NDAORALTABLET
Approved
Mar 2024
Lifecycle
Growth
Competitive Pressure
8/100
Clinical Trials
2
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 27m ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
OPSYNVI is a fixed-dose combination tablet containing macitentan (an endothelin receptor antagonist) and tadalafil (a phosphodiesterase-5 inhibitor) approved in March 2024 for pulmonary arterial hypertension (PAH). The combination targets dual pathways in PAH pathophysiology to improve hemodynamics and exercise capacity. This oral formulation simplifies the treatment regimen by combining two established therapeutic classes in a single dosage form.
Growth3.2 years to LOE
Early-stage commercial product in growth phase with high competitive intensity (8/10), suggesting active market development and expanding sales infrastructure.
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 (2)
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.