- Splash Beverage Group has expanded its exclusive global CannEpil® license to include veterinary therapeutic applications.
- The expanded agreement gives the company worldwide rights to develop, manufacture, market, and commercialize CannEpil for veterinary diseases and conditions.
- Splash plans to initially focus on companion animal oncology and chronic pain, with canine indications expected to lead development.
- The company intends to pursue U.S. regulatory approval through the FDA Center for Veterinary Medicine’s Investigational New Animal Drug (INAD) and Conditional Approval pathways.
- Splash will pay Argent BioPharma a 10% royalty on net revenue generated from veterinary applications and is finalizing a joint venture to lead the veterinary development program.
Splash Beverage Group has expanded its exclusive global license for CannEpil® to include veterinary therapeutic applications, creating a second regulated pharmaceutical development program in addition to its existing human pharmaceutical program.
The amended agreement grants Splash worldwide rights to develop, manufacture, commercialize, market, and distribute CannEpil for veterinary diseases and conditions.
CannEpil is a pharmaceutical-grade oral cannabinoid formulation containing cannabidiol (CBD) and tetrahydrocannabinol (THC) isolates manufactured under European Union Good Manufacturing Practice (EU-GMP) standards. The product was originally developed as a potential treatment for drug-resistant epilepsy and has been supplied through physician-directed access programs in international markets. For its human development program, CannEpil has also been assigned an Investigational New Drug (IND) application number by the U.S. Food and Drug Administration.
Initial focus on companion animal oncology and pain
Splash said it intends to initially evaluate CannEpil for companion animal oncology and chronic pain, with canine indications expected to be the first area of development.
The company plans to pursue regulatory approval through the FDA Center for Veterinary Medicine using the Investigational New Animal Drug (INAD) and Conditional Approval pathways.
According to market data cited by the company, the global veterinary pain management market was valued at approximately $2.6 billion in 2024 and is projected to reach approximately $3.8 billion by 2030. Splash also cited industry estimates placing the global veterinary oncology market between approximately $900 million and $1.7 billion.
The company also referenced data from the Veterinary Cancer Society indicating that one in four dogs will develop cancer during their lifetime, while approximately half of dogs over the age of 10 will develop cancer.
Development partnership planned
Under the amended licensing agreement, Splash will pay Argent BioPharma Limited a 10% royalty on net revenue generated from veterinary applications of CannEpil.
The company also announced it is finalizing a strategic joint venture with an established cannabinoid pharmaceutical company to lead the veterinary development program and expects to provide additional details in the near future.
Splash noted that development timelines, target indications, clinical requirements, and regulatory pathways will be determined following discussions with the FDA and other regulatory authorities. The company also stated there is no assurance CannEpil will receive regulatory approval or be successfully commercialized for veterinary use.
Information sourced from the company’s press release.
