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 2024
INN Trade Name Type Indication Primary Target Comments
berdazimer Zelsuvmi sm To treat molluscum contagiosum
cefepime  +  enmetazobactam Exblifep sm To treat complicated urinary tract infections
letibotulinumtoxinA-wlbg Letybo pep To temporarily improve the appearance of moderate-to-severe glabellar lines
tislelizumab Tevimbra mAb To treat unresectable or metastatic esophageal squamous cell carcinoma
resmetirom Rezdiffra sm To treat noncirrhotic non-alcoholic steatohepatitis with moderate to advanced liver scarring
aprocitentan Tryvio sm To treat hypertension
givinostat Duvyzat sm To treat Duchenne muscular dystrophy in individuals aged 6 years and older
sotatercept Winrevair fusion protein To treat pulmonary arterial hypertension (PAH)
vadadustat Vafseo sm To treat anemia due to chronic kidney disease First approval in Japan 2020
danicopan Voydeya sm To treat extravascular hemolysis with paroxysmal nocturnal hemoglobinuria First approval in Japan Jan 2024
ceftobiprole Zevtera sm To treat certain bloodstream infections, bacterial skin and associated tissue infections, and community-acquired bacterial pneumonia
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 recombinant IL-15 superagonist complex Altor BioScience, ImmunityBio
tovorafenib Ojemda sm To treat relapsed or refractory pediatric low-grade glioma
mavorixafor Xolremdi sm To treat WHIM syndrome
tarlatamab Imdelltra mAb To treat extensive stage small cell lung cancer
imetelstat Rytelo nucleotide To treat low- to intermediate-risk myelodysplastic syndromes telomerase inhibitor (GRN163L) https://pubmed.ncbi.nlm.nih.gov/15940257/- phosphoramide oligonucleotide ASO-palmitic acid conjugate- https://pubchem.ncbi.nlm.nih.gov/compound/72941969
elafibranor Iqirvo sm To treat primary biliary cholangitis in combination with ursodeoxycholic acid
sofpironium Sofdra sm To treat primary axillary hyperhidrosis. First approved in Japan Sep 2020
crovalimab Piasky mAb To treat paroxysmal nocturnal hemoglobinuria
ensifentrine Ohtuvayre sm To treat COPD PDE3/4 dual inhibitor
donanemab Kisunla mAb To treat early symptomatic AD
deuruxolitinib Leqselvi sm To treat severe alopecia areata
benzgalantamine Zunveyl sm To treat mild-to-moderate Alzheimer's disease galantamine prodrug galantamine prodrug
vorasidenib Voranigo sm To treat IDH1/2 mutation positive astrocytoma or oligodendroglioma
palopegteriparatide Yorvipath pep To treat hypoparathyroidism
nemolizumab Nemluvio mAb To treat prurigo nodularis First approval in Japan (March 2022) to treat atopic dermatitis
seladelpar Livdelzi sm To treat primary biliary cholangitis
axatilimab Niktimvo mAb To treat chronic graft-versus-host disease
lazertinib Lazcluze sm To treat non-small cell lung cancer (EGFR mutation positive advanced NSCLC) First approval in S Korea 2021
lebrikizumab Ebglyss mAb To treat moderate-to-severe atopic dermatitis
arimoclomol Miplyffa sm To treat Niemann-Pick disease type C
levacetylleucine Aqneursa sm To treat Niemann-Pick disease type C N-Acetyl-L-Leucine 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
flurpiridaz F 18 Flyrcado sm PET tracer for detection of coronary artery disease mitochondrial complex Targets 1 in cardiomyocytes (affinity IC50 11 nM vs submitochondrial particles isolated from bovine heart) PMID: 18422306
inavolisib Itovebi sm To treat locally advanced or metastatic breast cancer
marstacimab Hympavzi mAb To prevent or reduce bleeding episodes related to hemophilia A or B
