Macitentan

Generic Name
Macitentan
Brand Names
Opsumit
Drug Type
Small Molecule
Chemical Formula
C19H20Br2N6O4S
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
-

A Clinical Study to Investigate the Long-term Safety of the Drug Macitentan in Patients With Pulmonary Hypertension Who Were Previously Treated With Macitentan in Clinical Studies.

First Posted Date
2018-02-05
Last Posted Date
2024-12-05
Lead Sponsor
Actelion
Target Recruit Count
151
Registration Number
NCT03422328
Locations
🇧🇾

The Republican Scientific-Practical Center ''Cardiology'', Minsk, Belarus

🇫🇷

Hopital Bicetre Aphp Hopitaux Universitaires Paris Sud, Le Kremlin Bicetre cedex, France

🇫🇷

Hopital Europeen Georges Pompidou, Paris Cedex 15, France

and more 31 locations

Clinical Study to Investigate the Effect of Macitentan on the Concentrations of Rosuvastatin in the Blood of Healthy Male Subjects

Phase 1
Completed
Conditions
Interventions
First Posted Date
2017-12-02
Last Posted Date
2017-12-20
Lead Sponsor
Actelion
Target Recruit Count
20
Registration Number
NCT03359291
Locations
🇩🇪

CRS Clinical Research Services Mannheim, Mannheim, Germany

A Study to Evaluate Whether Macitentan is an Effective and Safe Treatment for Patients With Heart Failure With Preserved Ejection Fraction and Pulmonary Vascular Disease

First Posted Date
2017-05-15
Last Posted Date
2023-05-03
Lead Sponsor
Actelion
Target Recruit Count
143
Registration Number
NCT03153111
Locations
🇺🇸

Drexel University College of Medicine, Philadelphia, Pennsylvania, United States

🇺🇸

Allegheny, Pittsburgh, Pennsylvania, United States

🇺🇸

Vascular Medicine Institute University Of Pittsburgh, Pittsburgh, Pennsylvania, United States

and more 92 locations

Clinical Study Evaluating the Effects of First-line Oral cOmbination theraPy of maciTentan and tadalafIl in Patients With Newly Diagnosed pulMonary Arterial Hypertension (OPTIMA)

First Posted Date
2016-11-21
Last Posted Date
2019-10-08
Lead Sponsor
Actelion
Target Recruit Count
46
Registration Number
NCT02968901
Locations
🇫🇷

Hôpital de Haut Levêque, Bordeaux, France

🇫🇷

CHU Site du Bocage, Dijon, France

🇫🇷

Hôpital Louis Pradel, Lyon, France

and more 15 locations

A Study to Assess Whether Macitentan Delays Disease Progression in Children With Pulmonary Arterial Hypertension (PAH)

Phase 3
Active, not recruiting
Conditions
Interventions
First Posted Date
2016-10-13
Last Posted Date
2024-12-05
Lead Sponsor
Actelion
Target Recruit Count
165
Registration Number
NCT02932410
Locations
🇺🇸

UCLA Children's Heart Center, Los Angeles, California, United States

🇺🇸

Riley Hospital For Children, Indianapolis, Indiana, United States

🇺🇸

Nationwide Children's Hospital, Columbus, Ohio, United States

and more 83 locations

Macitentan in the Treatment of Organ Rejection After Lung Transplantation

First Posted Date
2016-09-08
Last Posted Date
2020-12-11
Lead Sponsor
University of California, Los Angeles
Registration Number
NCT02893176
Locations
🇺🇸

University of Califonia, Los Angeles, Los Angeles, California, United States

Macitentan in Pulmonary Hypertension of Sickle Cell Disease

Phase 2
Terminated
Conditions
Interventions
First Posted Date
2016-01-08
Last Posted Date
2020-12-08
Lead Sponsor
Boston University
Target Recruit Count
4
Registration Number
NCT02651272
Locations
🇺🇸

Boston University School of Medicine, Boston, Massachusetts, United States

The Efficacy and Safety of Initial Triple Versus Initial Dual Oral Combination Therapy in Patients With Newly Diagnosed Pulmonary Arterial Hypertension

First Posted Date
2015-09-23
Last Posted Date
2021-04-13
Lead Sponsor
Actelion
Target Recruit Count
247
Registration Number
NCT02558231
Locations
🇺🇸

University of Texas Southwestern Medical Center, Dallas, Texas, United States

🇺🇸

Boston University Medical Center, Boston, Massachusetts, United States

🇺🇸

Tufts Medical Center, Boston, Massachusetts, United States

and more 55 locations

PORtopulmonary Hypertension Treatment wIth maCitentan - a randOmized Clinical Trial

Phase 4
Completed
Conditions
Interventions
First Posted Date
2015-03-06
Last Posted Date
2019-11-05
Lead Sponsor
Actelion
Target Recruit Count
85
Registration Number
NCT02382016
Locations
🇺🇸

David Geffen School of Medicine, UCLA, Los Angeles, California, United States

🇨🇿

Lékařská fakulta a Všeobecná fakultní nemocnice v Praze, II. Interní klinika kardiologie a angiologie U, Prague, Czechia

🇪🇸

Hospital Universitario12 Octubre, Madrid, Spain

and more 48 locations

REPAIR: Right vEntricular Remodeling in Pulmonary ArterIal hypeRtension

Phase 4
Completed
Conditions
Interventions
First Posted Date
2014-12-08
Last Posted Date
2020-09-24
Lead Sponsor
Actelion
Target Recruit Count
89
Registration Number
NCT02310672
Locations
🇺🇸

Massachussetts General Hospital, Boston, Massachusetts, United States

🇺🇸

Washington University School of Medicine, Saint Louis, Missouri, United States

🇺🇸

Rudgers New Jersey Medical School, New Brunswick, New Jersey, United States

and more 38 locations
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