MIRA Pharmaceuticals Submits Phase 2a Ketamir‑2 Protocol For CIPN To IRB, Incorporating FDA Feedback And Targeting Q1 2027 Site Initiation

MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA) ("MIRA" or the "Company"), a clinical-stage pharmaceutical company developing novel oral small-molecule therapeutics, today announced that, following review and comments from the U.S. Food and Drug Administration (FDA), the Phase 2a protocol evaluating Ketamir-2 in chemotherapy-induced peripheral neuropathy (CIPN) has been submitted for Institutional Review Board (IRB) review at a leading cancer research institution.

MIRA incorporated the FDA's feedback into the protocol and is targeting site initiation in the first quarter of 2027, subject to completion of IRB review and other routine site activation requirements. The study represents Ketamir-2's first clinical evaluation in patients with CIPN and is designed to generate initial efficacy and dose-response data while further characterizing safety and tolerability.