Macitentan

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.

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

Title	Posted	Study ID	Phase	Status	Sponsor
Evaluation of the Efficacy of MACitentan in the Treatment of CoronaryMICrovascular Angina (MACMIC)	2025/02/06	NCT06811831	Early Phase 1	Recruiting	China-Japan Friendship Hospital
Macitentan and Tadalafil Film-coated Tablets 10 mg/40 mg and 'PrOpsynvi®' Macitentan and Tadalafil Film-coated Tablets 10 mg/40 mg	2024/08/14	NCT06553924	Phase 1	Completed	Humanis Saglık Anonim Sirketi
Bioequivalence Study of Macitentan and Tadalafil Film-coated Tablets 10 mg/40 mg and 'PrOpsynvi®' Macitentan and Tadalafil Film-coated Tablets 10 mg/40 mg	2024/08/14	NCT06553937	Phase 1	Completed	Humanis Saglık Anonim Sirketi
Macitentan to Prevent PRVO	2023/07/14	NCT05946811	Phase 3	Withdrawn	University of Maryland, Baltimore
A Study of Macitentan in Children Below 2 Years of Age	2023/02/16	NCT05731492	Phase 1	Withdrawn	Actelion
A Study of Two Macitentan Formulations in Healthy Adult Participants	2022/06/27	NCT05433675	Phase 1	Completed	Actelion
A Study of Two Different Test Formulations Compared to the Reference Formulation of Macitentan in Healthy Adult Participants	2022/05/26	NCT05392530	Phase 1	Completed	Actelion
Endothelin-1 and Cardiac Allograft Vasculopathy (CAV)	2022/05/13	NCT05373108	Phase 4	Completed	University of California, Los Angeles
A Study of Fixed Dose Combination of Macitentan/Tadalafil (10 mg/20 mg) Compared to the Reference Free Combination of Macitentan and Tadalafil in Healthy Adult Participants	2022/02/11	NCT05236231	Phase 1	Completed	Actelion
A Study Providing Treatment Access in Participants With Pulmonary Hypertension Completing a Parent Study and Having no Other Option	2022/01/05	NCT05179876	Phase 3	Recruiting	Actelion

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
OPSYNVI	Actelion Pharmaceuticals US, Inc.	66215-812	ORAL	10 mg in 1 1	4/2/2024
OPSYNVI	Actelion Pharmaceuticals US, Inc.	66215-814	ORAL	10 mg in 1 1	4/2/2024

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
Yuvanci	Janssen-Cilag International NV,Turnhoutseweg 30,2340 Beerse,Belgium	Authorised	9/27/2024
Opsumit	Janssen-Cilag International N.V.,Turnhoutseweg 30,BE-2340 Beerse,Belgium	Authorised	12/20/2013

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
OPSUMIT FILM-COATED TABLET 10MG	Patheon Italia S.p.A., Patheon France (Primary and Secondary Packager), Allpack Group AG (Primary and Secondary Packager), Excella GmbH & Co. KG	SIN14809P	TABLET, FILM COATED	10.00mg	7/15/2015
Opsynvi Film-coated Tablets 10mg/20mg	Penn Pharmaceutical Services Limited	SIN17241P	TABLET, FILM COATED	10mg	5/22/2025
Opsynvi Film-coated Tablets 10mg/40mg	Penn Pharmaceutical Services Limited	SIN17242P	TABLET, FILM COATED	10mg	5/22/2025

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
OPSYNVI 10/40 macitentan 10 mg / tadalafil 40 mg film-coated tablet blister pack	420130	Janssen-Cilag Pty Ltd	Medicine	A	9/16/2024
OPSUMIT macitentan 10 mg film coated tablet blister pack	205624	Janssen-Cilag Pty Ltd	Medicine	A	2/5/2014

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
OPSYNVI	Janssen Inc	02521083	Tablet - Oral	10 MG	11/25/2021
OPSUMIT	Janssen Inc	02415690	Tablet - Oral	10 MG	1/15/2014

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
OPSUMIT 10 mg COMPRIMIDOS RECUBIERTOS CON PELICULA	Janssen-Cilag International N.V	113893002	COMPRIMIDO RECUBIERTO CON PELÍCULA	Uso Hospitalario	Commercialized
YUVANCI 10 MG/20 MG COMPRIMIDOS RECUBIERTOS CON PELICULA	Janssen-Cilag International N.V	1241859001	COMPRIMIDO RECUBIERTO CON PELÍCULA	Uso Hospitalario	Commercialized
YUVANCI 10 MG/40 MG COMPRIMIDOS RECUBIERTOS CON PELICULA	Janssen-Cilag International N.V	1241859002	COMPRIMIDO RECUBIERTO CON PELÍCULA	Uso Hospitalario	Commercialized

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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