MIRA Pharmaceuticals advances oral Ketamir-2 into Phase 1 MAD study for chemotherapy-induced neuropathic pain

Advancing toward Phase 2a evaluation in chemotherapy-related pain, a condition with no approved treatments and potential for FDA Fast Track designation

MIRA Pharmaceuticals, a clinical-stage pharmaceutical company developing novel oral therapeutics for neurologic, neuropsychiatric, and metabolic disorders, 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 the selection of chemotherapy-induced peripheral neuropathy (CIPN) as the lead indication for its planned Phase 2a clinical evaluation.

This milestone follows the successful completion of dosing in the Single Ascending Dose (SAD) portion of the study. 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.

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 participants. The MAD portion includes three cohorts receiving repeat daily oral doses ranging from 150 mg to 600 mg over five days, building on the positive safety and pharmacokinetic data from the SAD phase.

MIRA’s decision to advance Ketamir-2 for chemotherapy-induced neuropathic pain is supported by a robust body of preclinical and peer-reviewed evidence demonstrating significant efficacy in validated models of neuropathic pain.

In a peer-reviewed study published in Frontiers in Pharmacology—“Oral Administration of Ketamir-2, a Novel Ketamine Analog, Attenuates Neuropathic Pain in Rodent Models via Selective NMDA Antagonism”—and in a poster presented at the Pain Therapeutics Summit in Boston, Ketamir-2 demonstrated superior performance compared to ketamine, gabapentin, and pregabalin across multiple gold-standard models of neuropathic pain.

In the widely used paclitaxel (PTX) chemotherapy-induced neuropathy model, Ketamir-2 achieved near-complete normalization of pain sensitivity, showing greater efficacy than gabapentin, the current FDA-approved treatment for neuropathic pain. Additional studies also revealed superior performance versus ketamine and pregabalin in restoring sensory function in sciatic nerve ligation models.

With these encouraging findings, MIRA Pharmaceuticals continues to advance Ketamir-2 as a potential next-generation, non-opioid therapy for neuropathic pain, addressing a significant unmet medical need in patients undergoing chemotherapy.