Inhibikase Therapeutics, Inc., a clinical-stage pharmaceutical company has announced that it expects to advance IKT-001 to a global pivotal Phase 3 clinical study in pulmonary arterial hypertension The Phase 3 study, named IMPROVE-PAH, is expected to be initiated in the first quarter of 2026.
IKT-001 is an investigational novel pro-drug of imatinib mesylate. Imatinib is an anti-proliferative tyrosine kinase inhibitor, TKI, with potential best-in-class improvements in pulmonary vascular resistance and 6-minute walk distance based on the 2013 Phase 3 IMPRES and Phase 2 studies. The IMPRES Phase 3 study demonstrated improved exercise capacity and hemodynamics in patients with advanced pulmonary arterial hypertension, but a high number of discontinuations and serious adverse events (e.g. subdural hematomas in some patients) led to the marketing application withdrawal at that time.
IKT-001 is a prodrug of imatinib which is engineered to realize the potential of imatinib in pulmonary arterial hypertension with lower side effets and discontinuations in the forthcoming Phase 3 study.
Read the press release at this link on Yahoo Finance
See also our article about the dose finding study for imatinib conducted at Imperial College London and published earlier this year here