First Patients Receive IV Selonabant for Acute Cannabinoid-Induced Toxicity in Phase 1 Trial

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Anebulo Pharmaceuticals announced that patients have begun receiving intravenous (IV) selonabant in the phase 1 singe ascending dose study investigating the drug for acute cannabis-induced toxicity.¹ The IV formulation of selonabant is being developed as a potential treatment for pediatric patients with acute cannabis-induced toxicity.

The phase 1 clinical trial is a randomized, double-blind, placebo-controlled, single ascending dose study of IV administration of selonabant. Healthy adult participants aged 18 to 25 will receive the drug, testing safety, tolerability, and pharmacokinetics. The study receives funding support from the National Institute on Drug Abuse and the National Institutes of Health.

Selonabant is a CB1 receptor competitive agonist; CB1 is the primary receptor implicated in the psychotropic effects of cannabis. The receptor is believed to be related to feelings of being high, anxiety, and impaired motor function with consumption of tetrahydrocannabinol (THC).

The chief executive officer of Anebulo Pharmaceuticals, Richie Cunningham, emphasized the potential use of this medication for children, stating, “in particular, acute cannabis exposure in children can result in serious and potentially life-threatening consequences, including CNS depression, respiratory depression, coma, and in rare cases death. Research has shown that children are much more sensitive to the toxic effects of cannabis, due in part to age-related differences in the abundance and distribution of cannabis receptors in their brains. As a consequence, cannabis ingestion in children can result in much more serious outcomes than in adults, and a much greater risk of hospitalization and admission to intensive care.”

Selonabant was previously investigated as an oral treatment in a prior phase 2 trial by Anebulo, which showed the medication had potential to block and reverse negative effects of acute cannabinoid intoxication. The previous study used this oral administration in healthy adults to test effects of the drug against tetrahydrocannabinol.² A single dose of selonabant was found to almost completely block typical subjective effects of THC, like the feeling of being high and altered alertness.² The drug effectively blocked THC effects across the dose range tested in this previous oral administration study. The study found that selonabant was generally safe, with no serious adverse events. Adverse effects of nausea, vomiting, and hyperhidrosis were the most common; they were dose-dependent and not present at the efficacious but lower dose of 10 mg.

Cunningham also said of the trial, “this important milestone brings Anebulo closer to its goal of providing the first emergency antidote for acute cannabis-induced toxicity.” He added that “our interactions with the Food and Drug Administration have confirmed our belief that there is a significant and growing unmet need for a treatment for children exposed to cannabis toxicity. FDA has suggested a close collaboration with Anebulo to facilitate development of selonabant for this important pediatric condition. If approved, we believe selonabant has the potential to offer a much-needed targeted therapy for rapidly reversing the serious and life-threatening consequences of acute cannabis-induced toxicity in children.” The phase 1 study is currently ongoing.

References

1. Anebulo Pharmaceuticals announces first patients dosed in phase 1 single ascending dose study of intravenous selonabant, under development for acute cannabis-induced toxicity. Press release. September 25, 2025. Accessed September 25, 2025. https://www.benzinga.com/pressreleases/25/09/b47861587/anebulo-pharmaceuticals-announces-first-patients-dosed-in-phase-1-single-ascending-dose-study-of-i

2. Gorbenko AA, Heuberger JAAC, Juachon M, et al. CB₁ Receptor antagonist selonabant (ANEB-001) blocks acute THC effects in healthy volunteers: a phase II randomized controlled trial. Clin Pharmacol Ther. 2025;117(5):1427-1436.