MIRA (MIRA Pharmaceuticals, Inc.) PDUFA Date | FDA Catalyst & Approval Status

Jul 30, 2026

MIRA Pharmaceuticals Progresses MIRA-55 and SKNY-1 Toward IND-Enabling Studies

MIRA Pharmaceuticals is advancing its lead preclinical programs, MIRA-55 and SKNY-1, toward IND-enabling studies. Recent development activities include formulation optimization and exploratory toxicology studies in animal models. Both drug candidates have shown promising preclinical results, indicating potential for treating chronic inflammatory pain and obesity-related disorders. The company emphasizes a disciplined approach to drug development.

Jul 10, 2026

MIRA Pharmaceuticals Reports Successful Formulation Results Supporting Development of MIRA-55 as a Non-Opioid Oral Therapy for Chronic Inflammatory Pain

MIRA Pharmaceuticals has reported positive preclinical results for its oral drug candidate MIRA-55, aimed at treating chronic inflammatory pain without opioids. The optimized formulation showed favorable oral bioavailability and effective distribution in the brain and liver. This development supports the potential of MIRA-55 as a non-opioid therapy.

Jul 6, 2026

MIRA Pharmaceuticals Reports Successful Formulation Results for SKNY-1, Its Oral Drug Candidate for Obesity and Addiction

MIRA Pharmaceuticals has reported positive preclinical results for SKNY-1, its oral drug candidate targeting obesity and addiction. The studies show favorable oral bioavailability, significant brain penetration, and liver exposure, suggesting a potential for once-daily dosing. These findings mark a significant advancement in the development of SKNY-1.

Jun 25, 2026

MIRA Pharmaceuticals Reports New Preclinical Data Demonstrating Mira-55’s Differentiated Mechanism of Action and Anxiolytic Activity Relative to THC

MIRA Pharmaceuticals has reported new preclinical data for Mira-55, highlighting its unique pharmacological mechanism that does not induce central nervous system effects like THC. The data also indicate that Mira-55 exhibits anxiolytic activity, a benefit not associated with THC, reinforcing its potential for treating chronic inflammatory pain. This development supports ongoing research and clinical trials.

Jun 17, 2026

MIRA Pharmaceuticals Submits Phase 2a Clinical Trial Protocol to FDA for Ketamir-2 in Chemotherapy-Induced Peripheral Neuropathy

MIRA Pharmaceuticals has submitted a Phase 2a clinical trial protocol to the FDA for its investigational drug Ketamir-2, targeting chemotherapy-induced peripheral neuropathy. The study will be randomized, double-blind, and placebo-controlled, focusing on the safety, tolerability, and efficacy of oral Ketamir-2. This trial will take place at a leading cancer center in the U.S.

Jun 17, 2026

MIRA Pharmaceuticals Submits Phase 2a Clinical Trial Protocol to FDA for Ketamir-2 in Chemotherapy-Induced Peripheral Neuropathy Randomized, double-blind, placebo-controlled study to evaluate safety, tolerability, and do

MIRA Pharmaceuticals has submitted a Phase 2a clinical trial protocol to the FDA for its oral NMDA receptor modulator, Ketamir-2, targeting chemotherapy-induced peripheral neuropathy (CIPN). This condition affects a significant proportion of cancer survivors, and current treatments do not specifically address their symptoms. The study aims to evaluate the safety and tolerability of Ketamir-2, building on positive results from a prior Phase 1 study. Despite its promise, Ketamir-2 has not yet been approved by the FDA, and its effectiveness is still unproven.

Jun 4, 2026

MIRA Pharmaceuticals Secures Worldwide Exclusive Rights to MIRA-55 and SKNY-1

MIRA Pharmaceuticals has announced the acquisition of worldwide exclusive rights to MIRA-55 and SKNY-1, enhancing its strategic flexibility for future licensing and partnership opportunities. This agreement solidifies MIRA's position in the development of therapeutics targeting neurologic, neuropsychiatric, inflammatory, and metabolic disorders. The move is expected to strengthen MIRA's core therapeutic pipeline significantly.