foscarbidopa  +  foslevodopa Vyalev sm To treat advanced Parkinson's disease motor fluctuations
zolbetuximab Vyloy mAb To treat HER2-ve, CLDN18.2+ve unresectable, advanced/recurrent gastric cancer First approval in Japan Mar 2024
sulopenem  +  probenecid Orlynvah sm To treat uncomplicated UTIs
revumenib Revuforj sm To treat acute r/r leukemia with KMT2A translocation
zanidatamab Ziihera mAb To treat unresectable or metastatic HER2-positive (IHC 3+) biliary tract cancer EMA OD gastric cancer 2020; FDA accelerated approval
acoramidis Attruby sm To treat cardiomyopathy of wild-type or variant transthyretin-mediated amyloidosis
landiolol Rapiblyk sm To treat supraventricular tachycardia Approved by individual EU countries, not EU-wide
iomeprol Iomervu sm For use as a radiographic contrast agent Has been approved in the UK since early 1990s https://www.medicines.org.uk/emc/product/3893/smpc#gref
zenocutuzumab Bizengri mAb To treat advanced/metaststic pancreatic adenocarcinoma & NSCLC with NRG1 fusions FDA accelerated approval
crinecerfont Crenessity sm To treat classic congenital adrenal hyperplasia 
cosibelimab Unloxcyt mAb To treat cutaneous squamous cell carcinoma PD-L1
ensartinib Ensacove sm To treat non-small cell lung cancer
olezarsen Tryngolza nucleotide To treat familial chylomicronemia syndrome EMA OD familial chylomicronemia syndrome granted Aug 2024
vanzacaftor  +  tezacaftor  +  deutivacaftor Alyftrek  sm To treat cystic fibrosis
concizumab Alhemo mAb For routine prophylaxis to prevent bleeding episodes in hemophilia A and B EMA CHMP positive opinion Oct 2024
evocalcet Orkedia sm To treat hyperparathyroidism secondary to chronic kidney disease First approval in China 2024
garsorasib AnFangning sm To treat KRAS G12C mutation positive NSCLC First approval in China Nov 2024
iparomlimab  +  tuvonralimab Zimbab mAb To treat recurrent or metastatic cervical cancer First approval in China Oct 2024
linaprazan sm To treat gastroesophageal reflux disease First approval in China Dec 2024
mirogabalin Tarlige sm To treat diabetic peripheral neuropathy First approval in China 2024
ongericimab Junshida mAb To treat primary hypercholesterolemia (non-familial) and mixed dyslipidemia First approval in China 2024
SH-1028 Saint Rasa sm To treat EGFRT790M mutated NSCLC First approval in China Jun 2024
rezivertinib Rapida sm To treat EGFR T790M-positive NSCLC First approval in China 2024
sacituzumab tirumotecan Jiataile ADC To treat advanced triple-negative breast cancer First approval in China Nov 2024
serplulimab Hetronifly mAb To treat extensive-stage small-cell lung cancer (ES-SCLC) First approval in China Dec 2024
sugemalimab Cejemly mAb First line treatment for metastatic NSCLC without sensitising EGFR mutations, or ALK, ROS1 or RET genomic tumour aberrations First approval in EU Jul 2024
tagitanlimab Cotelet mAb To treat recurrent/metastatic nasopharyngeal cancer First approval in China Dec 2024
taletrectinib Dubbo sm To treat ROS1 fusion-positive First approval in China 2024
tasurgratinib Tasfygo sm To treat FGFR2 fusion-positive unresectable, biliary tract cancer First approval in Japan Sep 2024
zorifertinib Zerini sm To treat NSCLC with EGFR exon 19 deletions or exon 21 EGFRL858R mutation First approval in China Nov 2024
vunakizumab AnDajing mAb To treat moderate-to-severe plaque psoriasis First approval in China Aug 2024
enlonstobart Enshuxing mAb To treat recurrent/metastatic PD-L1-positive cervical cancer PD-1 First approval in China Jun 2024
stapokibart Kangyueda mAb To treat moderate-to-severe atopic dermatitis First approval in China Sep 2024
