Drug intelligence / Profile preview

macitentan + tadalafil

Development stage
Approved
Lead developer
Johnson & Johnson
Modality
Small Molecules
Administration
Oral
01

Overview

**Macitentan + tadalafil** is an oral fixed-dose combination of two small-molecule pulmonary arterial hypertension therapies: macitentan, a dual endothelin receptor antagonist, and tadalafil, a phosphodiesterase type 5 inhibitor. It is marketed as **Opsynvi** in the United States and **Yuvanci** in the European Union for chronic treatment or substitution treatment of adults with World Health Organization Group 1 pulmonary arterial hypertension and functional class II–III symptoms. The combination concurrently suppresses endothelin-mediated pulmonary vasoconstriction and increases nitric oxide–cGMP signaling, promoting pulmonary vasodilation and reducing pulmonary vascular resistance. ([accessdata.fda.gov](https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/218490s002lbl.pdf))

Brand names
OpsynviYuvanci
Other names
M/T FDCM/T STCTmacitentan and tadalafilmacitentan/tadalafil
02

Targets

EDNRA (Endothelin receptor type A)PDE5 (Phosphodiesterase 5A)EDNRB (Endothelin receptor type B)

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