Status: Not yet recruiting

Open-Label Study of IKT-001 in Pulmonary Arterial Hypertension (PAH)

This is a multicenter, open-label extension (OLE), single-arm study designed to assess the long-term safety and tolerability of oral IKT-001 administered once daily.

Participants needed: 484

Trial details

Phase: Phase 3Age: 18-75Biological sex: AllType: InterventionalSponsor: Inhibikase TherapeuticsUpdated: Jun 8, 2026

Eligibility criteria

Capable of giving signed informed consent. [+1]

ALT or AST levels >3× the ULN [+5]

Status: Recruiting

An Adaptive Program of IKT-001 in Pulmonary Arterial Hypertension (PAH)

This is an adaptive, 2-part, randomized, multicenter, double-blind, placebo-controlled, parallel-group study designed to evaluate the efficacy and safety of IKT-001 in adult participants with WHO Group 1 PAH.

Participants needed: 486

Trial details

Phase: Phase 3Age: 18-75Biological sex: AllType: InterventionalSponsor: Inhibikase TherapeuticsUpdated: May 12, 2026Locations: 2

Eligibility criteria

Idiopathic PAH [+9]

Diagnosis of PAH WHO Groups 2, 3, 4, or 5. [+28]

Clinical trials

Open-Label Study of IKT-001 in Pulmonary Arterial Hypertension (PAH)

An Adaptive Program of IKT-001 in Pulmonary Arterial Hypertension (PAH)