Drugs / Selexipag
Regulatory milestones approvals, filings & regulatory actions · 4 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (2) | US (FDA) | UPTRAVI | — | 2021-01-30 – 2026-05-23 | fda.gov ↗ |
| Approved | EU (EMA) | Uptravi | — | 2016-05-12 | europa.eu ↗ |
| Approved | US (FDA) | UPTRAVI | — | 2015-12-21 | fda.gov ↗ |
Trials 24 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 17 trials | ||||||
| Phase 1 | NCT04266756 | Jan → Aug 2020 | — | Actelion | Completed | No outcome recorded |
| Phase 1 | NCT03496506 | Mar → May 2018 | — | Actelion | Completed | No outcome recorded |
| Phase 1 | NCT02791815 | Jul → Sep 2016 | — | Actelion | Completed | No outcome recorded |
| Phase 1 | NCT02745860 | Jun 2016 | — | Actelion | Completed | No outcome recorded |
| Phase 1 | NCT02770222 | Jun → Jul 2016 | — | Actelion | Completed | No outcome recorded |
| Phase 1 | NCT02882425 | Jan → Apr 2015 | — | Actelion | Completed | No outcome recorded |
| Phase 1 | NCT02206204 | Jun → Nov 2012 | — | Actelion | Completed | No outcome recorded |
| Phase 24 trials | ||||||
| Phase 2 | NCT03942211 | Feb 2021 → Apr 2023 | pulmonary hypertension | Actelion | Terminated | No outcome recorded |
| Phase 2 | NCT04589390 | Oct 2020 → Nov 2021 | pulmonary hypertension, schistosomiasis | University of Sao Paulo General Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT03492177 | Jul 2018 → Mar 2022 overdue | pulmonary arterial hypertension | Actelion | Active not recruiting | No outcome recorded |
| Phase 2 | NCT02260557 | Oct 2014 → Apr 2015 | Raynaud disease | Actelion | Completed | No outcome recorded |
| Phase 39 trials | ||||||
| Phase 3 | NCT05179876 | May 2022 → Jan 2027 expected | pulmonary hypertension | Actelion | Recruiting | No outcome recorded |
| Phase 3 | NCT04565990 | May 2021 → Nov 2023 | pulmonary hypertension | Actelion | Completed | No outcome recorded |
| Phase 3 | NCT04175600 | Jan 2020 → Oct 2024 overdue | pulmonary hypertension | Actelion | Active not recruiting | No outcome recorded |
| Phase 3 | NCT03689244 | Jan 2019 → Jun 2022 | chronic thromboembolic pulmonary hypertension | Actelion | Terminated | No outcome recorded |
| Phase 3 | NCT03187678 | Dec 2017 → May 2018 | pulmonary arterial hypertension | Actelion | Completed | No outcome recorded |
| Phase 3 | NCT02558231 | May 2016 → Aug 2019 | pulmonary arterial hypertension | Actelion | Completed | No outcome recorded |
| Phase 3 | NCT02471183 | Oct 2015 → Dec 2016 | pulmonary arterial hypertension | Actelion | Completed | No outcome recorded |
| Phase 3 | NCT01112306 | Jul 2010 → Aug 2021 | pulmonary arterial hypertension | Actelion | Completed | No outcome recorded |
| Phase 3 | NCT01106014 | Dec 2009 → Apr 2014 | pulmonary arterial hypertension | Actelion | Completed | No outcome recorded |
| Phase 43 trials | ||||||
| Phase 4 | NCT07713914 | Jul 2026 → Jul 2028 expected | pulmonary arterial hypertension | University of Sao Paulo General Hospital | Recruiting | No outcome recorded |
| Phase 4 | NCT04435782 | Jul 2021 → Jul 2023 | pulmonary arterial hypertension | Actelion | Terminated | No outcome recorded |
| Phase 4 | NCT03078907 | Nov 2017 → Feb 2020 | pulmonary arterial hypertension | Actelion | Completed | No outcome recorded |
| Phase not stated1 trial | ||||||
| — | NCT04914247 | — | chronic ulcer of skin, thromboangiitis obliterans | Actelion | Approved for marketing | No outcome recorded |
Also used as a comparator or background therapy in 1 trial
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 4 | NCT05825417 Comparator | Jun 2023 → Jan 2027 expected | pulmonary arterial hypertension | Sheffield Teaching Hospitals NHS Foundation Trust | Recruiting | No outcome recorded |
Evidence & citations 9 cited values
Every value below carries the sentence it was read from. 27 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Selexipag | “Addition of a prostacyclin pathway agent (inhaled iloprost or oral selexipag) to ongoing dual therapy with an endothelin receptor antagonist and sildenafil as part of...” NCT07713914 ↗23“The oral prostacyclin receptor agonist selexipag significantly reduced the risk of disease progression” PMID 34727317 ↗ Oct 2021 |
| Known as | ACT-293987 | ChEMBL registry synonym — accepted as the source's own label CHEMBL238804 ↗ |
| Known as | JNJ-67896049 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04435782 ↗ |
| Known as | NS-304 | ChEMBL registry synonym — accepted as the source's own label CHEMBL238804 ↗ |
| Known as | Uptravi | “The purpose of this expanded access program (EAP) is to provide Selexipag (Uptravi) for the treatment of participant with non-healing wound, buerger's disease.” NCT04914247 ↗1“The first dose of selexipag (Uptravi) will be administered in the evening of Day 1 and will be based on the body weight.” NCT03492177 ↗ |
| Action | Activate | “selexipag, an oral selective IP prostacyclin-receptor agonist” PMID 26699168 ↗ Dec 20151“Prostanoid IP receptor agonist” CHEMBL238804 ↗ |
| Modality | Small molecule | — CHEMBL238804 ↗ |
| Route | Oral | “one 200 µg oral tablet on Day 1” NCT01106014 ↗ |
| Target | PTGIR | “Prostanoid IP receptor agonist” CHEMBL238804 ↗ |