MIRA Pharmaceuticals, Inc. has officially commenced the multiple ascending dose (MAD) component of its Phase 1 clinical trial for Ketamir-2, an oral therapeutic aimed at addressing significant neurological and neuropsychiatric disorders. This pivotal step was announced on October 24, 2025, and highlights the company’s focus on developing innovative treatments for conditions that currently lack effective solutions.
The trial is being conducted in healthy volunteers and serves as a critical assessment of Ketamir-2’s safety and tolerability. In conjunction with this announcement, MIRA has identified chemotherapy-induced peripheral neuropathy (CIPN) as the lead indication for its forthcoming Phase 2a clinical evaluation. CIPN is a prevalent and debilitating side effect experienced by cancer patients undergoing chemotherapy, affecting their quality of life and daily functioning.
Focus on Unmet Medical Needs
MIRA Pharmaceuticals, based in Miami, Florida, is positioning Ketamir-2 as a potential treatment for CIPN, a condition for which there are currently no FDA-approved therapies. The company aims to address this significant gap in care, seeking to provide relief for the thousands of patients affected by this painful condition.
The selection of CIPN as a lead indication underscores MIRA’s commitment to developing therapies that target critical unmet medical needs. The potential for FDA Fast Track designation may expedite the development process, allowing for faster access to this innovative treatment for patients suffering from chemotherapy-related pain.
MIRA Pharmaceuticals, which trades under the ticker symbol NASDAQ: MIRA, continues to advance its clinical programs, reflecting a robust pipeline dedicated to improving the lives of individuals facing challenging health conditions. As the company progresses through the clinical phases, it remains focused on gathering comprehensive data to support the efficacy and safety of Ketamir-2.
The Phase 1 trial’s results will provide essential insights into the pharmacokinetics and pharmacodynamics of Ketamir-2, laying the groundwork for subsequent Phase 2a studies. MIRA’s proactive approach in selecting CIPN as the primary focus area demonstrates its strategic vision in the competitive pharmaceutical landscape.
As MIRA Pharmaceuticals embarks on this journey, the medical community and patients alike are eager to see the outcomes of the trial and the potential approval of a much-needed treatment for chemotherapy-induced peripheral neuropathy.
