MIRA Pharmaceuticals has received approval to initiate its Phase 1 clinical trial for Ketamir-2, an oral ketamine analog developed for neuropathic pain treatment. The trial, set to begin subject recruitment in Q1 2025, will be conducted at Hadassah Medical Center in Jerusalem, Israel, following authorization from the Israeli Ministry of Health and the Institutional Review Board.
The randomized, double-blind study will assess the safety, tolerability, and pharmacokinetics of Ketamir-2 in healthy adults, with 32 participants in the Single Ascending Dose (SAD) phase and 24 in the Multiple Ascending Dose (MAD) phase. Preclinical data show Ketamir-2 outperforms existing treatments like gabapentin and pregabalin while minimizing side effects.
MIRA expects the trial to conclude by Q4 2025, paving the way for Phase 2a studies by the end of the year, positioning Ketamir-2 as a promising non-opioid treatment
