$MIRA News

Last published 2w ago

2w agoMIRAMIRA Pharmaceuticals Reports Significant Weight and Fat Reduction With Oral SKNY-1 in Obese Mice, Showing Favorable Lean-Mass and Weight-Regain Outcomes Compared With SemaglutideGlobeNewswireSKNY-1's Weight Reduction Without Significant Changes in Food Consumption Suggests a Potential Role for Energy Expenditure, Contrasting With Semaglutide's Initial Food-Intake Suppression and Significant
3w agoMIRAMIRA Pharmaceuticals Reports MIRA-55 Demonstrated Significant Pain Relief Comparable to Celebrex in Chronic Inflammatory Pain StudyGlobeNewswireMIAMI, Oct. 22, 2026 (GLOBE NEWSWIRE) -- MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA) ("MIRA" or the "Company"), a clinical-stage pharmaceutical company developing novel oral therapies for neurologic,
1mo agoMIRAMIRA Pharmaceuticals Advances Ketamir-2 to Phase 2a in Chemotherapy-Induced Peripheral Neuropathy (CIPN) Following FDA ReviewGlobeNewswireMIAMI, Sept. 17, 2026 (GLOBE NEWSWIRE) -- MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA) ("MIRA" or the "Company"), a clinical-stage pharmaceutical company developing novel oral small-molecule therapeutics,
2mo agoMIRAMIRA Pharmaceuticals Advances Non-Opioid Oral MIRA-55 for Inflammatory Pain Toward INDGlobeNewswireMIAMI, Sept. 01, 2026 (GLOBE NEWSWIRE) -- MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA) ("MIRA" or the "Company"), a clinical-stage pharmaceutical company developing novel oral small-molecule therapeutics,
3mo agoMIRAMIRA Reports Positive 7-Day Dog Study Results for SKNY-1GlobeNewswireObesity Treatment Candidate Designed to Preserve Lean Body Mass Toxicokinetic Findings De-Risk Dose Selection and Support Regulatory Pathway Toward IND MIAMI, Aug. 06, 2026 (GLOBE NEWSWIRE) -- MIRA Pharmaceuticals,
3mo agoMIRAMIRA Pharmaceuticals Progresses MIRA-55 and SKNY-1 Toward IND-Enabling StudiesGlobeNewswireMIAMI, July 30, 2026 (GLOBE NEWSWIRE) -- MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA) ("MIRA" or the "Company"), a clinical-stage pharmaceutical company developing novel oral small-molecule therapeutics,
4mo agoMIRAMIRA Pharmaceuticals Reports Successful Formulation Results Supporting Development of MIRA-55 as a Non-Opioid Oral Therapy for Chronic Inflammatory PainACCESS NewswireOptimized Oral Formulation Demonstrates Favorable Oral Bioavailability Together with Robust Brain and Liver Distribution Following Oral Administration MIAMI, FL / ACCESS Newswire / July 10, 2026 / MIRA Pharmaceuticals,
4mo agoMIRAMIRA Pharmaceuticals Reports Successful Formulation Results for SKNY-1, Its Oral Drug Candidate for Obesity and AddictionACCESS NewswireNew Preclinical Data Demonstrate Favorable Oral Bioavailability, Robust Brain Penetration and Liver Exposure with Once-Daily Dosing Potential MIAMI, FL / ACCESS Newswire / July 6, 2026 / MIRA Pharmaceuticals, Inc.
