Macitentan
Antihypertensives For Pulmonary Arterial Hypertension
Sold as Yuvanci · Opsumit · OPSYNVI
- Drug class
- Antihypertensives For Pulmonary Arterial Hypertension
- Availability
- See label
- Routes
- Oral
- Markets covered
- 3
- Products on record
- 26
Overview
Macitentan is an active pharmaceutical ingredient in the Antihypertensives For Pulmonary Arterial Hypertension group (C02KX). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.
Regulatory status by market
| Market | Regulator | Products | Last revision |
|---|---|---|---|
| GB United Kingdom | MHRA | 19 | May 15, 2026 |
| EU European Union | EMA | 4 | May 22, 2026 |
| CA Canada | Health Canada | 3 | March 6, 2026 |
GBUnited Kingdom· MHRA
19 products
Uses
1). 1).
How to take
EUEuropean Union· EMA
4 products
Uses
Yuvanci is indicated as substitution therapy for the long-term treatment of pulmonary arterial hypertension (PAH) in adult patients of WHO Functional Class (FC) II to III, who are already treated with the combination of macitentan and tadalafil given concurrently as separate tablets.
How to take
CACanada· Health Canada
3 products
Uses
OPSUMIT® (macitentan) is indicated for: • the long-term treatment of pulmonary arterial hypertension (PAH, WHO Group I) to reduce morbidity in adult patients of WHO Functional Class II or III whose PAH is either idiopathic or heritable, or associated with connective tissue disease or congenital heart disease.
• the long-term treatment of pulmonary arterial hypertension (PAH, WHO Group I) in pediatric patients aged 2 to less than 18 years of WHO Function Class II-III whose PAH is either idiopathic or heritable, or associated with connective tissue disease or congenital heart disease.
OPSUMIT® is effective when used as monotherapy or in combination with phosphodiesterase-5 inhibitors. 1 Clinical Trials by Indication). 2 Geriatrics Geriatrics (≥ 65 years of age): Of the total number of subjects in the clinical study of OPSUMIT® for PAH, 14% were ≥65 years of age.
Drug interactions
Known interactions involving Macitentan. Select one for details. This list is informational and not a complete interaction checker.
Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.
Sources & citations
- [1]MHRA (UK) · PL494450239 · revised May 20, 2025
- [2]European Medicines Agency · EMEA/H/C/005001 · revised May 22, 2026
- [3]Health Canada (DPD) · 02415690 · revised October 28, 2025
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.