Center for Veterinary Medicine has determined that the proposed use of CannEpil®, an investigational cannabidiol ("CBD") and tetrahydrocannabinol ("THC") oral solution, for the control of pain associated with bone cancer in dogs qualifies as a "minor use" under the Minor Use and Minor Species ("MUMS") program.
The FDA determination establishes CannEpil’s eligibility to pursue the conditional approval pathway for this proposed indication. The FDA further determined that the minor-use status will be maintained through approval of the applicable New Animal Drug Application ("NADA").
Under the MUMS framework, qualifying new animal drugs may be eligible for conditional approval which is a regulatory pathway designed to facilitate earlier availability of therapies for uncommon diseases and conditions in animals. Conditional approval requires satisfaction of applicable FDA requirements, including safety and manufacturing standards and a reasonable expectation of effectiveness, while allowing additional effectiveness data required for full approval to be collected following conditional approval.
Endovia and Lupvindol are scheduled to meet formally with the FDA on November 19, 2026, for a Pre-Submission Conference to discuss and align with the FDA on the proposed CannEpil® development program, including the studies, manufacturing requirements and regulatory submissions necessary to pursue conditional approval.
In parallel with the regulatory program, Endovia and Lupvindol are actively sourcing and finalizing U.S.-based manufacturing capabilities for CannEpil®. This work is intended to establish a scalable, FDA-compliant domestic supply chain capable of supporting the clinical and regulatory program and, subject to receipt of the necessary regulatory approvals, a potential commercial launch for veterinary use in 2027.
"This determination represents an important regulatory milestone for CannEpil® and provides greater clarity around the pathway we are pursuing with the FDA," said Brady Cobb, Interim Chief Executive Officer of Endovia Health Sciences. "Importantly, we are not waiting to begin preparing for commercialization. Alongside Lupvindol, we are advancing our FDA development program while simultaneously working to establish U.S. manufacturing and supply capabilities that can support a potential veterinary launch in 2027, subject to regulatory approval."
Cobb continued, "We believe CannEpil has the potential to demonstrate what a science-driven, federally regulated cannabinoid medicine can look like in the United States. Our veterinary program gives us an opportunity to address a serious unmet need for dogs suffering from cancer-related pain while building the regulatory, manufacturing and scientific infrastructure that we believe can support the broader development of CannEpil."
The MUMS conditional approval pathway was established to encourage development of new animal drugs for uncommon conditions affecting relatively small populations. Following conditional approval, a sponsor may legally market a qualifying animal drug while continuing to collect the additional effectiveness data necessary to support full FDA approval, subject to applicable statutory and regulatory requirements and annual FDA renewal.
CannEpil® remains an investigational new animal drug and has not been approved or conditionally approved by the FDA. The Company’s anticipated development timelines, including a potential 2027 commercial launch, remain subject to FDA review, successful completion of applicable regulatory requirements, manufacturing readiness and other factors.