezivertinib | Rapida | sm | To treat EGFR T790M-positive NSCLC | EGFR T790M | First approval in China 2024 | China NMPA (2024) |
| seniprutug | Tribuvia | mAb | To treat axial spondyloarthritis (ankylosing spondylitis) | TRBV9 | First approved in Russia 2024 | Russia Minzdrav (2024) |
| zorifertinib | Zerini | sm | To treat NSCLC with EGFR exon 19 deletions or exon 21 EGFRL858R mutation | EGFR TK | First approval in China Nov 2024 | China NMPA (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 | DPP-4 | Approved by China NMPA in June 2024 | China NMPA (2024) |
| cetagliptin | unknown | sm | To treat type 2 diabetes mellitus (T2DM) | DPP-4 | Approved by China MNPA in 2024 | China NMPA (2024) |
| bevifibatide | Betagrin | peptide | Anti-thrombotic agent for use during percutaneous coronary intervention | αIIbβ3 and αvβ3 integrins | Approved by the China NMPA in 2024 | China NMPA (2024) |
| ivarmacitinib | unknown | sm | To treat rheumatoid arthritis, atopic dermatitis and active ankylosing spondylitis | JAK1 | First approved by China NMPA in September 2024 | China NMPA (2024) |
| envonalkib | Anrakuharu | sm | To treat ALK-positive non-small cell lung cancer | ALK RTK | First approval in China 2024 | China NMPA (2024) |
| entinostat | Zhuda | sm | To treat recurrent metastatic non-small cell lung cancer | HDACs 1, 2, 3, 8 | First approval in China 2024 | China NMPA (2024) |
| ebronucimab | Yixining | mAb | To treat primary hypercholesterolaemia and mixed hyperlipidaemia | proprotein convertase subtilisin/kexin type 9 (PCSK9) | First approval in China Sep 2024 | China NMPA (2024) |
| crisugabalin | unknown | sm | To treat diabetic peripheral neuropathic pain, and postherpetic neuralgia | α2-δ subunits of voltage-gated calcium channels (CACNA2D1 and CACNA2D2) | First approval in China May 2024 | China NMPA (2024) |
| cofrogliptin | unknown | sm | To manage T2DM | dipeptidyl aminopeptidase 4 (DPP-4) | First approval in China Jun 2024 | China NMPA (2024) |
| benmelstobart | Andervi | mAb | To treat extensive-stage small cell lung cancer | PD-L1 | First approval in China May 2024 | China NMPA (2024) |
| ainuovirine | sm | To treat HIV type 1 infection | HIV reverse transcriptase | First approval in China Sep 2024 | China NMPA (2024) | |
| ivonescimab | Idafang | mAb | To treat advanced EGFR-mutated NSCLC | PD-1 and VEGFA | First approved in China 2024 | China NMPA (2024) |
| vunakizumab | AnDajing | mAb | To treat moderate-to-severe plaque psoriasis | IL-17A | First approval in China Aug 2024 | China NMPA (2024) |
| unecritinib | Ambani | sm | To treat ROS1 fusion-positive NSCLC | ALK RTK | First approval in China Apr 2024 | China NMPA (2024) |
| tasurgratinib | Tasfygo | sm | To treat FGFR2 fusion-positive, unresectable biliary tract cancer | FGFR1-3 RTKs | First approval in Japan Sep 2024 | Japan PMDA (2024) |
| taletrectinib | Dubbo | sm | To treat ROS1 fusion-positive non-small cell lung cancer (NSCLC) | NTRK1/2/3 and ROS RTKs | First approval in China 2024 | China NMPA (2024) US FDA (2025) |
| tagitanlimab | Cotelet | mAb | To treat recurrent/metastatic nasopharyngeal cancer | PD-L1 | First approval in China Dec 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 | PD-L1 | First approval in EU Jul 2024 | China NMPA (2021) |
| stapokibart | Kangyueda | mAb | To treat moderate-to-severe atopic dermatitis | IL-4Rα | First approval in China Sep 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) |
| sacituzumab tirumotecan | Jiataile | ADC | To treat advanced triple-negative breast cancer | TROP-2 | First approval in China Nov 2024 | China NMPA (2024) |
| zastaprazan | JAQBO | sm | To treat GERD | gastric H+/K+ ATPase | First approved in South Korea Apr 2024 | South Korea MFDS (2024) |
| SH-1028 | Saint Rasa | sm | To treat EGFRT790M mutated NSCLC | EGFR T790M TK | First approval in China Jun 2024 | China NMPA (2024) |
| ongericimab | Junshida | mAb | To treat primary hypercholesterolemia (non-familial) and mixed dyslipidemia | proprotein convertase subtilisin/kexin type 9 (PCSK9) | First approval in China 2024 | China NMPA (2024) |
