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nintedanib

Trade name: ofev

Small moleculeapprovedOrphan Drug FDAFast Track FDABreakthrough Therapy FDA

Approved

Oct 15, 2014

Nintedanib is a receptor tyrosine kinase inhibitor with potential antiangiogenic and antineoplastic activities. It is the only kinase inhibitor drug approved to treat idiopathic pulmonary fibrosis. that targets multiple receptor tyrosine kinases (RTKs) and non-receptor tyrosine kinases (nRTKs). Nintedanib inhibits the following RTKs: platelet-derived growth factor receptor (PDGFR) α and β, fibroblast growth factor receptor (FGFR) 1-3, vascular endothelial growth factor receptor (VEGFR) 1-3, and Fms-like tyrosine kinase-3 (FLT3). Among them, FGFR, PDGFR, and VEGFR have been implicated in IPF pathogenesis. Nintedanib binds competitively to the adenosine triphosphate (ATP) binding pocket of these receptors and blocks the intracellular signaling which is crucial for the proliferation, migration, and transformation of fibroblasts representing essential mechanisms of the IPF pathology. — NCATS

Clinical trial activity

164 trials · 109 clinical orgs · 8 marketing orgs

Phase 1
70
Phase 2
87
Phase 3
25
Phase 4
11

Earliest trial started Nov 1, 2002 (NCT01951846)

Timeline

2000s

  1. Jan 1, 2002

    Boehringer Ingelheim — Earliest Phase 1 Sponsor(trial)

  2. Jan 1, 2005

    Boehringer Ingelheim — Earliest Phase 2 Sponsor(trial)

  3. Jan 1, 2008

    Boehringer Ingelheim — Earliest Phase 3 Sponsor(trial)

2010s

  1. Jun 29, 2011

    Orphan Drug Designation

  2. Oct 15, 2014

    Boehringer Ingelheim — Earliest FDA Approval

  3. Oct 15, 2014

    Boehringer Ingelheim — NDA Secondary Org

  4. Oct 15, 2014

    Boehringer Ingelheim — NDA Organization

2020s

  1. Aug 4, 2020

    Accord Research — Marketing Organization

  2. Jun 22, 2021

    Glenmark Pharmaceuticals — Marketing Organization

  3. May 12, 2022

    Eugia Pharma — Marketing Organization

  4. Jan 12, 2023

    Lotus Pharmaceutical — Marketing Organization

  5. Jan 12, 2023

    Alvogen — Marketing Organization

  6. Jul 2, 2025

    Cipla — Marketing Organization

  7. Aug 15, 2025

    Teva — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedPriority reviewFast trackBreakthroughOct 15, 2014

Chemistry & pharmacology

Loading structure…

SMILES

COC(=O)c1ccc2c(c1)NC(=O)/C2=C(\Nc1ccc(N(C)C(=O)CN2CCN(C)CC2)cc1)c1ccccc1
Mol. weight
539.64 g/mol
Lipinski Ro5
1 violation(s)
Rule of 3
No
Chirality
Achiral Molecule
Inorganic
No
Polymer
No
Delivery
Oral
Availability
Prescription Only

Oral

Yes

Parenteral

No

Topical

No

First in class

Sources

Also known as

  • bibf1120
  • bibf1120
  • bibf1120
  • bibf1120
  • bibf1120
  • bibf1120
  • bibf 1120
  • bibf 1120
  • bibf 1120
  • bibf 1120
  • bibf-1120
  • bibf-1120
  • bibf-1120
  • cbt-001
  • intedanib
  • methyl (3z)-3-[(4-{methyl[(4-methylpiperazin-1-yl)acetyl]amino}anilino)(phenyl)methylidene]-2-oxo-2,3-dihydro-1h-indole-6-carboxylate
  • methyl (3z)-3-[(4-{methyl[(4-methylpiperazin-1-yl)acetyl]amino}anilino)(phenyl)methylidene]-2-oxo-2,3-dihydro-1h-indole-6-carboxylate
  • methyl (3z)-3-(((4-(n-methyl-2-(4-methylpiperazin-1-yl)acetamido)phenyl)amino)(phenyl)methylidene)-2-oxo-2,3-dihydro-1h-indole-6-carboxylate
  • nibtedanib
  • nintedanib
  • nintedanib
  • nintedanib
  • nintedanib
  • nintedanib
  • nintedanib
  • nintedanib
  • nintedanib
  • nintedanib
  • nintedanib
  • nintedanib (bibf 1120)
  • nintedanib esylate
  • nintedanib esylate
  • nintedanib esylate
  • nintedanib esylate
  • nintedanib esylate
  • nintedanib ethanesulfonate
  • ofev
  • ofev
  • ofev
  • ofev
  • ofev
  • vargatef
  • vargatef