4mo agoMIRAMIRA Pharmaceuticals Reports New Preclinical Data Demonstrating Mira-55's Differentiated Mechanism of Action and Anxiolytic Activity Relative to THCACCESS NewswireData show Mira-55 does not produce the central nervous system effects associated with THC and acts through a distinct pharmacological mechanism, while demonstrating anxiolytic activity, which THC does not produce,
4mo agoMIRAMIRA Pharmaceuticals Submits Phase 2a Clinical Trial Protocol to FDA for Ketamir-2 in Chemotherapy-Induced Peripheral NeuropathyACCESS NewswireRandomized, double-blind, placebo-controlled study to evaluate safety, tolerability, and dose-response efficacy of oral Ketamir-2 at a leading U.S. cancer center MIAMI, FL / ACCESS Newswire / June 17, 2026 / MIRA
5mo agoMIRAMIRA Pharmaceuticals Secures Worldwide Exclusive Rights to MIRA-55 and SKNY-1ACCESS NewswireAgreement Establishes Global Exclusivity Across MIRA's Core Therapeutic Pipeline and Enhances Strategic Flexibility for Future Licensing and Partnership Opportunities MIAMI, FL / ACCESS Newswire / June 4, 2026 / MIRA
5mo agoMIRAMIRA Pharmaceuticals Secures Worldwide Rights for Ketamir-2, Expanding Global IP Portfolio Across 10 Major Markets Ahead of Phase 2a in CIPNACCESS NewswireExpanded Global Intellectual Property Portfolio Enhances Strategic Flexibility and Long-Term Value Potential for Ketamir-2 MIAMI, FL / ACCESS Newswire / May 27, 2026 / MIRA Pharmaceuticals, Inc. ("MIRA" or
6mo agoMIRAMIRA Pharmaceuticals Reports Positive Unblinded Phase 1 Data for Ketamir-2ACCESS NewswireSelective oral NMDA receptor modulator demonstrated favorable safety, tolerability, and pharmacokinetic profile supporting planned Phase 2a development in chemotherapy-induced peripheral neuropathy MIAMI, FL / ACCESS
6mo agoMIRAMIRA Pharmaceuticals Announces Acceptance of Peer-Reviewed SKNY-1 Manuscript Highlighting Oral Obesity and Nicotine Addiction Drug CandidateACCESS NewswirePeer-reviewed publication highlights preclinical findings demonstrating weight loss, lipid normalization, and reduction of compulsive feeding and nicotine-seeking behaviors MIAMI, FL / ACCESS Newswire / May 13, 2026 /
7mo agoMIRAMIRA Pharmaceuticals Reports Mira-55 Shows No THC- or Rimonabant-Associated CNS Side Effects in Preclinical StudiesACCESS NewswirePreviously shown to deliver morphine-comparable pain relief without opioid-related risks in a validated inflammatory pain model, supporting planned IND submission for inflammatory painMIAMI, FL / ACCESS Newswire / March
8mo agoMIRAMIRA Pharmaceuticals Completes Phase 1 Dosing of Ketamir-2ACCESS NewswireAdvancing a selective oral NMDA receptor modulator toward Phase 2a in chemotherapy-induced peripheral neuropathy following favorable Phase 1 safety and tolerability findingsMIAMI, FLORIDA / ACCESS Newswire / March 4,
9mo agoMIRAMIRA Pharmaceuticals Initiates Final Cohort of Ketamir-2 Phase 1 Clinical Study as Company Prepares for Phase 2a StudyACCESS NewswireCompany to Participate in BIO Partnering Summit and Present Phase 1 Ketamir-2 Data at American Association for Cancer Research Annual MeetingMIAMI, FLORIDA / ACCESS Newswire / February 3, 2026 / MIRA
1y agoMIRAMIRA Pharmaceuticals Initiates Multiple Ascending Dose (MAD) Phase 1 Study of Oral Ketamir-2 and Selects Chemotherapy-Induced Neuropathic Pain as Lead Phase 2a IndicationACCESS NewswireAdvancing toward Phase 2a clinical evaluation in chemotherapy-related pain, a condition with no approved treatments and potential for FDA Fast Track consideration MIAMI, FLORIDA / ACCESS Newswire / October 24, 2025 /
1y agoMIRAMIRA Pharmaceuticals Announces Oral Mira-55 Outperformed Injected Morphine in Normalizing Pain and Reducing Inflammation, Supporting Its Planned IND for Chronic Inflammatory PainACCESS NewswireFindings show oral Mira-55 fully normalized pain and significantly reduced inflammation, supporting IND plans and reinforcing MIRA's position in a $70 billion non-opioid pain market. MIAMI, FLORIDA / ACCESS Newswire /
1y agoMIRAMIRA Pharmaceuticals Closes Acquisition of SKNY Pharmaceuticals, Expands Pipeline with SKNY-1 for Obesity and Nicotine AddictionACCESS NewswireClosing adds $5 million in marketable securities, strengthens financial position, and complements MIRA's advancing programs including Ketamir-2 and MIRA-55 MIAMI, FLORIDA / ACCESS Newswire / September 30, 2025 / MIRA
1y agoMIRAMIRA Pharmaceuticals Announces Favorable Topline Results from Phase 1 SAD Study of Oral Ketamir-2, a Next-Generation Non-Scheduled Ketamine AnalogACCESS NewswireStudy demonstrated Ketamir-2 was safe and well tolerated at all dose levels, with a favorable safety and tolerability profile, with no severe or clinically significant adverse effects observed. The drug showed rapid and
1y agoMIRAMIRA Pharmaceuticals Reports Positive PTSD Data Demonstrating Ketamir-2 Restores Normalized Behavior in Stressed AnimalsACCESS NewswireMIRA advances Ketamir-2 in the clinic for neuropathic pain while broadening development into neuropsychiatric disorders such as PTSD MIAMI, FLORIDA / ACCESS Newswire / September 16, 2025 / MIRA Pharmaceuticals, Inc.
