MIRA Pharma receives FDA IND clearance for Ketamir-2, advancing neuropathic pain program

MIRA PHARMACEUTICALS, INC.

FDA cleared IND for Ketamir-2, an oral NMDA antagonist for neuropathic pain, enabling U.S. clinical trials.
Preclinical head-to-head data showed superior efficacy to gabapentin and pregabalin with no ketamine-related neurotoxicity.
Phase 1 single ascending dose portion nearing completion; U.S. Phase 2a efficacy trial planned for Q4 2025.
Acquisition of SKNY Pharmaceuticals on track; SKNY-1 shows efficacy in obesity and nicotine craving models.
MIRA-55 oral cannabinoid analog demonstrated comparable efficacy to morphine in inflammatory pain models.

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