Macitentan/tadalafil
combination drug
Macitentan/tadalafil, sold under the brand name Opsynvi, is a fixed dose combination medication used for the treatment of pulmonary arterial hypertension. It contains macitentan, an endothelin receptor antagonist (ERA); and tadalafil, a phosphodiesterase 5 (PDE5) inhibitor.
Macitentan/tadalafil was approved for medical use in Canada in October 2021, in the United States in March 2024, and in the European Union in September 2024.
Medical uses
Macitentan/tadalafil is indicated for the chronic treatment of pulmonary arterial hypertension (PAH, WHO Group I) in adults of WHO functional class (FC) II-III.
Adverse effects
Macitentan/tadalafil may cause harm to the fetus.
Society and culture
Legal status
In July 2024, the Committee for Medicinal Products for Human Use of the European 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). The applicant for this medicinal product is Janssen-Cilag International NV. The combination was authorized for medical use in the European Union in September 2024.
The public source identifies “Macitentan/tadalafil” as combination drug. This brief keeps that definition visible, then builds a research path around Macitentan, tadalafil and combination.
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The citation trail is more important than the brevity of the summary: it shows where individual claims can be examined in context. The source revision retrieved here is dated Sep 28, 2025. The linked authority identifier is Q125176581. The first chronological checks are 2021 and 2024.
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This entry incorporates text from “Macitentan/tadalafil” on English Wikipedia. Contributors are listed in the page history. Text is available under the Creative Commons Attribution-ShareAlike 4.0 License. Selected authority identifiers and statements are retrieved from Wikidata under CC0; their references and qualifiers remain part of the verification path.