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MIRA Pharmaceuticals Initiates Multiple Ascending Dose (MAD) Phase 1 Study of Oral Ketamir-2 and Selects Chemotherapy-Induced Neuropathic Pain as Lead Phase 2a Indication
Advancing toward Phase 2a clinical evaluation in chemotherapy-related pain, a condition with no approved treatments and potential for FDA Fast Track consideration MIAMI, FLORIDA / ACCESS Newswire / October 24, 2025 / MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA) ...
About this update from Mira Pharmaceuticals, Inc.
[{"type":"text","content":"Advancing toward Phase 2a clinical evaluation in chemotherapy-related pain, a condition with no approved treatments and potential for FDA Fast Track consideration","length":162,"tagName":"p"},{"type":"text","content":"MIAMI, FLORIDA / ACCESS Newswire / October 24, 2025 / MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA) ("MIRA" or the "Company"), a clinical-stage pharmaceutical company developing novel oral therapeutics for neurologic, neuropsychiatric, and metabolic disorders, today announced the initiation of the multiple ascending dose (MAD) portion of its ongoing Phase 1 clinical trial evaluating its lead oral candidate, Ketamir-2, in healthy volunteers. The Company also announced that it has selected chemotherapy-induced peripheral neuropathy (CIPN) - a common and debilitating side effect of cancer treatment - as the lead indication for its planned Phase 2a clinical evaluation.","length":688,"tagName":"p"},{"type":"text","content":"Phase 1 Progress","length":16,"tagName":"p"},{"type":"text","content":"This milestone follows the completion of dosing in the single ascending dose (SAD) portion of the study. According to data reviewed to date, no serious or dose-limiting adverse events have been observed, and no clinically significant safety concerns have been reported. Comprehensive pharmacokinetic analyses will be performed following unblinding to further characterize Ketamir-2's absorption and half-life profile.","length":421,"tagName":"p"},{"type":"text","content":"The ongoing randomized, double-blind, placebo-controlled Phase 1 study is evaluating single and multiple oral doses of Ketamir-2 to assess its safety, tolerability, and pharmacokinetics in healthy volunteers. The MAD portion includes three cohorts of repeat daily oral dosing (150 mg to 600 mg for five days), building on the safety and PK data from the SAD phase.","length":364,"tagName":"p"},{"type":"text","content":"Peer-Reviewed and Preclinical Data Support Ketamir-2's Promise in Chemotherapy-Related Nerve Pain","length":101,"tagName":"p"},{"type":"text","content":"Ketamir-2's advancement is supported by a growing body of preclinical and peer-reviewed research demonstrating efficacy in validated neuropathic pain models.","length":161,"tagName":"p"},{"type":"text","content":"In a poster presented at the Pain Therapeutics Summit in Boston an...