MIAMI, September 1, 2026
MIRA Pharmaceuticals, Inc. has reported positive results from completed 7-day dose-range finding toxicology and toxicokinetic studies of MIRA-55 in rats and dogs, advancing the company’s ongoing IND-enabling program for its investigational oral, non-opioid therapy for inflammatory pain. The studies characterized tolerability, toxicity and systemic exposure across both species and generated data intended to guide dose selection for the next stage of development. MIRA is targeting submission of an Investigational New Drug (IND) application to the U.S. Food and Drug Administration in the first quarter of 2027, subject to completion of remaining IND-enabling studies and applicable regulatory requirements.
MIRA-55 Toxicology Studies Inform Dose Selection
The cross-species studies provided important information on how MIRA-55 was tolerated and absorbed following administration. Rats were identified as the more sensitive species, while dogs demonstrated greater tolerance across the dose levels evaluated. Toxicokinetic analyses confirmed systemic exposure in both species and characterized changes in exposure following different doses and repeated administration. According to MIRA, the studies achieved their primary dose-range finding objective by establishing the cross-species information needed to select doses for subsequent GLP-compliant toxicology studies. The findings therefore represent a key transition point in the preclinical development of MIRA-55 as the company prepares for the studies required before initiating human clinical development.
Non-Opioid Approach Targets Pain and Inflammation
MIRA-55 is an investigational oral small-molecule therapy designed to modulate cannabinoid pathways involved in both pain signaling and inflammation. In previously reported preclinical research conducted separately from the newly announced toxicology studies, oral MIRA-55 demonstrated analgesic and anti-inflammatory activity in a validated inflammatory pain model, including normalization of pain responses and reductions in inflammation. Additional behavioral studies reported by MIRA indicated that the compound did not produce the characteristic central nervous system effects associated with THC. The company is developing MIRA-55 as a potential alternative to opioid-based approaches, with the objective of addressing both pain signaling and inflammatory processes contributing to inflammatory pain.
Advertisement
MIRA Targets Q1 2027 IND Submission
Following completion of the dose-range finding studies, MIRA Pharmaceuticals plans to incorporate the findings into the next phase of its IND-enabling toxicology program while continuing manufacturing scale-up and formulation activities for MIRA-55. Subject to successful completion of the remaining preclinical studies and regulatory requirements, the company expects to submit an IND application in Q1 2027. The program is being advanced against a significant unmet need for non-opioid pain treatments, with MIRA positioning MIRA-55 around a differentiated pharmacological mechanism intended to provide analgesic and anti-inflammatory effects without the characteristic psychoactive effects associated with THC. The upcoming IND submission will represent the next major development milestone as MIRA-55 moves toward potential first-in-human evaluation.
Source :MIRA Pharmaceuticals press relese
