MIRA Pharmaceuticals Initiates Multiple Ascending Dose Phase 1 Study of Ketamir‑2, Targets Chemotherapy‑Induced Neuropathic Pain

MIRA
October 24, 2025

On October 24, 2025, MIRA Pharmaceuticals, Inc. announced the initiation of the multiple ascending dose (MAD) portion of its Phase 1 clinical trial evaluating its lead oral candidate, Ketamir‑2, in healthy volunteers. This follows the completion of the single ascending dose phase earlier in the year and represents the next step in the drug’s clinical development program.

The company also announced that it has selected chemotherapy‑induced peripheral neuropathy (CIPN) as the lead indication for its planned Phase 2a study. CIPN is a common and debilitating side effect of cancer treatment, for which no approved therapies exist, and the indication carries potential for FDA Fast Track designation, positioning Ketamir‑2 for accelerated regulatory review.

The initiation of the MAD study marks a critical milestone for MIRA, expanding its pipeline into a high‑need oncology supportive‑care market and setting the stage for subsequent Phase 2a trials. This development enhances the company’s clinical momentum and may open new commercial opportunities in a sizable patient population.

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