Endovia Health Sciences Receives FDA Minor Use Determination for CannEpil® to Treat Pain in Dogs with Bone Cancer

Endovia Health Sciences, Inc. (NYSE American: EDVA) announced on October 5, 2026, that the U.S. Food and Drug Administration (FDA) has granted a minor use designation for CannEpil®, an investigational oral solution containing cannabidiol (CBD) and tetrahydrocannabinol (THC). This determination allows the company to pursue conditional approval for CannEpil® aimed at alleviating pain associated with bone cancer in dogs under the Minor Use and Minor Species (MUMS) program.

The FDA's decision enables Endovia Health Sciences and its collaborator, Lupvindol BioSciences, to take the next steps in their regulatory journey. According to the FDA, the minor-use designation will remain in effect as they prepare their New Animal Drug Application (NADA).

The MUMS program is designed to expedite drug availability for rare conditions in animals. Conditional approval through this pathway necessitates conformity with FDA safety standards and a reasonable expectation of efficacy, allowing further data on effectiveness to be gathered after the initial approval.

Endovia and Lupvindol plan to meet with the FDA on November 19, 2026, for a Pre-Submission Conference to discuss the CannEpil® development program, including requisite studies and regulatory submissions for conditional approval. Concurrently, the companies are working on establishing U.S.-based manufacturing capabilities for CannEpil® to support its clinical program and a potential commercial launch in 2027, contingent on receiving necessary regulatory approvals.

Brady Cobb, Interim CEO of Endovia Health Sciences, highlighted the significance of the FDA determination as a regulatory milestone and emphasized that preparations for commercialization are already underway. He stated that they are committed to advancing their FDA development program while establishing the manufacturing and supply networks needed for a possible veterinary launch.

CannEpil® is still considered an investigational new animal drug and has not yet received FDA approval for veterinary use. The timeline for potential commercial availability in 2027 depends on the successful completion of regulatory requirements, manufacturing readiness, and other factors.

Endovia Health Sciences aims to create cannabinoid-based therapeutics through established regulatory avenues, addressing unmet veterinary needs while building a foundation for future human therapeutic applications as well.

Lupvindol BioSciences, led by Dr. Hunter Land, brings expertise in cannabinoid therapeutics and FDA processes, having been involved in the development of notable products such as Epidiolex® and Sativex®.