Company: MIRA
Filing Date: 2025-06-17
Form Type: PREM14A
Source: 0001641172-25-015340
Chunk: 16

Company: MIRA PHARMACEUTICALS, INC.
Filing Date: 2025-06-17
Form: PREM14A
Chunk 16
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Ketamir-2 is a patent-pending, oral ketamine analog currently being evaluated for the treatment of diabetic neuropathy and is in an ongoing Phase I clinical trial. The compound is designed to overcome the limitations of existing ketamine-based treatments, offering the potential for enhanced safety, improved tolerability, and better oral bioavailability. If approved, Ketamir-2 could provide a safer, more effective option for patients suffering from neuropathic pain, treatment-resistant depression (TRD), major depressive disorder with suicidal ideation (MDD-SI), and post-traumatic stress disorder (PTSD), with the potential for further clinical development across these and other neuropsychiatric indications..

Neuropathic pain is a complex, chronic condition resulting from damage or dysfunction in the nervous system, leading to abnormal sensations or pain responses. Common symptoms include burning, coldness, “pins and needles” sensations, numbness, itching, and sudden electric shock-like pain. Neuropathic pain can arise from metabolic disorders (such as diabetic neuropathy), viral infections (like post-herpetic neuralgia), autoimmune diseases, chemotherapy-induced neuropathy, traumatic nerve injury, stroke, or spinal cord injury.

Existing treatment options include antidepressants (tricyclic antidepressants and serotonin-norepinephrine reuptake inhibitors), anticonvulsants (gabapentin and pregabalin), topical agents (lidocaine patches and capsaicin), and opioids. However, these therapies often provide incomplete relief, have significant side effects, and, in the case of opioids, carry a high risk of addiction. Ketamine has demonstrated efficacy for neuropathic pain, but its poor oral bioavailability and high risk of side effects have limited its widespread use. Ketamir-2 aims to address these challenges, offering a treatment with fewer side effects, lower abuse potential, and more convenient oral dosing.

MIRA-55 is a preclinical-stage investigational drug designed to support cognitive function and enhance memory. It is currently being evaluated in preclinical studies for its potential benefits in neuropsychiatric, inflammatory, and neurologic disorders. If approved, MIRA-55 could provide a breakthrough treatment for patients experiencing cognitive decline, including those with early neurodegenerative conditions.

Regulatory and DEA Classification

The U.S. Drug Enforcement Administration (DEA) has completed its scientific review of both Ketamir-2 and MIRA-55, determining that neither compound will be classified as a controlled substance or listed chemical under