GlobeNewswire·Sep 1, 2026, 8:00 AM ET

MIRA Pharmaceuticals Advances Non-Opioid Oral MIRA-55 for Inflammatory Pain Toward IND

MIRA Pharmaceuticals announced positive results from 7-day dose-range finding toxicology and toxicokinetic studies of MIRA-55 in rats & dogs.
Rats were identified as the more sensitive species while dogs demonstrated greater tolerance across tested dose levels.
The studies successfully generated cross-species data to guide dose selection for the next phase of MIRA-55's IND-enabling program.
MIRA-55 is an investigational oral, non-opioid small-molecule candidate designed to modulate cannabinoid pathways for inflammatory pain.
Preclinical data indicates MIRA-55 normalizes pain responses, reduces inflammation, & does not produce CNS effects associated with THC.
The U.S. Drug Enforcement Administration has determined that MIRA-55 is not classified as a controlled substance.
Manufacturing scale-up & formulation work for MIRA-55 has been successfully advanced in support of clinical development preparations.
The Company targets submission of an Investigational New Drug application to the FDA in the first quarter of 2027 pending successful completion of remaining studies.