| Combination of | |
|---|---|
| Macitentan | Endothelin receptor antagonist |
| Tadalafil | Phosphodiesterase 5 (PDE5) inhibitor |
| Clinical data | |
| Trade names | Opsynvi |
| AHFS/Drugs.com | Monograph |
| MedlinePlus | a624029 |
| License data | |
| Pregnancy category |
|
| Routes of administration | By mouth |
| ATC code | |
| Legal status | |
| Legal status | |
| Identifiers | |
| KEGG | |
Macitentan/tadalafil, sold under the brand nameOpsynvi, is afixed dose combination medication used for the treatment ofpulmonary arterial hypertension.[3][6] It containsmacitentan, anendothelin receptor antagonist (ERA); andtadalafil, aphosphodiesterase 5 (PDE5) inhibitor.[3]
Macitentan/tadalafil was approved for medical use in Canada in October 2021,[7] in the United States in March 2024,[8][9] and in the European Union in September 2024.[4][5]
Macitentan/tadalafil isindicated for the chronic treatment of pulmonary arterial hypertension (PAH, WHO Group I) in adults of WHO functional class (FC) II-III.[3]
Macitentan/tadalafil may cause harm to the fetus.[3]
In July 2024, theCommittee for Medicinal Products for Human Use of theEuropean Medicines Agency adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Yuvanci, intended for the treatment of pulmonary arterial hypertension (PAH).[4] The applicant for this medicinal product is Janssen-Cilag International NV.[4] The combination was authorized for medical use in the European Union in September 2024.[4][5]
