TheraRadar

FDA First-in-Class Drug Approvals

192 novel drug approvals with the First-in-Class designation, 2016–2025.

First drug with a novel mechanism of action for a given disease. These approvals often open entirely new therapeutic categories and set the foundation for follow-on competition.

Key insights (2016–2025)

  • First-in-Class applies to 42% of all FDA novel drug approvals in this period (192 of 458 drugs).
  • Activity has held roughly steady at ~22/year in 2023–2025 vs 2020–2022. Peak year: 2021 with 27 approvals.
  • 124 unique sponsors received this designation; the top sponsor is Novartis (8 approvals). Top 5 sponsors account for 16% of all First-in-Class approvals.
  • 74% of First-in-Class drugs also received Priority Review designation — the most common pairing.

Approvals by year

2016 8 2017 15 2018 19 2019 20 2020 18 2021 27 2022 20 2023 20 2024 24 2025 21

All First-in-Class approvals

2025
ANDEMBRY (GARADACIMAB-GXII) CSL Behring
2025
2025
BLENREP (BELANTAMAB MAFODOTIN-BLMF) GSK
2025
BLUJEPA (GEPOTIDACIN MESYLATE) GSK
2025
BRINSUPRI (BRENSOCATIB) INSMED INC
2025
2025
EMRELIS (TELISOTUZUMAB VEDOTIN-TLLV) AbbVie
2025
FORZINITY (ELAMIPRETIDE HYDROCHLORIDE) STEALTH BIOTHERAPS
2025
JASCAYD (NERANDOMILAST) Boehringer Ingelheim
2025
2025
KYGEVVI (DOXECITINE) UCB INC
2025
LYNKUET (ELINZANETANT) Bayer
2025
MODEYSO (DORDAVIPRONE HYDROCHLORIDE) CHIMERIX
2025
NUZOLVENCE (ZOLIFLODACIN) ENTASIS THERAP
2025
QFITLIA (FITUSIRAN SODIUM) Sanofi
2025
REDEMPLO (PLOZASIRAN SODIUM) ARROWHEAD
2025
RHAPSIDO (REMIBRUTINIB) Novartis
2025
TRYPTYR (ACOLTREMON) Novartis
2025
VOYXACT (SIBEPRENLIMAB-SZSI) OTSUKA
2025
WAYRILZ (RILZABRUTINIB) Sanofi
2025
YARTEMLEA (NARSOPLIMAB-WUUG) OMEROS CORP
2024
ANKTIVA (nogapendekin alfa inbakicept-pmln) ALTOR BIOSCIENCE, LLC, AN INDIRECT WHOLLY-OWNED SU
2024
AQNEURSA (LEVACETYLLEUCINE) INTRABIO
2024
BIZENGRI (ZENOCUTUZUMAB-ZBCO) MERUS N.V.
2024
COBENFY (TROSPIUM CHLORIDE) Bristol-Myers Squibb
2024
CRENESSITY (CRINECERFONT) NEUROCRINE
2024
DUVYZAT (GIVINOSTAT HYDROCHLORIDE) ITALFARMACO SPA
2024
HYMPAVZI (MARSTACIMAB-HNCQ) Pfizer
2024
IMDELLTRA (TARLATAMAB-DLLE) Amgen
2024
IQIRVO (ELAFIBRANOR) IPSEN
2024
LUMISIGHT (PEGULICIANINE ACETATE) LUMICELL
2024
MIPLYFFA (ARIMOCLOMOL CITRATE) ZEVRA DENMARK
2024
NEMLUVIO (NEMOLIZUMAB-ILTO) GALDERMA LABS LP
2024
