This section highlights FDA-related milestones and regulatory updates for drugs developed by MIRA Pharmaceuticals (MIRA).
Over the past two years, MIRA Pharmaceuticals has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
Ketamir-2, MIRA-55, and SKNY-1. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Ketamir-2 - FDA Regulatory Timeline and Events
Ketamir-2 is a drug developed by MIRA Pharmaceuticals for the following indication: to treat depression and treatment-resistant depression (TRD).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Ketamir-2
- Announced Date:
- May 6, 2025
- Indication:
- to treat depression and treatment-resistant depression (TRD).
Announcement
MIRA Pharmaceuticals Tells Benzinga 'Preclinical 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'
AI Summary
MIRA Pharmaceuticals recently announced promising preclinical findings for its oral NMDA receptor antagonist, Ketamir-2, stating that the data support its advancement as a safe, next‐generation alternative to ketamine. In neurotoxicity studies, high doses of Ketamir-2 were given to rats, and results showed no signs of brain damage or related adverse effects, unlike what is seen with older drugs such as MK-801. These outcomes have built confidence in Ketamir-2’s favorable safety profile.
The encouraging data have fueled ongoing momentum in its clinical development, with active enrollment in the Phase I clinical trial. MIRA plans to continue advancing Ketamir-2 toward additional trials that investigate its effectiveness, especially for patients suffering from neuropathic pain. This progress marks an important step toward offering a promising, non-invasive alternative treatment option.
Read Announcement- Drug:
- Ketamir-2
- Announced Date:
- April 23, 2025
- Indication:
- to treat depression and treatment-resistant depression (TRD).
Announcement
MIRA Pharmaceuticals, Inc announced a key development milestone that may significantly advance the Company’s topical drug pipeline: its novel topical formulation of Ketamir-2 demonstrated successful, dose-proportional drug release in a validated laboratory study, marking a critical step forward in the program’s progression toward clinical testing.
Read Announcement- Drug:
- Ketamir-2
- Announced Date:
- April 16, 2025
- Indication:
- to treat depression and treatment-resistant depression (TRD).
Announcement
MIRA Pharmaceuticals announced compelling data demonstrating the efficacy of the oral ketamine analog, Ketamir-2, in a validated animal model of diabetic neuropathy.
AI Summary
MIRA Pharmaceuticals has announced promising data on its oral ketamine analog, Ketamir-2, which showed strong efficacy in a validated animal model of diabetic neuropathy. In the study, Type 2 diabetes was induced in rats through a high-fat diet and a low dose of Streptozotocin, leading to high blood sugar and nerve pain similar to what is seen in humans. The treatment with Ketamir-2 resulted in a significant reduction in pain, with some animals even returning to their normal sensitivity levels before diabetes onset.
This encouraging result supports the potential of Ketamir-2 as a non-opioid treatment option for diabetic neuropathy, a condition with few effective therapies. MIRA plans further clinical trials to evaluate the safety and effectiveness of this compound in patients, which could eventually lead to a new, safer therapy for managing chronic neuropathic pain.
Read Announcement- Drug:
- Ketamir-2
- Announced Date:
- April 15, 2025
- Indication:
- to treat depression and treatment-resistant depression (TRD).
Announcement
EXCLUSIVE: MIRA Pharmaceuticals Ketamir-2 Shows Efficacy In Diabetes-Associated Nerve Damage In Animal Study
AI Summary
MIRA Pharmaceuticals recently announced promising results from an animal study testing its oral ketamine analog, Ketamir-2, for treating diabetic neuropathy—a nerve damage condition common in diabetes patients. In the study, Type 2 diabetes was induced in rats using a high-fat diet and a low dose of Streptozotocin. After treatment with Ketamir-2, many animals experienced a significant drop in neuropathic pain symptoms, with some returning completely to their normal pain sensitivity levels.
The study highlights that Ketamir-2 not only reduced nerve pain effectively but also outperformed other FDA-approved medications like pregabalin and gabapentin in previous models. Importantly, unlike traditional ketamine, Ketamir-2 avoids causing dissociative or psychedelic effects, making it a strong candidate for a safer, non-addictive treatment option in a field where current therapies often come with significant side effects.
Read Announcement- Drug:
- Ketamir-2
- Announced Date:
- April 1, 2025
- Indication:
- to treat depression and treatment-resistant depression (TRD).
