Mira Pharmaceuticals Inc. Receives FDA Clearance for Ketamir-2 IND, Advancing U.S. Clinical Trials for Neuropathic Pain

Reuters
07-29
Mira Pharmaceuticals Inc. Receives FDA Clearance for Ketamir-2 IND, Advancing U.S. Clinical Trials for Neuropathic Pain

MIRA Pharmaceuticals Inc. $(MIRA)$ has announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug $(IND.AU)$ application for Ketamir-2, a novel oral NMDA receptor antagonist aimed at treating neuropathic pain. This regulatory approval enables MIRA to initiate U.S.-based clinical trials. Ketamir-2 has demonstrated superior efficacy to existing treatments such as gabapentin and pregabalin in preclinical studies, with a favorable safety profile and no evidence of ketamine-associated neurotoxicity. MIRA is advancing through Phase 1 trials and plans to initiate U.S. Phase 2a trials by the end of 2025.

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: 0001641172-25-021155), on July 28, 2025, and is solely responsible for the information contained therein.

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