Drugs / Aprocitentan
Aprocitentan
Regulatory milestones approvals, filings & regulatory actions · 5 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed resistant hypertension 4 milestones | |||||
| Filed | EU (EMA) | — | resistant hypertension | 2023-01-31 | “today announced that it has submitted a marketing authorisation application (MAA) to the European Medicines Agency (EMA)” idorsia.com ↗ “the market authorisation application (MAA) was submitted to the EMA at the end of January 2023” idorsia.com ↗ “A market authorisation application (MAA) was submitted to the EMA at the end January 2023.” idorsia.com ↗ |
| Filed | US (FDA) | — | resistant hypertension | 2022-12-20 | “today announced that it has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA)” idorsia.com ↗ “A new drug application (NDA) for aprocitentan was filed with the US FDA in December 2022” idorsia.com ↗ |
| Filed | Other | JERAYGO | resistant hypertension | — | “JERAYGO™ (aprocitentan) approved by the European Commission in June 2024 and marketing authorization applications submitted in the UK, Canada, and Switzerland.” idorsia.com ↗ |
| Filed | UK (MHRA) | JERAYGO | resistant hypertension | — | “JERAYGO™ (aprocitentan) approved by the European Commission in June 2024 and marketing authorization applications submitted in the UK, Canada, and Switzerland.” idorsia.com ↗ |
| Approved Indication not stated 1 milestone | |||||
| Approved | US (FDA) | TRYVIO | — | 2024-03-19 | fda.gov ↗ |
Trials 13
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 19 trials | ||||||
| Phase 1 | NCT06799884 | Jan → Feb 2025 | — | Idorsia Pharmaceuticals Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT04252495 | Jun 2020 → Apr 2021 | — | Idorsia Pharmaceuticals Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT04281342 | Jan 2020 → Aug 2021 | — | Idorsia Pharmaceuticals Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT03586570 | Jul → Sep 2018 | — | Idorsia Pharmaceuticals Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT03245229 | Aug → Sep 2017 | — | Idorsia Pharmaceuticals Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT03165071 | Jun → Oct 2017 | — | Idorsia Pharmaceuticals Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT03100591 | Mar → Apr 2017 | — | Idorsia Pharmaceuticals Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT02841761 | Jul → Sep 2016 | — | Idorsia Pharmaceuticals Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT02708004 | Jun → Dec 2016 | — | Idorsia Pharmaceuticals Ltd. | Completed | No outcome recorded |
| Phase 21 trial · 1 met primary | ||||||
| Phase 2 | NCT02603809 | Dec 2015 → Feb 2017 | essential hypertension | Idorsia Pharmaceuticals Ltd. | Completed | Met primary |
| Phase 33 trials · 1 met primary | ||||||
| Phase 3 | NCT07635914 | May 2026 → Dec 2029 expected | resistant hypertension | CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd. | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT04162366 | Jan 2020 → Jun 2021 | chronic kidney disease, hypertensive disorder | Idorsia Pharmaceuticals Ltd. | Withdrawn | No outcome recorded Stop: Business |
| Phase 3 | NCT03541174 | Jun 2018 → May 2021 | resistant hypertension | Idorsia Pharmaceuticals Ltd. | Completed | Met primary |
News releases announcing trial results or a regulatory action · 22
| Date | Issuer | Release |
|---|---|---|
| 2026-10-05 | Idorsia Pharmaceuticals Ltd. | Results Efficacy of aprocitentan in patients across the cardiometabolic disease spectrum including obesity to be presented at AHA Hypertension idorsia.com ↗
Idorsia Ltd (SIX: IDIA) announces positive findings from two new analyses of the pivotal Phase 3 PRECISION study highlighting the importance of endothelin pathway blockade in patients with obesity-associated resistant hypertension and across the cardiovascular-kidney-metabolic continuum. |
| 2026-06-01 | Idorsia Pharmaceuticals Ltd. | Results New analysis of Idorsia’s aprocitentan demonstrates significant and sustained reduction in albuminuria in patients with uncontrolled / resistant hypertension idorsia.com ↗
Idorsia Ltd (SIX: IDIA) announces new analyses from the Phase 3 PRECISION study demonstrating that aprocitentan, Idorsia’s dual endothelin receptor antagonist, significantly reduces albuminuria and improves albuminuria risk categories in patients with resistant hypertension. |
