MIRA Pharmaceuticals Completes Phase 1 Dosing of Ketamir-2

Advancing a selective oral NMDA receptor modulator toward Phase 2a in chemotherapy-induced peripheral neuropathy following favorable Phase 1 safety and tolerability findings.

Published on Mar. 4, 2026

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MIRA Pharmaceuticals, a clinical-stage pharmaceutical company, has announced the completion of dosing in its Phase 1 clinical trial evaluating Ketamir-2, the company's proprietary selective oral NMDA receptor modulator. The study was conducted at the Clinical Pharmacology Unit of Hadassah Medical Center in Jerusalem, Israel, and was designed to characterize the safety, tolerability, and pharmacokinetics of orally administered Ketamir-2.

Why it matters

Ketamir-2 is being developed as a potential treatment for chemotherapy-induced peripheral neuropathy (CIPN), a debilitating and often dose-limiting complication of cancer treatment. There are currently no FDA-approved therapies specifically indicated for this condition, and management typically relies on off-label agents or intravenous ketamine. The global CIPN market is projected to reach approximately $1.7 billion by 2035, driven by increasing cancer survivorship and expanded use of neurotoxic chemotherapy regimens.

The details

The randomized, double-blind, placebo-controlled Phase 1 study enrolled 56 healthy adult volunteers across single ascending dose (SAD) and multiple ascending dose (MAD) cohorts. Based on safety data reviewed to date, no serious adverse events or dose-limiting toxicities have been reported at any dose level tested. In addition, no clinically significant dissociative or psychotomimetic effects typically associated with ketamine were observed. MIRA intends to submit the Phase 2a clinical study and supporting documentation to the U.S. Food and Drug Administration under its active IND in the first half of 2026, targeting patients with moderate to severe CIPN.

  • The Phase 1 study was conducted at the Clinical Pharmacology Unit of Hadassah Medical Center in Jerusalem, Israel.
  • MIRA plans to submit the Phase 2a clinical study and supporting documentation to the U.S. Food and Drug Administration under its active IND in the first half of 2026.

The players

MIRA Pharmaceuticals, Inc.

A clinical-stage pharmaceutical company focused on developing novel oral therapeutics for neuropathic and inflammation-driven pain conditions, metabolic disorders, and oncology-related indications.

Ketamir-2

A proprietary, orally bioavailable new molecular entity designed as a next-generation NMDA receptor antagonist with potential as an oral, non-opioid therapy for neuropathic pain and related conditions.

Hadassah Medical Center

The clinical pharmacology unit where the Phase 1 study of Ketamir-2 was conducted.

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What they’re saying

“Completion dosing of Phase 1 marks an important inflection point for MIRA as we advance Ketamir-2 into patient studies. Our objective has been to create a selective oral NMDA modulator with a differentiated safety profile suitable for chronic use. With favorable Phase 1 findings and a clear regulatory path forward, we are now focused on generating clinical efficacy data in a high-unmet-need indication.”

— Erez Aminov, Chairman and CEO of MIRA

“Ketamir-2 was rationally engineered to achieve selective NMDA modulation with a pharmacokinetic and CNS profile distinct from ketamine. The Phase 1 program provides a translational foundation for patient studies. As we move into Phase 2a, our priority is executing a scientifically rigorous trial capable of producing high-quality data that can withstand regulatory and academic scrutiny.”

— Dr. Itzchak Angel, Chief Scientific Advisor of MIRA

What’s next

MIRA plans to submit the Phase 2a clinical study and supporting documentation to the U.S. Food and Drug Administration under its active IND in the first half of 2026, targeting patients with moderate to severe chemotherapy-induced peripheral neuropathy (CIPN).

The takeaway

Ketamir-2, a selective oral NMDA receptor modulator developed by MIRA Pharmaceuticals, has shown promising safety and tolerability results in a Phase 1 clinical trial, paving the way for a Phase 2a study in patients with chemotherapy-induced peripheral neuropathy, a debilitating condition with limited treatment options.