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MIRA Pharmaceuticals Advances Ketamir-2 to Phase 2a in Chemotherapy-Induced Peripheral Neuropathy (CIPN) Following FDA Review

MIRA
  • MIRA Pharmaceuticals submitted its Phase 2a protocol for Ketamir-2 to the Institutional Review Board following FDA review & comments.
  • The company targets site initiation in the first quarter of 2027, pending IRB completion & other activation requirements.
  • This study marks the first clinical evaluation of Ketamir-2 in patients with chemotherapy-induced peripheral neuropathy (CIPN).
  • The randomized, double-blind, placebo-controlled study will enroll adults with moderate-to-severe persistent CIPN.
  • Participants will receive 300 mg or 600 mg doses of oral Ketamir-2 or placebo across three seven-day periods separated by 13-day washouts.
  • The trial aims to generate initial efficacy, dose-response, safety, & tolerability data while assessing CNS adverse effects.
  • Ketamir-2 is an oral NMDA receptor modulator designed to avoid controlled substance classification & intravenous administration limitations of ketamine.
  • Phase 1 data in healthy volunteers showed a favorable safety profile with no serious adverse events or dose-limiting toxicities.
  • MIRA plans to present Phase 1 update data at the International Conference on Addiction and Psychiatry in Tokyo on October 5–6, 2026.
  • The company will also participate in BioJapan in October to advance licensing & strategic partnership discussions.
  • MIRA holds exclusive worldwide rights to Ketamir-2 & is pursuing intellectual property protection globally.
  • The pipeline also includes MIRA-55 for inflammatory pain & SKNY-1 for obesity, both determined by the DEA to be non-controlled substances.