Nintedanib is a small-molecule tyrosine kinase inhibitor marketed as Ofev for fibrosing interstitial lung diseases. It is used in idiopathic pulmonary fibrosis and progressive fibrosing ILD settings, including systemic sclerosis-associated ILD. The FDA first approved Ofev on October 15, 2014.
Deupirfenidone, a deuterated form of pirfenidone, is set to be tested in a phase 3 trial this year after successful phase 2b results. The FDA and European Commission have granted orphan drug designation to support its late-stage development.
DelveInsight releases three separate pipeline reports covering metastatic prostate cancer (80+ companies, 85+ drugs), iPSC-derived NK cells (12+ companies, 15+ drugs), and interstitial lung diseases (120+ companies, 120+ drugs), highlighting recent regulatory approvals, trial launches, and emerging therapies.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07588646 |
Study To Investigate The Potential DDI Between HEC585 And Pirfenidone/Nintedanib In Healthy Subjects |
COMPLETED | PHASE1 |
| NCT07454291 |
A Study to Evaluate Pharmacokinetics and Drug-drug Interactions of ENV-101 (Taladegib) in Healthy Participants |
RECRUITING | PHASE1 |
| NCT07335562 |
A Study to Compare the Efficacy and Safety of BMS-986353 (Zolacabtagene- Autoleucel / Zola-cel), CD19-CAR T Cells, Versus Standard of Care in Participants With Active Systemic Sclerosis |
RECRUITING | PHASE3 |
| NCT07162961 |
Nintedanib for Improving Reproductive Outcomes in Adenomyosis |
NOT_YET_RECRUITING | PHASE3 |
| NCT07015398 |
A Study of the Pharmacokinetic Interaction Between Pirfenidone, Nintedanib, and Nalbuphine Extended Release (NAL ER) in Healthy Participants |
COMPLETED | PHASE1 |
| NCT06643091 |
Nintedanib Treatment in Unicentric Castleman Disease |
NOT_YET_RECRUITING | PHASE2 |
| NCT06625489 |
A Study to Evaluate the Safety, Tolerability and Blood Levels of GSK3915393 Administered to Healthy Participants of Chinese, Japanese and European Ancestry and to Assess Effects of GSK3915393 on Nintedanib |
COMPLETED | PHASE1 |
| NCT06570317 |
Nintedanib for the Prevention of Radiation Pneumonia in Unresectable NSCLC |
RECRUITING | |
| NCT06568458 |
A Study to Assess the Extent of Drug Interaction Between BMS-986278 and Nintedanib, the Relative Bioavailability of BMS-986278 in Tablet and the Effect That Food Has on BMS-986278 in Tablet Formulations in Healthy Participants |
COMPLETED | PHASE1 |
| NCT06485635 |
Real-life-persistence to Antifibrotic Treatments |
COMPLETED |
