NCT07365332

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

An Adaptive, 2-Part, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of IKT-001 in Pulmonary Arterial Hypertension (PAH)

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 486 (estimated)
• Sponsor: Inhibikase Therapeutics · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Pulmonary Arterial Hypertension

Interventions

Type	Name	Description
DRUG	IKT-001	IKT-001 tablets for PO administration
DRUG	Placebo	Placebo to IKT-001 tablets for PO administration

Timeline

• Start date: 2026-03-01
• Primary completion: 2029-06-01
• Completion: 2029-12-01
• First posted: 2026-01-26
• Last updated: 2026-01-27

Regulatory

• FDA-regulated drug study