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07229716Phase 1Nov 30, 2025Hengrui Therapeutics, Inc.
NCT07308041Phase 1Nov 11, 2025Cinclus Pharma AG
NCT07141810Phase 4Oct 1, 2025Huazhong University of Science and Technology
NCT07162961Phase 3Sep 1, 2025Sun Yat-Sen University
NCT07015398Phase 1Jun 30, 2025Trevi Therapeutics
NCT06717100Phase 1Dec 31, 2024Novotech, PureTech
NCT06643091Phase 2Nov 1, 2024Assistance Publique - Hôpitaux de Paris
NCT06625489Phase 1Oct 3, 2024GlaxoSmithKline
NCT06568458Phase 1Sep 19, 2024Bristol-Myers Squibb
NCT06479603Phase 4Jun 30, 2024Postgraduate Institute of Medical Education and Research
NCT06297096Phase 3Apr 1, 2024Government of Poland
NCT05635071Phase 2/Phase 3 (Phase 3)Dec 1, 2023Sun Yat-Sen University
NCT06070610Phase 1Nov 8, 2023Boehringer Ingelheim
NCT06071013Phase 1/Phase 2 (Phase 2)Sep 28, 2023China Medical University
NCT06151587Phase 3Aug 20, 2023Qilu Pharmaceutical Co., Ltd.
NCT05799755Phase 4Aug 1, 2023Boehringer Ingelheim, University of Pittsburgh
NCT05817240Phase 1May 3, 2023Endeavor Biomedicines, Endeavor Biomedicines, Inc.
NCT05830799Phase 1Mar 29, 2023Clinical Trial Consultants AB, Vicore Pharma AB
NCT05195918Phase 1Mar 1, 2023Cornell University, Harvard University, Temple University, University of California, San Francisco, University of Michigan, University of Washington
NCT05644600Phase 1Jan 10, 2023AstraZeneca, Parexel
Showing 20 of 164 trials
Page 1 / 9

Organizations

Research & Development (109)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Boehringer IngelheimFor profit1057452002
National Cancer Institute (NCI)Government7022011
European Organisation for Research and Treatment of CancerAcademic/Hospital5412014
State University of New York, BuffaloAcademic/Hospital4412014
ARCAGY-GINECOFor profit3112012
Assistance Publique - Hôpitaux de ParisAcademic/Hospital3322018
Cornell UniversityAcademic/Hospital3222014
Katholieke Universiteit LeuvenAcademic/Hospital3112014
National Comprehensive Cancer NetworkAcademic/Hospital3022015
University of Texas at HoustonAcademic/Hospital3222011
Aktion Bronchialkarzinom e.V.Academic/Hospital2212013
CelgeneFor profit2122017
Cloudbreak Therapeutics, LLCFor profit2222017
Harvard UniversityAcademic/Hospital2122012
Huazhong University of Science and TechnologyAcademic/Hospital2222020
Institut Gustave RoussyAcademic/Hospital2122014
Nordic Society for Gynaecologic OncologyAcademic/Hospital2112015
North Eastern Germany Society of Gynaecologic OncologyAcademic/Hospital2012014
Philipps University of MarburgAcademic/Hospital2012013
Postgraduate Institute of Medical Education and ResearchAcademic/Hospital2212021
109 organizations
Page 1 / 6

Marketing (9)

OrganizationOrg typeRelationshipDate
Accord ResearchFor profitMKTGAug 4, 2020
AlvogenFor profitMKTGJan 12, 2023
Boehringer IngelheimFor profitNDA2Oct 15, 2014
Boehringer IngelheimFor profitNDAOct 15, 2014
CiplaFor profitMKTGJul 2, 2025
Eugia PharmaFor profitMKTGMay 12, 2022
Glenmark PharmaceuticalsFor profitMKTGJun 22, 2021
Lotus PharmaceuticalFor profitMKTGJan 12, 2023
TevaFor profitMKTGAug 15, 2025