New Preclinical Data on ART12.11 for the Treatment of Mood and Anxiety Disorders

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Artelo Biosciences today announced the publication of new preclinical data on ART12.11, its proprietary cannabidiol:tetramethylpyrazine (CBD:TMP) cocrystal. ART12.11 significantly outperformed cannabidiol (CBD) alone in reducing stress-induced depression and anxiety symptoms, and also achieved superior oral bioavailability.^1,2

“In our recent study, we found that ART12.11 produced promising anti-depressant- and anti-anxiety-like effects. Our results suggest that ART12.11 works by selectively influencing serotonergic activity and endocannabinoid signaling—key pathways in mood regulation—while leaving other systems largely unaffected. This selectivity may help maximize therapeutic benefits while minimizing side effects,” said Matt Jones, the lead researcher of the study at the University of Western Ontario.

Investigators found that ART12.11 reversed stress-induced behavioral deficits and produced robust antidepressant and anxiolytic-like effects. These benefits were superior to CBD alone, TMP alone, or a noncrystalline mixture of CBD and TMP. Additionally, oral administration of ART12.11 resulted in higher plasma concentrations of CBD and its major metabolite, highlighting that ART12.11 has improved pharmacokinetic properties over conventional CBD formulations. ART12.11 also enhanced activation of the endocannabinoid and serotonergic systems in critical brain regions for mood regulation, such as the prefrontal cortex, ventral hippocampus, and nucleus accumbens. The peer-reviewed study, which was conducted in collaboration with researchers at Western Ontario University, was published in Progress in Neuro-Psychopharmacology and Biological Psychiatry.

According to these results ART12.11 could be posed to fill the market gaps for mood and anxiety disorders, as conventional CBD, due to its inconsistent efficacy and poor bioavailability, has had limited clinical adoption. By addressing these shortcomings, ART12.11 may represent a significant advancement in cannabinoid-based therapeutics for anxiety and depression disorders.

“Collectively, our findings indicate that ART12.11 may offer significant advantages over delivering CBD by more traditional approaches in the treatment of mood and anxiety disorders,” wrote study authors.²

The UK regulatory authority Medicines and Healthcare products Regulatory Agency (MHRA) has agreed that Artelo may rely on the substantial body and sufficient nonclinical and clinical evidence for CBD and may leverage the legacy data for TMP, which could provide a scientifically justified basis for its clinical trial application. Additionally, guidance from the MHRA will help in streamlining the nonclinical development plan for ART12.11, which should reduce costs and enable rapid advancement towards the proposed first human ART12.11 study planned for 2026.

“We are pleased to see the publication of this important work demonstrating the impact of our oral ART12.11 CBD cocrystal in stress-induced anxiety and depression. ART12.11’s ability to improve stress-induced symptoms was not seen with CBD alone, the cocrystal coformer alone, or coadministration of CBD and the cocrystal conformer TMP. This shows the uniqueness of ART12.11,” said Saoirse E. O'Sullivan, vice president of translational sciences at Artelo.

References

1. Artelo Biosciences announces publication of preclinical data demonstrating superior efficacy and bioavailability of ART12.11 in reducing stress-induced depression and anxiety symptoms. News release. September 10, 2025. Accessed September 10, 2025. https://www.globenewswire.com/news-release/2025/09/10/3147737/0/en/Artelo-Biosciences-Announces-Publication-of-Preclinical-Data-Demonstrating-Superior-Efficacy-and-Bioavailability-of-ART12-11-in-Reducing-Stress-Induced-Depression-and-Anxiety-Sympt.html

2. Jones MJ, Uzuneser TC, O’Sullivan SE, et al. A novel cannabidiol:tetramethylpyrazine cocrystal (CBD:TMP, ART12.11) improves the efficacy and bioavailability of cannabidiol in reducing stress-induced depressive and anxiety symptoms. Prog Neuropsychopharmacol Biol Psychiatry. 2025:141:111478.