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NCT03683186Phase 3ENROLLING BY INVITATION

A Study Evaluating the Long-Term Efficacy and Safety of Ralinepag in Subjects With PAH Via an Open-Label Extension

Study Summary

Study ROR-PH-303, ADVANCE EXTENSION, is an open-label extension (OLE) study for participants with WHO Group 1 PAH who have participated in another Phase 2 or Phase 3 study of ralinepag.

Conditions
PAHPulmonary HypertensionPulmonary Arterial HypertensionHypertensionConnective Tissue DiseasesFamilial Primary Pulmonary HypertensionVascular DiseasesCardiovascular DiseasesHypertension, PulmonaryLung DiseasesRespiratory Tract Disease
Interventions / Drugs
Ralinepag
View on ClinicalTrials.gov ↗
Sponsor
UTHR
United Therapeutics
Pulmonary
D35/100
Study Details
Enrollment1000 participants
Primary Completion—
Lead SponsorUnited Therapeutics
Data Retrieved2026-04-11 04:30:42.432933+00:00
What This Trial Means for Biotech Investors
Trial Phase Context

Phase 3 trials are pivotal studies with large patient populations (hundreds to thousands) designed to prove efficacy and safety for FDA submission. A successful Phase 3 readout is typically the last major hurdle before a New Drug Application (NDA) or BLA filing.

Status & Expected Data

Current status: ENROLLING BY INVITATION.

Enrolled: 1,000 participants
Sponsor Catalyst Profile

United Therapeutics (UTHR) is the sponsoring company for this trial. BiotechSign currently grades this company D (35/100) based on composite catalyst signals across its full pipeline. This trial is one data point in that overall catalyst picture.

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