Macitentan
- Generic Name
- Macitentan
- Brand Names
- Opsumit
- Drug Type
- Small Molecule
- Chemical Formula
- C19H20Br2N6O4S
- CAS Number
- 441798-33-0
- Unique Ingredient Identifier
- Z9K9Y9WMVL
Overview
Macitentan is a dual endothelin receptor antagonist used in the treatment of pulmonary arterial hypertension. It was first approved by the FDA in 2013. Macitentan differs from its predecessor bosentan due to its lower risk of hepatotoxicity.
Background
Macitentan is a dual endothelin receptor antagonist used in the treatment of pulmonary arterial hypertension. It was first approved by the FDA in 2013. Macitentan differs from its predecessor bosentan due to its lower risk of hepatotoxicity.
Indication
Macitentan is indicated for the treatment of WHO group 1 pulmonary arterial hypertension (PAH) both alone and in combination with tadalafil.
Associated Conditions
- Pulmonary arterial hypertension WHO functional class I
Clinical Trials
FDA Approved Products
OPSYNVI
Manufacturer:Actelion Pharmaceuticals US, Inc.
Route:ORAL
Strength:10 mg in 1 1
Approved: 2024/04/02
NDC:66215-812
OPSYNVI
Manufacturer:Actelion Pharmaceuticals US, Inc.
Route:ORAL
Strength:10 mg in 1 1
Approved: 2024/04/02
NDC:66215-814
Singapore Approved Products
OPSUMIT FILM-COATED TABLET 10MG
Manufacturer:Patheon Italia S.p.A., Patheon France (Primary and Secondary Packager), Allpack Group AG (Primary and Secondary Packager), Excella GmbH & Co. KG
Form:TABLET, FILM COATED
Strength:10.00mg
Online:Yes
Approved: 2015/07/15
Approval:SIN14809P
Opsynvi Film-coated Tablets 10mg/20mg
Manufacturer:Penn Pharmaceutical Services Limited
Form:TABLET, FILM COATED
Strength:10mg
Online:Yes
Approved: 2025/05/22
Approval:SIN17241P
Opsynvi Film-coated Tablets 10mg/40mg
Manufacturer:Penn Pharmaceutical Services Limited
Form:TABLET, FILM COATED
Strength:10mg
Online:Yes
Approved: 2025/05/22
Approval:SIN17242P
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