MIRA Pharmaceuticals Completes Exploratory Toxicology Dosing for MIRA-55 and SKNY-1, Advancing Preclinical Programs Toward IND-Enabling Design

MIRA Pharmaceuticals, Inc. (NASDAQ: MIRA), a clinical-stage pharmaceutical company developing oral small-molecule therapeutics for neurologic, inflammatory, metabolic, and neuropsychiatric disorders, announced on July 30, 2026 that both MIRA-55, its cannabinoid analog targeting chronic inflammatory pain, and SKNY-1, its oral CB1 receptor modulator for obesity and addiction, have completed the dosing and necropsy phases of exploratory non-GLP toxicology studies. Analysis of collected samples is ongoing and CMC work continues. The results will inform the design of future IND-enabling studies for each program. The announcement consolidates a rapid series of preclinical milestones across both programs and arrives as the company’s lead asset Ketamir-2 awaits FDA feedback on its Phase 2a protocol for chemotherapy-induced peripheral neuropathy.

MIRA-55 Builds a Differentiated Pain Profile Across Multiple Preclinical Studies

MIRA-55 has now generated a multi-layered preclinical dataset across efficacy, mechanism, and formulation. In March 2026, the company reported that MIRA-55 produced no THC-like or rimonabant-associated CNS side effects across a battery of validated behavioral assays, and delivered morphine-comparable pain relief in a validated inflammatory pain model without opioid-related risks. In June 2026, new mechanistic data confirmed that MIRA-55 engages cannabinoid receptors differently from THC and produces an anxiolytic effect that THC does not. In July 2026, optimized oral formulation studies showed favorable bioavailability and brain-liver distribution. Taken together, these three rounds of data build a pharmacological profile that differs from both opioids and THC, targeting the large and underserved chronic inflammatory pain market with a non-scheduled oral candidate. All data remain preclinical and need further validation in translational and toxicology studies before IND submission.

SKNY-1 Targets Obesity and Addiction With a Purpose-Built Oral Profile

SKNY-1 is a novel oral small-molecule CB1 receptor modulator designed to sidestep the liabilities of prior CB1 antagonists. The FDA withdrew rimonabant, the only CB1 antagonist to reach clinical approval, in 2009 following serious psychiatric adverse events including depression and suicidality. MIRA engineered SKNY-1 to avoid those CNS-related effects while retaining the metabolic and anti-addictive activity of CB1 modulation, and to sidestep the muscle loss associated with some GLP-1 injectable therapies. July 6 formulation results confirmed favorable oral bioavailability, robust brain penetration, and substantial liver exposure with once-daily dosing potential in preclinical models. MIRA has now completed the dosing and necropsy phases of SKNY-1’s exploratory toxicology study, with sample analysis ongoing. Those results, alongside continuing CMC work, will shape the design of formal IND-enabling toxicology studies ahead of a planned IND submission. If MIRA-55 and SKNY-1 both reach IND-enabling status by year-end as targeted, MIRA will run three active INDs in parallel across pain, neuropathy, and metabolic disease.

Ketamir-2 Phase 2a Awaits FDA Feedback as the Pipeline’s Clinical Anchor

While MIRA-55 and SKNY-1 advance through preclinical development, Ketamir-2 anchors the portfolio at the clinical stage. The company completed Phase 1 dosing in March 2026 and submitted the Phase 2a protocol to the FDA in June 2026, targeting patients with moderate to severe chemotherapy-induced peripheral neuropathy (CIPN). Phase 1 data are scheduled for presentation at a scientific conference later in 2026. MIRA secured worldwide exclusive rights to the Ketamir-2 IP in May 2026 and the June 2026 acquisition of worldwide exclusive rights to MIRA-55 and SKNY-1, putting all three programs on a firm proprietary footing ahead of IND and Phase 2 filing activities. The company’s cash position and near-term capital needs remain key variables for investors to monitor as all three programs approach inflection points simultaneously.

Strategic Investment Summary

• IND-Enabling Progress: MIRA Pharmaceuticals (NASDAQ: MIRA) announced on July 30, 2026 that both MIRA-55 and SKNY-1 have completed the dosing and necropsy phases of exploratory non-GLP toxicology studies; sample analysis is ongoing and CMC work continues, with results intended to inform the design of future IND-enabling studies.
• MIRA-55 Data Package: Three rounds of preclinical data published since March 2026 establish MIRA-55’s differentiated profile: morphine-comparable pain relief without opioid risks, no THC-like CNS side effects, a novel anxiolytic effect, and favorable oral bioavailability with brain-liver distribution.
• SKNY-1 Formulation: July 6 preclinical data confirmed favorable oral bioavailability, robust brain penetration, and substantial liver exposure with once-daily dosing potential, supporting SKNY-1’s advancement into IND-enabling toxicology studies for obesity and addiction.
• Ketamir-2 Phase 2a: MIRA submitted the Phase 2a protocol for Ketamir-2 in chemotherapy-induced peripheral neuropathy to the FDA in June 2026 following Phase 1 completion; FDA feedback is pending and Phase 1 data are scheduled for scientific presentation later in 2026.
• IP Rights Secured: MIRA secured worldwide exclusive rights to Ketamir-2 in May 2026 and to MIRA-55 and SKNY-1 in June 2026, placing all three programs on a firm proprietary footing ahead of IND and Phase 2 filing activities.
• Early-Stage Risk: All MIRA-55 and SKNY-1 data are preclinical; both programs require IND-enabling toxicology, regulatory clearance, and clinical validation before any clinical conclusions can be drawn, and the company’s capital position warrants monitoring as three programs approach simultaneous inflection points.

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