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Macitentan is a dual endothelin receptor antagonist that blocks both ETA and ETB receptors to reduce pulmonary vascular resistance and improve exercise capacity in pulmonary arterial hypertension.
Macitentan is a dual endothelin receptor antagonist that blocks both ETA and ETB receptors to reduce pulmonary vascular resistance and improve exercise capacity in pulmonary arterial hypertension. Used for Pulmonary arterial hypertension (PAH).
At a glance
| Generic name | Macitentan Group |
|---|---|
| Also known as | JNJ-67896062 |
| Sponsor | University of Giessen |
| Drug class | Dual endothelin receptor antagonist |
| Target | ETA and ETB receptors |
| Modality | Small molecule |
| Therapeutic area | Cardiovascular |
| Phase | Phase 3 |
Mechanism of action
Endothelin is a potent vasoconstrictor involved in the pathophysiology of pulmonary arterial hypertension (PAH). By antagonizing both ETA and ETB receptors on vascular smooth muscle and endothelial cells, macitentan reduces vasoconstriction, inhibits cell proliferation, and promotes vasodilation. This dual antagonism provides more comprehensive blockade compared to selective ETA antagonists, leading to improved hemodynamics and clinical outcomes in PAH patients.
Approved indications
- Pulmonary arterial hypertension (PAH)
Common side effects
- Headache
- Nasopharyngitis
- Anemia
- Peripheral edema
- Flushing
Key clinical trials
- Outcome Study Assessing a 75 Milligrams (mg) Dose of Macitentan in Patients With Pulmonary Arterial Hypertension (PHASE3)
- A Study to Assess Whether Macitentan Delays Disease Progression in Children With Pulmonary Arterial Hypertension (PAH) (PHASE3)
- Efficacy and Mechanisms of Macitentan for Non-Coronary Obstructive Angina (EARLY_PHASE1)
- Clinical Study to Compare the Efficacy and Safety of Macitentan and Tadalafil Monotherapies With the Corresponding Fixed-dose Combination Therapy in Subjects With Pulmonary Arterial Hypertension (PAH) (PHASE3)
- Clinical Trial to Evaluate the Efficacy and Safety in Concomitant Administration of Macitentan and Dapagliflozin in Patients With Heart Failure With Mildly Reduced and Preserved Ejection Fraction (HFmrEF and HFpEF) and Combined Pre- and Post-capillary Pulmonary Hypertension (CpcPH) (PHASE4)
- Data Analysis for Drug Repurposing for Effective Alzheimer's Medicines (DREAM) - PDE5
- A Study to Evaluate Efficacy and Safety of Macitentan 75 mg in Inoperable or Persistent/Recurrent Chronic Thromboembolic Pulmonary Hypertension (PHASE3)
- Clinical Study to Assess the Efficacy and Safety of Macitentan in Patients With Pulmonary Hypertension After Left Ventricular Assist Device Implantation (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Macitentan Group CI brief — competitive landscape report
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- University of Giessen portfolio CI