MIAMI, Fla. — September 17, 2026
MIRA Pharmaceuticals announced that its 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 following review and feedback from the U.S. Food and Drug Administration. MIRA has incorporated the FDA’s comments into the protocol and is targeting site initiation in the first quarter of 2027, subject to IRB review and routine site activation requirements. The study will represent the first clinical evaluation of Ketamir-2 in patients with persistent CIPN and is designed to generate initial efficacy, dose-response, safety and tolerability data.
Phase 2a Study Uses Randomized Crossover Design
The Phase 2a trial will be a randomized, double-blind, placebo-controlled, three-period crossover study enrolling adults with moderate-to-severe persistent CIPN. Participants will receive Ketamir-2 at 300 mg and 600 mg, along with placebo, across three seven-day treatment periods separated by 13-day washout periods. The crossover design will allow each participant to serve as their own control while investigators assess the drug’s impact on post-chemotherapy neuropathic pain intensity. Additional endpoints will examine CIPN-related symptoms, functional status, safety, tolerability and potential central nervous system adverse effects. The program is being conducted under MIRA’s active Investigational New Drug (IND) application.
Oral NMDA Modulator Targets Unmet CIPN Need
Ketamir-2 is an oral NMDA receptor modulator being developed for neuropathic pain, with CIPN representing its initial clinical indication. CIPN can persist after chemotherapy and cause ongoing neuropathic pain and functional impairment, while there are currently no FDA-approved therapies specifically indicated for CIPN. MIRA’s development strategy is based on the role of NMDA receptor signaling in neuropathic pain and the analgesic activity historically associated with ketamine. The company said Ketamir-2 is designed to selectively modulate the NMDA receptor PCP binding site with low binding affinity and limited off-target receptor activity. Its Phase 1 program in healthy volunteers reported a favorable safety, tolerability and pharmacokinetic profile, with no serious adverse events or dose-limiting toxicities.
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MIRA Targets Broader Neuropathic Pain Development
MIRA is positioning CIPN as a potential clinical entry point for Ketamir-2 across a broader neuropathic pain market. The company said its Phase 1 pharmacokinetic findings support once-daily oral dosing, while the compound is not classified as a controlled substance by the U.S. Drug Enforcement Administration. MIRA plans to present Ketamir-2 clinical development data at the International Conference on Addiction and Psychiatry in Tokyo on October 5–6, 2026, and expects to participate in BioJapan as it pursues licensing and strategic partnership discussions. Beyond Ketamir-2, MIRA’s pipeline includes MIRA-55 for inflammatory pain and SKNY-1 for obesity, both investigational oral small-molecule candidates. Positive Phase 2a findings in CIPN could provide clinical evidence for further evaluation of Ketamir-2 in additional neuropathic pain conditions.
Source: MIRA Pharmaceuticals,, press release