1y agoMIRAMIRA Pharmaceuticals Shareholders Approve Acquisition of SKNY Pharmaceuticals, Advancing Next-Generation Oral Therapeutic for Obesity and Smoking CessationACCESS NewswireSKNY transaction strengthens MIRA pipeline with SKNY-1, a differentiated oral candidate that has demonstrated up to 30% weight loss and nicotine craving reversal in preclinical studies. MIAMI, FL / ACCESS Newswire /
1y agoMIRAMIRA Pharmaceuticals Announces Completion of Phase 1 Single Ascending Dose for Oral Ketamir-2 with No Safety Concerns, Advances to Multiple Ascending Dose StageACCESS NewswireFollowing FDA IND clearance for neuropathic pain, the Company is preparing to initiate its U.S. Phase 2a trial in Q4 2025 MIAMI, FL / ACCESS Newswire / August 19, 2025 / MIRA Pharmaceuticals, Inc.
1y agoMIRAMIRA Pharmaceuticals' Second Ketamir-2 Manuscript Accepted for Peer-Reviewed Publication Demonstrating Superior Efficacy in Preclinical Neuropathic Pain Models Versus Ketamine, Gabapentin, or PregabalinACCESS NewswireManuscript accepted for publication in Frontiers in Pharmacology, "Oral Administration of Ketamir-2, a Novel Ketamine Analog, Attenuates Neuropathic Pain in Rodent Models via Selective NMDA Antagonism" details
1y agoMIRAMIRA Pharmaceuticals Reports New Topical Ketamir-2 shows comparable effects to Injected Morphine in Preclinical Pain StudyACCESS NewswireTopical Ketamir-2 significantly reduced both acute and inflammatory pain behaviors in animals, demonstrating rapid onset, durable effect, and comparable efficacy to injected morphine across both pain phases MIAMI,
1y agoMIRAMIRA Pharmaceuticals Announces FDA Clearance of IND for Ketamir-2, Enabling U.S. Clinical Trials in Neuropathic PainACCESS NewswireOral, non-opioid drug candidate advancing through Phase 1 and nearing completion of the single ascending dose portion as the Company prepares to launch U.S. Phase 2a by year-end MIAMI, FLORIDA / ACCESS Newswire /
1y agoMIRAMIRA 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 AcquisitionACCESS NewswireSKNY-1 was previously shown to achieve up to 30% weight loss, reverse nicotine craving, and preserve muscle mass in an animal model-and is designed to avoid the CNS side effects that halted earlier CB1-targeting drugs
1y agoMIRAMIRA Reports Potent Inflammatory Pain Relief from Non-Psychoactive Marijuana Analog Mira-55 in Animal Model, Matching Morphine Without Opioid RisksACCESS NewswireWith Mira-55 and Ketamir-2, MIRA is advancing complementary non-opioid therapies for two of the largest pain markets MIAMI, FLORIDA / ACCESS Newswire / July 3, 2025 / MIRA Pharmaceuticals, Inc.
