ARK001

ARK001 is an investigational topical gel formulation of esmolol, an ultra-short-acting beta-1 selective adrenergic receptor antagonist, being developed by Arkayli Biopharma. It is designed with a proprietary precision drug delivery system to localize therapy within skin lesions while minimizing systemic exposure, thereby reducing the risk of systemic side effects such as hypoglycemia, bradycardia, or sleep disturbances. ARK001 is being developed for the treatment of infantile hemangioma (IH), a rare pediatric vascular anomaly. The U.S. FDA has cleared its Investigational New Drug (IND) application with a Study May Proceed letter, allowing Arkayli to initiate a Phase 1b clinical trial in infants with proliferating IH.