Mira Pharmaceuticals Inc. (K6S)
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MIRA Pharmaceuticals Submits IND for Ketamir-2 to FDA, Marking a Significant Milestone in the Company's Pipeline Development
MIAMI, FL / ACCESSWIRE / December 19, 2024 / MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA), a preclinical-stage pharmaceutical company focused on developing therapies for neurological and neuropsychiatric disorders, today announced that it has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for Ketamir-2, its novel oral ketamine analog for the treatment of neuropathic pain. The IND submission marks a major step in advancing Mira's lead drug candidate while reflecting its commitment to meeting milestones and timelines.
MIRA Pharmaceuticals Validates Ketamir-2's Safety Profile With No Adverse Findings, Paving the Way for IND Submission by Year-End
Strong Safety Profile Validated Across Studies, Setting the Stage for Clinical Trials in Neuropathic Pain MIAMI, FL / ACCESSWIRE / December 10, 2024 / MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA), a preclinical-stage pharmaceutical company, proudly announces the successful completion of its current Good Laboratory Practice (GLP) preclinical safety program for Ketamir-2, a novel oral ketamine analog. The results confirm no adverse findings, clearing a critical milestone as the Company progresses toward submitting its Investigational New Drug (IND) application by year-end 2024.
MIRA Reveals Innovative Phase I/IIa Protocol Design and Selection of Clinical Trial Site
Backed by a Strong Balance Sheet, MIRA Accelerates Toward Becoming a Clinical-Stage Company and Advancing Breakthroughs in Pain and Depression Treatment MIAMI, FL / ACCESSWIRE / November 20, 2024 / MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA), a preclinical-stage pharmaceutical company, is pleased to announce the selection of The Centre for Human Drug Research (CHDR) in Leiden, The Netherlands, as the site for its Phase I/IIa clinical trial of Ketamir-2, a novel oral ketamine analog. Recruitment for the trial is set to begin in Q1 2025, with initial safety and efficacy results from the Phase I study in healthy subjects expected in the second half of 2025.
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Mira Pharmaceuticals Inc. Profile
| Pharmaceuticals Industry | Healthcare Sector | Erez Aminov CEO | XMUN Exchange | US60458C1045 ISIN |
| US Country | 2 Employees | - Last Dividend | - Last Split | 3 Aug 2023 IPO Date |
Overview
MIRA Pharmaceuticals, Inc. is a pioneering force in the neuropharmaceutical sector, focusing its efforts on the development of groundbreaking treatments for a spectrum of neurologic and neuropsychiatric disorders. Its operations span the pre-clinical stages of pharmaceutical development, backed by an ambitious vision to address unmet medical needs within the realm of neuroscience. The company's strategic acquisition of exclusive rights in the U.S., Canada, and Mexico for its flagship compounds underlines its commitment to bringing innovative solutions to market. Originally established as MIRA1a Therapeutics, Inc., the company rebranded to MIRA Pharmaceuticals, Inc. in 2020 and has since positioned its headquarters in Miami, Florida, serving as a beacon of pharmaceutical innovation.
Products and Services
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Ketamir-2
An oral ketamine analog, Ketamir-2 is currently under investigation for its potential to provide ultra-rapid antidepressant effects. With a focus on individuals suffering from conditions marked by difficult-to-treat depression, major depressive disorder coupled with suicidal ideation, and post-traumatic stress disorder (PTSD), this patent-pending compound symbolizes hope for patients in dire need of effective treatments. Its design leverages the exclusive rights held by MIRA Pharmaceuticals in key North American markets, promising a novel approach to mental health management.
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MIRA-55
This investigational oral pharmaceutical-grade marijuana aims to offer therapeutic benefits to adult patients grappling with anxiety and cognitive decline, symptoms often linked to early-stage dementia. MIRA-55 represents the company's venture into harnessing the medicinal properties of cannabis for neurological health, underlining MIRA Pharmaceuticals' dedication to exploring all possible avenues in the fight against neurodegenerative and neuropsychiatric diseases.
