DR003

DR003 is an investigational, repurposed drug candidate being developed by Drug Rediscovery Group (DRG) for the treatment of sleep disorders, including insomnia. It is a novel formulation of promethazine, a first-generation antihistamine with well-established sedative properties. DR003 is designed to be administered via a non-oral route, such as sublingual or buccal delivery, to optimize its pharmacokinetic profile and provide a faster onset of action for sleep induction. The development follows the FDA 505(b)(2) regulatory pathway, leveraging the known safety and efficacy of promethazine while introducing a new delivery method. Promethazine acts primarily as a potent H1 receptor antagonist, blocking the wake-promoting effects of histamine in the brain, and also exhibits antagonistic activity at muscarinic and dopaminergic receptors.