IKT-001 - (IMPROVE-PAH)

July 23, 2026: Inhibikase Therapeutics, Inc. (NASDAQ: IKT) said the FDA granted Orphan Drug Designation (ODD) to its lead candidate IKT-001 (a prodrug of imatinib mesylate) for treatment of pulmonary arterial hypertension (PAH). The company noted ODD was granted to the active moiety (imatinib) rather than a specific formulation and may provide incentives such as tax credits for qualified clinical trial costs, exemption from certain FDA user fees, and potential seven years of market exclusivity upon approval.

Inhibikase also referenced recent presentations of IKT-001 preclinical data at the American Thoracic Society International Conference in Orlando, reporting improvements in pulmonary vascular and hemodynamic markers of PAH and a lower potential for GI toxicity versus imatinib mesylate. The company said its pivotal Phase 3 PAH study, IMPROVE-PAH, across ~180 sites globally, is actively enrolling patients.