MIRA Pharmaceuticals submits IND to FDA for Ketamir-2

MIRA Pharmaceuticals (MIRA), has submitted an Investigational New Drug application to the U.S. Food and Drug Administration for Ketamir-2, its novel oral ketamine analog for the treatment of neuropathic pain. The IND submission marks a major step in advancing Mira’s lead drug candidate while reflecting its commitment to meeting milestones and timelines. The IND application includes comprehensive data and reports detailing Ketamir-2’s pharmacology, pharmacokinetics, and toxicology, along with results from both in vitro and in vivo studies, including validated neuropathic pain disease models. In parallel with the submission, the company is preparing to conduct a complementary neurotoxicity study, as required by the FDA’s written feedback to the pre-IND documentation. With the IND submitted, MIRA expects to initiate Phase I Clinical Trials in Q1 2025 to evaluate safety, tolerability, pharmacokinetics and pharmacodynamics in healthy volunteers. Phase IIa trials are expected to follow in late 2025 to assess efficacy in neuropathic pain patients. Beyond neuropathic pain, the company is exploring additional indications for Ketamir-2, including MDD, MDD-SI, TRD and PTSD.