MIRA Pharmaceuticals Reports Positive Phase 1 Results for Ketamir-2

MIRA Pharmaceuticals has announced promising results from its Phase 1 SAD study of Ketamir-2, a novel ketamine analog. The study, conducted with 32 healthy volunteers, confirmed the drug's safety and tolerability across all dose levels, ranging from 50 mg to 600 mg. No severe adverse effects were noted, and the drug showed rapid absorption, supporting a once-daily dosing regimen without CNS side effects typical of ketamine.

Ketamir-2's pharmacokinetic profile revealed dose-proportional exposure and a favorable half-life, which may offer benefits over traditional ketamine's erratic absorption and short half-life. This positions Ketamir-2 as a potential treatment for neuropathic pain and other CNS conditions. MIRA Pharmaceuticals plans to advance to multiple ascending dose studies and Phase 2a trials to further assess the drug's efficacy.