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On July 23, 2026, Inhibikase Therapeutics announced that the FDA granted Orphan Drug Designation (ODD) to its lead…
IKTInhibikase Therapeutics, Inc.
On July 23, 2026, Inhibikase Therapeutics announced that the FDA granted Orphan Drug Designation (ODD) to its lead product candidate, IKT-001, for the treatment of Pulmonary Arterial Hypertension (PAH). The ODD applies to the active moiety, imatinib, and provides incentives including tax credits for clinical trial costs, exemption from certain FDA user fees, and potential seven-year market exclusivity upon approval. IKT-001 is currently in a pivotal Phase 3 clinical study named IMPROVE-PAH, which is actively enrolling patients across approximately 180 global sites. The company is a clinical-stage pharmaceutical company developing therapeutics to modify the course of cardiopulmonary diseases.