zastaprazan JAQBO sm To treat GERD First approved in South Korea Apr 2024
unecritinib Ambani sm to treat ROS1 fusion-positive NSCLC First approval in China Apr 2024
ivonescimab Idafang mAb To treat advanced EGFR-mutated NSCLC First approved in China 2024
senipurtug Tribuvia First approved in Russia 2024
xeligekimab Jinlixi mAb To treat plaque psoriasis IL-17A First approval in China Aug 2024
tegileridine Asut sm To treat postoperative pain First approved in China, Jan 2024
tunlametinib Kolupin sm To treat RAS/RAF mutated melanoma First approval in China March 2024
golidocitinib GaoRuizhe sm To treat r/r PTCL JAK1 First approval in China Jun 2024
fulzerasib Dupert sm To treat KRAS G12C adv NSCLC KRAS G12C First approval in China 2024
ainuovirine sm To treat HIV type 1 infection First approval in China Sep 2024
benmelstobart Andervi mAb To treat extensive-stage small cell lung cancer First approval in China May 2024
cofrogliptin sm To manage T2DM First approval in China Jun 2024
crisugabalin sm To treat diabetic peripheral neuropathic pain, and postherpetic neuralgia First approval in China May 2024
ebronucimab mAb To treat primary hypercholesterolaemia and mixed hyperlipidaemia First approval in China Sep 2024
entinostat Zhuda sm To treat recurrent metastatic non-small cell lung cancer First approval in China 2024
envonalkib Anrakuharu sm To treat ALK-positive non-small cell lung cancer First approval in China 2024
Drug Approvals in 2023
INN Trade Name Type Indication Primary Target Comments
lecanemab Leqembi mAb To treat Alzheimer’s disease amyloid β
bexagliflozin Brenzavvy sm To improve glycemic control in adults with type 2 diabetes mellitus as an adjunct to diet and exercise SGLT2; SLC5A2
pirtobrutinib Jaypirca sm To treat mantle cell lymphoma BTK EMA OD MCL June 2021
elacestrant Orserdu sm To treat advanced/metastatic ER-positive, HER2-negative, ESR1 mutated breast cancer ERalpha SERM/SERD hybrid (SSH)
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
velmanase alfa-tycv Lamzede pep To treat non-central nervous system manifestations of alpha-mannosidosis ERT, recombinant MAN2B1
sparsentan Filspari sm To reduce proteinuria in adults with primary immunoglobulin A nephropathy at risk of rapid disease progression EMA OD primary IgA nephropathy Jan 2022
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 Fc-VWF-XTEN Fusion Protein-ehtl; factor VIII replacement therapy
omaveloxolone Skyclarys sm To treat Friedreich’s ataxia in adults and adolescents aged 16 years and older EMA OD June 2018, to treat Friedreich’s ataxia
zavegepant Zavzpret sm To treat migraine with or without aura in adults CGRP receptor
trofinetide Daybue pep To treat Rett syndrome
rezafungin Rezzayo sm To treat candidemia and invasive candidiasis antifungal; EMA OD invasive candidiasis June 2022
retifanlimab Zynyz mAb To treat metastatic or recurrent locally advanced Merkel cell carcinoma FDA & EMA ODs in 2020/21/23 anal cancer, Merkel cell carcinoma
leniolisib Joenja sm To treat activated phosphoinositide 3-kinase delta syndrome (APDS) PI3Kdelta EMA OD APDS Oct 2020
tofersen Qalsody nucleic acid To treat amyotrophic lateral sclerosis in adults who have a SOD1 gene mutation EMA OD for SOD1 ALS Aug 2016
pegunigalsidase alfa-iwxj Elfabrio pep To treat confirmed Fabry disease EMA OD Fabry disese Dec 2017 (withdrawn when fully approved)
fezolinetant Veozah sm To treat moderate to severe hot flashes caused by menopause NK3
