MIRA Pharmaceuticals has secured regulatory approval from the Israeli Ministry of Health and IRB to commence a Phase 1 clinical trial for Ketamir-2, their novel oral ketamine analog targeting neuropathic pain. The trial will be conducted at Hadassah Medical Center in Jerusalem, with recruitment starting in Q1 2025.The randomized, double-blind, placebo-controlled study aims to assess safety, tolerability, and pharmacokinetics of single and multiple ascending doses in healthy adult volunteers. The company awaits neurotoxicity study results, required by FDA, expected by Q2 2025, which should not affect the planned development timeline.MIRA anticipates completing Phase 1 by Q4 2025 and plans to initiate a Phase 2a study in neuropathic pain patients by year-end.

MIRA Pharmaceuticals has secured regulatory approval from the Israeli Ministry of Health and IRB to commence a Phase 1 clinical trial for Ketamir-2, their novel oral ketamine analog targeting neuropathic pain. The trial will be conducted at Hadassah Medical Center in Jerusalem, with recruitment starting in Q1 2025.The randomized, double-blind, placebo-controlled study aims to assess safety, tolerability, and pharmacokinetics of single and multiple ascending doses in healthy adult volunteers. The company awaits neurotoxicity study results, required by FDA, expected by Q2 2025, which should not affect the planned development timeline.MIRA anticipates completing Phase 1 by Q4 2025 and plans to initiate a Phase 2a study in neuropathic pain patients by year-end.