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

On Thursday, MIRA Pharmaceuticals, Inc. 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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