perfluorhexyloctane Miebo inert sm To treat signs and symptoms of dry eye disease water-free, semifluorinated alkane, forms a layer over the tear film and reduces tear evaporation - increases tear film thickness and lipid layer thickness in DED. Synonym NOV03
epcoritamab Epkinly/Tepkinly mAb To treat R/R DLBCL and HGBL EMA OD DLBCL & FL 2022
sulbactam  +  durlobactam Xacduro sm To treat hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia caused by susceptible isolates of Acinetobacter baumannii-calcoaceticus complex
nirmatrelvir  +  ritonavir Paxlovid sm To treat mild-to-moderate COVID-19 in adults at high risk for progression to severe COVID-19 MHRA approval 2021
flotufolastat F 18 Posluma sm To use with positron emission tomography imaging in certain patients with prostate cancer binds PSMA
sotagliflozin Inpefa sm To treat heart failure 
glofitamab Columvi mAb To treat DLBCL or LBCL) first approved in Canada in March 2023
ritlecitinib Litfulo sm To treat severely patchy hair loss (alopecia areata)
somatrogon Ngenla pep To treat growth failure due to inadequate secretion of endogenous growth hormone
rozanolixizumab Rystiggo mAb To treat antibody positive generalized myasthenia gravis EMA OD myasthenia gravis, 22/04/2020
nirsevimab-alip Beyfortus mAb To prevent respiratory syncytial virus (RSV) lower respiratory tract disease in infants
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) first approval in Japan June 2019
NY0116 Ycanth sm To treat molluscum contagiosum
lotilaner Xdemvy sm To treat Demodex blepharitis previously used in vet med for flea/tick infestations in cats & dogs (EMA approval 2017)
zuranolone Zurzuvae sm To treat postpartum depression
avacincaptad pegol Izervay nucleic acid To treat geographic atrophy (secondary to AMD)
talquetamab Talvey mAb To treat adults with relapsed or refractory multiple myeloma who have received at least four prior therapies EMA OD for MM 20/08/2021
elranatamab Elrexfio mAb To treat adults with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy EMA OD for MM 19/07/2021
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 EMA & FDA OD for heterotopic ossification in FOP; Canada approval in 2022
pozelimab Veopoz mAb To treat patients 1 year old and older with CD55-deficient protein-losing enteropathy (PLE), also known as CHAPLE disease
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 EMA OD pancreatic cancer 2020
momelotinib Ojjaara sm To treat intermediate or high-risk myelofibrosis in adults with anemia EMA OD primary myelofibrosis & post-polycythaemia vera myelofibrosis Aug 2022
gepirone Exxua sm To treat major depressive disorder
cipaglucosidase alfa-atga Pombiliti pep To treat late-onset Pompe disease 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
etrasimod Velsipity sm To treat moderately to severely active ulcerative colitis in adults
bimekizumab Bimzelx mAb To treat moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy
zilucoplan Zilbrysq pep To treat generalized myasthenia gravis in adults who are anti-acetylcholine receptor (AChR) antibody positive EMA OD for gMG 18/07/2022; earliest approval in Japan in Sept 2023
mirikizumab Omvoh mAb To treat ulcerative colitis
mirikizumab Omvoh mAb To treat ulcerative colitis first approval in Japan 27/03/2023
vamorolone Agamree sm To treat Duchenne muscular dystrophy EMA OD for DMD, 14/09/2022 & _ve opinion in Oct 2023
toripalimab Loqtorzi mAb To treat advanced nasopharyngeal carcinoma
fruquintinib Fruzaqla sm To treat metastatic colorectal cancer. Approved in China 2018
ADAMTS13  +  recombinant-krhn Adzynma pep To treat congenital thrombotic thrombocytopenic purpura EMA OD cTTP 2008
