On Tuesday, the Israeli Ministry of Health and the Institutional Review Board (IRB) approved MIRA Pharmaceuticals, Inc.'s (NASDAQ:MIRA) Phase 1 trial for Ketamir-2, the company's novel oral ketamine analog in development for neuropathic pain.

In December, MIRA Pharmaceuticals submitted an Investigational New Drug (IND) application to the FDA to start human trials for Ketamir-2.

MIRA's preclinical studies demonstrate Ketamir-2's superior efficacy, safety, and optimized pharmacokinetics, supporting its advancement into Phase 1 clinical trials.

Also Read: EXCLUSIVE: MIRA Pharmaceuticals Validates Ketamir-2's Safety Profile, Paving Way For Human Trials In Neuropathic Pain

Subject recruitment is scheduled to begin in the first quarter of 2025.

The study will be conducted at the Clinical Pharmacology Unit, Hadassah Medical Center in Jerusalem, Israel.

The Phase 1, randomized, double-blind, placebo-controlled, single-center study evaluates the safety, tolerability, and pharmacokinetics of orally administered Ketamir-2 in healthy adult volunteers.

The trial consists of two parts:

• Single Ascending Dose (SAD) Part: 32 participants
• Multiple Ascending Dose (MAD) Part: 24 participants

In addition to assessing the frequency and severity of adverse events (AEs) and serious adverse events (SAEs), the study will closely evaluate ketamine-related behavioral side effects and assess Ketamir-2's distinct pharmacological profile.

The decision to conduct the study in Israel was made to accelerate timelines and optimize costs, allowing Mira to efficiently allocate resources and extend its operational runway.

The company expects Phase 1 to conclude by the fourth quarter of 2025, paving the way for a Phase 2a study in neuropathic pain patients to be initiated by the end of the year.

Neuropathic pain is a rapidly growing market, projected to reach $5.2 billion in North America by 2030.

Beyond neuropathic pain, MIRA Pharmaceuticals is conducting ongoing preclinical studies evaluating Ketamir-2 in post-traumatic stress disorder (PTSD) and a potential topical formulation for localized pain relief.

These additional indications could significantly broaden the clinical and commercial potential of Ketamir-2.

In parallel, the company is assessing Mira-55 for its potential in memory enhancement.

Price Action: MIRA stock traded higher by 7.52% to $0.98 premarket at the last check on Tuesday.

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This article EXCLUSIVE: MIRA Pharmaceuticals Kick Starts Human Trial In Israel For Ketamir-2 For Neuropathic Pain originally appeared on Benzinga.com

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