| mirogabalin | Tarlige | sm | To treat diabetic peripheral neuropathy | α2δ subunit of voltage-gated calcium channels | First approval in China 2024 | China NMPA (2024) |
| linaprazan | sm | To treat gastroesophageal reflux disease | gastric H+/K+ ATPase | First approval in China Dec 2024 | China NMPA (2024) | |
| iparomlimab + tuvonralimab | Zimbab | mAb | To treat recurrent or metastatic cervical cancer | PD-1 and CTLA4 | First approval in China Oct 2024 | iparomlimab: China NMPA (2024) tuvonralimab: China NMPA (2024) |
| aprocitentan | Tryvio | sm | To treat hypertension | endothelin endothelin receptor type A (ETA) | US FDA (2024) | |
| resmetirom | Rezdiffra | sm | To treat noncirrhotic non-alcoholic steatohepatitis with moderate to advanced liver scarring | thyroid receptor β (THRβ) | US FDA (2024) | |
| tegileridine | Asut | sm | To treat postoperative pain | μ-opioid receptor | First approved in China, Jan 2024 | China NMPA (2024) |
| tislelizumab | Tevimbra | mAb | To treat unresectable or metastatic esophageal squamous cell carcinoma | PD-1 | China NMPA (2024) China NMPA (2019) | |
| tunlametinib | Kolupin | sm | To treat RAS/RAF mutated melanoma | MEK1/2 kinases | First approval in China March 2024 | China NMPA (2024) |
| garsorasib | AnFangning | sm | To treat KRAS G12C mutation positive NSCLC | KRAS G12C | First approval in China Nov 2024 | China NMPA (2024) |
| evocalcet | Orkedia | sm | To treat hyperparathyroidism secondary to chronic kidney disease | calcium-sensing receptor (CASR) | First approval in China 2024 | China NMPA (2024) |
| berdazimer | Zelsuvmi | sm | To treat molluscum contagiosum | n/a | ||
| cefepime + enmetazobactam | Exblifep | sm | To treat complicated urinary tract infections | bacterial targets | 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 | |||
| givinostat | Duvyzat | sm | To treat Duchenne muscular dystrophy in individuals aged 6 years and older | HDACs | US FDA (2024) | |
| sotatercept | Winrevair | fusion protein | To treat pulmonary arterial hypertension (PAH) | ACVR2A ligand trap | US FDA (2024) | |
| vadadustat | Vafseo | sm | To treat anemia due to chronic kidney disease | prolyl-hydroxylases PHD1, PHD2 and PHD3 | 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) |
| ceftobiprole | Zevtera | sm | To treat certain bloodstream infections, bacterial skin and associated tissue infections, and community-acquired bacterial pneumonia | bacterial targets | 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 | ||
| nogapendekin alfa inbakicept-pmln | Anktiva | pep | To treat bladder cancer | IL-15 receptor | recombinant IL-15 superagonist complex | |
| tovorafenib | Ojemda | sm | To treat relapsed or refractory pediatric low-grade glioma | RAF kinases | 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 and DLL3 | US FDA (2024) | |
| imetelstat | Rytelo | nucleotide | To treat low- to intermediate-risk myelodysplastic syndromes | telomerase reverse transcriptase (TERT) | inhibits TERT function | EU EMA (2025) US FDA (2024) |
| elafibranor | Iqirvo | sm | To treat primary biliary cholangitis in combination with ursodeoxycholic acid | PPARα/δ | EU EMA (2024) US FDA (2024) | |
| sofpironium | Sofdra | sm | To treat primary axillary hyperhidrosis. | Acetylcholine (muscarinic) receptors | 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 | PDE3/4 | US FDA (2024) | |
| donanemab | Kisunla | mAb | To treat early symptomatic Alzheimer's disease | amyloid β | China NMPA (2024) US FDA (2024) | |
| deuruxolitinib | Leqselvi | sm | To treat severe alopecia areata | JAK1/2 | US FDA (2024) | |
| benzgalantamine | Zunveyl | sm | To treat mild-to-moderate Alzheimer's disease | galantamine prodrug | US FDA (2024) | |
| vorasidenib | Voranigo | sm | To treat IDH1/2 mutation positive astrocytoma or oligodendroglioma | IDH1 and IDH2 | US FDA (2024) | |
| palopegteriparatide | Yorvipath | pep | To treat hypoparathyroidism | parathyroid hormone mimetic | 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 | PPARδ | US FDA (2024) | |
| axatilimab | Niktimvo | mAb | To treat chronic graft-versus-host disease | CSF-1R | US FDA (2024) | |
