Drugs / Clazosentan
Clazosentan
also known as
ACT-108475 · ACT-108475A · Axv-034 · AXV-034343 · AXV-343434 · Clazosentan disodium salt · CLAZOSENTAN SODIUM · Pivlaz · +2 more
Small molecule targets EDNRA via inhibition
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | Japan (PMDA) | — | acquired aneurysmal subarachnoid hemorrhage | 2021-03-01 | “today announced the submission of a New Drug Application (NDA) to the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) for clazosentan” idorsia.com ↗ |
| Filed | Other | — | acquired aneurysmal subarachnoid hemorrhage | — | “clazosentan in the Republic of Korea, following the filing of a request for market registration, during the third quarter of 2022” idorsia.com ↗ “Clazosentan – Market registration, based on Japanese data, requested in Republic of Korea” idorsia.com ↗ |
Trials 7
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT03657446 | Sep → Oct 2018 | — | Idorsia Pharmaceuticals Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT03596294 | Jul → Aug 2018 | — | Idorsia Pharmaceuticals Ltd. | Completed | No outcome recorded |
| Phase 22 trials | ||||||
| Phase 2 | NCT02560532 | Mar 2016 → May 2017 | acquired aneurysmal subarachnoid hemorrhage | Idorsia Pharmaceuticals Ltd. | Completed | No outcome recorded |
| Phase 2 | NCT00111085 | Jan 2005 → Mar 2006 | acquired aneurysmal subarachnoid hemorrhage | Idorsia Pharmaceuticals Ltd. | Completed | No outcome recorded |
| Phase 33 trials · 1 met primary · 2 missed | ||||||
| Phase 3 | NCT03585270 | Feb 2019 → Jun 2022 | acquired aneurysmal subarachnoid hemorrhage | Idorsia Pharmaceuticals Ltd. | Completed | Missed primary |
| Phase 3 | NCT00940095 | Jul 2009 → Oct 2010 | acquired aneurysmal subarachnoid hemorrhage | Idorsia Pharmaceuticals Ltd. | Terminated | Met primary |
| Phase 3 | NCT00558311 | Dec 2007 → Jun 2010 | acquired aneurysmal subarachnoid hemorrhage | Idorsia Pharmaceuticals Ltd. | Completed | Missed primary |
News releases announcing trial results or a regulatory action · 6
| Date | Issuer | Release |
|---|---|---|
| 2023-02-06 | Idorsia Pharmaceuticals Ltd. | Results Idorsia announces the results of REACT a Phase 3 study of clazosentan in patients following aneurysmal subarachnoid hemorrhage idorsia.com ↗
The study did not meet the primary endpoint. |
| 2022-04-20 | Idorsia Pharmaceuticals Ltd. | Regulatory PIVLAZ (clazosentan) – Idorsia’s first commercial product – now available for patients in Japan idorsia.com ↗
Idorsia Ltd (SIX: IDIA) and Idorsia Pharmaceuticals Japan today announced that PIVLAZ™ (clazosentan) is now available to physicians in Japan to start treating aSAH patients. |
| 2022-04-04 | Idorsia Pharmaceuticals Ltd. | Results The Journal of Neurosurgery reports impact of clazosentan on cerebral vasospasm-related morbidity and all-cause mortality after aneurysmal subarachnoid hemorrhage idorsia.com ↗
Results published in the Journal of Neurosurgery show that clazosentan significantly reduced the combined incidence of vasospasm-related morbidity and all-cause mortality post-aSAH with no unexpected safety findings. |
| 2022-01-20 | Idorsia Pharmaceuticals Ltd. | Regulatory Idorsia receives Japanese PMDA approval of PIVLAZ (clazosentan sodium) 150 mg idorsia.com ↗
Idorsia Ltd (SIX: IDIA) and Idorsia Pharmaceuticals Japan today announce that the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) has approved PIVLAZ™ (clazosentan sodium) 150 mg, a selective endothelin A (ETA) receptor antagonist, for the prevention of cerebral vasospasm, vasospasm-related cerebral infarction and cerebral ischemic symptoms after aneurysmal subarachnoid hemorrhage (aSAH). |
| 2021-03-01 | Idorsia Pharmaceuticals Ltd. | Regulatory Idorsia submits NDA for clazosentan to Japanese PMDA idorsia.com ↗ |
| 2020-11-23 | Idorsia Pharmaceuticals Ltd. | Results Idorsia announces positive results of the two Japanese registration studies with clazosentan idorsia.com ↗
Idorsia Ltd (SIX: IDIA) today announced positive top-line results of the Japanese registration program investigating clazosentan in adult Japanese patients post-aSAH. |
All press releases naming this drug 10 releases
Evidence & citations 15 cited values
Every value below carries the sentence it was read from. 8 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Clazosentan | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03657446 ↗ |
| Known as | ACT-108475 | ChEMBL registry synonym — accepted as the source's own label CHEMBL109648 ↗ |
| Known as | ACT-108475A | ChEMBL registry synonym — accepted as the source's own label CHEMBL109648 ↗ |
| Known as | Axv-034 | ChEMBL registry synonym — accepted as the source's own label CHEMBL109648 ↗ |
| Known as | AXV-034343 | ChEMBL registry synonym — accepted as the source's own label CHEMBL109648 ↗ |
| Known as | AXV-343434 | ChEMBL registry synonym — accepted as the source's own label CHEMBL109648 ↗ |
| Known as | Clazosentan disodium salt | ChEMBL registry synonym — accepted as the source's own label CHEMBL109648 ↗ |
| Known as | CLAZOSENTAN SODIUM | ChEMBL registry synonym — accepted as the source's own label CHEMBL109648 ↗ |
| Known as | Pivlaz | ChEMBL registry synonym — accepted as the source's own label CHEMBL109648 ↗ |
| Known as | RO-61-1790 | ChEMBL registry synonym — accepted as the source's own label CHEMBL109648 ↗ |
| Known as | VML-588 | ChEMBL registry synonym — accepted as the source's own label CHEMBL109648 ↗ |
| Action | Inhibit | “a Selective Endothelin A (ETA) Receptor Antagonist” NCT00111085 ↗1“Endothelin receptor ET-A antagonist” CHEMBL109648 ↗ |
| Modality | Small molecule | — CHEMBL109648 ↗ |
| Route | Intravenous | “intravenous clazosentan at a rate of 1 mg/h” NCT00111085 ↗ |
| Target | EDNRA | “Endothelin receptor ET-A antagonist” CHEMBL109648 ↗ |