repotrectinib Augtyro sm To treat locally advanced or metastatic ROS1-positive non-small cell lung cancer
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
capivasertib Truqap sm To treat HR+ve, HER2-ve adv breast cancer with AKT pathway activating mutations
efbemalenograstim alfa-vuxw Ryzneuta Fc fusion peptide To treat neutropenia long-acting hG-CSF fused to IgG2-Fc
nirogacestat Ogsiveo sm To treat progressing desmoid tumours
iptacopan Fabhalta  sm To treat paroxysmal nocturnal hemoglobinuria
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
tafolecimab Sintbilo mAb To treat primary hyperlipidemia First approved in China in Aug 2023
divozilimab Ivlizi mAb To treat relapsing multiple sclerosis First approved in Russia April 2023
keverprazan sm To treat reflux oesophagitis and duodenal ulcer 15/02/2023- China approval
narlumosbart Jinlitai mAb To treat Giant Cell Tumor of Bone First approval in China in Sept 2023
iruplinalkib Qixinke sm To treat advanced ALK+ve NSCLC Approved in China June 2023
befotertinib Surmana sm To treat adv/met NSCLC with mut EGFR China approval 05/2023
aponermin pep To treat relapsed or refractory multiple myeloma First approved in China, Nov 2023
concizumab Alhemo mAb To treat hemophilia B first approval Canada March 2023
sovateltide Tycamzzi pep To treat acute cerebral ischemic stroke India approval 05/2023
lebrikizumab Ebglyss mAb To treat atopic dermatitis
dimdazenil Junoenil sm To treat insomnia First approved in China, Nov 2023
adebrelimab Arelili, Ariely mAb To treat advanced small cell lung cancer First approval in China in March 2023
sunvozertinib n/a sm To treat EGFRexon20ins met NSCLC First approved in China in Aug 2023
Drug Approvals in 2022
INN Trade Name Type Indication Primary Target Comments
daridorexant Quviviq sm To treat insomnia orexin receptors (antagonist)
abrocitinib Cibinqo sm To treat refractory, moderate-to-severe atopic dermatitis JAK1
tebentafusp Kimmtrak pep To treat unresectable or metastatic uveal melanoma  CD3-TCR (gp100) fusion protein
faricimab Vabysmo mAb To treat wet AMD and diabetic macular edema (DME) Ang2/VEGFA bispecific
sutimlimab Enjaymo mAb To decrease the need for red blood cell transfusion due to hemolysis in cold agglutinin disease EMA OSs 2016 autoimmune haemolytic anaemia, 2020 ITP
mitapivat Pyrukynd sm To treat hemolytic anemia caused by PK deficiency EMA OD 2020, for treatment of PK deficiency
pacritinib Vonjo sm To treat intermediate or high-risk primary or secondary myelofibrosis in adults with low platelets JAK2 inhib EMA OD since 2010 primary & secondary myelofibrosis
relatlimab Opdualag mAb fixed-dose combination To treat unresectable or metastatic melanoma relatlimab-rmbw is the NME
ganaxolone Ztalmy sm To treat seizures in cyclin-dependent kinase-like 5 deficiency disorder EMA OD 2019 for treatment of CDKL5 deficiency disorder
lutetium (177Lu) vipivotide tetraxetan Pluvicto sm To treat prostate-specific membrane antigen-positive metastatic castration-resistant prostate cancer following other therapies radioligand- DOTA-conjugated PSMA inhibitor
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
vonoprazan  +  amoxicillin  +  clarithromycin Voquezna sm To treat Helicobacter pylori infection vonoprazan is the NME
tirzepatide Mounjaro pep To improve blood sugar control in diabetes, in addition to diet and exercise
tapinarof Vtama sm To treat plaque psoriasis
vutrisiran Amvuttra nuc To treat polyneuropathy of hereditary transthyretin-mediated amyloidosis
