NDAORALTABLET
Approved
Mar 2024
Lifecycle
Growth
Competitive Pressure
8/100
Clinical Trials
3
Data completeness
4/8 — Partial
OPSYNVI (macitentan and tadalafil) by Johnson & Johnson is phosphodiesterase 5 inhibitors [moa]. First approved in 2024.
Drug data last refreshed 13h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
OPSYNVI is a fixed-dose combination oral tablet containing macitentan (endothelin receptor antagonist) and tadalafil (phosphodiesterase-5 inhibitor) approved in March 2024. It is indicated for pulmonary arterial hypertension (PAH), a rare progressive disease of the pulmonary vasculature. The dual mechanism targets both endothelin and nitric oxide pathways to improve hemodynamics and exercise capacity.
Growth3.0 years to LOE
Early-stage growth product with high competitive pressure (score: 8/10), indicating active commercial build-out and need for experienced brand and field teams.
Mechanism of Action
Phosphodiesterase 5 Inhibitors
Pharmacologic Class:
Phosphodiesterase 5 Inhibitor
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (3)
A Study of Opsynvi in Adults Participants With Pulmonary Arterial Hypertension in Korea
Started Nov 2026
333 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 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.