IKT-001 + sotatercept

IKT-001 + sotatercept is an investigational combination therapy being evaluated for the treatment of pulmonary arterial hypertension (PAH). The combination consists of IKT-001 (IkT-001Pro), a novel once-daily oral prodrug of the tyrosine kinase inhibitor imatinib mesylate, and sotatercept (Winrevair), an FDA-approved subcutaneous activin signaling inhibitor. IKT-001 is designed to deliver the anti-proliferative benefits of imatinib—targeting PDGFR and c-Kit pathways to reverse pulmonary vascular remodeling—while minimizing gastrointestinal exposure and improving tolerability. Sotatercept acts as a ligand trap that sequesters pro-proliferative activins and growth differentiation factors (GDFs), restoring the balance between pro-remodeling and anti-remodeling pathways. Developed by Inhibikase Therapeutics, the combination is currently in nonclinical development, with studies aimed at demonstrating additive hemodynamic improvements and disease-modifying synergy in PAH.