MIRA Pharmaceuticals Designates Neuropathic Pain as Primary Indication for Ketamir-2 and Submits Pre-IND Meeting Request to FDA [Yahoo! Finance]
MIRA Pharmaceuticals, Inc. (MIRA)
Company Research
Source: Yahoo! Finance
MIAMI, FL / ACCESSWIRE / September 11, 2024 / MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA), a preclinical-stage pharmaceutical company focused on developing innovative therapies for neurologic and neuropsychiatric disorders, announced today that it has selected neuropathic pain as the initial and primary indication for its novel oral ketamine analog, Ketamir-2. The company has submitted a request for a pre-Investigational New Drug (IND) meeting with the U.S. Food and Drug Administration (FDA) and anticipates the meeting to occur in November 2024. All ongoing regulatory IND-enabling studies are advancing smoothly, and MIRA remains on track to submit its IND to the FDA by the end of this year, with human trials expected to begin in the first quarter of 2025. The Growing Neuropathic Pain Market Neuropathic pain is a complex and debilitating condition caused by a variety of causes, induced by damage or dysfunction of the nervous system. It often presents as burning, electric shocks, or "
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MIRA
News
- MIRA Pharmaceuticals Advances Ketamir-2 Development Following Phase 1 Design Completion, Focusing on Early Clinical Efficacy Demonstration for Neuropathic Pain in 2025Accesswire
- MIRA Pharmaceuticals Designates Neuropathic Pain as Primary Indication for Ketamir-2 and Submits Pre-IND Meeting Request to FDAAccesswire
- MIRA Pharmaceuticals Achieves 100% Reversal of Neuropathic Pain With Oral Ketamir-2 in Breakthrough StudyAccesswire
- MIRA Pharmaceuticals Showcases Significant Progress and Announces Final Phase of Regulatory Work as It Prepares for IND Submission by Year-End [Yahoo! Finance]Yahoo! Finance
- MIRA Pharmaceuticals Showcases Significant Progress and Announces Final Phase of Regulatory Work as It Prepares for IND Submission by Year-EndAccesswire
MIRA
Sec Filings
- 9/12/24 - Form 8-K
- 9/10/24 - Form 8-K
- 9/6/24 - Form 144/A
- MIRA's page on the SEC website