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.

NCT Number	NCT07612657
Lead Sponsor	VIVUS LLC
Conditions	Pulmonary Arterial Hypertension, Pulmonary Arterial Hypertension (PAH), Pulmonary Arterial Hypertension (PAH) (WHO Group 1 PH), Pulmonary Arterial Hypertension PAH, Pulmonary Arterial Hypertension WHO Group I
Enrollment	300 participants
Start Date	2026-05-29
Primary Completion	2028-05-31 (estimated)
Study Completion	2029-11-30 (estimated)
Updated on ClinicalTrials.gov	2026-05-29