nintedanib
nintedanib: sourced relationships with 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 · 1 study sponsors
Related indications
Study sponsors
Dated Pipeline Records (3)
| Company | Dated record stage |
|---|---|
| GYRE THERAPEUTICS, INC. (GYRE) IPF, SSc-ILD, and Progressive Fibrosing Interstitial Lung Di… | Approved |
| DR REDDYS LABORATORIES LTD (RDY) Reported 2026-04-02 · Current development: unknownSource | Approved |
| DR REDDYS LABORATORIES LTD (RDY) Reported 2026-04-02 · Current development: unknownSource | Approved |
Clinical Trial Registry Records (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
Which companies have sourced relationships with nintedanib?
nintedanib has dated SEC/FDA relationship records for 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.