Announcement
MIRA Pharmaceuticals,announced the enrollment of the first subjects in its Phase 1 clinical trial of Ketamir-2, a novel oral ketamine analog in development for the treatment of neuropathic pain.
AI Summary
MIRA Pharmaceuticals has reached a key milestone by enrolling the first subjects in its Phase 1 clinical trial for Ketamir-2, a promising new oral ketamine analog designed to treat neuropathic pain. The study is being carried out at the Clinical Pharmacology Unit of Hadassah Medical Center in Jerusalem, Israel. In this randomized, double-blind, placebo-controlled trial, 56 healthy adult volunteers will be divided into two cohorts—Single Ascending Dose and Multiple Ascending Dose—to evaluate the safety, tolerability, and pharmacokinetics of Ketamir-2.
Early preclinical data suggest that Ketamir-2 may offer improved pain relief compared to current treatments, along with a strong safety profile. If successful, this novel therapy could become a safer, non-addictive alternative for managing neuropathic pain without the dissociative effects often seen with traditional ketamine treatments.
Read Announcement- Drug:
- Ketamir-2
- Announced Date:
- March 4, 2025
- Indication:
- to treat depression and treatment-resistant depression (TRD).
Announcement
MIRA Pharmaceuticals, Inc announced that the Israeli Ministry of Health and the Institutional Review Board (IRB) Phase 1 trial for Ketamir-2, the company's novel oral ketamine analog in development for neuropathic pain.
AI Summary
The Israeli Ministry of Health and the Institutional Review Board (IRB) approved MIRA Pharmaceuticals’ Phase 1 trial for Ketamir-2, the company’s novel oral ketamine analog designed to treat neuropathic pain. This study will evaluate how safe and well-tolerated Ketamir-2 is and examine its pharmacokinetic properties in healthy adult volunteers.
The trial, to be conducted at the Clinical Pharmacology Unit at Hadassah Medical Center in Jerusalem, Israel, will start recruiting subjects in the first quarter of 2025. It comprises two parts—a Single Ascending Dose (SAD) phase with 32 participants and a Multiple Ascending Dose (MAD) phase with 24 participants. The successful completion of this Phase 1 trial is an important milestone for MIRA Pharmaceuticals, setting the stage for future trials involving patients with neuropathic pain.
Read Announcement- Drug:
- Ketamir-2
- Announced Date:
- December 19, 2024
- Indication:
- to treat depression and treatment-resistant depression (TRD).
Announcement
MIRA Pharmaceuticals 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.
AI Summary
MIRA Pharmaceuticals has submitted an Investigational New Drug (IND) application to the FDA for its new drug candidate, Ketamir-2. This novel oral ketamine analog is designed to treat neuropathic pain and promises a better safety profile compared to traditional options. Ketamir-2 works by selectively targeting the NMDA receptor, which helps reduce common side effects like psychotropic effects, sedation, and hyperactivity seen with conventional ketamine therapy. Preclinical studies have shown that Ketamir-2 can fully reverse pain in neuropathic pain models without the risks associated with opioids. This IND submission is a significant step in advancing the drug’s development, and MIRA plans to start Phase I clinical trials soon to assess its safety and effectiveness. The company is committed to bringing innovative and safer therapies to patients with unmet medical needs.
Read Announcement- Drug:
- Ketamir-2
- Announced Date:
- November 20, 2024
- Indication:
- to treat depression and treatment-resistant depression (TRD).
Announcement
MIRA Pharmaceuticals, Inc. 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.
AI Summary
MIRA Pharmaceuticals, Inc. has announced that its Phase I/IIa clinical trial for Ketamir-2, a novel oral ketamine analog, will take place at The Centre for Human Drug Research (CHDR) in Leiden, The Netherlands. This site was selected because of its advanced PainCart® technology, which is capable of measuring pain response—a critical component for evaluating early efficacy. In Phase I, the trial will study healthy subjects through single and multiple ascending dose cohorts to assess safety, tolerability, pharmacokinetics, and pharmacodynamics. Recruitment is set to begin in Q1 2025, with initial safety and efficacy data expected by the later half of 2025. Phase IIa will then target diabetic neuropathy patients, aiming to confirm the drug’s effectiveness in managing pain. This trial design marks an important step in advancing Ketamir-2 and MIRA’s mission to offer new, non-addictive treatment options for pain and depression.
