MIRA PHARMACEUTICALS, INC. 8-K

What Happened

• MIRA Pharmaceuticals (filed 2026-05-13) announced unblinded positive results from its completed randomized, double-blind, placebo-controlled Phase 1 study of Ketamir-2, a selective oral NMDA receptor modulator. The trial enrolled 57 healthy volunteers across seven single-ascending-dose (SAD) and multiple-ascending-dose (MAD) cohorts; all participants completed the study with no withdrawals. No serious adverse events or dose-limiting toxicities were reported, and adverse events were mostly mild — incidence was higher in the placebo group than in Ketamir-2-treated subjects. Pharmacokinetic (PK) results showed rapid oral absorption, dose-proportional Cmax across doses, and similar PK on Day 1 versus Day 5.

Key Details

• 57 healthy volunteers enrolled across seven cohorts (including placebo); all completed the study.
• No serious adverse events or dose-limiting toxicities; adverse events mostly mild; higher AE incidence in placebo.
• PK: Ketamir-2 half-life ~2.5–7 hours; active metabolite nor-Ketamir-2 half-life ~7–9 hours; profile may support once-daily dosing.
• Regulatory/next steps: DEA determined Ketamir-2 is not a controlled substance; company preparing Phase 2a protocol and supporting documents to submit to FDA under its active IND to study Ketamir-2 in chemotherapy-induced peripheral neuropathy (CIPN).
• Preclinical note: In validated neuropathic pain models (paclitaxel-induced neuropathy, sciatic nerve ligation), Ketamir-2 showed superior efficacy versus ketamine, pregabalin and gabapentin (preclinical data).

Why It Matters

• For investors, these Phase 1 results address early safety and PK questions: no serious safety signals, completed enrollment, and PK that could enable once-daily oral dosing. The DEA’s determination that Ketamir-2 is not controlled may simplify development and commercialization pathways compared with controlled NMDA agents. MIRA is moving toward a Phase 2a patient trial in CIPN (IND-stage), so the program is transitioning from healthy-volunteer testing to disease-specific clinical evaluation. Note this is still early-stage clinical development—efficacy in patients has not yet been demonstrated.