| lazertinib | Lazcluze | sm | To treat non-small cell lung cancer (EGFR mutation positive advanced NSCLC) | mutant EGFR TKs | First approval in S Korea 2021 | South Korea MFDS (2021) EU EMA (2025) US FDA (2025) |
| 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 | unknown | US FDA (2024) | |
| levacetylleucine | Aqneursa | sm | To treat Niemann-Pick disease type C | N-Acetyl-L-Leucine (IB1001); 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 and M4 muscarinic acetylcholine receptors | xanomeline: US FDA (2024) trospium: US FDA (2004) | |
| flurpiridaz F 18 | Flyrcado | sm | PET tracer for detection of coronary artery disease | mitochondrial complex | ||
| inavolisib | Itovebi | sm | To treat locally advanced or metastatic breast cancer | PIK3CA | US FDA (2024) | |
| marstacimab | Hympavzi | mAb | To prevent or reduce bleeding episodes related to hemophilia A or B | tissue factor pathway inhibitor (TFPI) | 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) | |
| zolbetuximab | Vyloy | mAb | To treat HER2-ve, CLDN18.2+ve unresectable, advanced/recurrent gastric cancer | CLDN18.2 | First approval in Japan Mar 2024 | China NMPA (2024) Japan PMDA (2024) EU EMA (2024) US FDA (2024) |
| sulopenem + probenecid | Orlynvah | sm | To treat uncomplicated UTIs | bacterial targets | sulopenem: US FDA (2024) probenecid: US FDA (1951) | |
| revumenib | Revuforj | sm | To treat acute r/r leukemia with KMT2A translocation | Menin-KMT2A protein-protein interaction | US FDA (2024) | |
| zanidatamab | Ziihera | mAb | To treat unresectable or metastatic HER2-positive (IHC 3+) biliary tract cancer | ERBB2 (HER2) | EMA OD gastric cancer 2020; FDA accelerated approval | 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) |
| acoramidis | Attruby | sm | To treat cardiomyopathy of wild-type or variant transthyretin-mediated amyloidosis | transthyretin (TTR) | TTR stabiliser | EU EMA (2025) 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 | ERBB2/3 (HER2/3) RTKs | FDA accelerated approval | US FDA (2024) |
| cosibelimab | Unloxcyt | mAb | To treat cutaneous squamous cell carcinoma | PD-L1 | US FDA (2024) | |
| crinecerfont | Crenessity | sm | To treat classic congenital adrenal hyperplasia | CRF-1 receptor | US FDA (2024) | |
| ensartinib | Ensacove | sm | To treat non-small cell lung cancer | ALK RTK | US FDA (2024) | |
| olezarsen | Tryngolza | nucleotide | To treat familial chylomicronemia syndrome | apolipoprotein C-III (APOC3) mRNA | EMA OD familial chylomicronemia syndrome granted Aug 2024 | US FDA (2024) |
| concizumab | Alhemo | mAb | For routine prophylaxis to prevent bleeding episodes in hemophilia A and B | tissue factor pathway inhibitor (TFPI) | EMA CHMP positive opinion Oct 2024 | Canada HC (2023) EU EMA (2024) US FDA (2024) |
| vanzacaftor + tezacaftor + deutivacaftor | Alyftrek | sm | To treat cystic fibrosis | cystic fibrosis transmembrane regulator (CFTR) | vanzacaftor: UK MHRA (2025) US FDA (2024) tezacaftor: EU EMA (2018) US FDA (2018) deutivacaftor: UK MHRA (2025) US FDA (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) |
| fulzerasib | Dupert | sm | To treat KRAS G12C adv NSCLC | KRAS G12C | First approval in China 2024 | China NMPA (2024) |
| xeligekimab | Jinlixi | mAb | To treat plaque psoriasis | IL-17A | First approval in China Aug 2024 | China NMPA (2024) |
Drug Approvals in 2023
| INN | Trade Name | Type | Indication | Primary Target | Comments | Approval Sources |
| sovateltide | Tycamzzi | pep | To treat acute cerebral ischemic stroke | endothelin-B receptor (ETB) | India approval 05/2023 | India CDSCO (2023) |
| iruplinalkib | Qixinke | sm | To treat advanced ALK+ve NSCLC | ALK/ROS1 tyrosine kinases | Approved in China June 2023 | China NMPA (2023) |
| keverprazan | sm | To treat reflux oesophagitis and duodenal ulcer | gastric H+,K+-ATPase | 15/02/2023- China approval | China NMPA (2023) | |
| adebrelimab | Arelili, Ariely | mAb | To treat advanced small cell lung cancer | PD-L1 | First approval in China in March 2023 | China NMPA (2023) |
| aponermin | pep | To treat relapsed or refractory multiple myeloma | death receptors (DR) 4 and 5 (TRAIL mimetic) | First approved in China, Nov 2023 | China NMPA (2023) | |