Jun 4, 2026

MIRA Pharmaceuticals Secures Worldwide Exclusive Rights to MIRA-55 and SKNY-1 Agreement Establishes Global Exclusivity Across MIRA's Core Therapeutic Pipeline and Enhances Strategic Flexibility for Future Licensing and P

MIRA Pharmaceuticals, Inc. has announced that it has secured worldwide exclusive rights to MIRA-55 and SKNY-1 through an amended license agreement with MIRALOGX LLC. This move enhances MIRA's strategic flexibility for future licensing and commercialization efforts, providing them with a unified rights structure across their core therapeutic pipeline. MIRA-55 is currently being developed for chronic inflammatory pain, while SKNY-1 targets obesity and addiction-related disorders. The agreement strengthens MIRA's position with partners and investors as they advance the development of their investigational drug candidates.

MIRA Pharmaceuticals Secures Worldwide Rights for Ketamir-2, Expanding Global IP Portfolio Across 10 Major Markets Ahead of Phase 2a in CIPN

MIRA Pharmaceuticals has secured worldwide rights for Ketamir-2, enhancing its intellectual property portfolio across 10 major markets. This move is expected to provide the company with increased strategic flexibility and potential long-term value. The announcement comes ahead of the Phase 2a clinical trial for the treatment of chemotherapy-induced peripheral neuropathy (CIPN).

May 27, 2026

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MIRA Pharmaceuticals Secures Worldwide Rights for Ketamir-2, Expanding Global IP Portfolio Across 10 Major Markets Ahead of Phase 2a in CIPN Expanded global intellectual property portfolio enhances strategic flexibility

MIRA Pharmaceuticals has announced the acquisition of worldwide rights for its investigational drug Ketamir-2. This expansion enhances the company's intellectual property portfolio across ten major markets ahead of the planned Phase 2a development for chemotherapy-induced peripheral neuropathy (CIPN). The move is expected to significantly strengthen MIRA's strategic flexibility and long-term commercial prospects for Ketamir-2, particularly after positive Phase 1 clinical results were reported. The company is now advancing toward the submission of its Phase 2a protocol documentation to the FDA.

May 14, 2026

MIRA Pharmaceuticals Reports Positive Unblinded Phase 1 Data for Ketamir-2

MIRA Pharmaceuticals has reported positive unblinded results from its Phase 1 clinical trial of Ketamir-2, a selective oral NMDA receptor modulator. The trial demonstrated a favorable safety and tolerability profile, which supports the company's plans for Phase 2a development targeting chemotherapy-induced peripheral neuropathy. This advancement marks a significant step for MIRA in its drug development pipeline.

May 13, 2026

MIRA Pharmaceuticals Announces Acceptance of Peer-Reviewed SKNY-1 Manuscript Highlighting Oral Obesity and Nicotine Addiction Drug Candidate

MIRA Pharmaceuticals has announced the acceptance of a peer-reviewed manuscript detailing the preclinical findings of its drug candidate SKNY-1. The study highlights significant results, including weight loss, lipid normalization, and a decrease in compulsive feeding and nicotine-seeking behaviors. This publication is expected to bolster the company's position in the market.

MIRA Pharmaceuticals Reports Mira-55 Shows No THC- or Rimonabant-Associated CNS Side Effects in Preclinical Studies

MIRA Pharmaceuticals has reported promising preclinical data for Mira-55, indicating it does not cause CNS side effects linked to THC or Rimonabant. The compound has previously shown the ability to provide pain relief comparable to morphine without the associated risks of opioids. This data supports the company's upcoming IND submission for treating inflammatory pain.

