MIRA Pharmaceuticals Inc. $(MIRA)$ has announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug $(IND.AU)$ application for Ketamir-2, a novel oral NMDA receptor antagonist aimed at treating neuropathic pain. This regulatory approval enables MIRA to initiate U.S.-based clinical trials. Ketamir-2 has demonstrated superior efficacy to existing treatments such as gabapentin and pregabalin in preclinical studies, with a favorable safety profile and no evidence of ketamine-associated neurotoxicity. MIRA is advancing through Phase 1 trials and plans to initiate U.S. Phase 2a trials by the end of 2025.
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