NDAORALTABLET
Approved
Oct 2013
Lifecycle
Peak
Competitive Pressure
8/100
Clinical Trials
6
Data completeness
6/8 — Strong
OPSUMIT (macitentan) by Johnson & Johnson is endothelin receptor antagonists [moa]. Approved for pulmonary arterial hypertension. First approved in 2013.
Drug data last refreshed 20h ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
OPSUMIT (macitentan) is an oral endothelin receptor antagonist approved by the FDA in October 2013 for the treatment of pulmonary arterial hypertension (PAH). The drug works by blocking endothelin receptors, which are responsible for vasoconstriction and cell proliferation in the pulmonary vasculature. Macitentan is a selective dual endothelin receptor antagonist that has demonstrated efficacy in reducing PAH disease progression and improving exercise capacity in patients.
$1.0BPart D
3.5 years to LOEMechanism of Action
Endothelin Receptor Antagonists
Pharmacologic Class:
Endothelin Receptor Antagonist
Indications (1)
Clinical Trials (6)
A Study of Macitentan in Japanese Pediatric Participants With Pulmonary Arterial Hypertension
Started Nov 2022
7 enrolled
Pulmonary Arterial Hypertension
A Study of Macitentan/Tadalafil Combination Administered a Fixed-dose Combination Formulation Compared to the Reference Free Combination of Macitentan and Tadalafil
Started Apr 2021
18 enrolled
Healthy
A Study of Pulmonary Arterial Hypertension Participants Treated With Macitentan or Selexipag
Started Oct 2020
372 enrolled
Pulmonary Arterial Hypertension
A Study of Macitentan, in Healthy Japanese Male Participants
Started Jul 2020
24 enrolled
Healthy
A Study of Macitentan and Tadalafil as a Fixed Dose Combination and the Free Combination in Healthy Adult Participants
Started Jan 2020
62 enrolled
Healthy
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.