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MIRA Pharmaceuticals, Inc. (NASDAQ: MIRA) is a pre-clinical-stage pharmaceutical development company renowned for its innovative approach to treating neurologic and neuropsychiatric disorders. The company is currently focused on two groundbreaking neuroscience programs: the novel oral pharmaceutical marijuana analog, MIRA-55, and the patent-pending oral ketamine analog, Ketamir-2.
MIRA-55 is under investigation as a potential treatment for anxiety and cognitive decline, particularly linked to early-stage dementia. Unlike traditional THC, which can impair cognitive function, MIRA-55 has shown potential to improve memory significantly without the adverse effects. Recently, the U.S. Drug Enforcement Administration (DEA) concluded that MIRA-55 is not a controlled substance, paving the way for more focused development efforts in the $90 billion neurological and $30 billion cannabis markets.
Ketamir-2 is a novel compound designed to deliver ultra-rapid antidepressant effects, providing hope for those battling treatment-resistant depression (TRD), major depressive disorder with suicidal ideation (MDSI), and post-traumatic stress disorder (PTSD). The DEA has also determined that Ketamir-2 is not a controlled substance, which enhances its development potential. Recent collaborations with Pharmaseed Ltd. and Frontage Laboratories have yielded promising preclinical results, demonstrating Ketamir-2’s efficacy in treating TRD, PTSD, and neuropathic pain. The company aims to submit an Investigational New Drug (IND) Application to the FDA by the end of the year, a significant step toward human clinical trials.
MIRA Pharmaceuticals has partnered with renowned entities such as InSilicoTrials, Pharmaseed Ltd., and Memorial Sloan Kettering Cancer Center to leverage AI and computational simulations in drug development. These strategic collaborations have accelerated the development process, providing robust data on the safety and efficacy of MIRA’s drug candidates.
Under the leadership of CEO Erez Aminov and the newly appointed Chief Scientific Advisor, Dr. Itzchak Angel, the company continues to push the boundaries of neuropharmacology. Dr. Angel brings over 40 years of experience in drug development, having played pivotal roles in advancing several drugs through to clinical trials.
Financial and Market Potential: MIRA Pharmaceuticals represents a significant commercial opportunity in the multi-billion dollar market for neuropharmacological therapies. With a strong pipeline and strategic collaborations, the company is well-positioned to meet the unmet needs of millions suffering from neuropsychiatric disorders.
For more information about their ongoing projects and financial reports, visit www.mirapharmaceuticals.com.
MIRA Pharmaceuticals (NASDAQ:MIRA) has submitted an Investigational New Drug (IND) application to the FDA for Ketamir-2, its novel oral ketamine analog for treating neuropathic pain. The submission includes comprehensive data on pharmacology, pharmacokinetics, and toxicology, along with in vitro and in vivo study results.
The North American neuropathic pain market is valued at $3.1 billion with expected growth to $4.5 billion by 2030. Ketamir-2 addresses limitations of existing treatments through selective NMDA receptor targeting, showing 100% pain reversal in preclinical studies without psychotropic effects. The company plans to initiate Phase I Clinical Trials in Q1 2025, followed by Phase IIa trials in late 2025.
MIRA Pharmaceuticals (NASDAQ:MIRA) announces successful completion of Good Laboratory Practice preclinical safety program for Ketamir-2, their novel oral ketamine analog. The studies showed no adverse findings across multiple safety assessments, including cardiovascular safety in dogs, CNS assessment in rats, and respiratory safety tests.
The company plans to submit an Investigational New Drug (IND) application by end of 2024, with Phase I clinical trials scheduled to begin in Q1 2025. The trial design includes pain tests to evaluate effects on neuropathic pain and psychosis, with data expected by Q2 2025. A Phase IIa proof-of-concept study is planned for Q4 2025, with results anticipated by year-end.
MIRA Pharmaceuticals (NASDAQ:MIRA) has selected The Centre for Human Drug Research (CHDR) in Leiden, Netherlands, for its Phase I/IIa clinical trial of Ketamir-2, a novel oral ketamine analog. The trial will begin recruitment in Q1 2025, with Phase I results expected in H2 2025 and Phase IIa results in H1 2026. The study will utilize CHDR's proprietary PainCart technology to measure pain response in healthy subjects during Phase I, followed by testing in diabetic neuropathy patients in Phase IIa. The trial is designed as a randomized, double-blind, placebo-controlled study. Ketamir-2 has shown superior efficacy compared to pregabalin and gabapentin in preclinical studies, with no reported side effects to date.
MIRA Pharmaceuticals (NASDAQ:MIRA) announces that its novel oral ketamine analog Ketamir-2 shows 60% greater efficacy than FDA-approved gabapentin in treating chemotherapy-induced neuropathic pain in preclinical studies. Using the paclitaxel model, Ketamir-2 achieved near-complete pain normalization at 300 mg/kg dose. The company plans to submit an IND application by end of 2024 and begin Phase I trials in Q1 2025. MIRA is also evaluating Ketamir-2 for diabetic neuropathy, PTSD, and other conditions. The drug could potentially qualify for FDA breakthrough therapy designation, fast track, and priority review for treating rare cancer-related neuropathic pain.
