Drugs / Selexipag
Regulatory milestones approvals, filings & regulatory actions · 5 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed pulmonary arterial hypertension 1 milestone | |||||
| Filed | US (FDA) | UPTRAVI | pulmonary arterial hypertension | 2020-09-30 | “Janssen Submits New Drug Application (NDA) to U.S. FDA for UPTRAVI® (selexipag) Injection for Intravenous Use to Treat Pulmonary Arterial Hypertension (PAH)” jnj.com ↗ “Zydus was one of the first ANDA applicants to submit a substantially complete ANDA with a paragraph IV certification for Selexipag Tablets” zyduslife.com ↗ |
| Approved Indication not stated 3 milestones | |||||
| 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 23
| 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 | NCT02770222 | Jun → Jul 2016 | — | Actelion | Completed | No outcome recorded |
| Phase 1 | NCT02745860 | Jun 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 · 1 missed | ||||||
| Phase 2 | NCT03942211 | Feb 2021 → Apr 2023 | pulmonary hypertension | Actelion | Terminated | No outcome recorded Stop: Enrollment |
| 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 | Missed primary |
| Phase 39 trials · 2 met primary · 3 missed | ||||||
| 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 | Missed primary |
| Phase 3 | NCT03689244 | Jan 2019 → Jun 2022 | chronic thromboembolic pulmonary hypertension | Actelion | Terminated | Missed primary |
| 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 | Missed primary |
| 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 | Met primary |
| Phase 3 | NCT01106014 | Dec 2009 → Apr 2014 | pulmonary arterial hypertension | Actelion | Completed | Met primary |
| Phase 42 trials | ||||||
| Phase 4 | NCT07713914 | Jul 2026 → Jul 2028 expected | pulmonary arterial hypertension | University of Sao Paulo General Hospital | Recruiting | 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 |
| Comparator or background therapy1 trial | ||||||
| Phase 4 | NCT05825417 Comparator | Jun 2023 → Jan 2027 expected | pulmonary arterial hypertension | Sheffield Teaching Hospitals NHS Foundation Trust | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 14
| Date | Issuer | Release |
|---|---|---|
| 2024-07-01 | Alembic Pharmaceuticals Ltd. | Regulatory 12th July, 2024, Vadodara, India alembicpharmaceuticals.com ↗
Alembic Pharmaceuticals Limited (Alembic) today announced that it has received tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Selexipag for Injection, 1,800 mcg/vial. |
| 2024-05-01 | Alembic Pharmaceuticals Ltd. | Regulatory Press Release USFDA Products Approval dated 9th May, 2024 alembicpharmaceuticals.com ↗
This is to inform the exchanges that the Company has received various US Food & Drug Administration (USFDA) (Tentative or Final) Product Approvals. |
| 2024-01-01 | Alembic Pharmaceuticals Ltd. | Regulatory Press Release USFDA Products Approvals For the Qtr ended 31st Dec, 2023 alembicpharmaceuticals.com ↗ |
| 2023-11-02 | Lupin Limited | Regulatory Lupin Receives Tentative Approval from U.S. FDA for Selexipag for Injection lupin.com ↗ |
| 2022-12-22 | Zydus Lifesciences Limited | Regulatory Zydus receives final approval and 180 days shared exclusivity from the USFDA for Selexipag Tablets zyduslife.com ↗
Zydus Lifesciences Limited’s (formerly known as Cadila Healthcare Limited) subsidiary Zydus Worldwide DMCC (Zydus) has received final approval from the United States Food and Drug Administration (USFDA) to market Selexipag Tablets, 200 mcg, 400 mcg, 600 mcg, 800 mcg, 1,000 mcg, 1,200 mcg, 1,400 mcg, and 1,600 mcg (USRLD: Uptravi® tablets). |
