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Item 8.01 Other Events
MIRA Pharmaceuticals Reports Mira-55 Shows No THC- or Rimonabant-Associated CNS Side Effects in Preclinical Studies
Previously shown to deliver morphine-comparable pain relief without opioid-related risks in a validated inflammatory pain model, supporting planned IND submission for inflammatory pain.
On March 23, 2026, MIRA Pharmaceuticals, Inc. (NASDAQ: MIRA) (the “Company”) is reporting new preclinical data evaluating the central nervous system (CNS) and behavioral effects of Mira-55 in a series of established assays commonly used to assess cannabinoid-related side effects.
The study, conducted in collaboration with Pharmaseed, evaluated oral Mira-55 at doses of 10, 30, and 100 mg/kg and included comparisons to Δ9-tetrahydrocannabinol (THC) and the CB1 receptor antagonist rimonabant. The assessment included hypothermia, catalepsy, Elevated Plus Maze (EPM), and Open Field (OF) assays, which are commonly used to evaluate cannabinoid-related psychogenic, motor, and anxiety-like effects.
Study Results:
| ● | Mira-55 did not produce cannabinoid-like psychogenic effects at any tested dose. | |
| ● | No evidence of sedation, catalepsy, or motor impairment was observed. | |
| ● | No anxiogenic effects were observed, in contrast to rimonabant, which demonstrated anxiety-like behavioral changes. | |
| ● | In the Elevated Plus Maze (EPM), Mira-55 showed a dose-dependent increase in time spent in open arms, consistent with reduced anxiety-like behavior. | |
| ● | In Open Field (OF) testing, Mira-55-treated groups were comparable to vehicle controls. Rimonabant-treated groups demonstrated reduced time spent in the center of the open field, a commonly used indicator of anxiety-like behavior, supporting the sensitivity of the experimental model. | |
| ● | These findings build on previously reported preclinical data demonstrating that Mira-55 produced morphine-comparable analgesic effects in a validated model of inflammatory pain, reducing pain sensitivity and restoring thresholds to near-baseline levels, without opioid-related risks. |
The Company is advancing Mira-55 toward an Investigational New Drug (IND) submission for inflammatory pain and continues to conduct additional preclinical studies to support potential future clinical development.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| MIRA PHARMACUTICALS, INC. | ||
| Dated: March 23, 2026 | By: | /s/ Erez Aminov |
| Name: | Erez Aminov | |
| Title: | Chief Executive Officer | |