Mira Pharmaceuticals reports positive toxicology results for MIRA-55

MIRA Pharmaceuticals announced on September 1, 2026 that it had completed dose-range finding toxicology and toxicokinetic studies of MIRA-55 in rats and dogs, with results characterized as positive.¹ MIRA-55 is the company's investigational oral, non-opioid drug candidate being developed for inflammatory pain.¹

The studies looked at tolerability, toxicity, and drug exposure across species. The completed studies characterized tolerability, toxicity, and systemic exposure across both species, with rats identified as the more sensitive species while dogs demonstrated greater tolerance across the dose levels studied.¹ Toxicokinetic analyses confirmed systemic exposure in both species and characterized how exposure changed with dose and repeated administration.¹

According to the company, the studies achieved their intended dose-range finding objective by generating the cross-species information needed to guide dose selection for the next phase of MIRA-55's ongoing IND-enabling program.¹ The company said it plans to use these findings to inform the design of subsequent GLP-compliant toxicology studies.¹

Looking ahead, the company said it has also advanced manufacturing scale-up and formulation work for MIRA-55 in support of broader preparations for clinical development.¹ Subject to completion of remaining IND-enabling studies, applicable regulatory requirements, and other development considerations, the company is targeting submission of an Investigational New Drug application for MIRA-55 to the FDA in the first quarter of 2027.¹

Separately, the filing noted that following scientific review, the U.S. Drug Enforcement Administration determined that MIRA-55 is not classified as a controlled substance.¹ The company's broader pipeline includes Ketamir-2 for chemotherapy-induced peripheral neuropathy, which has completed Phase 1 and is advancing toward Phase 2a under an active IND, and SKNY-1, an investigational oral drug candidate for obesity.¹