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Get filing alertsMIRA reports positive Phase 1 safety data for Ketamir-2, advances to Phase 2a neuropathy trial
Filed May 13, 2026 · Period ending May 13, 2026 · ~1 min read
Key Changes
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Phase 1 trial of Ketamir-2 completed with zero serious adverse events, no dose-limiting toxicities, and no patient withdrawals across 57 healthy volunteers. Adverse events were mild and more common in placebo group than treatment group.
Item 7.01 verify on EDGAR → -
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DEA determined Ketamir-2 is not a controlled substance, removing prescribing and distribution barriers that typically apply to ketamine-related compounds. This could significantly ease commercial pathway if approved.
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Company preparing Phase 2a protocol submission to FDA for chemotherapy-induced peripheral neuropathy indication. Preclinical data showed Ketamir-2 outperformed ketamine, pregabalin, and gabapentin in neuropathic pain models.
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Pharmacokinetic analysis showed rapid oral absorption, dose-proportional exposure, and consistent multi-day profile. Drug half-life of 2.5-7 hours and active metabolite half-life of 7-9 hours may support once-daily dosing.
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Summary
MIRA Pharmaceuticals announced completion of its Phase 1 clinical trial for Ketamir-2, an oral NMDA receptor modulator, with results that clear a critical early safety hurdle. All 57 healthy volunteers completed the study without serious adverse events or dose-limiting toxicities, and the drug showed favorable pharmacokinetics supporting potential once-daily dosing.
Importantly, the DEA ruled that Ketamir-2 is not a controlled substance, distinguishing it from ketamine and removing regulatory friction that could complicate prescribing and distribution. For retail investors, this represents meaningful de-risking of MIRA's lead asset as it advances toward patient trials.
The company is now preparing a Phase 2a protocol for chemotherapy-induced peripheral neuropathy, a condition with limited treatment options where preclinical data showed Ketamir-2 outperformed standard therapies. The next catalyst to watch is FDA acceptance of the Phase 2a protocol and initiation of patient enrollment, which would mark the drug's first test in the target indication. Success in neuropathy could open additional indications for this novel NMDA modulator platform.
Section-by-Section Diff
Event · Item 7.01 — Regulation FD Disclosure
MIRA announced positive Phase 1 trial results for Ketamir-2, showing safety and favorable pharmacokinetics, advancing toward Phase 2a for neuropathy.
Added in current filing · verify on EDGAR →
Pharmacokinetic analysis demonstrated rapid oral absorption and favorable systemic exposure, with dose-proportional Cmax observed across the evaluated dose range. No major differences were observed in pharmacokinetic parameters for Ketamir-2 or its active metabolite, nor-Ketamir-2, between Day 1 and Day 5 of administration. The half-life (t1/2) of Ketamir-2 ranged from approximately 2.5 to 7 hours, while the active metabolite nor-Ketamir-2 demonstrated a half-life of approximately 7 to 9 hours. Based on the observed pharmacokinetic profile of the parent compound and active metabolite, Ketamir-2 may support once-daily administration, subject to further clinical evaluation.
Ketamir-2 showed rapid oral absorption, dose-proportional exposure, and consistent pharmacokinetics over multiple days. The drug's half-life of 2.5 to 7 hours and its active metabolite's half-life of 7 to 9 hours suggest the potential for once-daily dosing, which could improve patient compliance if confirmed in further studies.
Added in current filing · verify on EDGAR →
Following scientific review, the U.S. Drug Enforcement Administration (DEA) determined that Ketamir-2 is not classified as a controlled substance.
The DEA determined that Ketamir-2 is not a controlled substance, which removes regulatory barriers related to prescribing, distribution, and patient access. This is significant for a drug structurally related to ketamine, which is a Schedule III controlled substance, and could facilitate broader commercial adoption if approved.
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Figures/quotes linked to EDGAR · Narrative written by AI · Jun 10, 2026 · How we verify