1y agoMIRAMIRA 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 AcquisitionACCESS NewswireOral therapy designed to minimize CNS side effects shows dual activity in weight loss and smoking cessation models without muscle loss MIAMI, FLORIDA / ACCESS Newswire / June 30, 2025 / MIRA today announced
1y agoMIRAMIRA 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 EffectsACCESS NewswireMIAMI, FL / ACCESS Newswire / June 25, 2025 / MIRA Pharmaceuticals, Inc. , a clinical-stage pharmaceutical company focused on developing novel therapeutics for
1y agoMIRAMIRA Pharmaceuticals' Lead Drug Candidate Ketamir-2 First Manuscript Accepted for Publication in the Peer-Reviewed Journal Frontiers in PharmacologyACCESS NewswireMIAMI, FL / ACCESS Newswire / June 18, 2025 / MIRA Pharmaceuticals, Inc. , a clinical-stage pharmaceutical company developing novel therapeutics for neurologic,
1y agoMIRAMIRA Pharmaceuticals to Participate in BIO 2025 in Boston and Highlights Ongoing Progress Across Clinical ProgramACCESS NewswireThe company will engage in BIO One-on-One Partnering™ meetings as it advances Phase 1 for Ketamir-2, prepares Phase IIa study in neuropathic pain, and finalizes filings for SKNY acquisition. MIAMI, FL / ACCESS
1y agoMIRAMIRA Pharmaceuticals Announces Board Approval of SKNY Acquisition Reflecting $60+ Million in Combined Enterprise Value Based on Independent ReviewACCESS NewswireWith valuations confirmed by the board, MIRA advances strategic acquisition targeting obesity and nicotine dependence, which includes a $5 million contribution in cash or assets from SKNY to be transferred at closing.
1y agoMIRAMIRA Pharmaceuticals Reports No Brain Toxicity in FDA-Required Study of Ketamir-2, Confirming Absence of Ketamine-Linked NeurotoxicityACCESS NewswirePreclinical data supports the advancement of oral Ketamir-2 as a safe, next-generation alternative to ketamine, with ongoing momentum in Phase I clinical trial enrollment MIAMI, FL / ACCESS Newswire / May 6, 2025 / MIRA
1y agoMIRAMIRA 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 DesignationACCESS NewswireMIAMI, FLORIDA / ACCESS Newswire / April 23, 2025 / MIRA Pharmaceuticals, Inc. , or MIRA, a clinical-stage pharmaceutical company focused on developing novel therapeutics for neurologic and neuropsychiatric
1y agoMIRAMIRA Pharmaceuticals Announces Positive Results for Ketamir-2 in Diabetic Neuropathy Animal Model, Reinforcing Confidence Ahead of Phase I CompletionACCESS NewswireKetamir-2 Demonstrates Strong Efficacy in Diabetic Neuropathy Model, with Some Subjects Achieving Complete Symptom Reversal MIAMI, FLORIDA / ACCESS Newswire / April 16, 2025 / MIRA Pharmaceuticals, Inc. , or
1y agoMIRAMIRA Pharmaceuticals Enrolls First Subjects in Phase 1 Clinical Trial of Ketamir-2 for Neuropathic PainACCESS NewswireMIAMI, FLORIDA / ACCESS Newswire / April 1, 2025 / MIRA Pharmaceuticals, Inc. , a clinical-stage pharmaceutical company developing breakthrough therapeutics for neurologic and neuropsychiatric disorders,
1y agoMIRAMIRA Pharmaceuticals Signs Binding Letter of Intent to Acquire SKNY Pharmaceuticals, Securing a $5 Million Capital Infusion to Advance Weight Loss and Smoking Cessation Drug DevelopmentACCESS NewswireStrategic acquisition expands MIRA's pipeline with SKNY-1, a next-generation oral therapeutic targeting the two leading causes of preventable death-obesity and smoking. MIAMI, FL / ACCESS Newswire / March 24, 2025 / MIRA
