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Drug

Nintedanib

Approved · FDA / EMA
Late-stage development

Also known as Ofev.

RxNorm1592737ChEMBLCHEMBL502835UNIIG6HRD2P839
10
Active clinical trials
6
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Approval: NINTEDANIB (ANDA212555)

Regulatory2026-07-09FDA

Approval: NINTEDANIB (ANDA218472)

Regulatory2026-07-09FDA

A Single-center, Randomized, Prospective, Controlled Clinical Study on the Efficacy of Nintedanib in Improving Reproductive Outcomes in Women With Adenomyosis

Clinical trial2026-06-30Primary completion · ClinicalTrials.gov

A Phase 3, Randomized, Open-label, Multicenter Study to Compare the Efficacy and Safety of BMS-986353, CD19-targeted NEX-T CAR T Cells, Versus Standard of Care in Participants With Active Systemic Sclerosis (Breakfree-SSc)

Clinical trial2026-06-15Results expected Q4 2028 · ClinicalTrials.gov

A Phase 1, Open-Label Study to Evaluate Pharmacokinetics and Drug-drug Interactions of ENV-101 in Healthy Participants

Clinical trial2026-05-15Results expected Q4 2026 · ClinicalTrials.gov

Early Nintedanib Deployment in COVID-19 Interstitial Lung Disease

Clinical trial2026-04-30Results posted · ClinicalTrials.gov

Multicentre Clinical Trial Evaluating the Safety and Efficacy of the Combination of Nintedanib+Tocilizumab Compared to Standard Treatment in Patients With Systemic Sclerosis and Interstitial Lung Disease. Analysis With Theranostic Approach

Clinical trial2026-04-08Results expected Q4 2027 · ClinicalTrials.gov

Phase I/II Study of Nivolumab and Ipilimumab Combined With Nintedanib in Non Small Cell Lung Cancer

Clinical trial2026-04-02Results posted · ClinicalTrials.gov

Phase II Multicentric Randomized Study on Efficacy of Nintedanib for Treatment of Epistaxis in Hereditary Hemorrhagic Telangiectasia (HHT) Patients

Clinical trial2026-03-11Results expected Q4 2026 · ClinicalTrials.gov

An Open-label Trial of the Long-term Safety and Tolerability of Nintedanib Per os, on Top of Standard of Care, Over at Least 3 Years, in Children and Adolescents With Clinically Significant Fibrosing Interstitial Lung Disease (InPedILD®-ON)

Clinical trial2026-03-04Results posted · ClinicalTrials.gov

Approval: Nintedanib Viatris (EMA)

Regulatory2025-08-22EMA

Approval: Nintedanib Accord (EMA)

Regulatory2024-04-19EMA

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Nintedanib
Aliases & brands
Ofev
RxNorm CUI
1592737
ChEMBL ID
CHEMBL502835
UNII
G6HRD2P839
Regulatory jurisdictions
emafda

Regulatory timeline

6 events

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2014-11-21
Latest approval
2026-07-09
Authorities
FDA · EMA
Total events
6
fdaU.S. Food and Drug Administration· 2 events
2026-07-09Approval
Approval: NINTEDANIB (ANDA212555)
Evidence ↗
2026-07-09Approval
Approval: NINTEDANIB (ANDA218472)
Evidence ↗
emaEuropean Medicines Agency· 4 events
2025-08-22Approval
Approval: Nintedanib Viatris (EMA)
Indication: Nintedanib Viatris is indicated in adults for the treatment of idiopathic pulmonary fibrosis (IPF). Nintedanib Viatris is also indicated in adults for the treatment of other… Show full indication

Nintedanib Viatris is indicated in adults for the treatment of idiopathic pulmonary fibrosis (IPF). Nintedanib Viatris is also indicated in adults for the treatment of other chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype. Nintedanib Viatris is indicated in children and adolescents from 6 to 17 years old for the treatment of clinically significant, progressive fibrosing interstitial lung diseases (ILDs). Nintedanib Viatris is indicated in adults, adolescents and children aged 6 years and older for the treatment of systemic sclerosis associated interstitial lung disease (SSc-ILD).