| dimdazenil | Junoenil | sm | To treat insomnia | α1β2γ2 GABAA receptors | First approved in China, Nov 2023 | |
| concizumab | Alhemo | mAb | To treat hemophilia B | tissue factor pathway inhibitor (TFPI) | first approval Canada March 2023 | Canada HC (2023) EU EMA (2024) US FDA (2024) |
| befotertinib | Surmana | sm | To treat adv/met NSCLC with mutated EGFR | EGFR TK | China approval 05/2023 | China NMPA (2023) |
| divozilimab | Ivlizi | mAb | To treat relapsing multiple sclerosis | CD20 | First approved in Russia April 2023 | Russia MinzDRAV (2023) |
| narlumosbart | Jinlitai | mAb | To treat giant cell tumor of bone | RANKL | First approval in China in Sept 2023 | China NMPA (2023) |
| tafolecimab | Sintbilo | mAb | To treat primary hyperlipidemia | PCSK9 | First approved in China in Aug 2023 | China NMPA (2023) |
| lebrikizumab | Ebglyss | mAb | To treat atopic dermatitis | IL-13 | EU EMA (2023) | |
| sunvozertinib | n/a | sm | To treat EGFRexon20ins met NSCLC | EGFR TK mutants | First approved in China in Aug 2023 | US FDA (2025) China NMPA (2023) |
| 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; SLC5A2 | 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 | ERalpha | 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 hydroxylase | Approved in Japan in 2020, EMA application withdrawn July 2023 | Japan PMDA (2020) US FDA (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 | angiotensin AT1 receptor and endothelin 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 transcription factor | 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) | |
| rezafungin | Rezzayo | sm | To treat candidemia and invasive candidiasis | fungal target | antifungal; EMA OD invasive candidiasis June 2022 | |
| 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) |
| leniolisib | Joenja | sm | To treat activated phosphoinositide 3-kinase delta syndrome (APDS) | PI3Kdelta | 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 | SOD1 mRNA | EMA OD for SOD1 ALS Aug 2016 | China NMPA (2024) EU EMA (2024) US FDA (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 | CD3e and CD20 | 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 | bacterial β-lactamase | 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 | SARS-CoV-2 Mpro | 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 | PSMA | ||
| sotagliflozin | Inpefa | sm | To treat heart failure | SGLT1 and SGLT2 | EU EMA (2019) US FDA (2023) | |
| glofitamab | Columvi | mAb | To treat DLBCL or LBCL | CD3e and CD20 | 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 and TEC family kinases | UK MHRA (2023) EU EMA (2023) US FDA (2023) | |
| rozanolixizumab | Rystiggo | mAb | To treat antibody positive generalized myasthenia gravis | FcRn (FCGRT) | 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) | |
| nirsevimab-alip | Beyfortus | mAb | To prevent respiratory syncytial virus (RSV) lower respiratory tract disease in infants | RSV fusion (F) protein | ||
| 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) | multiple RTKs | first approval in Japan June 2019 | Japan PMDA (2019) US FDA (2023) |
| cantharidin | Ycanth | sm | To treat molluscum contagiosum | serine proteases and protein phosphatase PPA2 | US FDA (2023) | |
| lotilaner | Xdemvy | sm | To treat Demodex blepharitis | ectoparasites | 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 and 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 | TNFRSF17 (BCMA) and 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-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 | component C5 | US FDA (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 | JAK1/2 and ACVR1 | 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 | enzyme replacement therapy | 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 | lactate dehydrogenase A (LDHA) mRNA | siRNA vs lactate dehydrogenase A mRNA | US FDA (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 and IL-7F | China NMPA (2024) EU EMA (2021) US FDA (2023) | |
| mirikizumab | Omvoh | mAb | To treat ulcerative colitis | IL-23A | Japan PMDA (2023) US FDA (2023) EU EMA (2023) | |
| vamorolone | Agamree | sm | To treat Duchenne muscular dystrophy | multi-functional drug | EMA OD for DMD (4/09/2022) and negative opinion in Oct 2023 | China NMPA (2024) EU EMA (2023) US FDA (2023) |