NIKTIMVO (axatilimab-csfr) INCYTE CORP
2024
REVUFORJ (REVUMENIB CITRATE) SYNDAX
2024
REZDIFFRA (RESMETIROM) MADRIGAL
2024
RYTELO (IMETELSTAT SODIUM) GERON
2024
2024
TRYVIO (APROCITENTAN) IDORSIA
2024
2024
VYLOY (ZOLBETUXIMAB-CLZB) ASTELLAS
2024
WINREVAIR (SOTATERCEPT-CSRK) Merck
2024
XOLREMDI (MAVORIXAFOR) X4 PHARMS
2024
ZELSUVMI (BERDAZIMER SODIUM) LNHC
2024
ZIIHERA (ZANIDATAMAB-HRII) JAZZ PHARMS
2023
DAYBUE (TROFINETIDE) ACADIA PHARMS INC
2023
DEFENCATH (HEPARIN SODIUM) CORMEDIX
2023
FABHALTA (IPTACOPAN HYDROCHLORIDE) Novartis
2023
FILSPARI (SPARSENTAN) TRAVERE
2023
FILSUVEZ (BIRCH TRITERPENES) CHIESI
2023
JESDUVROQ (DAPRODUSTAT) GSK
2023
JOENJA (LENIOLISIB PHOSPHATE) PHARMING
2023
LAMZEDE (VELMANASE ALFA-TYCV) CHIESI FARMACEUTICI SPA
2023
MIEBO (PERFLUOROHEXYLOCTANE) BAUSCH AND LOMB
2023
OGSIVEO (NIROGACESTAT HYDROBROMIDE) SPRINGWORKS
2023
PAXLOVID (COPACKAGED) (NIRMATRELVIR) Pfizer
2023
QALSODY (TOFERSEN) Biogen
2023
RIVFLOZA (NEDOSIRAN SODIUM) Novo Nordisk
2023
SKYCLARYS (OMAVELOXOLONE) Biogen
2023
SOHONOS (PALOVAROTENE) IPSEN
2023
TALVEY (TALQUETAMAB-TGVS) Johnson & Johnson
2023
TRUQAP (CAPIVASERTIB) AstraZeneca
2023
VEOPOZ (POZELIMAB-BBFG) Regeneron
2023
VEOZAH (FEZOLINETANT) ASTELLAS
2023
XDEMVY (LOTILANER) TARSUS
2022
2022
ELAHERE (MIRVETUXIMAB SORAVTANSINE-GYNX) IMMUNOGEN INC
2022
2022
KIMMTRAK (TEBENTAFUSP-TEBN) IMMUNOCORE LTD
2022
LUNSUMIO (MOSUNETUZUMAB-AXGB) Roche
2022
MOUNJARO (TIRZEPATIDE) Eli Lilly
2022
2022
PLUVICTO (LUTETIUM LU-177 VIPIVOTIDE TETRAXETAN) Novartis
2022
PYRUKYND (MITAPIVAT SULFATE) AGIOS PHARMS INC
2022
SOTYKTU (DEUCRAVACITINIB) Bristol-Myers Squibb
2022
SPEVIGO (SPESOLIMAB-SBZO) Boehringer Ingelheim
2022
SUNLENCA (LENACAPAVIR SODIUM) Gilead Sciences
2022
TECVAYLI (TECLISTAMAB-CQYV) Johnson & Johnson
2022
TERLIVAZ (TERLIPRESSIN ACETATE) MALLINCKRODT IRELAND
2022
TZIELD (TEPLIZUMAB-MZWV) PROVENTION BIO INC
2022
2022
VTAMA (TAPINAROF) Merck
2022
XENOVIEW (XENON XE-129 HYPERPOLARIZED) POLAREAN
2022
XENPOZYME (OLIPUDASE ALFA-RPCP) Sanofi
2022
ZTALMY (GANAXOLONE) IMMEDICA PHARMA
2021
ADBRY (TRALOKINUMAB) LEO PHARMA AS
2021
ADUHELM (ADUCANUMAB-AVWA) Biogen
2021
BESREMI (ROPEGINTERFERON ALFA-2B-NJFT) PHARMAESSENTIA CORP
2021
BREXAFEMME (IBREXAFUNGERP CITRATE) GSK
2021
BYLVAY (ODEVIXIBAT) IPSEN
2021
COSELA (TRILACICLIB DIHYDROCHLORIDE) PHARMACOSMOS
2021