Evidence ↗
2024-04-19Approval
Approval: Nintedanib Accord (EMA)
Indication: Nintedanib Accord is indicated in adults for the treatment of idiopathic pulmonary fibrosis (IPF). Nintedanib Accord is also indicated in adults for the treatment of other… Show full indication

Nintedanib Accord is indicated in adults for the treatment of idiopathic pulmonary fibrosis (IPF). Nintedanib Accord is also indicated in adults for the treatment of other chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype (see section 5.1). Nintedanib Accord is indicated in adults for the treatment of systemic sclerosis associated interstitial lung disease (SSc-ILD). Nintedanib Accord is indicated in adults for the treatment of idiopathic pulmonary fibrosis (IPF). Nintedanib Accord is also indicated in adults for the treatment of other chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype. Nintedanib Accord is indicated in children and adolescents from 6 to 17 years old for the treatment of clinically significant, progressive fibrosing interstitial lung diseases (ILDs). Nintedanib Accord is indicated in adults, adolescents and children aged 6 years and older for the treatment of systemic sclerosis associated interstitial lung disease (SSc-ILD).

Evidence ↗
2015-01-14Accelerated approval
Accelerated approval: Ofev (EMA)

Indication: Ofev is indicated in adults for the treatment of Idiopathic Pulmonary Fibrosis (IPF).

Evidence ↗

Data from the U.S. Food and Drug Administration (U.S. Food and Drug Administration), public domain (CC0).

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

90 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
90
registered trials across all phases
LATEST COMPLETION 2026
10
Active studies
8
Recruiting
30
Late-stage (III+)
60
Completed
20
Discontinued
PHASE DISTRIBUTIONn = 90
Phase 130Phase 1 / 24Phase 226Phase 2 / 32Phase 319Phase 49

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

A Randomised Controlled Trial to Study the Efficacy and Safety of Nintedanib in Fibrotic Sarcoidosis

RecruitingPH IVPost Graduate Institute of Medical Education and Research, Chandigarhn=1202026

Nintedanib Plus Standard of Care Immunosuppression Versus Standard of Care Immunosuppression Alone in Patients With Progressive Fibrotic Myositis Associated - Interstitial Lung Disease: A Randomized, Double-Blind, Exploratory Trial

CompletedPH IVRohit Aggarwal, MDn=492025

Early Nintedanib Deployment in COVID-19 Interstitial Lung Disease

CompletedPH IVIcahn School of Medicine at Mount Sinain=1032024

A Study of the Efficacy and Safety of Pirfenidone vs. Nintedanib in the Treatment of Fibrotic Lung Disease After Coronavirus Disease-19 Pneumonia

Unknown statusPH IVPost Graduate Institute of Medical Education and Research, Chandigarhn=482022

Study of Pulmonary Rehabilitation In Nintedanib Treated Patients With IPF: Improvements in Activity, Exercise Endurance Time, and QoL

TerminatedPH IVBoehringer Ingelheimn=192020

Recent completions

Trials that read out recently, adding to the completed evidence base.

Phase Ib Trial Of Pembrolizumab And Nintedanib

CompletedPH IGustave Roussy, Cancer Campus, Grand Parisn=1962026

Nintedanib Plus Standard of Care Immunosuppression Versus Standard of Care Immunosuppression Alone in Patients With Progressive Fibrotic Myositis Associated - Interstitial Lung Disease: A Randomized, Double-Blind, Exploratory Trial

CompletedPH IVRohit Aggarwal, MDn=492025

A Phase 1, Two-Part, Open-Label Drug-Drug Interaction Study to Evaluate the Steady State Pharmacokinetics and Safety Following Co-Administration of Nalbuphine Extended-Release Tablets (NAL ER), and Pirfenidone or Nintedanib in Healthy Adult Subjects

CompletedPH ITrevi Therapeuticsn=1322025

An Open-label Trial of the Long-term Safety and Tolerability of Nintedanib Per os, on Top of Standard of Care, Over at Least 3 Years, in Children and Adolescents With Clinically Significant Fibrosing Interstitial Lung Disease (InPedILD®-ON)

CompletedPH IIIBoehringer Ingelheimn=542025

A Pilot Study of Nintedanib in Molecularly Selected Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)

CompletedPH IIWashington University School of Medicinen=202025

A Multi-center, Randomised, Double-blind Trial of Nintedanib in Lung Transplant (LTx) Recipients With Bronchiolitis Obliterans Syndrome (BOS) Grade 0p-1-2

CompletedPH IIIAssistance Publique - Hôpitaux de Parisn=582025
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.