MIRA 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.

  Item 7.01 verify on EDGAR →