Welcome to our dedicated page for Mira Pharma news (Ticker: MIRA), a resource for investors and traders seeking the latest updates and insights on Mira Pharma stock.
Mira Pharmaceuticals Inc (NASDAQ:MIRA) is a preclinical-stage biopharmaceutical company pioneering novel therapies for neurological and neuropsychiatric disorders. This news hub provides investors and industry stakeholders with timely updates on Ketamir-2 and MIRA-55 development progress, regulatory milestones, and strategic initiatives.
Access authoritative reporting on clinical trial developments, FDA communications, and research breakthroughs related to MIRA's innovative drug candidates. Our curated news collection covers essential updates including:
• Preclinical study results for oral ketamine and marijuana analogs
• Regulatory filings including IND application progress
• Intellectual property developments and partnership announcements
• Scientific presentations at major medical conferences
Bookmark this page for consolidated access to verified MIRA Pharma updates, enabling informed tracking of therapeutic advancements in neuropathic pain management and neurocognitive disorder treatments. Check regularly for new developments in this innovative neuroscience pipeline.
MIRA Pharmaceuticals (NASDAQ: MIRA) has announced promising preclinical results for its oral ketamine analog, Ketamir-2, showing it does not induce hyper-locomotor activity, a psychotic symptom common with traditional ketamine use.
This indicates Ketamir-2 could offer safer mental health treatments. Conducted with Biotrial, the study evaluated Ketamir-2's effects on spontaneous locomotor activity in mice. Unlike traditional ketamine, Ketamir-2 did not trigger hyperlocomotion, suggesting reduced risks of psychotic behaviors and misuse.
MIRA plans to submit an IND application to the FDA by year-end. This development positions Ketamir-2 for broader psychiatric and neurologic applications, potentially reducing healthcare costs for conditions like treatment-resistant depression, which currently costs the U.S. $43.8 billion annually.
Further studies on Ketamir-2's safety and efficacy are ongoing, with potential applications for cancer pain and PTSD.
MIRA Pharmaceuticals announced positive preclinical results for Ketamir-2, an oral ketamine analog, suggesting it as a potential superior alternative to traditional ketamine for treating depression and treatment-resistant depression (TRD). The study conducted by Pharmaseed revealed that Ketamir-2 showed higher efficacy and safety compared to oral ketamine in male mice, with significant improvements in locomotor activity, reduced anxiety, and antidepressant effects. Unlike ketamine, Ketamir-2 can be administered orally, promising better patient compliance and is not a controlled substance under DEA rules. MIRA plans to submit an Investigational New Drug Application (IND) to the FDA later this year to initiate human trials.
Mira Pharmaceuticals announced that its novel drug MIRA-55 has been ruled by the DEA as not being a controlled substance. This decision eliminates regulatory barriers for manufacturing, research, and commercialization. MIRA-55, aimed at treating neuropathic pain, anxiety, and cognitive decline, shows promise in enhancing memory and cognitive performance without the adverse effects associated with THC in marijuana. The drug also demonstrates stable anti-anxiety effects and reduced intoxicating effects, providing a significant advantage over traditional cannabis. With access to large neurological and cannabis markets, MIRA-55 represents a promising value for the company.
MIRA Pharmaceuticals (NASDAQ: MIRA) is in advanced talks with Memorial Sloan Kettering Cancer Center (MSK) to evaluate MIRA's novel oral ketamine analog, Ketamir-2, for cancer-related pain and depression. This collaboration could validate Ketamir-2's potential and expand its application beyond depression and PTSD. MSK currently treats refractory cancer pain with intravenous ketamine, but Ketamir-2 may offer a more convenient oral alternative with higher bioavailability and a better safety profile. The study will compare Ketamir-2's efficacy to traditional ketamine in rodent models. MIRA also collaborates with Pharmaseed to explore Ketamir-2's effects on neuropathic pain. Successful preclinical results could accelerate FDA approval and create non-dilutive funding opportunities. Cancer pain affects 44% of patients, with 31% experiencing moderate to severe pain, and 25% suffering from depression.
Mira Pharmaceuticals has announced significant advancements in preclinical trials for Ketamir-2, an oral ketamine analog aimed at treating PTSD, depression, and neuropathic pain, including cancer pain. The company plans to submit an Investigational New Drug (IND) application to the FDA by year-end, aiming for human trials in 2025.
In collaboration with Pharmaseed, MIRA is testing Ketamir-2's efficacy in severe PTSD using rat models. Another study with Biotrial will evaluate the drug's locomotor effects in mice. MIRA has also initiated toxicological studies with Frontage Laboratories and improved the manufacturing process to reduce costs.
The potential market for Ketamir-2 is substantial, with PTSD affecting 8 million adults annually in the U.S. and the market for PTSD treatments projected to reach $26 billion by 2031.
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