Mira Pharmaceuticals announces FDA clearance of IND for Ketamir-2

MIRA Pharmaceuticals (MIRA) announced that the U.S. Food and Drug Administration has cleared its Investigational New Drug application for Ketamir-2, a novel oral NMDA receptor antagonist for the treatment of neuropathic pain. The IND submission included a comprehensive data package encompassing preclinical pharmacology, safety, and toxicology studies, including a pivotal neurotoxicity study in Sprague-Dawley rats which showed no evidence of brain lesions or adverse CNS effects-a key distinction from traditional ketamine, which has been associated with NMDA-linked neurotoxicity and the formation of Olney lesions in similar preclinical models. These findings were reinforced by multiple validated neuropathic pain models-including chemotherapy-induced, diabetic, and nerve ligation-induced neuropathy-where Ketamir-2 consistently demonstrated potent analgesic effects and superior efficacy to gabapentin and pregabalin, with reversal of pain sensitivity observed in select models. The IND also incorporated the Company’s Phase 1 readiness data and manufacturing documentation. MIRA is nearing completion of the Single Ascending Dose portion of its international Phase 1 trial at Hadassah Medical Center in Jerusalem, with dose escalation progressing smoothly. The Company is now preparing to initiate the Multiple Ascending Dose portion of the study, which will assess the safety, tolerability, and pharmacokinetics of repeated dosing over several days. These data will help inform optimal dosing strategies as MIRA moves toward a Phase 2a study, with the goal of initiating its first U.S.-based efficacy trial in Q4 2025.