Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03683186 | A Study Evaluating the Long-Term Efficacy and Safety of Ralinepag in Subjects With PAH Via an Open-Label Extension | PHASE3 | ENROLLING BY_INVITATION | 1,000 | — | — | Sep 23, 2019 | Dec 1, 2026 | Feb 20, 2026 | 190 | United States, Argentina +31 |
| NCT03626688 | A Study Evaluating the Efficacy and Safety of Ralinepag to Improve Treatment Outcomes in PAH Patients | PHASE3 | COMPLETED | 687 | — | — | Aug 30, 2018 | Dec 31, 2025 | Apr 14, 2026 | 209 | United States, Argentina +31 |
The safety and tolerability of ralinepag will be evaluated by the Number of subjects with treatment-emergent adverse events
Clinical worsening events are defined as death, nonelective hospital admission for worsening PAH (further defined in clinical study protocol), initiation of parenteral or inhaled prostacyclin pathway agent for treatment of worsening PAH, disease progression (further defined in clinical study protocol), or unsatisfactory long-term clinical response (further defined in clinical study protocol).
| Arm | Type | Description |
|---|---|---|
| Ralinepag | EXPERIMENTAL | Ralinepag once daily extended-release tablets (oral) 50, 250, and 400 mcg titrated to the highest tolerated dose. |
| Placebo | PLACEBO_COMPARATOR | Matching placebo tablets (oral) |
| Name | Type | Description |
|---|---|---|
| Ralinepag | DRUG | Active |
| Placebo | DRUG | Placebo |
Inclusion Criteria: 1. Evidence of a personally signed and dated informed consent form indicating that the subject has been informed of all pertinent aspects of the study prior to initiation of any study-related procedures. 2. Subjects who are willing and able to comply with scheduled visits, treat...