MIRA Pharmaceuticals (NASDAQ:MIRA) announces that its novel oral ketamine analog, Ketamir-2, outperforms FDA-approved neuropathic pain treatments Gabapentin and Pregabalin in preclinical studies. Key findings show Ketamir-2 provided up to 112% more effective results than Pregabalin and 70% greater relief than Gabapentin at higher doses by Day 22 in female rats.
Ketamir-2 offers advantages over current treatments, including being non-habit forming and potentially avoiding sedation and cognitive impairment. MIRA is preparing to submit an Investigational New Drug (IND) application by year-end, with Phase 1 clinical trials scheduled for Q1 2025 and Phase 2 trials in Q4 2025. The company is also exploring Ketamir-2's potential for PTSD treatment and pursuing government grants to accelerate development.
MIRA Pharmaceuticals (NASDAQ:MIRA) announced new preclinical data on Ketamir-2, its lead development product, will be presented at the 18th Annual Pain Therapeutics Summit in Boston on October 28-29, 2024. The presentation, titled "Selective NMDA Receptor Modulation: The Superior Efficacy of Ketamir-2 in Neuropathic Pain Treatment," will showcase breakthrough findings where Ketamir-2 achieved 100% reversal of neuropathic pain in preclinical models.
Ketamir-2, a novel oral Ketamine analog, selectively targets the PCP site of the NMDA receptor, offering enhanced efficacy with fewer side effects compared to ketamine. In preclinical studies using the Chung model of neuropathic pain, Ketamir-2 demonstrated superior efficacy to ketamine, achieving full normalization of pain response. MIRA plans to submit an Investigational New Drug (IND) application to the U.S. FDA by December 2024, with aims to demonstrate efficacy in humans as early as 2025.
MIRA Pharmaceuticals (NASDAQ:MIRA) has announced significant progress in the clinical development of its novel oral ketamine analog, Ketamir-2. The company has initiated drug product development in collaboration with Formulex, focusing on spray-dry based granulation in capsules. MIRA is on track for its Investigational New Drug (IND) filing with the FDA in December 2024. The company aims to demonstrate clinical efficacy for neuropathic pain as early as 2025 through innovative Phase I/II study designs. MIRA has finalized its Phase I clinical trial design, set to begin in early Q1 2025, assessing safety, tolerability, and pharmacokinetics in humans. The company is also exploring additional indications in mental health, including Major Depressive Disorder with Suicidal Ideation, Treatment-Resistant Depression, and Post-Traumatic Stress Disorder.
MIRA Pharmaceuticals (NASDAQ:MIRA) has chosen neuropathic pain as the primary indication for its novel oral ketamine analog, Ketamir-2. The company has submitted a pre-IND meeting request to the FDA, expected in November 2024. MIRA aims to submit its IND by year-end, with human trials anticipated in Q1 2025.
Ketamir-2 is designed to offer enhanced therapeutic efficacy, improved oral bioavailability, and a superior safety profile compared to existing treatments. It's a non-opioid, non-controlled substance, potentially offering safer and more accessible pain relief. The North American neuropathic pain market is projected to reach $5.2 billion by 2030, driven by an aging population and increasing prevalence of conditions like diabetes.
MIRA Pharmaceuticals (NASDAQ:MIRA) has announced a breakthrough in neuropathic pain treatment. Their novel oral ketamine analog, Ketamir-2, achieved 100% reversal of neuropathic pain in a pre-clinical rat study, outperforming traditional oral ketamine. Key findings include:
- Low doses led to significant pain reversal for 14-22 days post-operation
- Higher doses completely normalized pain thresholds
- Ketamir-2 showed superior efficacy compared to oral ketamine
- Additional studies are underway for cancer-induced depression and neuropathic pain
- Human efficacy could potentially be demonstrated as early as 2025
MIRA is now focusing on scaling production and preparing for clinical trials, positioning Ketamir-2 as a potential game-changer in neuropathic pain treatment.
MIRA Pharmaceuticals Inc. (NASDAQ:MIRA) has made significant progress in its drug development programs, particularly with its novel oral ketamine analog, Ketamir-2. The company has enhanced its leadership by appointing Dr. Itzchak Angel as Chief Scientific Advisor. Recent preclinical studies have shown that Ketamir-2 offers a superior safety profile compared to traditional ketamine, with potential applications in treating depression, anxiety, and PTSD.
MIRA has also advanced its MIRA-55 program, a novel oral pharmaceutical marijuana analog, which has demonstrated higher efficacy at cannabinoid receptors compared to THC. The company is finalizing its Investigational New Drug (IND) application for Ketamir-2, with plans to submit by year-end. This progress positions MIRA to potentially transform patient care in neurological and neuropsychiatric disorders with innovative, at-home treatment options.
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