MIRA Pharmaceuticals, Inc. announced on September 17, 2026, that its Phase 2a clinical program for Ketamir-2 has advanced toward site initiation. The company stated that following a review by the U.S. Food and Drug Administration (FDA), it incorporated the agency's feedback into the study protocol. The protocol has now been submitted for Institutional Review Board (IRB) review at a leading cancer research institution.
The randomized, double-blind, placebo-controlled study is designed to enroll adults with moderate-to-severe persistent chemotherapy-induced peripheral neuropathy (CIPN). Participants will receive Ketamir-2 at doses of 300 mg and 600 mg, as well as placebo, across three seven-day treatment periods separated by 13-day washout periods. The study aims to evaluate the safety, tolerability, efficacy, and dose-response relationship of the oral drug, specifically looking at post-chemotherapy neuropathic pain intensity.
Ketamir-2 is an oral NMDA receptor modulator developed to target neuropathic pain. The company noted that the drug has completed a Phase 1 clinical program in healthy volunteers, demonstrating a favorable safety and pharmacokinetic profile. MIRA holds exclusive worldwide rights to Ketamir-2 and is pursuing intellectual property protection across major global markets. The company also indicated that the U.S. Drug Enforcement Administration has determined that Ketamir-2 is not classified as a controlled substance.
Regarding the broader pipeline, MIRA Pharmaceuticals is developing MIRA-55 for inflammatory pain and SKNY-1 for obesity. The company expects to present an abstract on Ketamir-2 at the International Conference on Addiction and Psychiatry in Tokyo on October 5–6, 2026.
