PAH stands for pulmonary arterial hypertension, a progressive disease characterized by elevated pulmonary arterial pressure and vascular remodeling that can lead to right heart failure.
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.
Insmed reported total revenues of $606.4 million for 2025, with ARIKAYCE growing 19% annually. The FDA granted orphan drug designation to treprostinil palmitil for pulmonary arterial hypertension treatment in January 2026.
Zydus Lifesciences received USFDA final approval for 32 mg bosentan tablets for pediatric PAH and Ammonium Lactate Cream, 12%, while launching an affordable respiratory device in India.
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 |
|---|---|---|---|
| NCT07498803 |
Sota-ES - Sotatercept in Patients With Congenital Heart Disease and Eisenmenger´s Syndrome |
NOT_YET_RECRUITING | PHASE2 |
| NCT06973382 |
Effects of Pulmonary Rehabilitation on Quality of Life and Health in Pulmonary Arterial Hypertension Patients |
NOT_YET_RECRUITING | NA |
| NCT06553937 |
Bioequivalence Study of Macitentan and Tadalafil Film-coated Tablets 10 Mg/40 Mg and 'PrOpsynvi®' Macitentan and Tadalafil Film-coated Tablets 10 Mg/40 Mg |
COMPLETED | PHASE1 |
| NCT06553924 |
Macitentan and Tadalafil Film-coated Tablets 10 mg/40 mg and 'PrOpsynvi®' Macitentan and Tadalafil Film-coated Tablets 10 mg/40 mg |
COMPLETED | PHASE1 |
| NCT04796337 |
A Long-term Follow-up Study of Sotatercept for PAH Treatment (MK-7962-004/A011-12) |
ACTIVE_NOT_RECRUITING | PHASE3 |
| NCT04309838 |
Observation Study With Implantable Medication Pump for Intravenous Treprostinil Therapy in Patients With Pulmonary Arterial Hypertension |
UNKNOWN | |
| NCT04084678 |
A Study of Ralinepag to Evaluate Effects on Exercise Capacity by CPET in Subjects With WHO Group 1 PH |
TERMINATED | PHASE3 |
| NCT04053543 |
CXA-10 Study in Subjects With Pulmonary Arterial Hypertension |
TERMINATED | PHASE2 |
| NCT03683186 |
A Study Evaluating the Long-Term Efficacy and Safety of Ralinepag in Subjects With PAH Via an Open-Label Extension |
ENROLLING_BY_INVITATION | PHASE3 |
| NCT03626688 |
A Study Evaluating the Efficacy and Safety of Ralinepag to Improve Treatment Outcomes in PAH Patients |
COMPLETED | PHASE3 |