CYTALUX (PAFOLACIANINE SODIUM) ON TARGET LABS
2021
EMPAVELI (PEGCETACOPLAN) APELLIS PHARMS
2021
EVKEEZA (EVINACUMAB-DGNB) Regeneron
2021
KERENDIA (FINERENONE) Bayer
2021
KORSUVA (DIFELIKEFALIN ACETATE) VIFOR INTL
2021
LEQVIO (INCLISIRAN SODIUM) Novartis
2021
LIVTENCITY (MARIBAVIR) Takeda
2021
LUMAKRAS (SOTORASIB) Amgen
2021
LUPKYNIS (VOCLOSPORIN) AURINIA
2021
NEXVIAZYME (AVALGLUCOSIDASE ALFA-NGPT) Sanofi
2021
NULIBRY (FOSDENOPTERIN HYDROBROMIDE) SENTYNL THERAPS INC
2021
REZUROCK (BELUMOSUDIL MESYLATE) KADMON PHARMS LLC
2021
RYBREVANT (AMIVANTAMAB-VMJW) Johnson & Johnson
2021
SAPHNELO (ANIFROLUMAB-FNIA) AstraZeneca
2021
TEZSPIRE (TEZEPELUMAB-EKKO) AstraZeneca
2021
TIVDAK (TISOTUMAB VEDOTIN-TFTV) SEAGEN
2021
VERQUVO (VERICIGUAT) Merck
2021
VOXZOGO (VOSORITIDE) BIOMARIN PHARM
2021
VYVGART (EFGARTIGIMOD ALFA) ARGENX BV
2021
WELIREG (BELZUTIFAN) Merck
2021
ZYNLONTA (LONCASTUXIMAB TESIRINE-LPYL) ADC Therapeutics SA
2020
ENSPRYNG (SATRALIZUMAB) Roche
2020
IMCIVREE (SETMELANOTIDE ACETATE) RHYTHM
2020
INMAZEB (ATOLTIVIMAB) Regeneron
2020
ISTURISA (OSILODROSTAT PHOSPHATE) RECORDATI RARE
2020
KLISYRI (TIRBANIBULIN) ALMIRALL
2020
KOSELUGO (SELUMETINIB SULFATE) AstraZeneca
2020
MONJUVI (TAFASITAMAB-CXIX) MORPHOSYS US INC
2020
NEXLETOL (BEMPEDOIC ACID) ESPERION THERAPS INC
2020
OXLUMO (LUMASIRAN SODIUM) ALNYLAM PHARMS INC
2020
RUKOBIA (FOSTEMSAVIR TROMETHAMINE) VIIV HLTHCARE
2020
TAUVID (FLORTAUCIPIR F-18) AVID RADIOPHARMS INC
2020
TAZVERIK (TAZEMETOSTAT HYDROBROMIDE) EPIZYME INC
2020
TRODELVY (SACITUZUMAB GOVITECAN-HZIY) IMMUNOMEDICS INC
2020
UPLIZNA (INEBILIZUMAB-CDON) VIELA BIO
2020
VEKLURY (REMDESIVIR) Gilead Sciences
2020
WINLEVI (CLASCOTERONE) Sun Pharma
2020
XEGLYZE (ABAMETAPIR) LNHC
2020
2019
ADAKVEO (CRIZANLIZUMAB-TMCA) Novartis
2019
BALVERSA (ERDAFITINIB) Johnson & Johnson
2019
CABLIVI (CAPLACIZUMAB-YHDP) ABLYNX NV
2019
EVENITY (ROMOSOZUMAB-AQQG) Amgen
2019
GIVLAARI (GIVOSIRAN SODIUM) ALNYLAM PHARMS INC
2019
IBSRELA (TENAPANOR HYDROCHLORIDE) ARDELYX INC
2019
NOURIANZ (ISTRADEFYLLINE) KYOWA KIRIN
2019
2019
PADCEV (ENFORTUMAB VEDOTIN-EJFV) ASTELLAS
2019
POLIVY (POLATUZUMAB VEDOTIN-PIIQ) Roche
2019
2019
REBLOZYL (LUSPATERCEPT-AAMT) Bristol-Myers Squibb
2019
REYVOW (LASMIDITAN SUCCINATE) Eli Lilly
2019
SCENESSE (AFAMELANOTIDE) CLIVUNEL INC
2019
TURALIO (PEXIDARTINIB HYDROCHLORIDE) DAIICHI SANKYO INC
