Extension Study of Seralutinib for Pulmonary Arterial Hypertension (PAH)

This study, called PROSERA-EXT, is an open-label extension study looking at the long-term safety and how well orally inhaled seralutinib works for adults with Pulmonary Arterial Hypertension (PAH). PAH is a type of high blood pressure in the arteries of your lungs. You can join if you are between 18 and 75 years old and have already completed a previous study with seralutinib. The main goal is to track any side effects that happen while taking seralutinib. This study plans to enroll about 330 people and will continue until seralutinib is approved for sale or the study ends.

Study design
This is an open-label study, meaning both you and the study team will know you are receiving seralutinib. It plans to include about 330 participants.
What's involved
You would take seralutinib using a dry powder inhaler. The treatment period is planned to run until the market approval of seralutinib or until the study is terminated.
Compensation
Not stated in the trial record.
Follow-up
The study will track side effects from when you start treatment until the end of the study, which could be up to 48 months or until the commercial product is available.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06274801

Open-label Extension Study of Seralutinib in Adult Subjects With PAH (PROSERA-EXT)

Recruiting
PHASE3Ages 18–75InterventionalTreatment
Gossamer Bio USA, Inc.
~330 participants
Updated 2026-07-29 on ClinicalTrials.gov
What's tested:SeralutinibGereic Dry Powder Inhaler

At a glance

Recruiting sites
100 of 120 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of treatment-emergent adverse events (TEAEs)
Measured over From baseline to end of study (up to 48 months or availability of commercial product)
Pulmonary Arterial Hypertension
120 sites across 48 states
Germany7
Japan7
Brazil6
United Kingdom6
Argentina5
Spain5
California4
Texas4
  • Richard Aranda, MD · STUDY_DIRECTOR · Gossamer Bio USA, Inc.

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  • Incidence of treatment-emergent adverse events (TEAEs)From baseline to end of study (up to 48 months or availability of commercial product)