| 2026-01-05 | Idorsia Pharmaceuticals Ltd. | Regulatory Idorsia’s JERAYGO (aprocitentan) approved in Canada for the treatment of resistant hypertension idorsia.com ↗
Idorsia Ltd (SIX: IDIA) announces that Health Canada has granted marketing authorization for JERAYGO™ (aprocitentan) for the treatment of resistant hypertension in adult patients in combination with at least three antihypertensive medicinal products. |
| 2025-12-10 | Idorsia Pharmaceuticals Ltd. | Results New Hypertension publication underscores aprocitentan’s potential in managing hypertension patients with CKD idorsia.com ↗
It significantly reduced both office and nighttime ambulatory blood pressure (BP), as well as markedly lowered albuminuria – a key marker of kidney damage – without increasing the risk of hyperkalemia. |
| 2025-11-10 | Idorsia Pharmaceuticals Ltd. | Results Idorsia’s aprocitentan improved key prognostic indicators in patients with difficult-to-control hypertension idorsia.com ↗
Aprocitentan (TRYVIO™/JERAYGO™), the first approved antihypertensive targeting the endothelin pathway, substantially lowered 24-hour blood pressure (BP) in patients with confirmed resistant hypertension, with particularly pronounced effects at night. |
| 2025-11-05 | Idorsia Pharmaceuticals Ltd. | Results Idorsia to present new aprocitentan insights at ASN Kidney Week & AHA Scientific Sessions idorsia.com ↗
The poster highlights that aprocitentan, in addition to at least three antihypertensives, substantially reduced systolic blood pressure and Urine Albumin-to-Creatinine Ratio (UACR) versus placebo across all subgroups with renal impairment and resistant hypertension. |
| 2025-09-19 | Idorsia Pharmaceuticals Ltd. | Regulatory Idorsia’s JERAYGO (aprocitentan) approved in Switzerland for the treatment of resistant hypertension idorsia.com ↗
Idorsia Ltd (SIX: IDIA) announces that Swissmedic has granted marketing authorization for JERAYGO™ (aprocitentan) for the treatment of resistant hypertension in adult patients in combination with at least three antihypertensive medicinal products. |
| 2025-04-09 | Idorsia Pharmaceuticals Ltd. | Results The effect of aprocitentan for reducing blood pressure and proteinuria in Black patients with resistant hypertension published in Hypertension idorsia.com ↗
Aprocitentan, on top of background therapy, showed clinically meaningful and durable blood pressure (BP) reduction and a decrease in proteinuria in Black patients with confirmed resistant hypertension |
| 2025-04-09 | Idorsia Pharmaceuticals Ltd. | Regulatory US FDA approves an updated label for TRYVIO (aprocitentan) removing the REMS requirement idorsia.com ↗ |
| 2025-03-17 | Idorsia Pharmaceuticals Ltd. | Regulatory US FDA removes REMS requirement for TRYVIO (aprocitentan) – minimizing the burden on the healthcare delivery systems and patients idorsia.com ↗
Idorsia Ltd (SIX: IDIA) today announced that – effective immediately – the US FDA has fully released TRYVIO™ (aprocitentan) from its REMS (Risk Evaluation and Mitigation Strategy) requirement. |
| 2024-07-01 | Idorsia Pharmaceuticals Ltd. | Regulatory Idorsia’s JERAYGO (aprocitentan) approved in Europe as first and only ERA for the treatment of resistant hypertension idorsia.com ↗
Idorsia Ltd (SIX: IDIA) announced today that the European Commission (EC) has approved JERAYGO™ (aprocitentan) for the treatment of resistant hypertension in adult patients in combination with at least three antihypertensive medicinal products. |
| 2024-04-26 | Idorsia Pharmaceuticals Ltd. | Regulatory JERAYGO (aprocitentan) recommended for approval in Europe for the treatment of resistant hypertension idorsia.com ↗
The CHMP has adopted a positive opinion for the use of 12.5 mg JERAYGO orally once daily. |
| 2024-03-20 | Idorsia Pharmaceuticals Ltd. | Regulatory US FDA approves Idorsia’s once-daily TRYVIO (aprocitentan) – the first and only endothelin receptor antagonist for the treatment of high blood pressure not adequately controlled in combination with other antihypertensives idorsia.com ↗ |
| 2023-11-03 | Idorsia Pharmaceuticals Ltd. | Results New Phase 3 data with aprocitentan for patients with resistant hypertension has been presented at the American Society of Nephrology Kidney Week 2023 idorsia.com ↗ |
| 2023-06-26 | Idorsia Pharmaceuticals Ltd. | Results New Phase 3 data with aprocitentan for patients with resistant hypertension has been presented at the European Society of Hypertension Annual Meeting 2023 idorsia.com ↗