Mar 4, 2026

MIRA Pharmaceuticals Completes Phase 1 Dosing of Ketamir-2

MIRA Pharmaceuticals has completed Phase 1 dosing of Ketamir-2, a selective oral NMDA receptor modulator, with favorable safety and tolerability outcomes. The study involved 56 healthy volunteers, and no serious adverse events were reported. MIRA plans to submit documentation for a Phase 2a trial targeting chemotherapy-induced peripheral neuropathy, a condition lacking FDA-approved therapies.

Feb 3, 2026

MIRA Pharmaceuticals Initiates Final Cohort of Ketamir-2 Phase 1 Clinical Study as Company Prepares for Phase 2a Study

MIRA Pharmaceuticals has commenced dosing in the final cohort of its Phase 1 clinical trial for Ketamir-2, an oral NMDA receptor antagonist. The trial aims to evaluate the safety and pharmacokinetics of the drug, with no serious adverse events reported thus far. MIRA plans to submit a Phase 2a protocol to the FDA following the completion of Phase 1, targeting chemotherapy-induced peripheral neuropathy, a condition with no approved treatments.

Oct 24, 2025

MIRA Pharmaceuticals Initiates Multiple Ascending Dose (MAD) Phase 1 Study of Oral Ketamir-2 and Selects Chemotherapy-Induced Neuropathic Pain as Lead Phase 2a Indication

MIRA Pharmaceuticals has launched a multiple ascending dose Phase 1 study for its oral Ketamir-2, targeting chemotherapy-induced neuropathic pain. This condition currently lacks approved treatments, highlighting the significance of the study. The company is also considering FDA Fast Track designation to expedite development.

MIRA Pharmaceuticals Announces Oral Mira-55 Outperformed Injected Morphine in Normalizing Pain and Reducing Inflammation, Supporting Its Planned IND for Chronic Inflammatory Pain

MIRA Pharmaceuticals announced promising preclinical data indicating that oral Mira-55 effectively normalized pain and significantly reduced inflammation, outperforming injected morphine. This development supports the company's plans for an Investigational New Drug (IND) application targeting chronic inflammatory pain. The findings bolster MIRA's competitive stance in the growing non-opioid pain management market.

Sep 30, 2025

MIRA Pharmaceuticals Closes Acquisition of SKNY Pharmaceuticals, Expands Pipeline with SKNY-1 for Obesity and Nicotine Addiction

MIRA Pharmaceuticals has successfully completed the acquisition of SKNY Pharmaceuticals, which enhances its pipeline with the addition of SKNY-1, targeting obesity and nicotine addiction. The acquisition also contributes $5 million in marketable securities, bolstering MIRA's financial stability. This strategic move complements MIRA's ongoing programs, including Ketamir-2 and MIRA-55.

MIRA Pharmaceuticals Announces Favorable Topline Results from Phase 1 SAD Study of Oral Ketamir-2, a Next-Generation Non-Scheduled Ketamine Analog

MIRA Pharmaceuticals announced positive topline results from its Phase 1 SAD study of Ketamir-2, a next-generation ketamine analog. The study indicated that Ketamir-2 was safe and well tolerated across all dose levels, with no severe adverse effects. Additionally, the drug exhibited rapid absorption and a favorable duration of action, allowing for once-daily dosing.

MIRA Pharmaceuticals Reports Positive PTSD Data Demonstrating Ketamir-2 Restores Normalized Behavior in Stressed Animals

MIRA Pharmaceuticals has reported encouraging results for its oral drug candidate, Ketamir-2, which has shown the ability to restore normalized behavior in stressed animals. This development marks a significant step as the company expands its focus from neuropathic pain to neuropsychiatric disorders, including PTSD. The positive data reinforces the potential of Ketamir-2 in treating these conditions.

Sep 12, 2025

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MIRA Pharmaceuticals Shareholders Approve Acquisition of SKNY Pharmaceuticals, Advancing Next-Generation Oral Therapeutic for Obesity and Smoking Cessation

MIRA Pharmaceuticals has received shareholder approval for the acquisition of SKNY Pharmaceuticals. This strategic move enhances MIRA's pipeline with SKNY-1, an oral therapeutic candidate that has shown promising results in preclinical studies, including up to 30% weight loss and reversal of nicotine cravings. The acquisition positions MIRA to advance its focus on metabolic disorders.