| toripalimab | Loqtorzi | mAb | To treat advanced nasopharyngeal carcinoma | PD-1 | China NMPA (2024) US FDA (2023) | |
| apadamtase alfa (recombinant ADAMTS13) | Adzynma | pep | To treat congenital thrombotic thrombocytopenic purpura | enzyme replacement therapy | EMA OD cTTP 2008 | |
| fruquintinib | Fruzaqla | sm | To treat metastatic colorectal cancer. | VEGFR 1-3 RTKs | Approved in China 2018 | China NMPA (2018) 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) | ||
| repotrectinib | Augtyro | sm | To treat locally advanced or metastatic ROS1-positive non-small cell lung cancer | ROS1/NTRK/ALK | China NMPA (2024) EU EMA (2025) US FDA (2023) | |
| efbemalenograstim alfa-vuxw | Ryzneuta | Fc fusion peptide | To treat neutropenia | GCSF mimetic | long-acting hG-CSF fused to IgG2-Fc | |
| capivasertib | Truqap | sm | To treat HR+ve, HER2-ve adv breast cancer with AKT pathway activating mutations | AKT serine/threonine protein kinases | UK MHRA (2024) EU EMA (2024) US FDA (2023) | |
| nirogacestat | Ogsiveo | sm | To treat progressing desmoid tumours | gamma secretase | US FDA (2023) | |
| iptacopan | Fabhalta | sm | To treat paroxysmal nocturnal hemoglobinuria | complement factor B serine protease | 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 | transthyretin (TTR) | UK MHRA (2024) EU EMA (2025) US FDA (2023) |
Drug Approvals in 2022
| INN | Trade Name | Type | Indication | Primary Target | Comments | Approval Sources |
| tixagevimab | Evusheld (tixagevimab + cilgavimab) | mAb fixed-dose combination | Pre-exposure prophylaxis of COVID-19 | SARS-CoV-2 spike protein | EU EMA (2022) | |
| gefapixant | Lyfnua | sm | To treat refractory or unexplained chronic cough | P2X3 and P2X2/3 receptor antagonist | Japan PMDA (2022) | |
| 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) |
| relatlimab | Opdualag | mAb | To treat unresectable or metastatic melanoma | LAG3 | EU EMA (2022) US FDA (2022) | |
| nirmatrelvir | Paxlovid (nirmatrelvir + ritonavir) | sm | To treat COVID-19 | SARS-CoV-2 Mpro | nirmatrelvir is the NME | UK MHRA (2021) EU EMA (2022) US FDA (2023) |
| cilgavimab | Evusheld (tixagevimab + cilgavimab) | mAb fixed-dose combination | Pre-exposure prophylaxis of COVID-19 | SARS-CoV-2 spike protein | EU EMA (2022) | |
| olverembatinib | n/a | sm | To treat CLL, AML, ALL, GIST | BCR-ABL1 tyrosine kinase | China NMPA (2021) | |
| 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) | |
| 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 | ||
| tapinarof | Vtama | sm | To treat plaque psoriasis | aryl hydrocarbon receptor (AhR) | China NMPA (2024) US FDA (2022) | |
| vutrisiran | Amvuttra | nucleic acid | To treat polyneuropathy of hereditary transthyretin-mediated amyloidosis | TTR mRNA | UK MHRA (2022) EU EMA (2022) US FDA (2022) | |
| spesolimab | Spevigo | mAb | To treat generalized pustular psoriasis flares | Interleukin-1 receptor-like 2 (IL1RL2) | China NMPA (2024) EU EMA (2022) 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 | GCSFR (CSF3R), GM-CSF receptor | recombinant G-CSF | US FDA (2022) |
| linzagolix | Yselty | sm | To treat uterine fibroids | GnRH receptor | EU EMA (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) | |
| terlipressin | Terlivaz | pep | To improve kidney function in adults with hepatorenal syndrome with rapid reduction in kidney function | vasopressin receptors | 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 | 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) | |
| teclistamab | Tecvayli | mAb | To treat relapsed or refractory multiple myeloma among adults who have received at least four specific lines of therapy | CD3e and BCMA | 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 α (FOLR1) | 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 | US FDA (2022) | |
| olipudase alfa | Xenpozyme | pep | To treat acid sphingomyelinase deficiency | enzyme replacement therapy | ||
| olutasidenib | Rezlidhia | sm | To treat adults with relapsed or refractory acute myeloid leukemia with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation | IDH1 | 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 G12C | US FDA (2022) | |
