Mira Pharmaceuticals Advances Ketamir-2 to Phase 2a Clinical Trial with FDA Approval for Neuropathic Pain Study, Following Successful Phase 1 Completion
On August 19, 2025, Mira Pharmaceuticals Inc. announced the successful completion of the Single Ascending Dose (SAD) portion of its Phase 1 clinical trial for oral Ketamir-2, with no safety concerns reported. This milestone follows the clearance from the U.S. Food and Drug Administration (FDA) for the company's Investigational New Drug $(IND.AU)$ application targeting neuropathic pain. Mira Pharmaceuticals is now advancing to the Multiple Ascending Dose $(MAD.AU)$ stage of the trial, which marks the final phase of Phase 1. The company plans to initiate a U.S. Phase 2a clinical trial in the fourth quarter of 2025, pending ongoing results and regulatory reviews. The trial is being conducted at the Hadassah Clinical Research Center in Israel under the guidance of Principal Investigator Prof. Yoseph Caraco.
Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Mira Pharmaceuticals Inc. published the original content used to generate this news brief via EDGAR, the Electronic Data Gathering, Analysis, and Retrieval system operated by the U.S. Securities and Exchange Commission (Ref. ID: 0001641172-25-024731), on August 19, 2025, and is solely responsible for the information contained therein.
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