olipudase alfa Xenpozyme pep To treat Acid Sphingomyelinase Deficiency
UCM-1306 Spevigo mAb To treat generalized pustular psoriasis flares
daxibotulinumtoixnA-lanm Daxxify pep To treat moderate-to-severe glabellar lines associated with corrugator and/or procerus muscle activity
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
deucravacitinib Sotyktu sm To treat moderate-to-severe plaque psoriasis
terlipressin Terlivaz pep To improve kidney function in adults with hepatorenal syndrome with rapid reduction in kidney function
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
omidenepag Omlonti sm To reduce elevated intraocular pressure in patients with open‑angle glaucoma or ocular hypertension
sodium phenylbutyrate  +  tauroursodeoxycholic acid Relyvrio sm mixture To treat amyotrophic lateral sclerosis (ALS)
futibatinib Lytgobi sm To treat unresectable, locally advanced/metastatic intrahepatic cholangiocarcinoma (iCCA; with confirmed FGFR2 gene fusions or other rearrangements EMA OD 2019- cholangiocarcinoma
tremelimumab Imjudo mAb To treat unresectable hepatocellular carcinoma In combination with durvalumab EMA OD- 2020 HCC
teclistamab Tecvayli mAb To treat relapsed or refractory multiple myeloma among adults who have received at least four specific lines of therapy
mirvetuximab soravtansine Elahere ADC To treat patients with recurrent ovarian cancer that is resistant to platinum therapy
teplizumab Tzield mAb To delay the onset of stage 3 type 1 diabetes
olutasidenib Rezlidhia sm To treat adults with relapsed or refractory acute myeloid leukemia with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation
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
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 × CD3 T-cell-engaging bispecific that redirects T cells to eliminate malignant B cells, accelerated approval
lenacapavir Sunlenca antiviral 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
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
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
ublituximab Briumvi mAb To treat relapsing forms of multiple sclerosis EMA OD 2009- CLL
tixagevimab Evusheld (tixagevimab + cilgavimab) mAb fixed-dose combination pre-exposure prophylaxis of COVID-19
cilgavimab Evusheld (tixagevimab + cilgavimab) mAb fixed-dose combination pre-exposure prophylaxis of COVID-19
somatrogon Ngenla pep growth hormone deficiency
palovarotene Sohonos sm To reduce heterotopic ossification in fibrodysplasia ossificans progressiva
rezvilutamide Ariane sm To treat metastatic hormone-sensitive prostate cancer
nirmatrelvir Paxlovid (nirmatrelvir + ritonavir) antiviral sm COVID-19 nirmatrelvir is the NME
olverembatinib n/a sm CLL, AML, ALL, GIST BCR-ABL1 tyrosine kinase inhibitor Ascentage Pharma
dorzagliatin Sinogliatin sm T2DM glucokinase activator
chiglitazar Bilessglu sm T2DM pan-PPAR agonist
clazosentan Pivlaz sm prevention of cerebral vasospasm, cerebral infarction and cerebral ischaemia post-aneurysmal subarachnoid haemorrhage ETA antagonist
valemetostat Ezharmia sm aggressive adult T-cell leukemia/lymphoma
gefapixant Lyfnua sm refractory or unexplained chronic cough P2X3 and P2X2/3 receptor antagonist
nemolizumab Mitchga mAb unresolved itch associated with AD
ensitrelvir Xocova antiviral sm COVID-19
linzagolix Yselty sm uterine fibroids
Drug Approvals in 2021
INN Trade Name Type Indication Primary Target Comments
casirivimab  +  imdevimab Ronapreve mAb anti-Spike mAbs. Regeneron/Roche anti-Spike mAb cocktail. FDA EUA only