Aug 19, 2025

MIRA Pharmaceuticals Announces Completion of Phase 1 Single Ascending Dose for Oral Ketamir-2 with No Safety Concerns, Advances to Multiple Ascending Dose Stage

MIRA Pharmaceuticals has successfully completed the Single Ascending Dose phase of its Phase 1 clinical trial for Oral Ketamir-2, reporting no safety concerns. The company is now advancing to the Multiple Ascending Dose stage. Additionally, MIRA is preparing to initiate a Phase 2a trial for neuropathic pain in the U.S. in Q4 2025.

Aug 12, 2025

MIRA Pharmaceuticals’ Second Ketamir-2 Manuscript Accepted for Peer-Reviewed Publication Demonstrating Superior Efficacy in Preclinical Neuropathic Pain Models Versus Ketamine, Gabapentin, or Pregabalin

MIRA Pharmaceuticals has announced that its manuscript detailing the efficacy of Ketamir-2 has been accepted for publication in Frontiers in Pharmacology. The study demonstrates that Ketamir-2 outperforms ketamine, gabapentin, and pregabalin in preclinical neuropathic pain models. This finding supports the company's plans to advance Ketamir-2 to Phase 2a clinical trials by the end of 2025.

Jul 30, 2025

MIRA Pharmaceuticals Reports New Topical Ketamir-2 shows comparable effects to Injected Morphine in Preclinical Pain Study

MIRA Pharmaceuticals has reported promising preclinical results for its topical Ketamir-2 cream, which effectively reduces acute and inflammatory pain behaviors in animal models, showing comparable efficacy to injected morphine. The cream's localized delivery minimizes systemic exposure, making it a potential next-generation non-opioid treatment. The company plans to advance its clinical strategy with both oral and topical formulations.

Jul 29, 2025

MIRAFDA Updates

MIRA Pharmaceuticals Announces FDA Clearance of IND for Ketamir-2, Enabling U.S. Clinical Trials in Neuropathic Pain

MIRA Pharmaceuticals has received FDA clearance for its IND application for Ketamir-2, an oral NMDA receptor antagonist aimed at treating neuropathic pain. The company is nearing completion of the Phase 1 trial and plans to initiate a Phase 2a clinical trial in the U.S. by the end of 2025. Preclinical studies indicate Ketamir-2's potential for effective pain relief without the side effects associated with traditional ketamine.

Jul 11, 2025

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MIRA Reports Clear Reversal of Anxiety-Related Behavior in Animal Model Using SKNY-1, an Oral Drug Candidate for Obesity and Nicotine Addiction Under Definitive Agreement for Acquisition

MIRA Pharmaceuticals announced promising preclinical results for SKNY-1, an oral drug candidate targeting obesity and nicotine addiction. The drug demonstrated the ability to reverse anxiety-related behaviors in an animal model while achieving significant weight loss and reducing cravings. This differentiated profile positions SKNY-1 as a potential treatment option without the CNS side effects associated with previous CB1-targeting drugs.

Jul 3, 2025

MIRA Reports Potent Inflammatory Pain Relief from Non-Psychoactive Marijuana Analog Mira-55 in Animal Model, Matching Morphine Without Opioid Risks

MIRA Pharmaceuticals announced positive preclinical results for Mira-55, a non-psychotropic marijuana analog, demonstrating pain relief comparable to morphine without the associated risks of addiction or sedation. The drug selectively activates CB2 receptors, minimizing side effects. MIRA aims to advance Mira-55 toward an IND submission while also progressing its other candidate, Ketamir-2, for neuropathic pain.

