AUSTIN, Texas – Anebulo Pharmaceuticals, Inc. (NASDAQ: ANEB), a clinical-stage biopharmaceutical company, has announced a significant milestone in its drug development program, dosing the first subjects in a Phase 1 single ascending dose (SAD) study of its investigational intravenous (IV) treatment, selonabant. This crucial trial, conducted in healthy young adults, is supported by a collaborative grant from the National Institute on Drug Abuse (NIDA), part of the National Institutes of Health (NIH). The commencement of this study marks a key step towards developing a potential emergency antidote for acute cannabis-induced toxicities.
Advancing the Phase 1 Trial for IV Selonabant
The Phase 1 study is designed to rigorously evaluate the safety, tolerability, and pharmacokinetics of intravenous selonabant in healthy adult volunteers. This foundational research is vital for understanding how the drug behaves in the body before it can be considered for therapeutic use in patients experiencing cannabis toxicity. The company’s announcement on September 25, 2025, positions this trial as a critical advancement in its mission.
The Science Behind Selonabant: A CB1 Receptor Antagonist
Selonabant, also known by its developmental code ANEB-001, is a potent, small molecule antagonist of the cannabinoid type 1 (CB1) receptor. The CB1 receptor plays a primary role in mediating the psychotropic effects of cannabis, particularly those induced by THC (Δ⁹-tetrahydrocannabinol). By blocking these receptors, selonabant aims to counteract the adverse and potentially dangerous effects of acute cannabinoid intoxication (ACI). Previous research, including a Phase 2 randomized controlled trial, demonstrated that oral formulations of selonabant could significantly reduce the subjective feeling of being “high” and increase “alertness” in healthy adults exposed to THC. This prior success provides a strong rationale for advancing the development of this compound.
Addressing a Critical Unmet Need: Pediatric Cannabis Toxicity
While the current Phase 1 study involves healthy adults, Anebulo Pharmaceuticals has prioritized the development of an IV formulation of selonabant as a potential treatment for pediatric patients suffering from acute cannabis-induced toxicity. This focus stems from the understanding that children are particularly vulnerable to the toxic effects of cannabis due to their developing endocannabinoid systems. Incidents of accidental pediatric cannabis ingestion can lead to severe outcomes, including central nervous system (CNS) depression, respiratory depression, coma, and in rare cases, death, often requiring hospitalization and intensive care. The company believes that addressing this urgent medical need, especially in children, may offer a more streamlined path to regulatory approval compared to an adult oral treatment.
NIDA Grant Provides Crucial Support
The development of intravenous selonabant is significantly supported by a cooperative grant from NIDA. This grant, potentially totaling approximately $1.9 million over two years, with an initial tranche of $0.9 million and subsequent milestone-based funding, underscores the scientific merit and clinical importance of Anebulo’s work. Ken Cundy, Chief Scientific Officer at Anebulo, expressed gratitude for the funding, highlighting it as validation of the urgent need for an antidote to cannabis toxicity. The second year of funding, amounting to $994,300, further solidifies this partnership.
Financial Health and Strategic Outlook
Anebulo Pharmaceuticals maintains a strong financial position, characterized by significant cash reserves exceeding debt obligations and a debt-to-equity ratio of zero. The company’s market capitalization hovers around $100 million, and its stock has experienced notable gains and volatility in recent periods. While the company is currently operating at a loss, analysts anticipate continued negative earnings this year. Alongside its drug development efforts, Anebulo is also exploring strategic alternatives, including a potential going-private transaction, indicating a dynamic corporate landscape.
A Glimpse into the Future of Cannabis Toxicity Treatment
The initiation of the Phase 1 IV selonabant study represents a pivotal moment for Anebulo Pharmaceuticals and offers a beacon of hope for managing acute cannabis toxicity. As this research progresses, it could pave the way for a much-needed emergency treatment, particularly for vulnerable pediatric populations, marking a significant development in the evolving landscape of cannabis-related health news. This ongoing news in pharmaceutical research highlights the trending interest in understanding and treating the side effects of cannabis use.