| 2022-05-06 | Zydus Lifesciences Limited | Regulatory Zydus Lifesciences receives tentative approval from USFDA for Selexipag tablets zyduslife.com ↗
Zydus Lifesciences Limited’s (formerly known as Cadila Healthcare Limited) subsidiary Zydus Worldwide DMCC has received tentative approval from the United States Food and Drug Administration (USFDA) to market Selexipag Tablets in the strengths of 200 mcg, 400 mcg, 600 mcg, 800 mcg, 1,000 mcg, 1,200 mcg, 1,400 mcg, and 1,600 mcg (USRLD: Uptravi®). |
| 2021-12-01 | Alembic Pharmaceuticals Ltd. | Regulatory 81h December, 2021, Vadodara, India alembicpharmaceuticals.com ↗
Alembic Pharmaceuticals receives USFDA Tentative Approval for Selexipaa Tablets, 200 mcg, 400 mcg, 600 mcg, 800 mcg, 1,400 mcg, and 1,600 mcg. |
| 2021-08-30 | Janssen Research & Development, LLC | Results New Data Demonstrate the Benefits of Early Use of UPTRAVI® (selexipag) in Delaying Disease Progression in a Broad Population of Patients with Pulmonary Arterial Hypertension (PAH) jnj.com ↗
New Data Demonstrate the Benefits of Early Use of UPTRAVI® (selexipag) in Delaying Disease Progression in a Broad Population of Patients with Pulmonary Arterial Hypertension (PAH) |
| 2021-07-30 | Janssen Research & Development, LLC | Regulatory UPTRAVI® (selexipag) Receives FDA Approval for Intravenous Use in Adult Patients with Pulmonary Arterial Hypertension (PAH) jnj.com ↗
The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the U.S. Food and Drug Administration (FDA) has approvedUPTRAVI®(selexipag) injection for intravenous (IV) use for the treatment of pulmonary arterial hypertension (PAH, WHO Group I) in adult patients with WHO functional class (FC) II–III, who are temporarily unable to take oral therapy. |
| 2021-07-30 | Janssen Research & Development, LLC | Regulatory UPTRAVI® (selexipag) Receives FDA Approval for Intravenous Use in Adult Patients with Pulmonary Arterial Hypertension (PAH) jnj.com ↗
the U.S. Food and Drug Administration (FDA) has approved UPTRAVI® (selexipag) injection for intravenous (IV) use |
| 2021-04-06 | Janssen Research & Development, LLC | Results New Real-World Observational Analysis of UPTRAVI® (selexipag) Underscores the Importance of Risk Assessment for Treating Pulmonary Arterial Hypertension (PAH) Patients jnj.com ↗
The SPHERE results were published in the April issue of theJournal of Heart and Lung Transplantation (JHLT). |
| 2020-09-30 | Janssen Research & Development, LLC | Regulatory Janssen Submits New Drug Application (NDA) to U.S. FDA for UPTRAVI® (selexipag) Injection for Intravenous Use to Treat Pulmonary Arterial Hypertension (PAH) jnj.com ↗ |
| 2020-09-30 | Janssen Research & Development, LLC | Regulatory Janssen Submits New Drug Application (NDA) to U.S. FDA for UPTRAVI® (selexipag) Injection for Intravenous Use to Treat Pulmonary Arterial Hypertension (PAH) jnj.com ↗
Janssen Submits New Drug Application (NDA) to U.S. FDA for UPTRAVI® (selexipag) Injection for Intravenous Use to Treat Pulmonary Arterial Hypertension (PAH) |
| 2020-04-03 | Janssen Research & Development, LLC | Results Results from Expert Delphi Consensus Survey on Treatment of Pulmonary Arterial Hypertension (PAH) with Oral Prostacyclin Pathway Agents (PPAs) Published in CHEST Journal jnj.com ↗
The panel considered parenteral prostacyclin therapy the treatment of choice in IPAH+ and PAH-CTD patients with high-risk hemodynamics irrespective of other clinical factors. |
All press releases naming this drug 15 releases
Evidence & citations 8 cited values
Every value below carries the sentence it was read from. 26 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 | 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 ↗ |