Macitentan

Generic Name: Macitentan

Brand Names: Opsumit

Drug Type: Small Molecule

Chemical Formula: C_₁₉H_₂₀Br_₂N_₆O_₄S

CAS Number: 441798-33-0

Unique Ingredient Identifier: Z9K9Y9WMVL

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

Associated Therapies: -

Clinical Trials

Extension of the Psychometric Validation Study ORCHESTRA in Patients With PAH

Phase 3

Completed

Conditions: Pulmonary Arterial Hypertension

Interventions: Drug: Macitentan

First Posted Date: 2014-04-14

Last Posted Date: 2019-09-20

Lead Sponsor: Actelion

Target Recruit Count: 88

Registration Number: NCT02112487

Locations: 🇪🇸
Hospital General de Alicante, Alicante, Spain
🇪🇸
Hospital Val Hebron, Barcelona, Spain
🇪🇸
Hospital Clinic, Barcelona, Spain

and more 29 locations

A Pulmonary Arterial Hypertension Study With Macitentan to Validate the PAH-SYMPACT™ in France, Italy and Spain

Phase 3

Terminated

Conditions: Pulmonary Arterial Hypertension

Interventions: Drug: Macitentan

First Posted Date: 2014-03-07

Last Posted Date: 2018-03-21

Lead Sponsor: Actelion

Target Recruit Count: 160

Registration Number: NCT02081690

Locations: 🇫🇷
CHU de Bicêtre, Le Kremlin-Bicêtre, France
🇫🇷
Hôpital Arnaud de Villeneuve, Montpellier, France
🇪🇸
Hospital Val Hebron, Barcelona, Spain

and more 36 locations

Clinical Study to Evaluate the Safety and Tolerability of Macitentan in Subjects With Combined Pre- and Post-capillary Pulmonary Hypertension (CpcPH) Due to Left Ventricular Dysfunction

Phase 2

Completed

Conditions: Pulmonary Hypertension

Interventions: Drug: Macitentan
Drug: Placebo

First Posted Date: 2014-02-25

Last Posted Date: 2019-05-15

Lead Sponsor: Actelion

Target Recruit Count: 63

Registration Number: NCT02070991

Locations: 🇦🇹
Medical University of Vienna and AKH Cardiology, Vienna, Austria
🇺🇸
The Lindner Clinical Trial Center, Cincinnati, Ohio, United States
🇦🇹
Krankenhaus der Elisabethinen Linz, 2. Interne Abteilung, Linz, Austria

and more 29 locations

Clinical Study to Assess the Safety, Tolerability and Efficacy of Macitentan in Subjects With Inoperable Chronic Thromboembolic Pulmonary Hypertension

Phase 2

Completed

Conditions: Chronic Thromboembolic Pulmonary Hypertension

Interventions: Drug: Macitentan

First Posted Date: 2014-02-12

Last Posted Date: 2023-04-11

Lead Sponsor: Actelion

Target Recruit Count: 76

Registration Number: NCT02060721

Clinical Study to Assess the Efficacy, Safety and Tolerability of Macitentan in Subjects With Inoperable Chronic Thromboembolic Pulmonary Hypertension

Phase 2

Completed

Conditions: Chronic Thromboembolic Pulmonary Hypertension

Interventions: Drug: Placebo
Drug: Macitentan

First Posted Date: 2013-12-27

Last Posted Date: 2020-06-04

Lead Sponsor: Actelion

Target Recruit Count: 80

Registration Number: NCT02021292

Locations: 🇱🇹
Lietuvos Sveikatos Mokslų Universiteto Ligoninės Kauno Klinikos Pulmonologijos-Imunologijos Klinika, Kaunas, Lithuania
🇲🇽
Instituto Nacional de Cardiologia (INC) Ignacio Chavez, Mexico City, Mexico
🇬🇧
Hammersmith Hospital, London, United Kingdom

and more 33 locations

Clinical Study of Macitentan in Patients With PAH to Psychometrically Validate PAH-SYMPACT Instrument

Phase 3

Terminated

Conditions: Pulmonary Arterial Hypertension

Interventions: Drug: Macitentan

First Posted Date: 2013-05-06

Last Posted Date: 2018-08-22

Lead Sponsor: Actelion

Target Recruit Count: 4

Registration Number: NCT01847014

Locations: 🇺🇸
Kentuckiana Pulmonary Associates, Louisville, Kentucky, United States
🇺🇸
The Carl & Edyth Lindner Center for Research & Education at The Christ Hospital, Cincinnati, Ohio, United States

Clinical Study of Macitentan in Patients With Pulmonary Arterial Hypertension to Psychometrically Validate the PAH-SYMPACT Instrument

Phase 3

Completed

Conditions: Pulmonary Arterial Hypertension

Interventions: Drug: Macitentan

First Posted Date: 2013-04-29

Last Posted Date: 2019-02-26

Lead Sponsor: Actelion

Target Recruit Count: 284

Registration Number: NCT01841762

Locations: 🇺🇸
Johns Hopkins University, Baltimore, Maryland, United States
🇺🇸
Ferrell-Duncan Clinic, Springfield, Missouri, United States
🇺🇸
UPMC, Pittsburgh, Pennsylvania, United States

and more 77 locations

Safety and Tolerability Study of Macitentan in Patients With Idiopathic Pulmonary Fibrosis

Phase 2

Withdrawn

Conditions: Idiopathic Pulmonary Fibrosis

Interventions: Drug: Macitentan

First Posted Date: 2011-05-04

Last Posted Date: 2014-09-03

Lead Sponsor: Actelion

Registration Number: NCT01346930

Clinical Study to Assess the Long-term Safety and Tolerability of ACT 064992 in Patients With Symptomatic Pulmonary Arterial Hypertension

Phase 3

Completed

Conditions: Pulmonary Arterial Hypertension

Interventions: Drug: Macitentan

First Posted Date: 2008-04-28

Last Posted Date: 2022-02-10

Lead Sponsor: Actelion

Target Recruit Count: 550

Registration Number: NCT00667823

Locations: 🇺🇸
Santa Barbara Cottage Hospital, Santa Barbara, California, United States
🇺🇸
Emory University Hospital - McKelvey Center for Lung Transplantation & Pulmonary Vascular Disease, Atlanta, Georgia, United States
🇺🇸
Allegheny General Hospital, Pittsburgh, Pennsylvania, United States

and more 155 locations

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