2019
VYLEESI (AUTOINJECTOR) (BREMELANOTIDE ACETATE) COSETTE
2019
VYNDAQEL (TAFAMIDIS MEGLUMINE) FOLDRX PHARMS
2019
WAKIX (PITOLISANT HYDROCHLORIDE) HARMONY
2019
2019
ZULRESSO (BREXANOLONE) SAGE THERAP
2018
AIMOVIG (ERENUMAB-AOOE) Amgen
2018
CRYSVITA (BUROSUMAB-TWZA) KYOWA KIRIN
2018
ELZONRIS (TAGRAXOFUSP-ERZS) STEMLINE THERAPEUTICS INC
2018
GALAFOLD (MIGALASTAT HYDROCHLORIDE) AMICUS THERAP US
2018
GAMIFANT (EMAPALUMAB-LZSG) NOVIMMUNE S.A.
2018
LUCEMYRA (LOFEXIDINE HYDROCHLORIDE) BIOCORRX PHARMS
2018
LUTATHERA (LUTETIUM LU 177 DOTATATE) AAA USA INC
2018
ONPATTRO (PATISIRAN SODIUM) ALNYLAM PHARMS INC
2018
ORILISSA (ELAGOLIX SODIUM) AbbVie
2018
OXERVATE (CENEGERMIN-BKBJ) DOMPE FARMACEUTICI
2018
PALYNZIQ (PEGVALIASE-PQPZ) BIOMARIN PHARM
2018
POTELIGEO (MOGAMULIZUMAB-KPKC) KYOWA KIRIN
2018
TAVALISSE (FOSTAMATINIB DISODIUM) RIGEL PHARMS
2018
TEGSEDI (INOTERSEN SODIUM) AKCEA THERAPS
2018
TIBSOVO (IVOSIDENIB) SERVIER
2018
TPOXX (TECOVIRIMAT) SIGA TECHNOLOGIES
2018
TROGARZO (IBALIZUMAB-UIYK) THERATECHNOLOGIES
2018
VITRAKVI (LAROTRECTINIB SULFATE) Bayer
2018
XOFLUZA (BALOXAVIR MARBOXIL) Roche
2017
BESPONSA (INOTUZUMAB OZOGAMICIN) Pfizer
2017
BRINEURA (CERLIPONASE ALFA) BIOMARIN PHARM
2017
DUPIXENT (DUPILUMAB) Regeneron
2017
EMFLAZA (DEFLAZACORT) PTC THERAP
2017
GIAPREZA (ANGIOTENSIN II ACETATE) LA JOLLA PHARMA
2017
HEMLIBRA (EMICIZUMAB) Roche
2017
IDHIFA (ENASIDENIB MESYLATE) Bristol-Myers Squibb
2017
MACRILEN (MACIMORELIN ACETATE) AETERNA ZENTARIS
2017
MEPSEVII (VESTRONIDASE ALFA-VJBK) ULTRAGENYX PHARM INC
2017
OCREVUS (OCRELIZUMAB) Roche
2017
PREVYMIS (LETERMOVIR) Merck
2017
RADICAVA (EDARAVONE) SHIONOGI
2017
RHOPRESSA (NETARSUDIL MESYLATE) Novartis
2017
RYDAPT (MIDOSTAURIN) Novartis
2017
XERMELO (TELOTRISTAT ETIPRATE) TERSERA
2016
CINQAIR (RESLIZUMAB) Teva
2016
DEFITELIO (DEFIBROTIDE SODIUM) JAZZ PHARMS
2016
NUPLAZID (PIMAVANSERIN TARTRATE) ACADIA PHARMS INC
2016
RUBRACA (RUCAPARIB CAMSYLATE) PHARMAAND
2016
SPINRAZA (NUSINERSEN SODIUM) Biogen
2016
TECENTRIQ (ATEZOLIZUMAB) Roche
2016
VENCLEXTA (VENETOCLAX) AbbVie
2016
ZINPLAVA (BEZLOTOXUMAB) Merck

Other FDA designations

Designation data from FDA Center for Drug Evaluation and Research (CDER) annual New Drug Therapy Approvals reports, 2016–2025. Each drug is counted once per the year of its novel approval; many drugs hold multiple designations.