nintedanib
nintedanib: developed by 2 companies · 5 clinical trials tracked · 1 FDA decision.
nintedanib evidence translation
What we can confirm
1 FDA record · 5 tracked trials
What it means
What to watch
Prepared research question
What is verified about nintedanib, and what remains unknown?
Traceable citations · Unknowns marked
See linked entities and source evidence6 indications · 2 study sponsors
Related indications
Development Pipeline (3)
| Company | Phase |
|---|---|
| GYRE THERAPEUTICS, INC. (GYRE) IPF, SSc-ILD, and Progressive Fibrosing Interstitial Lung Di… | Approved |
| DR REDDYS LABORATORIES LTD (RDY) | Approved |
| DR REDDYS LABORATORIES LTD (RDY) | Approved |
Clinical Trials (5)
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)
Primary endpoint: The absolute change from baseline in Forced Vital Capacity (FVC) in mL
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
Primary endpoint: The decrease in forced vital capacity (FVC) of the lungs
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
Primary endpoint: Maximum Plasma Concentration (Cmax) of NAL ER, Pirfenidone, and Nintedanib
A Single-center, Open-label Study Designed to Assess the Drug-drug Interaction of HEC585 And Pirfenidone/Nintedanib In Healthy Subjects
Primary endpoint: Area under the curve from 0 to 24 hours [AUC (0~24)]
A Phase II Randomized Study of Docetaxel With or Without NINTEDANIB (BIBF-1120) in Patient Receiving a First or Second-line of Chemotherapy for HER Negative Metastatic or Locally Recurrent Breast Cancer
Primary endpoint: Progression free survival (PFS) in patients receiving Docetaxel + Nintedanib treatment (Arm A) compared to Docetaxel alone (Arm B)
Frequently asked questions
Who is developing nintedanib?
nintedanib is being developed by GYRE THERAPEUTICS, INC., DR REDDYS LABORATORIES LTD.
How many clinical trials involve nintedanib?
BioSniper tracks 5 clinical trials involving nintedanib.
What is nintedanib's latest FDA decision?
The most recent tracked FDA decision for nintedanib is Approval, dated April 2, 2026.