Read Announcement- Drug:
- Ketamir-2
- Announced Date:
- September 27, 2024
- Indication:
- to treat depression and treatment-resistant depression (TRD).
Announcement
MIRA Pharmaceuticals, Inc. announced that new preclinical data on its lead development product, Ketamir-2, will be presented at the 18th Annual Pain Therapeutics Summit, taking place on October 28-29, 2024, in Boston, MA (the "Summit").
AI Summary
MIRA Pharmaceuticals, Inc. announced that it will showcase new preclinical data on its lead product, Ketamir-2, at the 18th Annual Pain Therapeutics Summit. The event is scheduled for October 28-29, 2024, in Boston, MA. During the conference, the company will present findings under the title “Selective NMDA Receptor Modulation: The Superior Efficacy of Ketamir-2 in Neuropathic Pain Treatment.”
The preclinical results reveal that Ketamir-2 achieved a full reversal of neuropathic pain in experimental models. This breakthrough study highlights the potential of Ketamir-2 to offer effective pain relief for patients suffering from chronic neuropathic pain. MIRA’s presentation at the Summit emphasizes its commitment to developing innovative therapies that address significant unmet medical needs in pain management.
Read Announcement- Drug:
- Ketamir-2
- Announced Date:
- August 26, 2024
- Indication:
- to treat depression and treatment-resistant depression (TRD).
Announcement
MIRA Pharmaceuticals, Inc. announce a major breakthrough in the treatment of neuropathic pain.
AI Summary
MIRA Pharmaceuticals recently announced a major breakthrough in the treatment of neuropathic pain. A pre-clinical study in rats showed that their new oral ketamine analog, Ketamir-2, effectively reversed neuropathic pain caused by nerve injury. At lower doses, the drug provided significant relief for up to several weeks, but the highest dose completely normalized pain thresholds—a 100% reversal of the pain signal. This result marks a significant improvement over traditional oral ketamine, which did not show effective pain relief under the same conditions. MIRA is excited about these promising results and plans to conduct further studies to explore Ketamir-2’s applications in neuropathic pain and other related conditions. This breakthrough could lead to a more accessible and effective treatment option for patients suffering from debilitating neuropathic pain.
Read Announcement- Drug:
- Ketamir-2
- Announced Date:
- July 22, 2024
- Indication:
- to treat depression and treatment-resistant depression (TRD).
Announcement
MIRA Pharmaceuticals, Inc. announced new preclinical study results for its novel oral ketamine analog, Ketamir-2.
AI Summary
MIRA Pharmaceuticals, Inc. announced promising new preclinical study results for its novel oral ketamine analog, Ketamir-2. The study shows that Ketamir-2 may offer several benefits over traditional ketamine formulations. Notably, Ketamir-2 is not a substrate for the protein P-glycoprotein (P-gp), which normally pumps drugs out of cells. This quality may help the drug achieve better oral absorption and more effective penetration into the brain, potentially offering faster and more reliable therapeutic effects for various neurological and neuropsychiatric disorders.
The promising data suggest that Ketamir-2 could provide improved safety and effectiveness, possibly requiring lower doses while reducing common side effects seen with traditional ketamine. This innovative oral formulation might also improve patient compliance by eliminating the need for intravenous administration, making it a more convenient treatment option.
Read Announcement
MIRA-55 - FDA Regulatory Timeline and Events
MIRA-55 is a drug developed by MIRA Pharmaceuticals for the following indication: Potential treatment for anxiety and cognitive decline.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- MIRA-55
- Announced Date:
- July 3, 2025
- Indication:
- Potential treatment for anxiety and cognitive decline.
Announcement
MIRA Pharmaceuticals, Inc. announced positive preclinical data demonstrating that Mira-55, the Company's proprietary non-psychotropic marijuana analog, delivered morphine-comparable pain relief in a validated model of inflammatory pain-without causing local inflammation.
