EXCLUSIVE: MIRA Pharmaceuticals Expands Pipeline, Enhances Value Proposition With Development Of Topical Formulation For Lead Pain Treatment Candidate

On Thursday, MIRA Pharmaceuticals Inc. MIRA announced the formulation of Ketamir-2 as a topical treatment for localized neuropathic and inflammatory pain.

The advancement expands the company's pain management portfolio beyond its ongoing Ketamir-2 oral treatment for neuropathic pain.

"The development of both an oral and topical formulation of Ketamir-2 significantly expands our pipeline and enhances the value proposition of MIRA," stated Erez Aminov, Chairman and CEO of MIRA. "By advancing two distinct formulations, we are positioning Ketamir-2 to address multiple pain conditions and broaden its potential applications."

Also Read: EXCLUSIVE: MIRA Pharmaceuticals Kick Starts Human Trial In Israel For Ketamir-2 For Neuropathic Pain

The topical treatment of Ketamir-2 is designed for slow release, delivering targeted pain relief directly at the application site while minimizing systemic exposure and side effects.

Unlike existing treatments—such as NSAIDs, lidocaine patches, capsaicin creams, and systemic painkillers—topical Ketamir-2 aims to provide effective, long-lasting relief without the risks of systemic side effects, sedation, or opioid dependency.

MIRA is actively advancing one clinical program and multiple preclinical programs, with significant milestones anticipated this year:

• The Phase 1 study for the Ketamir-2 oral treatment for neuropathic pain is advancing as planned, with full results anticipated later this year.
• Preclinical studies are investigating Ketamir-2's potential in treating post-traumatic stress disorder (PTSD), further expanding the drug's neuropsychiatric applications.
• Phase 2a for Diabetic Neuropathy Expected to Begin by Year-End—Preparations are underway for a Phase 2a study in diabetic neuropathy patients, with the first human efficacy data expected by Q1 2026.
• A preclinical study is currently assessing the efficacy of the new topical formulation in treating inflammatory pain, further expanding its potential applications as a topical agent for chronic pain conditions.
• Continued preclinical studies are evaluating MIRA-55's potential cognitive benefits.

Price Action: MIRA stock traded lower by 5% to $0.95 premarket at the last check on Thursday.

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