Inhibikase received EMA FAST-EU approval in late April for its IMPROVE-PAH Phase 3 study across 12 EU countries, bringing total regulatory clearances to 16 countries including the US, Canada, New Zealand and Argentina. The company plans to secure approvals in three additional EU nations over the coming months to broaden its global trial scope.

The adaptive two-part Phase 3 IMPROVE-PAH study features a 12-week dose titration period followed by Part A, a double-blind, placebo-controlled assessment of pulmonary vascular resistance in approximately 140 patients at Week 24. Part B will enroll about 346 patients to measure 6-minute walk distance at Week 24, with seamless enrollment and potential sample size re-estimation based on Part A findings; the first US site is active and patient enrollment has commenced.

As of March 31, 2026, cash, cash equivalents and marketable securities totaled $170.4 million. The company reported a net loss of $16.4 million ($0.10 per share) for Q1, with R&D expenses rising to $10.8 million from $10.5 million and SG&A expenses increasing to $7.4 million from $5.2 million year-over-year.

Inhibikase submitted an Orphan Drug Designation application to the FDA for IKT-001 in PAH, addressing a condition affecting roughly 50,000 Americans. Two presentations covering Phase 1 safety/pharmacokinetics and preclinical efficacy data will be delivered at the American Thoracic Society International Conference on May 17 and May 20, 2026.