| dorzagliatin | Sinogliatin | sm | To treat T2DM | glucokinase (GCK) | China NMPA (2022) | |
| chiglitazar | Bilessglu | sm | To treat T2DM | PPARs | China NMPA (2022) | |
| clazosentan | Pivlaz | sm | Prevention of cerebral vasospasm, cerebral infarction and cerebral ischaemia post-aneurysmal subarachnoid haemorrhage | endothelin receptor A (ETA) | Japan PMDA (2022) | |
| valemetostat | Ezharmia | sm | To treat aggressive adult T-cell leukemia/lymphoma | EZH1/EZH2 | Japan PMDA (2022) | |
| nemolizumab | Mitchga | mAb | To treat unresolved itch associated with atopic dermatitis | Interleukin-31 receptor, α subunit | Japan PMDA (2022) EU EMA (2025) US FDA (2024) | |
| ensitrelvir | Xocova | sm | To treat COVID-19 | SARS-CoV-2 Mpro | Japan PMDA (2022) | |
| rezvilutamide | Ariane | sm | To treat metastatic hormone-sensitive prostate cancer | androgen receptor | China NMPA (2022) | |
| ublituximab | Briumvi | mAb | To treat relapsing forms of multiple sclerosis | CD20 | EMA OD 2009- CLL | US FDA (2022) EU EMA (2023) |
| mitapivat | Pyrukynd | sm | To treat hemolytic anemia caused by PK deficiency | pyruvate kinases PKR (PKLR) and PKM2 (PKM ) | 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 receptor | EMA OD 2019 for treatment of CDKL5 deficiency disorder | China NMPA (2024) EU EMA (2023) US FDA (2022) |
| lutetium (177Lu) vipivotide tetraxetan | Pluvicto | sm | To treat prostate-specific membrane antigen-positive metastatic castration-resistant prostate cancer following other therapies | prostate-specific membrane antigen (PSMA) | radioligand- DOTA-conjugated PSMA inhibitor | |
| vonoprazan + amoxicillin + clarithromycin | Voquezna | sm | To treat Helicobacter pylori infection | bacterial targets | vonoprazan is the NME | vonoprazan: Japan PMDA (2014) US FDA (2022) amoxicillin: US FDA (1974) clarithromycin: US FDA (1991) |
| futibatinib | Lytgobi | sm | To treat unresectable, locally advanced/metastatic intrahepatic cholangiocarcinoma (iCCA; with confirmed FGFR2 gene fusions or other rearrangements | FGFRs | EMA OD 2019- cholangiocarcinoma | EU EMA (2023) US FDA (2022) |
| tremelimumab | Imjudo | mAb | To treat unresectable hepatocellular carcinoma In combination with durvalumab | CTLA4 (CD152) | EMA OD- 2020 HCC | EU EMA (2023) 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 and 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) |
| 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 | ||
| 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 | HIV capsid protein | 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) |
| tebentafusp | Kimmtrak | pep | To treat unresectable or metastatic uveal melanoma | TCR and CD3e | gp100-CD3 fusion protein (ImmTAC) | EU EMA (2022) US FDA (2022) |
| palovarotene | Sohonos | sm | To reduce heterotopic ossification in fibrodysplasia ossificans progressiva | RAR-γ | Canada HC (2022) US FDA (2023) | |
| daridorexant | Quviviq | sm | To treat insomnia | orexin receptors | EU EMA (2022) US FDA (2022) | |
| somatrogon | Ngenla | pep | To treat growth hormone deficiency | growth hormone receptor (GHR) | EU EMA (2022) US FDA (2023) | |
| faricimab | Vabysmo | mAb | To treat wet AMD and diabetic macular edema (DME) | Ang2 and VEGFA | China NMPA (2024) EU EMA (2022) US FDA (2022) | |
| mavacamten | Camzyos | sm | To treat class II-III obstructive hypertrophic cardiomyopathy | myosin in cardiac myofibrils | China NMPA (2024) EU EMA (2023) US FDA (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 | fungal target | ||
| tirzepatide | Mounjaro | pep | To improve blood sugar control in diabetes, in addition to diet and exercise | GIP and GLP-1 receptors | China NMPA (2024) EU EMA (2022) US FDA (2022) |
Drug Approvals in 2021
| INN | Trade Name | Type | Indication | Primary Target | Comments | Approval Sources |
| molnupiravir | Lagevrio | sm | To treat mild or moderate COVID-19, in at-risk patients | SARS-CoV-2 RNA-dependent RNA polymerase (RdRp) | UK MHRA (2021) | |
| 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 | ||