AI Summary
MIRA Pharmaceuticals recently announced promising preclinical results for its new compound, Mira-55. In a validated model of inflammatory pain using the formalin test, Mira-55 delivered pain relief comparable to that of morphine. Unlike traditional cannabinoids, this non-psychotropic marijuana analog is engineered to selectively stimulate CB2 receptors, which are linked to anti-inflammatory and analgesic effects, while avoiding the typical effects associated with CB1 activation such as euphoria or sedation. Importantly, the study found that Mira-55 provided effective pain reduction without causing local inflammation. These findings highlight Mira-55’s potential as a non-opioid pain treatment for inflammatory conditions, offering a safer alternative to conventional pain medications. This advancement reinforces the promise of Mira-55 in addressing significant unmet needs in pain management.
Read Announcement- Drug:
- MIRA-55
- Announced Date:
- August 19, 2024
- Indication:
- Potential treatment for anxiety and cognitive decline.
Announcement
MIRA Pharmaceuticals Inc. announced that it is pleased to provide a comprehensive update on its recent achievements and scientific advancements as it nears a crucial milestone
AI Summary
MIRA Pharmaceuticals Inc. recently provided a comprehensive update on its latest achievements and scientific advancements as it approaches a major milestone – submitting its Investigational New Drug (IND) application by the end of the year. The company shared progress in developing its novel oral ketamine analog, Ketamir-2, and detailed improvements in its manufacturing process, safety profile, and efficacy based on recent preclinical studies. These findings suggest that Ketamir-2 could offer a safer, at-home treatment option for mental health disorders.
MIRA also highlighted the strengthening of its leadership with the appointment of Dr. Itzchak Angel as Chief Scientific Advisor. His extensive experience supports the firm’s mission to push innovative drug candidates toward clinical trials, emphasizing the company’s commitment to developing breakthrough therapies for neurological and neuropsychiatric disorders.
Read Announcement- Drug:
- MIRA-55
- Announced Date:
- July 15, 2024
- Indication:
- Potential treatment for anxiety and cognitive decline.
Announcement
MIRA Pharmaceuticals, Inc announced promising new findings from recent preclinical studies of its novel oral pharmaceutical marijuana analog, MIRA-55, which is being studied as a potential treatment for anxiety and cognitive decline..
AI Summary
MIRA Pharmaceuticals, Inc. announced positive new preclinical results for its oral marijuana analog, MIRA-55. The studies indicate that MIRA-55 may be a promising treatment for anxiety and cognitive decline. In direct comparisons with THC—the main psychoactive ingredient in marijuana—MIRA-55 showed higher efficacy at both the CB1 and CB2 cannabinoid receptors, demonstrating a stronger and sustained agonist effect as the dosage increases. These findings suggest that MIRA-55 might offer more reliable relief from anxiety as well as improved cognitive functions.
Preclinical tests, including in vitro experiments and mouse models, also revealed MIRA-55’s consistent dose-dependent reduction in anxiety-like behaviors. Maintaining a stable balance of receptor activity even at higher doses, MIRA-55 has shown potential to outperform THC in delivering prolonged therapeutic benefits, making it a noteworthy candidate for further development in treating neurological and neuropsychiatric disorders.
Read Announcement
SKNY-1 - FDA Regulatory Timeline and Events
SKNY-1 is a drug developed by MIRA Pharmaceuticals for the following indication: For Obesity.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- SKNY-1
- Announced Date:
- July 11, 2025
- Indication:
- For Obesity
Announcement
MIRA Pharmaceuticals, Inc. announced new preclinical results from SKNY-1, an oral drug candidate for obesity and nicotine addiction currently under definitive agreement for acquisition.
AI Summary
MIRA Pharmaceuticals, Inc. announced promising new preclinical results for SKNY-1, an oral drug candidate aimed at treating obesity and nicotine addiction. The candidate, currently under a definitive acquisition agreement, has shown the ability to reverse anxiety-related behaviors in animal models while targeting the Cannabinoid 1 (CB1) receptor. In a zebrafish behavioral study, SKNY-1 was able to counteract the anxiety effects induced by a CB1 activator, a significant benefit compared to earlier drugs in this category that were halted due to central nervous system side effects.
Previously, SKNY-1 demonstrated up to 30% weight loss, reduced high-calorie food and nicotine cravings, and preserved muscle mass in preclinical studies. These encouraging results suggest it may offer a new approach to managing obesity and addiction without causing mood or behavioral problems.
Read Announcement
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