ACCESS Newswire·Mar 4, 2026, 8:00 AM ET

MIRA Pharmaceuticals Completes Phase 1 Dosing of Ketamir-2

MIRA

MIRA Pharmaceuticals completed dosing in the Phase 1 trial of Ketamir-2, a selective oral NMDA receptor modulator, with results showing no serious adverse events or dose-limiting toxicities.
The randomized, double-blind, placebo-controlled study enrolled 56 healthy volunteers across single & multiple ascending dose cohorts without observing clinically significant dissociative or psychotomimetic effects.
Final audited pharmacokinetic & safety analyses are underway, & Phase 1 data has been accepted for presentation at the upcoming American Association for Cancer Research Annual Meeting.
MIRA intends to submit Phase 2a study documentation to the U.S. FDA in the first half of 2026 to evaluate Ketamir-2 for moderate to severe chemotherapy-induced peripheral neuropathy.
Ketamir-2 is a non-scheduled, orally bioavailable new molecular entity designed to avoid off-target activity & P-glycoprotein substrate issues, featuring an active metabolite with a longer half-life.
Preclinical rodent models demonstrated superior efficacy for Ketamir-2 compared to ketamine, pregabalin, & gabapentin without inducing hyperlocomotor or psychotomimetic behaviors.
The Phase 2a proof-of-concept study will target patients with chemotherapy-induced peripheral neuropathy, a condition lacking FDA-approved therapies & projected to reach a $1.7 billion market by 2035.
Management plans to generate a well-controlled dataset suitable for regulatory advancement & peer-reviewed publication using rigorous methodological standards.