drugset
Drugs / Aprocitentan
last change May 2026 re-read 2 minutes ago

Aprocitentan

also known as ACT-132577 · Jeraygo · Macitentan metabolite m6 · SYH9108 · Tryvio

Small molecule

Developed for
resistant hypertension · chronic kidney disease · essential hypertension · hypertensive disorder
Investigated by
Idorsia Pharmaceuticals Ltd. · Janssen Biotech, Inc. · CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.

Regulatory milestones approvals, filings & regulatory actions · 1 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Approved US (FDA) TRYVIO — 2024-03-19 fda.gov ↗

Trials 13 · a red edge is where a trial was stopped

today
US approved 2024
NCT07635914 · Ph 3 NCT06799884 · Ph 1 NCT04252495 · Ph 1 NCT04162366 · Ph 3 NCT04281342 · Ph 1 NCT03586570 · Ph 1 NCT03541174 · Ph 3 NCT03245229 · Ph 1 NCT03165071 · Ph 1 NCT03100591 · Ph 1 NCT02841761 · Ph 1 NCT02708004 · Ph 1 NCT02603809 · Ph 2
201620172018201920202021202220232024202520262027202820292030
PhaseRegistry idDatesIndicationSponsorStatusOutcome
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
Phase 2 NCT02603809 Dec 2015 → Feb 2017 essential hypertension Idorsia Pharmaceuticals Ltd. Completed No outcome recorded
Phase 33 trials
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 Withdrawn No outcome recorded
Phase 3 NCT03541174 Jun 2018 → May 2021 resistant hypertension Idorsia Pharmaceuticals Ltd. Completed No outcome recorded

Evidence & citations 9 cited values

Every value below carries the sentence it was read from. 15 sources stand behind the page.

FieldValueCited text
Known as Aprocitentan ClinicalTrials.gov intervention name — accepted as the source's own label NCT02603809 ↗
10

NCT07635914 ↗

NCT04281342 ↗

NCT02841761 ↗

NCT03541174 ↗

NCT02708004 ↗

NCT04162366 ↗

NCT06799884 ↗

NCT03586570 ↗

NCT04252495 ↗

NCT03245229 ↗
Known as ACT-132577 ClinicalTrials.gov intervention name — accepted as the source's own label NCT03165071 ↗
1

NCT03100591 ↗
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 ↗