EXCLUSIVE: MIRA Pharmaceuticals Files FDA Application To Start Human Trials For Its Lead Pain Treatment

On Thursday, MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA) said it submitted an Investigational New Drug (IND) application to the FDA to start human trials for Ketamir-2, its novel oral ketamine analog for neuropathic pain.

An IND is submitted to propose studying an unapproved drug or an approved product for a new indication or in a new patient population.

The company’s IND application includes comprehensive data and reports detailing Ketamir-2’s pharmacology, pharmacokinetics, and toxicology, along with results from both in vitro and in vivo studies, including validated neuropathic pain disease models.

In parallel with the submission, the company is conducting a neurotoxicity study, as required by the FDA’s written feedback, to support the initiation of human dosing in the U.S.

Also Read: MIRA Pharmaceuticals’ Formulated Shows Greater Efficacy Than FDA-Approved Drug For Chemo-Induced Neuropathic Pain

Preclinical studies have demonstrated Ketamir-2’s ability to achieve 100% pain reversal, fully normalizing pain thresholds in validated neuropathic pain models.

Furthermore, Ketamir-2 has shown an encouraging safety profile, with no adverse effects observed.

The company plans to begin Phase 1 trials outside the United States in Q1 2025 to evaluate safety, tolerability, and pharmacokinetics in healthy volunteers.

Phase 2a trials are expected to follow in late 2025, assessing Ketamir-2’s efficacy in neuropathic pain patients.

The neuropathic pain market in North America, including the United States, Canada, and Mexico, is valued at $3.1 billion and is expected to grow at a 6-7% compound annual growth rate, reaching $4.5 billion by 2030.

Beyond neuropathic pain, the company is exploring additional indications for Ketamir-2, including Major Depressive Disorder (MDD), MDD with Suicidal Ideation, and Post-Traumatic Stress Disorder.

MIRA is also advancing MIRA-55, with preclinical trials targeting memory, cognition, and anxiety, and plans to submit an IND for MIRA-55 in 2025.

Price Action: MIRA stock is up 0.95% at $1.06 during the premarket session at last check Thursday.

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