Wednesday, July 8, 2026

Drug profile · INN

macitentan

macitentan (OPSUMIT) is a endothelin receptor, et-a/et-b antagonist. Associated with Janssen-Cilag Pty Ltd. Route of administration: oral. Current US regulatory status: approved.

FDA: approved EMA: approved TGA: approved Cardiovascular system (C02) C02KX54
US status approved
Patents linked 0
Pipeline programs 6
News articles 0
Drug details — macitentan
US status
approved
Class
Cardiovascular system (C02)
Route
ORAL
Patents
0
Programs
6
Data quality
0.84

Quick answer

macitentan (OPSUMIT) is a endothelin receptor, et-a/et-b antagonist. Associated with Janssen-Cilag Pty Ltd. Route of administration: oral. Current US regulatory status: approved.

Key facts

INN macitentan
Brand OPSUMIT
Mechanism Endothelin receptor, ET-A/ET-B antagonist
Target Endothelin receptor, ET-A/ET-B
Therapeutic class Cardiovascular system (C02)
Route ORAL
Formulation TABLET
ATC code C02KX54

Mechanism of action

Endothelin receptor, ET-A/ET-B antagonist

Primary target: Endothelin receptor, ET-A/ET-B

Approval history

Authority Status Date
FDA approved
EMA approved
TGA approved

Pipeline programs

  1. AC-055-315 Phase 3 · Anaxis Pharma · Pulmonary arterial hypertension
  2. NOPRODPAPUH3001 Phase 3 · Anaxis Pharma · pulmonary arterial hypertension
  3. Placebo de macitentan 10 mg, MACITENTAN Phase 2 · PARItec · Inoperable Chronic thromboembolic pulmonary hyperTension, Pn
  4. 67896062PAH1011 Phase 1 · Anaxis Pharma · Pulmonary Arterial Hypertension
  5. A Clinical Study to Compare the Impact of Mul... Phase 1 · Anaxis Pharma · Pulmonary Arterial Hypertension
  6. Macitentan 10 mg tablet, once daily. Phase 1 · Chinese Academy of · Coronary Microvascular Angina

Related & competitor drugs

  1. alirocumab Cardiovascular system (C10)
  2. aliskiren Cardiovascular system (C09)
  3. azilsartan medoxomil Cardiovascular system (C09)
  4. bempedoic acid Cardiovascular system (C10)
  5. bosentan Cardiovascular system (C02)
  6. dofetilide Cardiovascular system (C01)

Frequently asked questions

What is macitentan?

macitentan (OPSUMIT) is a endothelin receptor, et-a/et-b antagonist. Associated with Janssen-Cilag Pty Ltd. Route of administration: oral. Current US regulatory status: approved.

What is the brand name for macitentan?

OPSUMIT is a marketed brand name for macitentan. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of macitentan?

macitentan has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.