Status: Not yet recruiting
A Phase 3 Study of Extended-release Tacrolimus in Subjects With Pulmonary Arterial Hypertension and Functional Limitations
This study evaluates the effects of VI-0106 (an extended-release formulation of tacrolimus) in participants with pulmonary arterial hypertension (PAH) who continue to have functional limitations despite being on optimized background PAH therapy. Participants will be randomly assigned with equal chance to receive either VI-0106 or placebo in a double-blind fashion to assess whether VI-0106 improves outcomes in this population.
Participants needed: 300
Trial details
Phase: Phase 3Age: 18-75Biological sex: AllType: InterventionalSponsor: VIVUS LLCUpdated: May 29, 2026
Eligibility criteria
WHO Group 1 PH: Pulmonary Arterial Hypertension; [+3]
PAH due to pulmonary veno-occlusive disease or pulmonary capillary hemangiomatos... [+14]