elasomeran Spikevax mRNA vaccine Coronavirus vaccines. Moderna (CX-024414). FDA EUA 18/12/2020; EMA approval 06/01/2021; MHRA 08/01/2021
vericiguat Verquvo sm To treat chronic heart failure soluble guanylate cyclase (sGC) activator
cabotegravir  +  rilpivirine Vocabria sm To treat HIV the combination cabotegravir and rilpivirine (Cabenuva) is what was actually approved, but rilpivirine was already approved
voclosporin Lupkynis pep To treat lupus nephritis calcineurin EMA OD 2012 for non-infectious uveitis
tepotinib Tepmetko KI To treat metastatic NSCLC with MET exon 14 skipping alterations MET kinase
umbralisib Ukoniq KI For the treatment of certain patients with marginal zone lymphoma and follicular lymphoma PI3K-delta, CK1-epsilon
bamlanivimab  +  etesevimab mAb To treat mild or moderate COVID-19 cases anti-Spike mAbs. Eli Lilly anti-Spike mAb cocktail. FDA EUA only
evinacumab Evkeeza mAb For the treatment of homozygous familial hypercholesterolemia ANGPTL3
trilaciclib Cosela KI myelopreservation therapy for patients receiving chemo for SCLC CDK4/4
casimersen Amondys 45 nuc For the treatment of Duchenne muscular dystrophy antisense oligonucleotide (phosphorodiamidate morpholino oligomer PMO), indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients with a confirmed mutation amenable to exon 45 skipping
fosdenopterin Nulibry sm To treat patients with the rare genetic disease molybdenum cofactor deficiency Type A cyclic pyranopterin monophosphate (cPMP) replacement therapy EMA OD (2010) molybdenum-cofactor deficiency type A
melphalan flufenamide Pepaxto sm To treat relapsed/refractory MM peptide-conjugated alkylator for the treatment of relapsed and refractory multiple myeloma (RRMM); targets melphalan to cancer cells with high expression of aminopeptidases. Approval based on response rate in HORIZON (NCT02963493) study EMA OD (2015) plasma cell myeloma
serdexmethylphenidate  +  dexmethylphenidate Azstarys sm To treat ADHD approved in fixed-dose comb with dexmethylphenidate (LID 7554)
tivozanib Fotivda KI To treat advanced relapsed/refractory RCC
ponesimod Ponvory sm To treat relapsing forms of MS S1P1 modulator
dasiglucagon Zegalogue sm To treat severe hypoglycemia
viloxazine Qelbree sm To treat ADHD
drospirenone  +  estetrol Nextstellis (US), Lydisilka (EMA), Drovelis (EMA) sm To prevent pregnancy
dostarlimab Jemperli mAb To treat endometrial cancer PD-1
loncastuximab tesirine Zynlonta ADC To treat relapsed or refractory B cell malignancies CD19
pegcetacoplan Empaveli pep To treat paroxysmal nocturnal hemoglobinuria C3 C3 inhibitor; EMA OD C3 glomerulopathy 2019
amivantamab Rybrevant mAb To treat NSCLC with EGFR exon 20 mutations
piflufolastat F 18 injection Pylarify sm For positron emission tomography imaging of prostate-specific membrane antigen-positive lesions in men with prostate cancer
samidorphan  +  olanzapine Lybalvi sm To treat schizophrenia in adults and certain aspects of bipolar I disorder in adults
sotorasib Lumakras sm To treat adults with non-small cell lung cancer whose disease meets certain criteria (KRAS G12C mutation +ve)
infigratinib Truseltiq sm To treat adults with cholangiocarcinoma whose disease meets certain criteria EMA OD 2020 cholangiocarcinoma
ibrexafungerp Brexafemme sm To treat vulvovaginal candidiasis
aducanumab Aduhelm mAb To treat Alzheimer's disease
asparaginase erwinia chrysanthemi (recombinant)-rywn Rylaze rec enz 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
belumosudil Rezurock sm To treat chronic graft-versus-host disease after failure of at least two prior lines of systemic therapy
