Company: MIRA
Filing Date: 2025-03-04
Form Type: 8-K
Source: 0001493152-25-008977
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Company: MIRA PHARMACEUTICALS, INC.
Filing Date: 2025-03-04
Form: 8-K
Item: Item 8.01
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Item
8.01 Other Events

MIRA
Pharmaceuticals Announces Approval and Initiation of Phase 1 Clinical Trial for Ketamir-2 in Neuropathic Pain

MIRA
Pharmaceuticals, Inc. (NASDAQ: MIRA) (“ MIRA” or the “ Company”) today announced that it has received regulatory
approval from the Israeli Ministry of Health and the Institutional Review Board (IRB) to initiate a Phase 1 clinical trial for Ketamir-2,
the Company’s novel oral ketamine analog in development for neuropathic pain.

The
randomized, double-blind, placebo-controlled study will evaluate the safety, tolerability, and pharmacokinetics of single and multiple
ascending doses of orally administered Ketamir-2 in healthy adult volunteers. The trial will be conducted at the Clinical Pharmacology
Unit, Hadassah Medical Center in Jerusalem, Israel, with subject recruitment scheduled to begin in Q1 2025.

Mira
continues to await the results of its neurotoxicity study, a requirement from the FDA, prior to IND enabling and initiating of patient
dosing in the U. S.

MIRA
expects Phase 1 to conclude by Q4 2025, paving the way for a Phase 2a study in neuropathic pain patients expected to be initiated by
year-end.

For
more information, please visit www. mirapharmaceuticals. com.

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                                         
  Dated:             By:                       /s/                
                     Name:                     Erez               
                     Title:                    Chief