MIRA Pharmaceuticals Advances Ketamir-2 to Phase 2a for Chemotherapy-Induced Neuropathy
News related to:MIRA Pharmaceuticals, Inc · 2 min read
MIAMI, Sept. 17, 2026 /CourierPR/ -- MIRA Pharmaceuticals, Inc., a clinical-stage pharmaceutical company, has advanced its drug Ketamir-2 to Phase 2a clinical trials for the treatment of chemotherapy-induced peripheral neuropathy (CIPN). The move follows a review and feedback from the U.S. Food and Drug Administration (FDA), which has deemed the Phase 2a protocol suitable for submission to an Institutional Review Board (IRB) at a leading cancer research institution.
According to Erez Aminov, CEO of MIRA Pharmaceuticals, the company is targeting the initiation of the study in the first quarter of 2027, contingent upon the completion of IRB review and other routine site activation requirements. This marks the first clinical evaluation of Ketamir-2 in patients with persistent CIPN, aiming to generate initial efficacy and dose-response data while further characterizing the drug's safety and tolerability.
The Phase 2a study is a randomized, double-blind, placebo-controlled, three-period crossover trial. It will enroll adults with moderate-to-severe persistent CIPN and will assess the safety, tolerability, efficacy, and dose-response relationship of oral Ketamir-2. Participants will receive Ketamir-2 at 300 mg and 600 mg, as well as placebo, in a defined treatment sequence across three seven-day treatment periods, separated by 13-day washout periods. This design allows each participant to serve as their own control.
Ketamir-2 is an oral NMDA receptor modulator developed by MIRA Pharmaceuticals. The drug is designed to engage the NMDA receptor pathway, which has been validated through the analgesic activity of ketamine in neuropathic pain. However, ketamine's broader use as a chronic treatment is constrained by its intravenous administration, dissociative and neuropsychiatric effects, and its Schedule III controlled-substance status. Ketamir-2 aims to overcome these limitations by being orally administered, supporting once-daily dosing, and not being classified as a controlled substance by the U.S. Drug Enforcement Administration (DEA).
The Phase 2a study builds on the company's completed Phase 1 clinical program in healthy volunteers, which demonstrated a favorable safety, tolerability, and pharmacokinetic profile for Ketamir-2. No serious adverse events or dose-limiting toxicities were reported during this phase.
Addressing a significant unmet need in neuropathic pain, CIPN is a painful and potentially persistent complication of certain chemotherapies that can continue long after cancer treatment has ended. Existing treatment options remain limited, and there are currently no FDA-approved therapies specifically indicated for CIPN. The study will evaluate Ketamir-2's potential therapeutic effect in patients with persistent CIPN, with the goal of determining whether the drug can provide meaningful pain reduction.
MIRA Pharmaceuticals expects to present Ketamir-2 at the International Conference on Addiction and Psychiatry in Tokyo, Japan, on October 5-6, 2026. The company also plans to participate in BioJapan in October, continuing licensing and strategic partnership discussions around Ketamir-2 and its broader pipeline.
Ketamir-2 is part of MIRA Pharmaceuticals' pipeline, which includes other investigational oral drug candidates for inflammatory pain (MIRA-55) and obesity (SKNY-1). The company holds exclusive worldwide rights to Ketamir-2 and is pursuing intellectual property protection across major global pharmaceutical markets.