Drugs / Ralinepag
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | US (FDA) | — | pulmonary arterial hypertension | 2026-08-24 | “today announced that the FDA has accepted the New Drug Application ( NDA ) for ralinepag to treat PAH.” unither.com ↗ “In June 2026, United Therapeutics submitted a New Drug Application for ralinepag to treat PAH” unither.com ↗ “United Therapeutics submitted a New Drug Application for ralinepag to the FDA in June 2026.” unither.com ↗ |
Trials 6
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT04613999 | Oct → Nov 2020 | — | Everstar Medicines (Shanghai) Limited | Completed | No outcome recorded |
| Phase 22 trials | ||||||
| Phase 2 | NCT02279745 | Jul 2015 → Mar 2021 | pulmonary arterial hypertension | United Therapeutics | Completed | No outcome recorded |
| Phase 2 | NCT02279160 | Dec 2014 → Jun 2017 | pulmonary arterial hypertension | United Therapeutics | Completed | Mixed |
| Phase 33 trials · 1 met primary | ||||||
| Phase 3 | NCT04084678 | Jan 2021 → Apr 2023 | pulmonary arterial hypertension | United Therapeutics | Terminated | No outcome recorded Stop: Business |
| Phase 3 | NCT03683186 | Sep 2019 → Dec 2026 expected | connective tissue disorder, heritable pulmonary arterial hypertension, lung disorder | United Therapeutics | Enrolling by invitation | No outcome recorded |
| Phase 3 | NCT03626688 | Jan 2019 → Dec 2025 | connective tissue disorder, heritable pulmonary arterial hypertension, lung disorder | United Therapeutics | Completed | Met primary |
News releases announcing trial results or a regulatory action · 5
| Date | Issuer | Release |
|---|---|---|
| 2026-08-28 | United Therapeutics | Results United Therapeutics Presents Data at The European Society of Cardiology Congress 2026 and The European Respiratory Society International Congress 2026 unither.com ↗
ADVANCE OUTCOMES presentations include an analysis showing that ralinepag achieved clinical improvement in a lower risk pulmonary arterial hypertension ( PAH ) population and reduced clinical worsening in PAH patients with connective tissue disease |
| 2026-08-24 | United Therapeutics | Regulatory United Therapeutics Corporation Announces FDA Filing Acceptance of New Drug Application for Ralinepag to Treat Pulmonary Arterial Hypertension unither.com ↗
United Therapeutics Corporation (Nasdaq: UTHR ), a public benefit corporation, today announced that the FDA has accepted the New Drug Application ( NDA ) for ralinepag to treat PAH. |
| 2026-07-29 | United Therapeutics | Results United Therapeutics Corporation Announces ADVANCE OUTCOMES Study of Ralinepag Published in The Lancet unither.com ↗
Ralinepag reduced the risk of a clinical worsening event by 55% compared with placebo in patients with PAH (hazard ratio 0.45, 95% CI [0.33-0.62]; p<0.0001), meeting the study’s primary endpoint with statistical significance. |
| 2026-05-17 | United Therapeutics | Results United Therapeutics Corporation Announces ADVANCE OUTCOMES Study of Ralinepag Presented at ATS 2026 unither.com ↗
Ralinepag reduced the risk of a clinical worsening event by 55% compared with placebo in patients with PAH (hazard ratio 0.45, 95% CI [0.33-0.62]; p<0.0001), meeting the study’s primary endpoint. |
| 2026-03-02 | United Therapeutics | Results United Therapeutics Corporation Announces Ralinepag Achieved 55% Reduction in Risk of Clinical Worsening in Pivotal Pulmonary Arterial Hypertension Study, Delivering Exceptional, Highly Statistically Significant Efficacy unither.com ↗
The phase 3 ADVANCE OUTCOMES study of ralinepag met its primary endpoint and several important secondary endpoints, including increasing odds of clinical improvement by 47%, in predominantly pre-treated patients with pulmonary arterial hypertension ( PAH ) |
All press releases naming this drug 8 releases
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 8 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Ralinepag | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03683186 ↗ |
| Known as | APD811 | “Ralinepag (APD811) will be supplied as 50 mcg round, orange, XR tablets for oral administration.” NCT04613999 ↗ |
| Action | Activate | “a selective, non-prostanoid prostacyclin receptor agonist” PMID 31391223 ↗ Oct 20191“Prostanoid IP receptor agonist” CHEMBL3301604 ↗ |
| Modality | Small molecule | — CHEMBL3301604 ↗ |
| Route | Oral | “immediate-release orally administered ralinepag” PMID 31391223 ↗ Oct 2019 |
| Target | PTGIR | “Prostanoid IP receptor agonist” CHEMBL3301604 ↗ |