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Ralinepag

DRUG7 trials

Sponsors

United Therapeutics Corp., United Therapeutics, Everstar Medicines (Shanghai) Limited

Conditions

Cardiovascular DiseasesConnective Tissue DiseasesFamilial Primary Pulmonary HypertensionHealthy VolunteerHypertensionHypertension, PulmonaryLung DiseasesPAH

Phase 1

A Study of Ralinepag in Healthy Chinese Adult Subjects
CompletedNCT04613999
Everstar Medicines (Shanghai) LimitedHealthy Volunteer, Pharmacokinetic Study
Start: 2020-10-09End: 2020-11-09Updated: 2024-02-01

Phase 2

Long-term Safety and Efficacy of Ralinepag in Pulmonary Arterial Hypertension
CompletedNCT02279745
United TherapeuticsPulmonary Arterial Hypertension
Start: 2015-07-08End: 2021-03-29Updated: 2021-12-22

Phase 3

A Study Evaluating the Efficacy and Safety of Ralinepag to Improve Treatment Outcomes in PAH Patients
CompletedNCT03626688
United TherapeuticsCardiovascular Diseases, Connective Tissue Diseases, Familial Primary Pulmonary Hypertension +8
Start: 2019-01-24End: 2025-12-31Updated: 2026-06-16
A Study Evaluating the Long-Term Efficacy and Safety of Ralinepag in Subjects With PAH Via an Open-Label Extension
Enrolling by invitationNCT03683186
United TherapeuticsCardiovascular Diseases, Connective Tissue Diseases, Familial Primary Pulmonary Hypertension +8
Start: 2019-09-23End: 2026-12-01Target: 1000Updated: 2026-02-20
Study of Ralinepag on Exercise Capacity by Cardiopulmonary Exercise Testing (CPET) in WHO Group 1 PH Subjects
TerminatedNCT04084678
United TherapeuticsPulmonary Arterial Hypertension, Pulmonary Hypertension
Start: 2021-01-20End: 2023-04-12Updated: 2026-07-06
A Study Evaluating the Efficacy and Safety of Ralinepag to Improve Treatment Outcomes in PAH Patients (ADVANCE Outcomes)
CompletedCTIS2023-509304-16-00
United Therapeutics Corp.Pulmonary arterial hypertension (PAH)
Start: 2019-05-16End: 2026-01-21Target: 190Updated: 2026-01-15
A Study Evaluating the Long-term Efficacy and Safety of Ralinepag in Subjects with PAH via an Open-label Extension (ADVANCE-Extension)
RecruitingCTIS2023-509305-68-00
United Therapeutics Corp.Pulmonary arterial hypertension (PAH)
Start: 2019-05-16Target: 156Updated: 2026-01-15

Related Papers

Ralinepag for the treatment of pulmonary arterial hypertension (ADVANCE OUTCOMES): a randomised, double-blind, placebo-controlled phase 3 study.
2026-07-28