Seralutinib is an investigational, inhaled, small molecule, inhibitor of platelet-derived growth factor receptor (PDGFR), colony-stimulating factor 1 receptor (CSF1R) and mast/stem cell growth factor receptor kit (c-KIT). It was intentionally designed to target the mechanisms that underlie pulmonary hypertension and to be delivered to the site of disease, via dry powder inhaler.
Seralutinib completed a phase 3 clinical trial for the treatment of pulmonary arterial hypertension (PAH), the PROSERA Study. Additionally, Gossamer Bio activated the first clinical sites for a global phase 3 registrational clinical trial for the treatment of pulmonary hypertension associated with interstitial lung disease (PH-ILD) in 4Q25 but has since paused enrollment while it evaluates the implications of the PROSERA Study.
Seralutinib Clinical Development
| Indication | Phase 1 | Phase 2 | Phase 3 |
|---|---|---|---|
| PAH | Phase 3 PROSERA Study Completed | ||
| PH-ILD | First Ph.3 clinical site activated in 4Q25, but enrollment paused while the Company evaluates implications of PROSERA results | ||
| Phase 1 | Phase 2 | Phase 3 |
| PAHPhase 3 PROSERA Study Completed | ||
| PH-ILDFirst Ph.3 clinical site activated in 4Q25, but enrollment paused while the Company evaluates implications of PROSERA results | ||