Jun 30, 2025

MIRA Reports Up to 30% Weight Loss and Reversal of High-Calorie and Nicotine Cravings in an Animal Model of Obesity and Craving Using SKNY-1, a Drug Candidate Under Definitive Agreement for Acquisition

MIRA Pharmaceuticals announced promising results from an animal study of SKNY-1, a next-generation oral therapy aimed at obesity and nicotine addiction. The study showed a 30% weight loss and significant reductions in cravings for high-calorie foods and nicotine within six days of treatment. SKNY-1 preserves muscle mass while improving metabolic health, positioning it as a potential alternative to existing therapies.

Jun 25, 2025

MIRA Pharmaceuticals Announces New Data Underscoring Potential of SKNY-1 – A Drug Candidate Pending Acquisition – To Disrupt Weight Loss and Smoking Cessation Markets Without CNS Side Effects

MIRA Pharmaceuticals announced promising preclinical data for SKNY-1, an oral drug candidate aimed at obesity and smoking cessation. The drug is designed to avoid CNS side effects associated with earlier therapies by selectively modulating CB1 and CB2 receptors. MIRA has signed an agreement to acquire SKNY Pharmaceuticals, pending regulatory review and shareholder approval. The global markets for obesity and smoking cessation are expected to grow significantly, positioning SKNY-1 as a potential cornerstone asset for MIRA.

Jun 18, 2025

MIRA Pharmaceuticals’ Lead Drug Candidate Ketamir-2 First Manuscript Accepted for Publication in the Peer-Reviewed Journal Frontiers in Pharmacology

MIRA Pharmaceuticals announced that its lead drug candidate, Ketamir-2, has been accepted for publication in Frontiers in Pharmacology. The publication highlights Ketamir-2's unique pharmacological properties, including its selective targeting of NMDA receptors and favorable safety profile compared to ketamine. The ongoing Phase 1 trial is progressing well, with plans for a Phase 2a trial expected by the end of 2025.

May 28, 2025

MIRAConferences/Events

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MIRA Pharmaceuticals to Participate in BIO 2025 in Boston and Highlights Ongoing Progress Across Clinical Program

MIRA Pharmaceuticals will participate in the BIO International Convention 2025 in Boston, where it plans to engage in One-on-One Partnering meetings. The company is advancing its lead candidate, Ketamir-2, through Phase 1 trials and preparing for a Phase IIa study in neuropathic pain. Additionally, MIRA is finalizing regulatory filings for its acquisition of SKNY Pharmaceuticals.

MIRA Pharmaceuticals Announces Board Approval of SKNY Acquisition Reflecting $60+ Million in Combined Enterprise Value Based on Independent Review

MIRA Pharmaceuticals has received board approval for the acquisition of SKNY Pharmaceuticals, which is expected to create a combined enterprise value of over $60 million. The merger aims to enhance MIRA's pipeline targeting obesity and nicotine dependence, with SKNY-1 being a key therapeutic candidate. Shareholder approval is still required for the merger to proceed.

May 6, 2025

MIRA Pharmaceuticals Reports No Brain Toxicity in FDA-Required Study of Ketamir-2, Confirming Absence of Ketamine-Linked Neurotoxicity

MIRA Pharmaceuticals announced positive results from a neurotoxicity study of its oral NMDA receptor antagonist, Ketamir-2, showing no brain toxicity. This study, required by the FDA, supports the drug's safety profile and ongoing Phase I clinical trial enrollment. MIRA plans to submit these results to the FDA as part of its regulatory strategy.

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Apr 23, 2025

MIRAFDA Updates

MIRA Pharmaceuticals Reports Positive In Vitro Drug Release Data for Topical Ketamir-2, Targeting $11B+ U.S. Topical Pain Relief Market and Exploring FDA Fast Track Designation

MIRA Pharmaceuticals has reported positive in vitro drug release data for its topical formulation of Ketamir-2, aimed at treating pain-related conditions. The formulation demonstrated consistent release characteristics and stability, indicating potential for effective localized pain management. MIRA is also considering FDA Fast Track designation to expedite development, addressing a significant market opportunity in the U.S. topical pain relief market projected to exceed $11.5 billion by 2025.

