MIRA Pharmaceuticals, Inc.

MIRA Pharmaceuticals, Inc. is a clinical-stage pharmaceutical development company focused on creating new oral medicines for neurological, neuropsychiatric, metabolic, and addiction-related conditions. The company has exclusive rights in the United States, Canada, and Mexico to three drug candidates: Ketamir-2, MIRA-55, and SKNY-1. These candidates are designed to address unmet medical needs in areas such as neuropathic and inflammatory pain, central nervous system disorders, and metabolic and behavioral conditions. Ketamir-2 is an oral NMDA receptor modulator that has completed a Phase 1 clinical trial in healthy volunteers, involving both single-ascending-dose (SAD) and multiple-ascending-dose (MAD) cohorts. Preliminary safety data from this trial indicates no serious adverse events or dose-limiting toxicities, though the database is still blinded, and final analyses are ongoing. The company plans to start a Phase 2a clinical trial for Ketamir-2 in chemotherapy-induced peripheral neuropathy (CIPN) in the first half of 2026. MIRA-55 is a new oral, non-psychoactive cannabinoid analog currently in preclinical development for inflammatory pain and central nervous system conditions like anxiety and cognitive impairment. Preclinical studies have shown MIRA-55 has both pain-relieving and anti-inflammatory effects, comparable to morphine for pain relief, but without the central nervous system side effects seen with cannabinoids at tested doses. The company is moving MIRA-55 through IND-enabling development activities, aiming for an Investigational New Drug (IND) submission for inflammatory pain.