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Generic Dry Powder Inhaler

DEVICE6 trials

Sponsors

GB002, Inc., a wholly owned subsidiary of Gossamer Bio, Inc., Gossamer Bio USA, Inc., GB002, Inc.

Conditions

Pulmonary Arterial HypertensionPulmonary Artery HypertensionPulmonary Hypertension Associated With Interstitial Lung DiseaseSafety Issues

Phase 1

Phase 1A Safety Trial of Inhaled PK10571 (GB002)
CompletedNCT03473236
GB002, Inc., a wholly owned subsidiary of Gossamer Bio, Inc.Safety Issues
Start: 2017-09-06End: 2018-12-03Updated: 2020-06-09
Clinical Study of Inhaled GB002 for Treatment of WHO Group I Pulmonary Arterial Hypertension
CompletedNCT03926793
GB002, Inc., a wholly owned subsidiary of Gossamer Bio, Inc.Pulmonary Arterial Hypertension
Start: 2020-02-04End: 2021-05-05Updated: 2021-09-01

Phase 2

GB002 in Adult Subjects With Pulmonary Arterial Hypertension (PAH)
CompletedNCT04456998
GB002, Inc., a wholly owned subsidiary of Gossamer Bio, Inc.Pulmonary Artery Hypertension
Start: 2020-11-12End: 2022-11-01Updated: 2023-11-07
Open-label Extension Study of GB002 in Adult Subjects With Pulmonary Arterial Hypertension (PAH)
Active, not recruitingNCT04816604
Gossamer Bio USA, Inc.Pulmonary Arterial Hypertension
Start: 2021-04-05End: 2027-12-01Updated: 2026-07-27

Phase 3

Efficacy and Safety of Seralutinib in Adult Subjects With PAH (PROSERA)
CompletedNCT05934526
GB002, Inc.Pulmonary Arterial Hypertension
Start: 2023-12-28End: 2025-12-22Updated: 2026-05-19
Efficacy and Safety of Seralutinib in Adult Subjects With Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD)
SuspendedNCT07181382
GB002, Inc.Pulmonary Hypertension Associated With Interstitial Lung Disease
Start: 2026-02-01End: 2028-12-01Target: 480Updated: 2026-03-19

Related Papers

Seralutinib for the Treatment of Pulmonary Arterial Hypertension in Adults: TORREY Open-Label Extension Study
Advances in Therapy2025-08-111 citations
Seralutinib in adults with pulmonary arterial hypertension (TORREY): a randomised, double-blind, placebo-controlled phase 2 trial.
2024-05-0240 citations
Effects of inhaled seralutinib on right ventricular-pulmonary arterial (RV-PA) coupling and right heart function in pulmonary arterial hypertension (PAH)
European Heart Journal2023-11-01
Seralutinib improves pulmonary arterial blood vessel volume distribution in pulmonary arterial hypertension (PAH): results of the TORREY phase 2 imaging substudy
2023-09-095 citations
TORREY, a Phase 2 study to evaluate the efficacy and safety of inhaled seralutinib for the treatment of pulmonary arterial hypertension
Pulmonary Circulation2021-10-0153 citations
Late Breaking Abstract - Evidence of target engagement and pathway modulation: biomarker analysis of the phase 1b inhaled seralutinib study
2021-09-05
Pharmacologic characterization of GB002, a novel inhaled PDGFR kinase inhibitor in development for pulmonary arterial hypertension (PAH)
2020-09-071 citations