MIRA Pharmaceuticals Announces Positive Results for Ketamir-2 in Diabetic Neuropathy Animal Model, Reinforcing Confidence Ahead of Phase I Completion

MIRA Pharmaceuticals announced positive results for Ketamir-2 in a diabetic neuropathy animal model, showing significant efficacy in reducing neuropathic pain symptoms. The company aims to advance to Phase I completion and initiate a Phase IIa trial by the end of 2025. Ketamir-2 is positioned as a safer, non-opioid alternative for patients suffering from diabetic neuropathy.

Apr 1, 2025

MIRA Pharmaceuticals Enrolls First Subjects in Phase 1 Clinical Trial of Ketamir-2 for Neuropathic Pain

MIRA Pharmaceuticals has enrolled the first subjects in its Phase 1 clinical trial for Ketamir-2, an oral ketamine analog aimed at treating neuropathic pain. The trial will assess safety, tolerability, and pharmacokinetics in healthy volunteers. Promising preclinical data suggests Ketamir-2 may outperform existing treatments like pregabalin. MIRA plans to expand its research with a topical formulation and has also acquired SKNY Pharmaceuticals to enhance its therapeutic pipeline.

Mar 24, 2025

MIRA Pharmaceuticals Signs Binding Letter of Intent to Acquire SKNY Pharmaceuticals, Securing a $5 Million Capital Infusion to Advance Weight Loss and Smoking Cessation Drug Development

MIRA Pharmaceuticals has signed a binding letter of intent to acquire SKNY Pharmaceuticals, which includes a $5 million capital infusion. This acquisition aims to advance the development of SKNY-1, a preclinical oral drug candidate targeting obesity and smoking cessation. The move positions MIRA to enter high-growth markets with significant unmet medical needs.

Mar 4, 2025

MIRA Pharmaceuticals Announces Approval and Initiation of Phase 1 Clinical Trial for Ketamir-2 in Neuropathic Pain

MIRA Pharmaceuticals has received approval to initiate a Phase 1 clinical trial for Ketamir-2, an oral ketamine analog aimed at treating neuropathic pain. The trial, set to begin recruitment in Q1 2025, will assess the safety and pharmacokinetics of Ketamir-2. The company anticipates concluding Phase 1 by Q4 2025, with plans for a Phase 2a study thereafter. Preclinical results indicate Ketamir-2's potential as a safer and more effective treatment compared to existing therapies.

Dec 19, 2024

MIRAFDA Updates

MIRA Pharmaceuticals Submits IND for Ketamir-2 to FDA, Marking a Significant Milestone in the Company’s Pipeline Development

MIRA Pharmaceuticals has submitted an IND application for Ketamir-2, a novel oral ketamine analog aimed at treating neuropathic pain. This submission is a significant step in the company's drug development pipeline. Ketamir-2 is designed to overcome limitations of existing treatments and is expected to enter Phase I trials in Q1 2025. The drug shows promise for addressing unmet medical needs in various neuropsychiatric disorders.

Dec 10, 2024

MIRA Pharmaceuticals Validates Ketamir-2’s Safety Profile With No Adverse Findings, Paving the Way for IND Submission by Year-End

MIRA Pharmaceuticals has completed its preclinical safety program for Ketamir-2, confirming no adverse findings. This milestone supports the company's plan to submit an Investigational New Drug (IND) application by the end of 2024. The upcoming Phase I clinical trial aims to evaluate the drug's safety and efficacy in treating neuropathic pain, with results expected by mid-2025.

MIRA Reveals Innovative Phase I/IIa Protocol Design and Selection of Clinical Trial Site

MIRA Pharmaceuticals has selected The Centre for Human Drug Research in the Netherlands for its Phase I/IIa clinical trial of Ketamir-2, an oral ketamine analog. The trial will begin recruitment in Q1 2025, with initial results expected in late 2025. The innovative design aims to gather early efficacy data, potentially positioning MIRA for strategic partnerships.