| viloxazine | Qelbree | sm | To treat ADHD | NET (SLC6A2) and 5-HT receptors | US FDA (2021) | |
| casimersen | Amondys 45 | nucleic acid | For the treatment of Duchenne muscular dystrophy | dystrophin (DMD) | US FDA (2021) | |
| odevixibat | Bylvay | sm | To treat pruritus associated with progressive familial intrahepatic cholestasis (PFIC) | ASBT (SLC10A2) | EMA OD (2012) PFIC | China NMPA (2024) EU EMA (2021) US FDA (2021) |
| cabotegravir + rilpivirine | Vocabria | sm | To treat HIV | HIV integrase and reverse transcriptase | cabotegravir: EU EMA (2020) US FDA (2021) rilpivirine: EU EMA (2011) US FDA (2011) | |
| vericiguat | Verquvo | sm | To treat chronic heart failure | soluble guanylate cyclase (sGC) | activator | US FDA (2021) EU EMA (2021) |
| voclosporin | Lupkynis | pep | To treat lupus nephritis | calcineurin | EMA OD 2012 for non-infectious uveitis | EU EMA (2022) US FDA (2021) |
| evinacumab | Evkeeza | mAb | For the treatment of homozygous familial hypercholesterolemia | ANGPTL3 | US FDA (2021) EU EMA (2021) | |
| trilaciclib | Cosela | KI | myelopreservation therapy for patients receiving chemo for SCLC | CDK4/4 | 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 | targets melphalan to 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 | dopamine and norepinephrine transporters | serdexmethylphenidate: US FDA (2021) dexmethylphenidate: US FDA (2001) | |
| ponesimod | Ponvory | sm | To treat relapsing forms of multiple sclerosis | S1P1 receptor | 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 | C3 | EMA OD C3 glomerulopathy (2019) | |
| avalglucosidase alfa-ngpt | Nexviazyme | pep | To treat late-onset Pompe disease | enzyme replacement therapy | ||
| lonapegsomatropin-tcgd | Skytrofa | pep | To treat short stature due to inadequate secretion of endogenous growth hormone | growth hormone receptor | EMA OD growth hormone deficiency (2019) | |
| ropeginterferon alfa-2b-njft | Besremi | pep | To treat polycythemia vera, a blood disease that causes the overproduction of red blood cells | |||
| 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 | |||
| mobocertinib | Exkivity | sm | To treat NSCLC with EGFR exon 20 mutations | EGFR/HER2 RTKs | US FDA (2021) | |
| anifrolumab | Saphnelo | mAb | To treat moderate-to severe systemic lupus erythematousus along with standard therapy | IFNAR1 | EU EMA (2022) US FDA (2021) | |
| belzutifan | Welireg | sm | To treat VHL disease-associated cancers | HIF-2α (EPAS1) | US FDA (2021) | |
| difelikefalin | Korsuva | sm | To treat moderate-to-severe pruritus associated with chronic kidney disease in certain populations | κ-opioid receptor | EU EMA (2022) US FDA (2021) | |
| bimekizumab | Bimzelx | mAb | To treat moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy | IL-17A and IL-7F | China NMPA (2024) EU EMA (2021) US FDA (2023) | |
| tisotumab vedotin | Tivdak | mAb | To treat recurrent or metastatic cervical cancer with disease progression on or after chemotherapy | coagulation factor III | EU EMA (2025) US FDA (2021) | |
| atogepant | Qulipta | sm | For the preventive treatment of migraine | CGRP | EU EMA (2023) US FDA (2021) | |
| samidorphan + olanzapine | Lybalvi | sm | To treat schizophrenia in adults and certain aspects of bipolar I disorder in adults | μ-opioid receptor, plus potentially 5-HT2A, 5-HT2C, 5-HT3, 5-HT6 abd dopamine receptors | samidorphan: US FDA (2021) olanzapine: US FDA (1996) EU EMA (1996) | |
| vosoritide | Voxzogo | pep | To improve growth in children five years of age and older with achondroplasia and open epiphyses | Guanylyl cyclase-B (NPR2) | EU EMA (2021) US FDA (2021) | |
| pafolacianine | Cytalux | sm | To help identify ovarian cancer lesions (fluorescent imaging) | folate receptor alpha (FOLR1) | ||
| tezepelumab | Tezspire | mAb | To treat severe asthma as an add-on maintenance therapy | TSLP | EU EMA (2022) US FDA (2021) | |
| levoketoconazole | Recorlev | sm | To treat endogenous hypercortisolemia in adult patients with Cushing’s syndrome | 11β-hydroxylase (CYP11B1), 17α-hydroxylase/17,20-lyase (CYP17A1) and steroid 21-hydroxylase (CYP21A2) | US FDA (2021) | |