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) EMA OD 2012 PFIC
anifrolumab Saphnelo mAb To treat moderate-to severe systemic lupus erythematousus along with standard therapy
avalglucosidase alfa-ngpt Nexviazyme pep To treat late-onset Pompe disease https://www.ema.europa.eu/en/medicines?search_api_views_fulltext=avalglucosidase
belzutifan Welireg sm To treat VHL disease-associated cancers
tozinameran Comirnaty mRNA vaccine Coronavirus vaccines. Pfizer/BioNtech. MHRA 02/12/2020; EMA 21/12/2020; FDA 23/08/2021
difelikefalin Korsuva sm To treat moderate-to-severe pruritus associated with chronic kidney disease in certain populations
lonapegsomatropin-tcgd Skytrofa pep To treat short stature due to inadequate secretion of endogenous growth hormone EMA OD growth hormone deficiency (2019)
mobocertinib Exkivity sm To treat NSCLC with EGFR exon 20 mutations
tisotumab vedotin Tivdak mAb To treat recurrent or metastatic cervical cancer with disease progression on or after chemotherapy
atogepant Qulipta sm For the preventive treatment of migraine
maralixibat Livmarli sm To treat cholestatic pruritus in patients with Alagille syndrome EMA OD for several cholestatic liver diseases (2014, 2020)
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 EMA for ANCA vasculitis & C3 glomerulopathy (2014, 2017)
asciminib Scemblix sm To treat CML EMA OD for CML (2020)
ropeginterferon alfa-2b-njft Besremi pep To treat polycythemia vera, a blood disease that causes the overproduction of red blood cells
vosoritide Voxzogo pep To improve growth in children five years of age and older with achondroplasia and open epiphyses
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 
tezepelumab Tezspire  mAb To treat severe asthma as an add-on maintenance therapy 
efgartigimod alfa Vyvgart pep To treat generalized myasthenia gravis EMA OD 2018 (MG), 2019 (ITP)
inclisiran Leqvio nuc To treat heterozygous familial hypercholesterolemia or clinical atherosclerotic cardiovascular disease as an add-on therapy
tralokinumab Adbry mAb To treat moderate-to-severe atopic dermatitis  EU trade name is Adtralza
levoketoconazole Recorlev sm To treat endogenous hypercortisolemia in adult patients with Cushing’s syndrome
nirmatrelvir  +  ritonavir Paxlovid sm To treat mild or moderate COVID-19, in at-risk patients Mpro SARS-CoV sm antivirals. Approved 31/12/2021 (MHRA). FDA EUA only
bimekizumab Bimzelx mAb To treat moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy
sugemalimab Cejemly mAb To treat EGFR gene mutation and anaplastic lymphoma kinase (ALK) negative metastatic NSCLC approved in China, December 2021
sotrovimab Xevudy mAb anti-Spike mAbs. GSK/Vir Biotechnology. FDA EUA only
tixagevimab  +  cilgavimab Evusheld mAb anti-Spike mAbs. AZ. FDA EUA only
pamiparib Partruvix sm To treat recurrent/advanced ovarian, fallopian tube or primary peritoneal cancers with germline BRCA mutations approved in China, April 2021
n/a Vaxzevria adenovirus vaccine Coronavirus vaccines. Oxford/AZ (ChAdOx1-S). MHRA 30/12/2020; EMA 29/01/2021
penpulimab n/a mAb To treat nasopharyngeal cancer and NSCLC approved in China, August 2021
n/a adenovirus vaccine Coronavirus vaccines. J&J/Janssen (JNJ-78436735, Ad26.COV2-S). EMA approval 11/03/2021, MHRA May 2021
zimberelimab n/a mAb To treat cervical cancer, non-small cell lung cancer, classical Hodgkin's lymphoma approved in China, August 2021
molnupiravir Lagevrio sm To treat mild or moderate COVID-19, in at-risk patients RNA-dependent RNA polymerase SARS-CoV sm antivirals. Approved 4/11/2021 (MHRA). FDA EUA only