Seralutinib
Seralutinib is a PDGFR/FGFR/CSF1R kinase inhibitor developed by Gossamer Bio for pulmonary arterial hypertension. The next event is the FDA decision on Seralutinib, expected Q3 2027 (source).
- Also known as
- GB002
- Company
- Gossamer Bio (GOSS) · Developer
- How it works
- PDGFR/FGFR/CSF1R kinase inhibitor
- Approved
- Not approved in any market we track
Development by disease
| Pulmonary arterial hypertension | Filed |
| Pulmonary hypertension associated with interstitial lung disease | Phase 3 (enrollment paused) |
Upcoming events
Estimated timing · a month, quarter, half-year or year-end the company gave
Expected in Q3 2027
- Q3 2027
Past results and milestones
- Sep 23, 2026Gossamer submitted the NDA for seralutinib in PAH to the FDA in September 2026, supported by Phase 3 PROSERA and Phase 2 TORREY data. The submission follows the June 2026 Pre-NDA Type B meeting in which the FDA stated that statistical significance and treatment effect magnitude are review issues rather than filing issues. Source
- Jul 27, 2026reportedThe planned Type C meeting was upgraded to an in-person Pre-NDA Type B meeting, held in mid-June 2026; FDA's official minutes characterized the degree of statistical significance and magnitude of treatment effect in Phase 3 PROSERA as review issues rather than filing issues, clearing the path for an NDA submission. Source
- Feb 23, 2026Phase 3 PROSERA topline results: primary endpoint (6MWD improvement at Week 24) not met (p=0.0320 vs 0.025 threshold). However, secondary endpoints favored seralutinib (NT-proBNP reduction, clinical improvement, risk score reduction), and prespecified intermediate-to-high risk subgroup demonstrated meaningful efficacy signal (p=0.0207). Source
- Nov 5, 2025First clinical site activated in Q4 2025 for SERANATA Phase 3 registrational trial in PH-ILD. Approximately 480 patients to be randomized 1:1:1 to seralutinib 90mg BID, 120mg BID, or placebo over 24 weeks. Source
- Jun 16, 2025PROSERA Phase 3 enrollment completed on June 11, 2025, with 390 PAH patients (Functional Class II/III) enrolled on background PAH therapy. Mean baseline 6MWD was 374 meters and mean NT-proBNP was 987 ng/L. Source