NDAORALTABLET
Approved
Oct 2013
Lifecycle
Peak
Competitive Pressure
8/100
Clinical Trials
6
Data completeness
5/8 — Partial
OPSUMIT (macitentan) by Johnson & Johnson is endothelin receptor antagonists [moa]. First approved in 2013.
Drug data last refreshed 10h ago · AI intelligence enriched 2d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
OPSUMIT (macitentan) is an oral endothelin receptor antagonist approved in 2013 for the treatment of pulmonary arterial hypertension (PAH). It works by blocking endothelin receptors on vascular smooth muscle cells, preventing vasoconstriction and reducing disease progression. The drug targets patients with PAH to improve exercise capacity and delay clinical worsening.
$1.0BPart D
PeakStable
3.1 years to LOEThe product is at peak commercial maturity with $1B in Part D spending, indicating an established brand requiring defensive commercial strategy and market maintenance teams.
Mechanism of Action
Endothelin Receptor Antagonists
Pharmacologic Class:
Endothelin Receptor Antagonist
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
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.