Argent BioPharma has reached an early regulatory milestone for its CannEpil veterinary program, with the US Food and Drug Administration’s Center for Veterinary Medicine establishing an Investigational New Animal Drug (INAD) file for the cannabinoid formulation.
The file, numbered 14145, creates a formal pathway for discussions with the FDA’s veterinary medicines regulator as the program moves through product planning, manufacturing work, and the preclinical and clinical studies needed to support a future approval application.
CannEpil was originally developed for people with drug-resistant epilepsy. Argent is now seeking to extend the product’s potential commercial reach through a veterinary program focused initially on cancer-related pain in companion animals, beginning with dogs undergoing oncology treatment.
The development program is intended to advance through the FDA’s Minor Use and Minor Species and conditional approval pathways, subject to continued regulatory engagement and the completion of required studies.
Argent’s global CannEpil licensing partner, Endovia Health Sciences, formerly Splash Beverage Group, is advancing the veterinary strategy with Lupvindol Biosciences, which will lead the scientific, pharmaceutical development and regulatory work in the United States.
Chairman Roby Zomer said the INAD file marked the program’s transition from a commercial agreement into formal engagement with the FDA’s veterinary medicines division.
He said the company had recently expanded CannEpil’s licence into veterinary healthcare, appointed a specialist development partner and now secured a formal investigational regulatory file. While substantial work remained, he said the development created a potential additional value stream from an asset initially developed for human epilepsy.
CannEpil is a standardised oral liquid formulation containing cannabidiol and tetrahydrocannabinol isolates and manufactured under European Union good manufacturing practice standards.
