Ketamir-2

September 17, 2026: MIRA Pharmaceuticals (NASDAQ: MIRA) said its FDA-reviewed Phase 2a protocol for Ketamir-2 in chemotherapy-induced peripheral neuropathy (CIPN) has been submitted for Institutional Review Board review at a leading cancer research institution, with site initiation targeted for Q1 2027 pending IRB review and routine activation steps.

Ketamir-2’s first patient study in CIPN is a randomized, double-blind, placebo-controlled, three-period crossover trial in adults with moderate-to-severe persistent CIPN. Patients will receive 300 mg, 600 mg, and placebo in three 7-day treatment periods separated by 13-day washouts. The trial will assess safety, tolerability, efficacy, dose-response, neuropathic pain intensity, CIPN symptoms, functional status, and potential CNS adverse effects.

The program follows a completed Phase 1 in healthy volunteers that the company said showed favorable safety, tolerability, and pharmacokinetics, with no serious adverse events or dose-limiting toxicities, under an active IND.

Upcoming catalysts: MIRA expects an oral presentation on Ketamir-2 Phase 1 safety, PK, and development plans at the International Conference on Addiction and Psychiatry in Tokyo on October 5–6, 2026, and plans to participate in BioJapan in October while pursuing licensing and strategic partnership discussions.