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MIRA Pharmaceuticals Announces Favorable Topline Results from Phase 1 SAD Study of Oral Ketamir-2, a Next-Generation Non-Scheduled Ketamine Analog
Study demonstrated Ketamir-2 was safe and well tolerated at all dose levels, with a favorable safety and tolerability profile, with no severe or clinically significant adverse effects observed. The drug showed rapid and predictable absorption, a favorable ...
About this update from Mira Pharmaceuticals, Inc.
[{"type":"text","content":"Study demonstrated Ketamir-2 was safe and well tolerated at all dose levels, with a favorable safety and tolerability profile, with no severe or clinically significant adverse effects observed. The drug showed rapid and predictable absorption, a favorable duration of action supporting once-daily dosing, and no CNS side effects typically seen with ketamine.","length":358,"tagName":"p"},{"type":"text","content":"MIAMI, FLORIDA / ACCESS Newswire / September 22, 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 topline results from the single ascending dose (SAD) portion of its ongoing Phase 1 clinical trial evaluating the safety, tolerability, and pharmacokinetics (PK) of its lead oral candidate, Ketamir-2, in healthy volunteers.","length":517,"tagName":"p"},{"type":"text","content":"The randomized, placebo-controlled study enrolled 32 healthy adult participants across four escalating oral dose cohorts (50 mg to 600 mg). The primary endpoints were safety, tolerability, and PK characterization.","length":213,"tagName":"p"},{"type":"text","content":"Key Pharmacokinetic Findings","length":28,"tagName":"p"},{"type":"list","items":[{"val":[{"type":"text","content":"Dose-proportional increases in exposure (Cmax and AUC) were observed across all dose levels tested.","length":99,"tagName":"p"}]},{"val":[{"type":"text","content":"Median time to maximum plasma concentration (Tmax) reached within 1-2 hours, consistent across cohorts, confirming rapid and predictable absorption.","length":148,"tagName":"p"}]},{"val":[{"type":"text","content":"Terminal half-life (t½) of Ketamir-2 ranged from 2-5 hours, while its primary active metabolite, nor-Ketamir, demonstrated a longer half-life of 6.5-8.5 hours. This favorable duration of action supports convenient once-daily dosing and may contribute to sustained therapeutic benefit.","length":284,"tagName":"p"}]},{"val":[{"type":"text","content":"This contrasts with oral ketamine, which is characterized by erratic absorption and a much shorter half-life, limiting its clinical use in chronic treatment. The predictable PK profile of Ketamir-2 supports convenient once-daily dosing for patients with neuropathic pain ...