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 Study of Macitentan and Tadalafil as a Fixed Dose Combination and the Free Combination in Healthy Adult Participants
- Conditions
- Healthy
- Interventions
- First Posted Date
- 2020-01-21
- Last Posted Date
- 2020-09-30
- Lead Sponsor
- Janssen Research & Development, LLC
- Target Recruit Count
- 62
- Registration Number
- NCT04235270
- Locations
- 🇺🇸
Celerion, Tempe, Arizona, United States
A 2-part Study to Investigate the Effect of Macitentan in Healthy Male Participants
- Conditions
- Healthy
- Interventions
- First Posted Date
- 2019-12-26
- Last Posted Date
- 2022-05-25
- Lead Sponsor
- Actelion
- Target Recruit Count
- 47
- Registration Number
- NCT04211272
- Locations
- 🇧🇪
Clinical Pharmacology Unit, Merksem, Belgium
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.
- Conditions
- Pulmonary Arterial HypertensionChronic Thromboembolic Pulmonary Hypertension
- Interventions
- First Posted Date
- 2018-02-05
- Last Posted Date
- 2025-01-10
- Lead Sponsor
- Actelion
- Target Recruit Count
- 151
- Registration Number
- NCT03422328
- Locations
- 🇵🇱
Wojewodzki Szpital Specjalistyczny im Stefana Kardynala Wyszynskiego SPZOZ, Lublin, Poland
🇵🇱Wojewodzki Szpital Specjalistyczny Oddzial Kardiologiczny, Wroclaw, Poland
🇧🇾The Republican Scientific-Practical Center ''Cardiology'', Minsk, Belarus
Clinical Study to Investigate the Effect of Macitentan on the Concentrations of Rosuvastatin in the Blood of Healthy Male Subjects
- 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
- Conditions
- Heart Failure With Preserved Ejection Fraction
- Interventions
- Drug: PlaceboDrug: Macitentan
- 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
Clinical Study Evaluating the Effects of First-line Oral cOmbination theraPy of maciTentan and tadalafIl in Patients With Newly Diagnosed pulMonary Arterial Hypertension (OPTIMA)
- Conditions
- Pulmonary Arterial Hypertension
- Interventions
- 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
A Study to Assess Whether Macitentan Delays Disease Progression in Children With Pulmonary Arterial Hypertension (PAH)
- Conditions
- Pulmonary Arterial Hypertension
- Interventions
- Other: Standard-of-careDrug: Macitentan
- First Posted Date
- 2016-10-13
- Last Posted Date
- 2025-01-10
- 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
Macitentan in the Treatment of Organ Rejection After Lung Transplantation
- Conditions
- Lung Transplant Rejection
- Interventions
- Drug: placebo (for macitentan)Drug: macitentan
- 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
- 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
- Conditions
- Pulmonary Arterial Hypertension
- Interventions
- 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
Drug Development Updates
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