Summary by Moomoo AI
MIRA Pharmaceuticals submitted an Investigational New Drug (IND) application to the FDA on December 19, 2024, for Ketamir-2, a novel oral ketamine analog targeting neuropathic pain. This milestone advances the company's lead drug candidate in addressing unmet needs in neurological disorders. Preclinical studies showed Ketamir-2's potential for full pain reversal without adverse safety findings.MIRA plans to initiate Phase I clinical trials in Q1 2025, followed by Phase IIa trials in late 2025. The IND submission marks a significant step in the development of Ketamir-2, positioning MIRA to potentially enter clinical stages of drug development in the coming year.As an emerging growth company, MIRA's forward-looking statements are subject to risks and uncertainties. The company explicitly disclaims any obligation to update these statements except as required by law.
