Lupvindol Biosciences Ltd., a pioneer in steroid-sparing therapies for inflammation and pain, today announced that the U.S. Food and Drug Administration’s Center for Veterinary Medicine (FDA/CVM) has opened an Investigational New Animal Drug (INAD) file for the company’s first-in-class intra-articular (IA) sterile injectable investigational veterinary product for horse osteoarthritis (OA).
This achievement marks Lupvindol’s second INAD opened within two weeks, following the company’s recent milestone for canine inflammatory bowel disease (IBD), underscoring its commitment to pioneering science-driven solutions that address unmet needs in animal health.
Jennifer King, Director of Regulatory Affairs: “I’m proud to celebrate the establishment of an INAD for equine osteoarthritis! Alongside last week’s canine IBD milestone, this is a testament to Lupvindol Biosciences’ unwavering commitment to advancing safe, science-driven solutions for veterinary medicine.”
Tim Lefever, PhD, Vice President of R&D: “Our innovative intra-articular injection for horses with OA is expected to be a much safer option in treating this pervasive disease in horses.”
Hunter Land, PhD, Chief Executive Officer: “These milestones are a testament to our team’s dedication and vision driving safer, smarter corticosteroid therapies forward.”
Building on data presented at the International Cannabinoid Research Society (ICRS) 2025 Symposium, Lupvindol’s research demonstrated that its patented corticosteroid-cannabinoid combination approach reduces cytotoxicity, enhances anti-inflammatory efficacy, and minimizes cartilage degradation compared with conventional steroid monotherapy. The new equine OA INAD allows the company to advance protocol submissions, initiate preclinical safety work, and prepare for a product development meeting with the FDA.
Together, Lupvindol’s dual INADs—for equine OA and canine IBD—illustrate the company’s veterinary-first strategy, leveraging accelerated regulatory pathways to de-risk development and lay the groundwork for future translational applications in human medicine.
