MIRA Pharmaceuticals submits Phase 2a protocol for Ketamir-2
- MIRA Pharmaceuticals (NASDAQ:MIRA) has submitted its Phase 2a clinical trial protocol for Ketamir-2 to the U.S. Food and Drug Administration (FDA) to address chemotherapy-induced peripheral neuropathy (CIPN).
- The planned study is a randomized, double-blind, placebo-controlled, three-period crossover trial designed to evaluate the safety, tolerability, and dose-response efficacy of the drug.
- With no currently FDA-approved therapies specifically for CIPN, MIRA aims to position Ketamir-2 as a non-opioid, oral alternative for patients suffering from persistent neuropathic pain.
MIRA Pharmaceuticals (NASDAQ:MIRA) announced on June 17, 2026, the submission of its Phase 2a clinical trial protocol (Protocol Mira-002) to the FDA.
The trial will be conducted at a leading U.S. cancer center, utilizing a three-period crossover design where patients receive 300 mg or 600 mg doses of oral Ketamir-2 or a placebo across three treatment periods, separated by two-week washout intervals.
The study is designed to assess safety, tolerability, and the dose-response relationship of Ketamir-2 on neuropathic pain intensity using validated clinical instruments.
This development builds upon successful Phase 1 trials involving 56 healthy volunteers, which reported no serious adverse events or dose-limiting toxicities, and established a pharmacokinetic profile supporting once-daily dosing.
As the company moves into this proof-of-concept phase, it intends to gather high-quality data to support future regulatory advancement and potential peer-reviewed publication.
MIRA continues to position Ketamir-2 as a differentiated NMDA receptor modulator, aiming to provide effective pain relief without the dissociative or psychoactive effects associated with traditional ketamine.
