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Item 8.01 Other Events
MIRA Pharmaceuticals’ Second Ketamir-2 Manuscript Accepted for Peer-Reviewed Publication Demonstrating Superior Efficacy in Preclinical Neuropathic Pain Models versus Ketamine, Gabapentin, or Pregabalin
On August 12, 2025, MIRA Pharmaceuticals, Inc. (NASDAQ: MIRA) (“MIRA” or the “Company”) announced that a new manuscript describing its lead drug candidate, Ketamir-2, has been accepted for publication in the peer-reviewed journal Frontiers in Pharmacology. The accepted manuscript reports that Ketamir-2 outperformed ketamine, pregabalin, or gabapentin—depending on the comparator used—in two validated preclinical models of neuropathic pain, restoring sensory function and reversing pain behaviors across genders and species.
Neuropathic pain represents a significant and underserved market across North America. Epidemiology suggests approximately 7–10% of the population experiences neuropathic pain; in North America, this equates to approximately 36–51 million people across the U.S., Canada, and Mexico. According to Precedence Research, the global neuropathic pain market is valued at approximately $7.97 billion in 2024 and is projected to reach $16.79 billion by 2034, growing at a compound annual growth rate (CAGR) of 7.73%. North America accounts for a significant share of this market, representing an estimated $3.7–3.9 billion annually today. The U.S. neuropathic pain market is estimated at $2.79 billion in 2024 and is projected to reach $5.92 billion by 2034, growing at a CAGR of 7.80% over the same period.
These findings build on MIRA’s previously published characterization of Ketamir-2’s differentiated pharmacology and favorable safety profile and support the Company’s plan to submit a Phase 2a clinical trial protocol to the U.S. Food and Drug Administration (FDA) in Q4 2025 as a follow-up development to its active IND, with the goal of initiating the study in neuropathic pain by year-end. MIRA is also evaluating Ketamir-2’s potential in additional central nervous system indications, including depression, anxiety, post-traumatic stress disorder (PTSD), and as a topical formulation for localized pain conditions.
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 PHARMACEUTICALS, INC. | ||
| Dated: August 12, 2025 | By: | /s/ Erez Aminov |
| Name: | Erez Aminov | |
| Title: | Chief Executive Officer | |