MIRA-55

July 10, 2026: MIRA Pharmaceuticals, Inc. (NASDAQ: MIRA) reported positive preclinical pharmacokinetic results for optimized oral formulations of MIRA-55, its preclinical non-opioid oral candidate for chronic inflammatory pain. After comparing multiple formulations (with an intravenous reference arm to assess absolute oral bioavailability), the company selected a lead formulation showing favorable oral bioavailability, sustained systemic exposure, and reproducible distribution into brain and liver following oral dosing. The company said brain exposure may support central pain-pathway modulation and peripheral distribution may contribute to anti-inflammatory activity seen previously.

The update builds on prior preclinical reports that oral MIRA-55 normalized pain and reduced inflammation in a validated inflammatory pain model (stated to outperform injected morphine) and showed a pharmacology distinct from THC, including anxiolytic activity without characteristic THC-like CNS effects. MIRA also noted that the U.S. DEA determined MIRA-55 is not classified as a controlled substance. Next steps include further preclinical work evaluating relationships between tissue exposure, pharmacodynamics, and efficacy.

Pipeline context: Ketamir-2 completed Phase 1 and has a submitted Phase 2a protocol to FDA under an active IND for chemotherapy-induced peripheral neuropathy; SKNY-1 is preclinical for obesity and addiction-related disorders.