Seralutinib is a novel investigational inhaled tyrosine kinase inhibitor being developed for pulmonary arterial hypertension and pulmonary hypertension associated with interstitial lung disease. In February 2026, Phase 3 PROSERA topline results in PAH showed activity but did not meet the prespecified alpha threshold for the primary endpoint, and the company planned FDA discussions on next steps. It is not approved for marketing.
Phase 3 trial results show seralutinib missed its primary endpoint in PAH but showed benefit in advanced disease subgroups. Meanwhile, Winrevair demonstrated significant reductions in pulmonary vascular resistance in heart failure-related pulmonary hypertension in a Phase 2 study.
Gossamer Bio's seralutinib narrowly missed its primary endpoint in the Phase 3 PROSERA study for pulmonary arterial hypertension, achieving a p-value of 0.0320 versus the prespecified threshold of 0.025, though showing stronger results in intermediate- and high-risk patients.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07181382 |
Efficacy and Safety of Seralutinib in Adult Subjects With Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD) |
SUSPENDED | PHASE3 |
| NCT06274801 |
Open-label Extension Study of Seralutinib in Adult Subjects With PAH (PROSERA-EXT) |
ACTIVE_NOT_RECRUITING | PHASE3 |
| NCT05934526 |
Efficacy and Safety of Seralutinib in Adult Subjects With PAH (PROSERA) |
COMPLETED | PHASE3 |
