MIRA Pharmaceuticals has completed dosing in its Phase I clinical trial of Ketamir-2, the company’s selective oral N-methyl-D-aspartate (NMDA) receptor modulator, assessing its safety, tolerability, and pharmacokinetics.
Ketamir-2 is an orally administered new molecular entity and features predictable pharmacokinetics and non-scheduled status after review by the US Drug Enforcement Administration.
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The compound has shown no clinically significant dissociative effects in preclinical and Phase I studies to date.
The double-blind, placebo-controlled, randomised trial enrolled 56 healthy adult participants across single and multiple ascending dose cohorts.
It was conducted at the Clinical Pharmacology Unit of Hadassah Medical Center in Jerusalem, Israel.
Safety data reviewed so far has shown no serious adverse events or dose-limiting toxicities at any dose level.
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By GlobalDataAdditionally, no clinically psychotomimetic or significant dissociative effects commonly linked to ketamine were reported. Database lock, unblinding, and final audited safety and pharmacokinetic analyses are ongoing.
Safety of the central nervous system was assessed using the Bowdle visual analogue scale, the ketamine side effect tool, and the Columbia-suicide severity rating scale to evaluate perceptual, mood-related, or dissociative effects.
The company plans to submit the Phase IIa clinical study protocol and documentation to the US Food and Drug Administration (FDA) in the first half of 2026 under its active investigational new drug (IND).
This next phase will target patients with moderate to severe chemotherapy-induced peripheral neuropathy (CIPN).
MIRA Pharmaceuticals chairman and CEO Erez Aminov said: “Completion dosing of Phase I marks an important inflection point for MIRA as we advance Ketamir-2 into patient studies.
“Our objective has been to create a selective oral NMDA modulator with a differentiated safety profile suitable for chronic use. With favourable Phase I findings and a clear regulatory path forward, we are now focused on generating clinical efficacy data in a high-unmet-need indication.”