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Oct 29, 2024

MIRAConferences/Events

18th Annual Pain Therapeutics Summit

The article announces the 18th Annual Pain Therapeutics Summit, highlighting its relevance in the field of pain management. It provides an overview of the event but lacks specific details about speakers, topics, or outcomes. The summit is expected to gather professionals to discuss advancements in pain therapeutics.

Oct 29, 2024

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2024 Annual Meeting of Stockholders

The article announces the 2024 Annual Meeting of Stockholders for MIRA. It provides an overview of the company's governance, financial information, and investor relations resources. However, no specific details about the agenda or key topics for the meeting are mentioned.

Oct 28, 2024

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MIRA Pharmaceuticals’ Ketamir-2 Shows 60% Greater Efficacy Than FDA-Approved Gabapentin in Reversing Chemotherapy-Induced Neuropathic Pain

MIRA Pharmaceuticals announced that its novel oral ketamine analog, Ketamir-2, demonstrates 60% greater efficacy than gabapentin in alleviating chemotherapy-induced neuropathic pain. The findings will be presented at the Pain Therapeutics Summit in Boston. The company aims to pursue FDA breakthrough therapy designation and plans to initiate Phase I clinical trials in early 2025.

Oct 21, 2024

MIRA Pharmaceuticals Announces Ketamir-2 Outperforms Current FDA-Approved Neuropathic Pain Treatments, Gabapentin and Pregabalin, in Preclinical Study

MIRA Pharmaceuticals announced that its novel oral ketamine analog, Ketamir-2, outperformed FDA-approved neuropathic pain treatments Gabapentin and Pregabalin in a preclinical study. The study demonstrated significant pain relief with Ketamir-2, highlighting its potential as a non-opioid alternative. MIRA plans to submit an IND application and begin Phase 1 trials in early 2025.

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Sep 27, 2024

MIRAConferences/Events

MIRA Pharmaceuticals Announces New Preclinical Data for Ketamir-2 to Be Presented at the 18th Annual Pain Therapeutics Summit in Boston on October 28-29, 2024

MIRA Pharmaceuticals announced that new preclinical data for Ketamir-2 will be presented at the 18th Annual Pain Therapeutics Summit. The data reveals that Ketamir-2 achieved a complete reversal of neuropathic pain in preclinical models, suggesting its potential as a breakthrough therapy. The company plans to submit an IND application by December 2024, aiming for clinical trials in 2025.

MIRA Pharmaceuticals Advances Ketamir-2 Development Following Phase 1 Design Completion, Focusing on Early Clinical Efficacy Demonstration for Neuropathic Pain in 2025

MIRA Pharmaceuticals has made significant strides in developing Ketamir-2, an oral ketamine analog, with plans to demonstrate clinical efficacy for neuropathic pain by 2025. The company is on track for an IND filing with the FDA in December 2024 and has initiated drug product development in collaboration with Formulex. MIRA aims to gather early evidence of clinical benefits through innovative Phase I/II study designs.

MIRA Pharmaceuticals Designates Neuropathic Pain as Primary Indication for Ketamir-2 and Submits Pre-IND Meeting Request to FDA

MIRA Pharmaceuticals has designated 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, with human trials expected to begin in early 2025. Ketamir-2 aims to provide effective pain relief with fewer side effects compared to current treatments, positioning it as a potential breakthrough in neuropathic pain management.

MIRA Pharmaceuticals Achieves 100% Reversal of Neuropathic Pain With Oral Ketamir-2 in Breakthrough Study

MIRA Pharmaceuticals announced a breakthrough in neuropathic pain treatment with its oral ketamine analog, Ketamir-2, which achieved a complete reversal of pain in pre-clinical studies. The study demonstrated superior efficacy compared to traditional oral ketamine, with significant pain relief lasting up to 22 days. MIRA plans further studies to explore Ketamir-2's potential in treating cancer-induced depression and aims for human trials by 2025.

