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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) reported positive preclinical results for optimized oral formulations of MIRA-55, its non-opioid candidate for chronic inflammatory pain. A lead oral formulation was selected after comparison with an intravenous reference, demonstrating favorable oral bioavailability, sustained systemic exposure, and reproducible distribution to brain and liver tissue.
According to MIRA, brain and peripheral tissue exposure supports MIRA-55’s proposed central and anti-inflammatory mechanisms. Prior preclinical studies showed oral MIRA-55 normalized pain and reduced inflammation in a validated model, outperforming injected morphine, with a differentiated pharmacological profile and anxiolytic activity distinct from THC. The company plans further preclinical development.
MIRA Pharmaceuticals (NASDAQ:MIRA) reported positive preclinical results for SKNY-1, its oral drug candidate for obesity and addiction-related disorders. The optimized formulation showed favorable oral bioavailability, reproducible systemic exposure, robust brain penetration and substantial liver exposure, with peak plasma levels at 6–12 hours, supporting potential once-daily oral dosing.
SKNY-1 combines biased CB1 modulation, partial CB2 agonism and selective MAO-B inhibition, and has shown significant preclinical effects on body weight, lean mass, lipid parameters and addiction-related behaviors.
MIRA Pharmaceuticals (NASDAQ:MIRA) reported new preclinical data for Mira-55, its cannabinoid analog for chronic inflammatory pain. Results show Mira-55 engages cannabinoid receptors via a mechanism distinct from THC, avoids THC-like CNS effects, and demonstrates anxiolytic (anxiety-reducing) activity that THC does not produce.
Mira-55 previously delivered morphine-comparable pain relief without opioid-related risks, supporting advancement toward IND-enabling studies in chronic inflammatory pain.
MIRA Pharmaceuticals (NASDAQ:MIRA) submitted a Phase 2a clinical trial protocol to the FDA for Ketamir-2, an oral NMDA receptor modulator, to treat chemotherapy-induced peripheral neuropathy (CIPN). The randomized, double-blind, placebo-controlled study will assess safety, tolerability, and dose-response efficacy at a leading U.S. cancer center.
CIPN affects an estimated 30–40% of patients receiving neurotoxic chemotherapy and about 3 million new persistent cases annually worldwide. Symptoms often persist beyond treatment, and there are currently no FDA-approved therapies specifically for CIPN, leaving oncologists to use repurposed drugs with often incomplete relief.
MIRA Pharmaceuticals (NASDAQ:MIRA) executed an Amended and Restated Exclusive License Agreement with MIRALOGX, granting worldwide exclusive rights to MIRA-55 and SKNY-1.
The deal consolidates global development, commercialization, sublicensing, and IP enforcement across MIRA’s pipeline, including Ketamir-2, without materially changing core economic terms.
MIRA Pharmaceuticals (NASDAQ:MIRA) amended its Ketamir-2 license, expanding from North America to worldwide rights wherever patent protection exists.
The updated portfolio now includes the US, Europe, China, Japan, Canada, Australia, India, Israel, Mexico, and South Korea.
Ketamir-2, an oral NMDA modulator, showed favorable Phase 1 safety in 56 volunteers and is progressing toward planned Phase 2a in chemotherapy-induced peripheral neuropathy (CIPN) under an active FDA IND.
MIRA (NASDAQ:MIRA) reported positive unblinded Phase 1 data for Ketamir-2, an oral selective NMDA receptor modulator. The randomized, double-blind, placebo-controlled SAD/MAD trial enrolled 57 healthy volunteers with no withdrawals or serious adverse events.
Adverse events were mostly mild and occurred more often on placebo. Pharmacokinetics showed rapid absorption, dose-proportional Cmax, and half-lives supporting potential once-daily dosing, subject to further evaluation. MIRA plans a Phase 2a proof-of-concept study in chemotherapy-induced peripheral neuropathy, a condition with no FDA-approved therapies and a market projected at $1.7 billion by 2035.
MIRA Pharmaceuticals (NASDAQ:MIRA) announced acceptance of a peer-reviewed manuscript on SKNY-1, its oral investigational candidate for obesity and nicotine addiction, in the International Journal of Molecular Sciences.
The zebrafish preclinical data show dose‑dependent weight loss of about 30%, improved lipid markers, and reduced compulsive feeding and nicotine-seeking, while additional mammalian and safety studies are still required.
MIRA (NASDAQ:MIRA) reported preclinical data showing Mira-55 produced morphine-comparable analgesia in a validated inflammatory pain model and did not produce THC- or rimonabant-like CNS side effects across behavioral assays at oral doses up to 100 mg/kg.
Findings support advancement toward IND-enabling studies for inflammatory pain and show a dose-dependent increase in open-arm time on the Elevated Plus Maze, without sedation, catalepsy, or motor impairment.
MIRA (NASDAQ:MIRA) completed dosing in its Phase 1 study of Ketamir-2 on March 4, 2026, enrolling 56 healthy volunteers across SAD and MAD cohorts. No serious adverse events or dose-limiting toxicities were reported, and no clinically significant dissociative effects were observed.
Database lock, unblinding, and final audited pharmacokinetic and safety analyses are underway, and Phase 1 data are accepted for AACR presentation. MIRA aims to file a Phase 2a protocol to the FDA under its active IND in H1 2026 targeting chemotherapy-induced peripheral neuropathy.