MIRA Pharmaceuticals (MIRA) Introduces Nor-Ketamir – an Extended Duration, Brain-Penetrating, and Selective Compound Targeting the NMDA PCP Receptor

The PRISM Psychedelic Index company MIRA Pharmaceuticals, Inc. (MIRA), is a leading preclinical-stage pharmaceutical company who has unveiled new preclinical data shedding light on the mechanism of action for its innovative drug candidate, Ketamir-2, and its principal metabolite, Nor-Ketamir-2. The data reveals that, similar to Ketamir-2, Nor-Ketamir-2 selectively interacts with a low affinity at the NMDA PCP site while exhibiting high selectivity and no activity on the glutamate NMDA site, opiate receptors, or other sites. Additionally, a new salt formulation, Ketamir-2 Pamoate, was developed to potentially enhance pharmacokinetics, improve brain penetration, and achieve higher plasma and brain levels with a longer half-life, resulting in nearly 100% oral bioavailability of Nor-Ketamir-2.

Traditional ketamine, though effective, is hindered by very low oral bioavailability (less than 30%) and significant safety concerns due to its interaction with multiple NMDA and other receptor sites, often requiring intravenous or intranasal administration, limiting its practicality for at-home use.

The development of Ketamir-2 Pamoate with its new formulation is particularly significant. This advancement enhances pharmacokinetics, ensuring efficient absorption and utilization of both Ketamir-2 and Nor-Ketamir-2. With Nor-Ketamir-2 achieving nearly 100% oral bioavailability, the drug maintains higher levels in the bloodstream for extended periods, allowing for sustained therapeutic action and potentially reducing dosing frequency.

MIRA Pharmaceuticals is actively conducting studies to explore potential indications for faster approval pathways, including cancer neuropathic pain, chemo-induced depression, neuropathic pain, and PTSD. The company has initiated IND-enabling regulatory work and is progressing with Good Manufacturing Practice (GMP) drug scale-up. MIRA plans to submit an Investigational New Drug (IND) application by the end of the year, marking a crucial step towards clinical trials.

“Our mission at MIRA Pharmaceuticals is to improve the affordability, accessibility, and safety of treatments for neurological and neuropsychiatric disorders,” said Erez Aminov, Chairman and CEO of MIRA Pharmaceuticals. “The latest preclinical data on Ketamir-2 highlight our commitment, bringing us closer to filing an IND and starting clinical trials.”