Clinical TrialMay 13, 2026, 04:08 PM
MIRA Pharma's Ketamir-2 Phase 1 Trial Positive; Not Controlled Substance
AI Summary
MIRA Pharmaceuticals announced positive unblinded results from its completed Phase 1 clinical trial for Ketamir-2, its proprietary oral NMDA receptor modulator. The study demonstrated favorable safety, tolerability, and pharmacokinetics in 57 healthy volunteers, with no serious adverse events reported and predominantly mild adverse events. Additionally, the U.S. Drug Enforcement Administration determined that Ketamir-2 is not classified as a controlled substance. The company is now preparing for Phase 2a clinical protocol submission to the USFDA for evaluation in chemotherapy-induced peripheral neuropathy.
Key Highlights
- MIRA Pharmaceuticals announced positive unblinded results from its completed Phase 1 clinical trial for Ketamir-2.
- The study, involving 57 healthy volunteers, reported no serious adverse events or dose-limiting toxicities.
- Adverse events were predominantly mild, with a lower incidence in the Ketamir-2 group compared to placebo.
- Pharmacokinetic analysis showed rapid oral absorption, favorable systemic exposure, and dose-proportional Cmax.
- Ketamir-2's half-life ranged 2.5-7 hours, with its active metabolite nor-Ketamir-2 at 7-9 hours, potentially supporting once-daily administration.
- The U.S. Drug Enforcement Administration (DEA) determined that Ketamir-2 is not classified as a controlled substance.
- The company is preparing to submit its Phase 2a clinical protocol to the USFDA for chemotherapy-induced peripheral neuropathy (CIPN).