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

A Study of Macitentan in Children Below 2 Years of Age

Phase 1

Withdrawn

Conditions: Arterial Hypertension, Pulmonary

Interventions: Drug: Macitentan

First Posted Date: 2023-02-16

Last Posted Date: 2025-01-10

Lead Sponsor: Actelion

Registration Number: NCT05731492

Locations: 🇩🇪
Universitatsmedizin Gottingen, Goettingen, Germany
🇩🇪
Universitatsklinikum Freiburg, Freiburg im Breisgau, Germany
🇵🇱
Instytut Pomnik Centrum Zdrowia Dziecka, Warszawa, Poland

and more 1 locations

A Study of Two Macitentan Formulations in Healthy Adult Participants

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: Macitentan

First Posted Date: 2022-06-27

Last Posted Date: 2022-10-12

Lead Sponsor: Actelion

Target Recruit Count: 28

Registration Number: NCT05433675

Locations: 🇧🇪
SGS Belgium NV, Edegem, Belgium

A Study of Two Different Test Formulations Compared to the Reference Formulation of Macitentan in Healthy Adult Participants

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: Macitentan

First Posted Date: 2022-05-26

Last Posted Date: 2022-11-09

Lead Sponsor: Actelion

Target Recruit Count: 23

Registration Number: NCT05392530

Locations: 🇧🇪
SGS Belgium NV, Edegem, Belgium

Endothelin-1 and Cardiac Allograft Vasculopathy (CAV)

Phase 4

Completed

Conditions: Cardiac Allograft Vasculopathy

Interventions: Drug: Macitentan

First Posted Date: 2022-05-13

Last Posted Date: 2024-03-12

Lead Sponsor: University of California, Los Angeles

Target Recruit Count: 19

Registration Number: NCT05373108

Locations: 🇺🇸
Ronald Regan UCLA Medical Center, Los Angeles, California, United States

A Study Providing Treatment Access in Participants With Pulmonary Hypertension Completing a Parent Study and Having no Other Option

Phase 3

Recruiting

Conditions: Hypertension, Pulmonary

Interventions: Drug: Macitentan
Drug: Macitentan/Tadalafil FDC
Drug: Selexipag

First Posted Date: 2022-01-05

Last Posted Date: 2025-01-10

Lead Sponsor: Actelion

Target Recruit Count: 230

Registration Number: NCT05179876

Locations: 🇵🇱
Klinika Kardiologii Z Oddzialem Intensywnego Nadzoru Kardiologicznego UM W Bialymstoku, Bialystok, Poland
🇵🇱
SPSK nr 7 SUM w Katowicach Gornoslaskie Centrum Medyczne im Prof Leszka Gieca, Katowice, Poland
🇵🇱
Oddzial Kardiologii Wojewodzki Szpital Specjalistyczny im W Bieganskiego, Lodz, Poland

and more 30 locations

A Study of Macitentan in Japanese Pediatric Participants With Pulmonary Arterial Hypertension

Phase 3

Active, not recruiting

Conditions: Pulmonary Arterial Hypertension

Interventions: Drug: Macitentan

First Posted Date: 2021-12-22

Last Posted Date: 2025-01-10

Lead Sponsor: Janssen Pharmaceutical K.K.

Target Recruit Count: 7

Registration Number: NCT05167825

Locations: 🇯🇵
National Cerebral and Cardiovascular Center, Suita-Shi, Japan
🇯🇵
Osaka University Hospital, Suita-shi, Japan
🇯🇵
The University of Tokyo Hospital, Tokyo, Japan

and more 8 locations

A Study of Two Macitentan Pediatric Formulations in Healthy Adult Participants

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: Macitentan

First Posted Date: 2021-07-15

Last Posted Date: 2022-09-14

Lead Sponsor: Actelion

Target Recruit Count: 16

Registration Number: NCT04963439

Locations: 🇧🇪
Clinical Pharmacology Unit, Merksem, Belgium

Initial Dual Oral Combination Therapy Versus Standard-of-care Initial Oral Monotherapy Prior to Balloon Pulmonary Angioplasty in Patients with Inoperable Chronic Thromboembolic Pulmonary Hypertension

Phase 2

Active, not recruiting

Conditions: Thromboembolic Pulmonary Hypertension
Chronic Disease
Inoperable Disease

Interventions: Drug: Placebo
Drug: Macitentan 10mg

First Posted Date: 2021-03-04

Last Posted Date: 2024-12-16

Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Target Recruit Count: 96

Registration Number: NCT04780932

Locations: 🇫🇷
Hôpital Bicêtre, Le Kremlin-Bicêtre, Ile de France, France

Outcome Study Assessing a 75 Milligrams (mg) Dose of Macitentan in Patients With Pulmonary Arterial Hypertension

Phase 3

Active, not recruiting

Conditions: Pulmonary Arterial Hypertension

Interventions: Drug: Macitentan 10 mg
Drug: Macitentan 37.5 mg
Drug: Macitentan 75 mg
Drug: Placebo

First Posted Date: 2020-02-18

Last Posted Date: 2025-01-10

Lead Sponsor: Actelion

Target Recruit Count: 935

Registration Number: NCT04273945

Locations: 🇵🇱
Uniwersytecki Szpital Kliniczny w Bialymstoku, Bialystok, Poland
🇵🇱
SPSK nr 7 SUM w Katowicach Gornoslaskie Centrum Medyczne im Prof Leszka Gieca, Katowice, Poland
🇵🇱
Krakowski Szpital Specjalityczny im Jana Pawla II Oddzial Kliniczny Chorob Serca i Naczyn, Krakow, Poland

and more 270 locations

A Study to Evaluate Efficacy and Safety of Macitentan 75 mg in Inoperable or Persistent/Recurrent Chronic Thromboembolic Pulmonary Hypertension

Phase 3

Terminated

Conditions: Chronic Thromboembolic Pulmonary Hypertension

Interventions: Drug: Macitentan
Drug: Placebo

First Posted Date: 2020-02-17

Last Posted Date: 2024-12-05

Lead Sponsor: Actelion

Target Recruit Count: 127

Registration Number: NCT04271475

Locations: 🇧🇬
Military Medical Academy, Sofia, Bulgaria
🇧🇬
University Multiprofile Hospital for Active Treatment- UMHAT Sveta Anna AD, Sofia, Bulgaria
🇺🇸
University of Colorado Anschutz Medical Campus, Aurora, Colorado, United States

and more 165 locations

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