1y agoMIRAMIRA Pharmaceuticals Expands Ketamir-2 Development with Topical Treatment for Localized Neuropathic and Inflammatory PainACCESS NewswireMIAMI, FL / ACCESS Newswire / March 13, 2025 / MIRA Pharmaceuticals, Inc. , a clinical-stage pharmaceutical company focused on developing therapies for neurological and neuropsychiatric disorders, today
1y agoMIRAMIRA Pharmaceuticals Announces Approval and Initiation of Phase 1 Clinical Trial for Ketamir-2 in Neuropathic PainACCESS NewswireMIAMI, FL / ACCESS Newswire / March 4, 2025 / MIRA Pharmaceuticals, Inc. , a preclinical-stage pharmaceutical company focused on developing therapies for neurological and neuropsychiatric disorders, today
1y agoMIRAMIRA Pharmaceuticals Submits IND for Ketamir-2 to FDA, Marking a Significant Milestone in the Company's Pipeline DevelopmentACCESS NewswireMIAMI, FLORIDA / ACCESSWIRE / December 19, 2024 / MIRA Pharmaceuticals, Inc. , a preclinical-stage pharmaceutical company focused on developing therapies for neurological and neuropsychiatric disorders,
1y agoMIRAMIRA Pharmaceuticals Validates Ketamir-2's Safety Profile With No Adverse Findings, Paving the Way for IND Submission by Year-EndACCESS NewswireStrong Safety Profile Validated Across Studies, Setting the Stage for Clinical Trials in Neuropathic Pain MIAMI, FL / ACCESSWIRE / December 10, 2024 / MIRA Pharmaceuticals, Inc. , a preclinical-stage
1y agoMIRAMIRA Reveals Innovative Phase I/IIa Protocol Design and Selection of Clinical Trial SiteACCESS NewswireBacked 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,
2y agoMIRAMIRA Pharmaceuticals' Ketamir-2 Shows 60% Greater Efficacy Than FDA-Approved Gabapentin in Reversing Chemotherapy-Induced Neuropathic PainACCESS NewswirePromising Preclinical Results Position Ketamir-2 as a Potential Breakthrough Therapy That Surpasses Current Treatments, With Results to Be Presented at the Pain Therapeutics Summit in BostonMIAMI, FL / ACCESSWIRE /
2y agoMIRAMIRA Pharmaceuticals Announces Ketamir-2 Outperforms Current FDA-Approved Neuropathic Pain Treatments, Gabapentin and Pregabalin, in Preclinical StudyACCESS NewswireMIAMI, FL / ACCESSWIRE / October 21, 2024 / MIRA Pharmaceuticals, Inc. , a leading pre-clinical-stage pharmaceutical development company, is excited to announce that its novel oral ketamine analog,
2y agoMIRAMIRA Pharmaceuticals Announces New Preclinical Data for Ketamir-2 to Be Presented at the 18th Annual Pain Therapeutics Summit in Boston on October 28-29, 2024ACCESS NewswireConference presentation delivers preclinical results demonstrating Ketamir-2 achieves 100% reversal of neuropathic painMIAMI, FL / ACCESSWIRE / September 27, 2024 / MIRA Pharmaceuticals, Inc. , a
2y agoMIRAMIRA Pharmaceuticals Advances Ketamir-2 Development Following Phase 1 Design Completion, Focusing on Early Clinical Efficacy Demonstration for Neuropathic Pain in 2025ACCESS NewswireMIAMI, FL / ACCESSWIRE / September 18, 2024 / MIRA Pharmaceuticals, Inc. , a preclinical-stage pharmaceutical company focused on developing innovative therapies for neurologic and neuropsychiatric disorders,
2y agoMIRAMIRA Pharmaceuticals Designates Neuropathic Pain as Primary Indication for Ketamir-2 and Submits Pre-IND Meeting Request to FDAACCESS NewswireMIAMI, FL / ACCESSWIRE / September 11, 2024 / MIRA Pharmaceuticals, Inc. , a preclinical-stage pharmaceutical company focused on developing innovative therapies for neurologic and neuropsychiatric disorders,
2y agoMIRAMIRA Pharmaceuticals Achieves 100% Reversal of Neuropathic Pain With Oral Ketamir-2 in Breakthrough StudyACCESS NewswireStudy Highlights Superior Efficacy of Ketamir-2 Over Oral Ketamine, Achieving Full Normalization of Pain ThresholdsMIAMI, FL / ACCESSWIRE / August 26, 2024 / MIRA Pharmaceuticals, Inc. , a leading