MIRA Pharmaceuticals Announces Ketamir-2 Shows Promising Safety Profile in Comparison to Traditional Ketamine In Preclinical Testing

Core Insights - MIRA Pharmaceuticals is advancing its investigational compound Ketamir-2, a novel oral ketamine analog, which shows promise in treating mental health disorders without inducing psychotic symptoms [6][12][15] - The development of Ketamir-2 could lead to significant cost savings in healthcare, particularly for treatment-resistant depression, which currently imposes a financial burden of $43.8 billion annually in the U.S. [2] Company Overview - MIRA Pharmaceuticals, Inc. is a pre-clinical-stage pharmaceutical company focused on developing treatments for neurologic and neuropsychiatric disorders [13][20] - The company holds exclusive rights in the U.S., Canada, and Mexico for Ketamir-2, which is under investigation for its potential to deliver ultra-rapid antidepressant effects [13] Product Development - MIRA is on track to submit an Investigational New Drug (IND) application for Ketamir-2 to the FDA by the end of this year, marking a significant milestone toward clinical trials [3][7] - The company is also conducting further safety and efficacy studies on Ketamir-2, with additional research planned for cancer pain and PTSD [3][12] Safety and Efficacy - New preclinical studies indicate that Ketamir-2 does not induce hyper-locomotor activity, a side effect associated with traditional ketamine, suggesting a safer profile for patients [6][15] - The findings highlight Ketamir-2's potential to mitigate adverse effects commonly linked with traditional ketamine, enhancing patient compliance and treatment success [11][12] Broader Applications - Ketamir-2's improved safety profile allows for potential use in a wider range of psychiatric and neurologic conditions, positioning it as a versatile option in the pharmaceutical landscape [16] - MIRA's other investigational product, MIRA-55, is under investigation for treating neuropathic pain, anxiety, and cognitive decline, further expanding the company's therapeutic portfolio [5][18] Regulatory Considerations - The U.S. Drug Enforcement Administration has concluded that Ketamir-2 and MIRA-55 will not be classified as controlled substances, facilitating their development and commercialization [18]