MIRA Pharmaceuticals has begun dosing the final cohort of its Phase 1 multiple‑ascending‑dose study for Ketamir‑2, an oral NMDA receptor antagonist designed to treat neuropathic and inflammatory pain. The company has already dosed 50 healthy volunteers and is now administering the last dose to the six remaining subjects, completing the single‑ascending‑dose portion of the trial and moving the program toward its planned Phase 2a study in chemotherapy‑induced peripheral neuropathy (CIPN).
The milestone is a key step in the company’s development timeline. By finishing the Phase 1 safety and pharmacokinetic assessment, MIRA positions Ketamir‑2 to seek FDA Fast‑Track designation for CIPN, a condition that currently has no approved therapies. The Fast‑Track status would accelerate regulatory review and potentially shorten the time to market for a drug that could address a significant unmet need.
Ketamir‑2 differentiates itself from existing NMDA antagonists such as ketamine by offering an oral formulation that aims to provide analgesic benefits without the psychoactive side effects and administration challenges associated with intravenous ketamine. Early data from the single‑ascending‑dose phase indicated a favorable safety profile, and the company expects the final cohort to confirm these findings and provide the pharmacodynamic data needed for the next development stage.
Beyond Ketamir‑2, MIRA’s pipeline includes SKNY‑1, a weight‑loss and nicotine‑addiction candidate, and MIRA‑55, an inflammatory‑pain program. The company plans to present Phase 1 data at the April 2026 AACR meeting and will participate in the BIO Partnering Investment & Growth Summit in March 2026, where it seeks to engage potential partners and investors for its expanding portfolio.
The completion of the final Phase 1 cohort signals robust clinical progress and strengthens MIRA’s position in the competitive pain‑management space. It also provides a clearer roadmap for regulatory strategy and partnership opportunities, reinforcing investor confidence in the company’s ability to advance its lead candidate through the development pipeline.
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