The U.S. Food and Drug Administration (FDA) has granted orphan drug designation to IKT-001, an experimental formulation of imatinib that Inhibikase Therapeutics is developing to treat pulmonary arterial hypertension (PAH).
Orphan drug designation is granted to investigational medications aimed at treating rare diseases — conditions affecting fewer than 200,000 people in the U.S. The designation is meant to give drug developers extra incentives to invest in rare disease treatments, since a small patient population can make it difficult to recoup development costs and turn a profit. For Inhibikase, the designation brings several benefits, including tax breaks and fee waivers, along with a guaranteed seven years of market exclusivity should the Food and Drug Administration ultimately approve IKT-001.
See also our previous articles on IKT-001 here and here
Read more on company press release at this link