IPF Development Map 2025: Approvals and Discontinuations
Analysis of the latest trends in the IPF field in 2025. Visualizing a year of contrasts with Boehringer Ingelheim's first new approval in over a decade, United Therapeutics' Phase 3 success, and Pliant's discontinuation.
Introduction
IPF (Idiopathic Pulmonary Fibrosis) is a disease with a poor prognosis, having a median survival of 3-5 years from diagnosis, and there has been a long-standing desire for new therapeutic agents. The year 2025 was one of contrasts, seeing the birth of the first new approved drug in over a decade, while simultaneously witnessing the discontinuation of promising development candidates.
This article analyzes the IPF development race in 2025 from the perspectives of approvals and discontinuations.
IPF: Contrasts Between Approvals and Discontinuations
Approvals
Boehringer Ingelheim - Nerandomilast (Jascayd)
- Phase 3 FIBRONEER-IPF trial met primary endpoint in September 20241
- FDA approval obtained in October 2025, the first new IPF treatment in over a decade2
- Boehringer Ingelheim also markets IPF drug Ofev, strengthening its leadership in the IPF space3
Phase 3 Ongoing
United Therapeutics - Tyvaso (treprostinil)
- TETON-2 pivotal trial met primary endpoint (2025)45
- Showed statistically significant improvement in absolute FVC (forced vital capacity) compared to placebo after 52 weeks of treatment4
- Plans to meet with FDA by end of 2025 to pursue expansion to IPF indication56
Bristol Myers Squibb - BMS-986278 (Admilparant)
- Oral small molecule LPA1 (lysophosphatidic acid receptor 1) antagonist78
- Phase 3 ALOFT program (ALOFT-IPF and ALOFT-PPF) ongoing79
- Received FDA Breakthrough Therapy Designation, Fast-Track Designation, and Orphan Drug Designation8
Discontinuations
Pliant Therapeutics - Bexotegrast
- Phase 2b/3 BEACON-IPF trial discontinued in February/March 20251011
- Independent data safety monitoring board recommended discontinuation due to unfavorable risk-benefit profile with imbalance in IPF-related adverse events compared to placebo1011
- Implemented organizational restructuring and workforce reduction in May 202512
Industry Map: Visualizing IPF Development
The following Mermaid diagram visualizes the major approvals and development status in the IPF space in 2025.
Legend:
- 🟢 Green: Approved/Successful companies
- 🔴 Red: Discontinued companies
Analysis: Contrasts in IPF and Future Outlook
In the IPF space, while Boehringer Ingelheim's Nerandomilast achieved the first new approval in over a decade, Pliant's Bexotegrast was discontinued due to safety issues. This underscores the high safety risks inherent in fibrotic disease drug development.
The successful Nerandomilast and Tyvaso (inhalation) are expected to offer new therapeutic options for IPF treatments through different approaches.
Conclusion
The year 2025 was a monumental one for the IPF field, breaking a long silence with the arrival of Nerandomilast. On the other hand, the discontinuation of Bexotegrast illustrates the difficulties of drug discovery. Moving forward, the market penetration of Nerandomilast and the progress of follow-on drugs like Tyvaso and BMS-986278 will be closely watched.