USFDAJun 17, 2026, 08:06 AM
MIRA Pharma Submits Phase 2a Protocol for Ketamir-2 to FDA for CIPN
AI Summary
MIRA Pharmaceuticals, Inc. announced the submission of a Phase 2a clinical trial protocol to the U.S. Food and Drug Administration (FDA) for Ketamir-2, its proprietary oral NMDA receptor modulator, to treat chemotherapy-induced peripheral neuropathy (CIPN). The company also received an acknowledgment of receipt from the FDA, confirming acceptance of the submission. This randomized, double-blind, placebo-controlled study aims to evaluate the safety, tolerability, and dose-response efficacy of Ketamir-2 in patients with moderate-to-severe persistent CIPN, addressing a significant unmet medical need.
Key Highlights
- MIRA Pharmaceuticals submitted a Phase 2a clinical trial protocol for Ketamir-2 to the FDA.
- The FDA acknowledged receipt of the Phase 2a clinical trial protocol submission for Protocol Mira-002.
- Ketamir-2 is MIRA's proprietary oral NMDA receptor modulator for chemotherapy-induced peripheral neuropathy (CIPN).
- The Phase 2a study is a randomized, double-blind, placebo-controlled, three-period crossover trial.
- The study will evaluate Ketamir-2 at 300 mg or 600 mg dose levels.
- Primary objectives include safety, tolerability, and dose-response on neuropathic pain intensity.
- CIPN affects 30-40% of patients receiving neurotoxic chemotherapy, with ~3 million new persistent cases annually.
- There are currently no FDA-approved therapies specifically for CIPN.
- The Phase 1 study (MIRA-001) in 56 healthy volunteers showed no serious adverse events or dose-limiting toxicities.
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