The placebo-corrected systolic BP-lowering by aprocitentan at week 4 was more pronounced during night-time (–5.1 and –7.4 mmHg) compared with daytime (–3.8 and –5.3mmHg) for the 12.5 and 25mg doses, respectively. |
| 2023-01-31 | Idorsia Pharmaceuticals Ltd. | Regulatory Idorsia submits European marketing authorisation application for aprocitentan for the treatment of patients with resistant hypertension idorsia.com ↗
Idorsia Ltd (SIX: IDIA) today announced that it has submitted a marketing authorisation application (MAA) to the European Medicines Agency (EMA) for aprocitentan, Idorsia’s investigational, novel dual endothelin receptor antagonist, for the treatment of patients with resistant hypertension. |
| 2022-12-20 | Idorsia Pharmaceuticals Ltd. | Regulatory Idorsia submits a New Drug Application to the US FDA for aprocitentan for the treatment of patients with difficult-to-control hypertension idorsia.com ↗
Idorsia Ltd (SIX: IDIA) today announced that it has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) seeking approval for aprocitentan, Idorsia’s investigational, novel dual endothelin receptor antagonist, for the treatment of patients with difficult-to-control hypertension. |
| 2022-11-07 | Janssen Research & Development, LLC | Results Late-Breaking Data from Pivotal Phase 3 PRECISION Study Demonstrates Significant and Sustained Effect of Aprocitentan on Lowering Blood Pressure for Patients with Difficult-to-Control Hypertension jnj.com ↗
today announced results from the Phase 3 PRECISION study, which found aprocitentan, an investigational, novel dual endothelin receptor antagonist (ERA), significantly reduced blood pressure (BP) and maintained the effect for up to 48 weeks |
| 2022-11-07 | Janssen Research & Development, LLC | Results Late-Breaking Data from Pivotal Phase 3 PRECISION Study Demonstrates Significant and Sustained Effect of Aprocitentan on Lowering Blood Pressure for Patients with Difficult-to-Control Hypertension jnj.com ↗
Late-Breaking Data from Pivotal Phase 3 PRECISION Study Demonstrates Significant and Sustained Effect of Aprocitentan on Lowering Blood Pressure for Patients with Difficult-to-Control Hypertension |
| 2022-11-07 | Idorsia Pharmaceuticals Ltd. | Results The Lancet and AHA late-breaking science session reports significant and sustained effect of aprocitentan on lowering blood pressure for patients with resistant hypertension idorsia.com ↗
The Lancet reports that in patients with resistant hypertension, aprocitentan was well-tolerated and superior to placebo in lowering blood pressure at week 4 with a sustained effect at week 40 |
| 2022-05-23 | Idorsia Pharmaceuticals Ltd. | Results Positive Phase 3 study with aprocitentan demonstrates significant antihypertensive efficacy in patients with resistant hypertension idorsia.com ↗
Idorsia Ltd (SIX: IDIA) today announced positive top-line results of PRECISION, the Phase 3 study investigating aprocitentan, Idorsia’s dual endothelin receptor antagonist, for the treatment of patients whose blood pressure is not adequately controlled despite receiving at least triple antihypertensive therapy – known as resistant hypertension. |
| 2019-08-31 | Idorsia Pharmaceuticals Ltd. | Results Phase 2 data of aprocitentan, Idorsia’s dual endothelin receptor antagonist, presented at ESC 2019 idorsia.com ↗
Phase 2 dose-finding study demonstrated the blood pressure lowering effect of aprocitentan |
All press releases naming this drug 37 releases
Evidence & citations 9 cited values
Every value below carries the sentence it was read from. 15 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | aprocitentan | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06799884 ↗ |
| Known as | ACT-132577 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03165071 ↗ |
| Known as | Jeraygo | ChEMBL registry synonym — accepted as the source's own label CHEMBL2165326 ↗ |
| Known as | Macitentan metabolite m6 | ChEMBL registry synonym — accepted as the source's own label CHEMBL2165326 ↗ |
| Known as | SYH9108 | “Aprocitentan tablets(SYH9108)” NCT07635914 ↗ |
| Known as | Tryvio | ChEMBL registry synonym — accepted as the source's own label CHEMBL2165326 ↗ |
| Action | Inhibit | “a dual endothelin A/endothelin B receptor antagonist” PMID 32063059 ↗ Feb 2020 |
| Modality | Small molecule | — CHEMBL2165326 ↗ |
| Route | Oral | “One capsule of 5 mg aprocitentan, orally, once daily in the morning for 8 weeks” NCT02603809 ↗ |