MIRA Pharmaceuticals Showcases Significant Progress and Announces Final Phase of Regulatory Work as It Prepares for IND Submission by Year-End

MIRA Pharmaceuticals has announced significant progress towards submitting its IND application by year-end. The company has made advancements with its novel oral ketamine analog, Ketamir-2, which shows a promising safety profile and efficacy in preclinical studies. Additionally, MIRA-55, a novel marijuana analog, has demonstrated advantages over THC, positioning both compounds as potential treatments for neuropsychiatric disorders.

Aug 12, 2024

MIRA Pharmaceuticals Unveils Ketamir-2’s Principal Metabolite: Nor-Ketamir – a Longer-Acting, Brain Penetrating and Selective Compound Acting on the NMDA PCP Receptor

MIRA Pharmaceuticals has announced promising preclinical data on its drug candidate, Nor-Ketamir-2, a metabolite of Ketamir-2. This compound exhibits high selectivity and nearly 100% oral bioavailability, making it a potential candidate for at-home treatment of neurological disorders. The company is advancing towards filing an IND application to initiate clinical trials.

MIRA Pharmaceuticals Announces Positive Discovery of Ketamir-2’s Selective NMDA Binding Mechanism of Action

MIRA Pharmaceuticals announced promising preclinical results for Ketamir-2, a novel ketamine analog. The data reveals its selective NMDA receptor inhibition, which may reduce side effects compared to traditional ketamine. Additionally, toxicology studies show a strong safety profile, supporting the potential for an IND submission to the FDA later this year.

Jul 22, 2024

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MIRA Pharmaceuticals Reveals Preclinical Success: Ketamir-2 Optimized for Brain Delivery, Avoiding Ketamine’s Drug Resistance

MIRA Pharmaceuticals has announced promising preclinical results for its oral ketamine analog, Ketamir-2, which may offer advantages in treating neurological and neuropsychiatric disorders. The drug shows improved oral bioavailability and better brain penetration, potentially enhancing patient compliance. MIRA aims to submit an IND application to the FDA by year-end to initiate human trials.

Mira Pharmaceuticals Announces Promising Results for MIRA-55 in Multiple Preclinical Tests Compared to THC

MIRA Pharmaceuticals announced positive preclinical results for MIRA-55, a novel oral marijuana analog. The findings indicate that MIRA-55 outperforms THC in efficacy and anxiolytic effects, maintaining its effectiveness across various doses. The company plans further studies to advance towards an Investigational New Drug application.

MIRA Pharmaceuticals Announces Exclusive Licensing Agreement for Oral Ketamine Analog, Ketamir-2 - New Chemical Entity Aims to Provide New Treatments for Refractory Depression and Depression with Suicidal Thoughts - - Ke

MIRA Pharmaceuticals has announced an exclusive licensing agreement to develop Ketamir-2, an oral ketamine analog aimed at treating refractory depression and major depressive disorder with suicidal thoughts. This new compound could offer ultra-rapid antidepressant effects and is not classified as a controlled substance by the DEA, facilitating its development. The partnership with MIRALOGX includes a $3 million line of credit for initial funding. The leadership of Dr. Adam Kaplin further pushes the innovative nature of the therapy as the company aims to enhance mental health treatment options.

Aug 9, 2023

MIRA Pharmaceuticals, Inc. Discusses Potential of Revolutionary THC Analog Drug, MIRA1a, with The Stock Day Podcast

MIRA Pharmaceuticals, Inc. has discussed its lead drug candidate, MIRA1a, which is a novel synthetic THC analog aimed at treating anxiety, cognitive decline, and chronic pain. CEO Erez Aminov highlighted the drug's potential to enhance cognition without the impurities of traditional cannabis. The company is currently in the toxicology stage and plans to apply for a new drug application in 2024, with Phase 1/2 trials expected by late 2024 or early 2025.

Aug 2, 2023