A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Oral Inhalation of Seralutinib for the Treatment of Pulmonary Arterial Hypertension (PAH)
Latest Information Update: 23 Mar 2025
At a glance
- Drugs Seralutinib (Primary)
- Indications Pulmonary arterial hypertension
- Focus Registrational; Therapeutic Use
- Acronyms PROSERA
- Sponsors Gossamer Bio
- 05 Mar 2024 According to a Gossamer Bio media release, Pharmaceuticals and Medical Devices Agency of Japan, or PMDA, allowed inclusion of Japanese clinical trial sites in the ongoing Phase 3 PROSERA Study. Subject to final clinical trial results, PROSERA could form the basis of a commercial marketing application in Japan.
- 05 Mar 2024 According to a Gossamer Bio media release, topline results from the PROSERA Study are expected in the fourth quarter of 2025.
- 05 Mar 2024 According to a Gossamer Bio media release, first patient was dosed in the fourth quarter of 2023.