MIRA Pharmaceuticals, a pioneering clinical-stage pharmaceutical company specializing in treatments for neurologic, neuropsychiatric, and metabolic disorders, has achieved a major milestone with the clearance of its Investigational New Drug (IND) application for Ketamir-2 by the U.S. Food and Drug Administration (FDA). This groundbreaking oral NMDA receptor antagonist shows significant promise for alleviating neuropathic pain, marking a significant step forward in the development of non-opioid, non-controlled therapies. With the successful progression of the Single Ascending Dose (SAD) portion of its Phase 1 trial, MIRA is now gearing up for the Multiple Ascending Dose (MAD) phase to evaluate safety, tolerability, and pharmacokinetics. These crucial data will guide the optimal dosing strategies as the company gears up for its Phase 2a study and plans to initiate its first U.S.-based efficacy trial in the fourth quarter of 2025. The robust efficacy and safety profile of Ketamir-2 have been consistently demonstrated in various preclinical studies, showcasing its potential as a leading treatment option for neuropathic pain. This significant advancement underscores MIRA’s commitment to innovation and its dedication to addressing unmet medical needs in the field of neurology.
Read more from usatoday.com