| finerenone | Kerendia | sm | To reduce the risk of kidney and heart complications in chronic kidney disease associated with type 2 diabetes | mGluR2 | EU EMA (2022) 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 | prostate-specific membrane antigen (PSMA) | ||
| dasiglucagon | Zegalogue | sm | To treat severe hypoglycemia | glucagon receptor (GCGR) | ||
| inclisiran | Leqvio | nuc | To treat heterozygous familial hypercholesterolemia or clinical atherosclerotic cardiovascular disease as an add-on therapy | PCSK9 mRNA | UK MHRA (2021) EU EMA (2020) US FDA (2021) | |
| aducanumab | Aduhelm | mAb | To treat Alzheimer's disease | amyloid beta (Aβ) | US FDA (2021) | |
| ibrexafungerp | Brexafemme | sm | To treat vulvovaginal candidiasis | fungal target | ||
| sotorasib | Lumakras | sm | To treat adults with non-small cell lung cancer whose disease meets certain criteria (KRAS G12C mutation +ve) | KRAS G12C | EU EMA (2022) US FDA (2021) | |
| infigratinib | Truseltiq | sm | To treat adults with cholangiocarcinoma whose disease meets certain criteria | FGFRs | EMA OD 2020 cholangiocarcinoma | US FDA (2021) |
| maralixibat | Livmarli | sm | To treat cholestatic pruritus in patients with Alagille syndrome | ASBT (SLC10A2) | 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 (C5AR1) | EMA for ANCA vasculitis & C3 glomerulopathy (2014, 2017) | EU EMA (2022) US FDA (2021) |
| asciminib | Scemblix | sm | To treat CML | BCR-ABL1 | EMA OD for CML (2020) | EU EMA (2022) US FDA (2021) |
| amivantamab | Rybrevant | mAb | To treat NSCLC with EGFR exon 20 mutations | EGFR and MET RTKs | EU EMA (2021) US FDA (2021) | |
| drospirenone + estetrol | Nextstellis (US), Lydisilka (EMA), Drovelis (EMA) | sm | To prevent pregnancy | progseterone receptor and estrogen receptor alpha | drospirenone: estetrol: EU EMA (2021) US FDA (2021) | |
| tivozanib | Fotivda | KI | To treat advanced relapsed/refractory RCC | VEGF receptor | US FDA (2021) EU EMA (2017) | |
| 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 | CMV pUL97 kinase | EMA OD 2007 to prevent CMV infection in patients with impaired cell-mediated immunity | |
| efgartigimod alfa | Vyvgart | pep | To treat generalized myasthenia gravis | FcRn (FCGRT) | EMA OD 2018 (MG), 2019 (ITP) | EU EMA (2022) 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) |
| pamiparib | Partruvix | sm | To treat recurrent/advanced ovarian, fallopian tube or primary peritoneal cancers with germline BRCA mutations | PARP1 and 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 | PD-L1 | approved in China, December 2021 | China NMPA (2021) |
| penpulimab | n/a | mAb | To treat nasopharyngeal cancer and NSCLC | PD-1 | approved in China, August 2021 | China NMPA (2021) US FDA (2025) |
| zimberelimab | n/a | 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 | SARS-CoV-2 Mpro | 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) |
| bamlanivimab + etesevimab | n/a | mAb | FDA emergency use authorisation granted in early 2020, as treatment for mild or moderate COVID-19 cases. This was revoked in 2021. | SARS-CoV-2 spike protein | anti-Spike mAbs. Eli Lilly anti-Spike mAb cocktail. FDA EUA only | bamlanivimab: etesevimab: |
| casirivimab + imdevimab | Ronapreve | mAb | To treat COVID-19 | SARS-CoV-2 spike protein | 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 | SARS-CoV-2 spike protein | 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) | SARS-CoV-2 spike protein | anti-Spike mAbs. AZ. FDA EUA only | tixagevimab: EU EMA (2022) cilgavimab: EU EMA (2022) |
| 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 | ||
| umbralisib | Ukoniq | sm | For the treatment of certain patients with marginal zone lymphoma and follicular lymphoma | PI3K-delta, CK1-epsilon | US FDA (2021) | |
| fexinidazole | fexinidazole | sm | To treat human African trypanosomiasis caused by the parasite Trypanosoma brucei gambiense | non-human target | ||
| tepotinib | Tepmetko | sm | To treat metastatic NSCLC with MET exon 14 skipping alterations | MET kinase | UK MHRA (2021) EU EMA (2021) US FDA (2021) | |
| belumosudil | Rezurock | sm | To treat chronic graft-versus-host disease after failure of at least two prior lines of systemic therapy | ROCK2 | US FDA (2021) |
