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MIRA Pharmaceuticals, Inc. develops oral small-molecule therapeutics for neurologic, neuropsychiatric, metabolic and inflammatory disorders. Recurring company news centers on Ketamir-2, a selective oral NMDA receptor modulator studied for neuropathic pain, including chemotherapy-induced peripheral neuropathy, and on clinical safety, tolerability and pharmacokinetic findings from Phase 1 testing.
Updates also cover Mira-55, a cannabinoid analog designed to modulate CB1 and CB2 receptor activity while limiting central nervous system side effects, with preclinical work in inflammatory pain. Following the completed acquisition of SKNY Pharmaceuticals, MIRA’s pipeline also includes SKNY-1 for obesity and nicotine addiction. Company announcements additionally address shareholder voting matters, operating and financial results, capital actions and other corporate developments.
MIRA Pharmaceuticals (NASDAQ:MIRA) has revealed promising new in vitro preclinical data for SKNY-1, a novel drug candidate pending acquisition through SKNY Pharmaceuticals. The oral therapy targets both weight loss and smoking cessation markets through a dual-receptor strategy.
SKNY-1 functions as a biased CB1 modulator and partial CB2 agonist, designed to avoid the psychiatric side effects that led to the withdrawal of previous cannabinoid-based therapies. The drug selectively blocks β-arrestin signaling while preserving G-protein signaling, potentially enabling weight reduction and decreased cravings without mood disruption.
The compound also features mild MAO-B inhibition for dopamine regulation, positioning it as a differentiated alternative to injectable GLP-1 drugs. The global obesity drug market is projected to exceed $150 billion by 2030, while the U.S. smoking cessation market is expected to grow from $28 billion in 2024 to over $50 billion by decade's end.
MIRA Pharmaceuticals (NASDAQ:MIRA) has announced positive in vitro release testing (IVRT) results for its topical Ketamir-2 formulation, targeting the $11.5B U.S. topical pain relief market. The 5% ointment formulation demonstrated consistent and dose-proportional release in Franz diffusion cell model testing.
The company is advancing preclinical studies to evaluate the topical formulation for inflammatory and neuropathic pain conditions. The development aims to address chronic pain affecting 51.6 million U.S. adults, including osteoarthritis (32.5 million adults) and diabetic peripheral neuropathy (28% of diabetic adults).
MIRA is exploring FDA Fast Track designation possibilities and is simultaneously conducting a Phase 1 clinical trial of oral Ketamir-2 in healthy volunteers, with plans for a Phase 2a study in diabetic neuropathy.
MIRA Pharmaceuticals (NASDAQ:MIRA) has announced positive results for its oral ketamine analog Ketamir-2 in a diabetic neuropathy animal model. The study demonstrated significant reduction in neuropathic pain symptoms, with some subjects achieving complete reversal to pre-diabetic baseline sensitivity.
The company is currently conducting a Phase I clinical trial at Hadassah Medical Center, with completion expected in Q4 2025. MIRA plans to initiate a Phase IIa trial in diabetic neuropathy patients by year-end, with first human efficacy data expected in H1 2026.
Ketamir-2 has shown superior performance compared to FDA-approved medications like pregabalin and gabapentin in preclinical studies. Unlike traditional ketamine, it doesn't cause dissociative effects and offers better blood-brain barrier penetration. The company is also developing a topical slow-release formulation and exploring applications for PTSD treatment.
MIRA Pharmaceuticals (NASDAQ:MIRA) has initiated its Phase 1 clinical trial of Ketamir-2, enrolling the first subjects at Hadassah Medical Center in Jerusalem. The trial will evaluate this novel oral ketamine analog for neuropathic pain treatment across 56 subjects in Single and Multiple Ascending Dose cohorts.
Preclinical data showed Ketamir-2's superior efficacy compared to pregabalin and gabapentin, with strong safety profile and oral bioavailability, without ketamine's typical dissociative effects. The Phase 1 study is expected to complete by Q4 2025, followed by a Phase 2a trial in diabetic neuropathic pain patients.
MIRA is also developing a topical Ketamir-2 formulation and advancing the acquisition of SKNY Pharmaceuticals, which includes a $5 million capital infusion. The acquisition brings SKNY-1, a non-GLP-1 oral therapy for weight loss and smoking cessation, into MIRA's pipeline.
MIRA Pharmaceuticals (NASDAQ:MIRA) has signed a binding letter of intent to acquire SKNY Pharmaceuticals, securing a $5 million capital infusion. The acquisition includes SKNY-1, a preclinical-stage oral drug candidate targeting weight loss and smoking cessation.
The transaction will be executed through a stock exchange, with SKNY shareholders receiving MIRA common stock at a valuation determined by an independent third-party firm. The deal positions MIRA in two significant markets: the weight loss drug market, projected to exceed $150 billion by early 2030s, and the smoking cessation market, expected to reach $51 billion by 2030.
SKNY-1 is being developed to interact with cannabinoid receptors CB1 and CB2 pathways for appetite, metabolism, and energy balance regulation. The drug aims to address limitations of current treatments, including severe side effects and the need for lifelong injections in existing weight loss medications.
The transaction is subject to a 90-day due diligence period, regulatory approvals, and board approvals.
MIRA Pharmaceuticals (NASDAQ:MIRA) has successfully developed a topical formulation of Ketamir-2 for localized neuropathic and inflammatory pain treatment, expanding beyond its existing oral formulation. The topical treatment is designed for slow release, providing targeted pain relief while minimizing systemic exposure and side effects.
The new formulation targets multiple conditions including:
- Neuropathic pain conditions (diabetic neuropathy, postherpetic neuralgia)
- Inflammatory pain conditions (osteoarthritis, rheumatoid arthritis)
- Nerve compression & musculoskeletal pain
MIRA's clinical progress includes:
- Ongoing Phase 1 trial for oral Ketamir-2
- Preclinical PTSD studies
- Planned Phase 2a study for diabetic neuropathy by year-end
- Animal study for topical Ketamir-2
- MIRA-55 preclinical studies for memory enhancement