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# Janssen Stops Macitentan Phase 3 Study
- URL: https://www.fdaweb.com/janssen-stops-macitentan-phase-3-study/
- Published: 2023-09-07T12:00:00.000Z
- Updated: 2026-09-14T18:54:52.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5155270

Janssen Pharmaceutical has stopped, due to futility, its Phase 3 MACiTEPH study evaluating macitentan 75 mg in patients with chronic thromboembolic pulmonary hypertension. The decision to stop follows a recommendation by the study’s independent data monitoring committee after a pre-planned interim analysis. “Additionally, the pivotal Phase 3 UNISUS study, which aims to establish the superiority of a 75 mg dose of macitentan over the currently available 10 mg dose (Opsumit) in patients with pulmonary arterial hypertension, is currently continuing as planned,” the company says.