New York, USA – October 13, 2025
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 its patented fixed-dose combination therapy. This milestone enables the company to advance investigational studies for the control of clinical signs associated with inflammatory bowel disease (IBD) in dogs. Thanks to the exceptional efforts of our team, we have achieved this milestone ahead of schedule, with study results in line with our initial projections, setting a strong foundation for future advancements.
The therapy combines a low-dose corticosteroid with cannabidiol (CBD), aiming to explore potential improvements in safety and efficacy over traditional high-dose steroid treatments.
” Opening an INAD with the FDA for canine use marks more than a regulatory step—it’s the first pawprint on a path toward transformative care for dogs suffering from IBD,” said Jennifer King, Director of Regulatory Affairs at Lupvindol Biosciences. “We’ve worked closely with the FDA to align on this pathway. Our collaborative approach ensures we meet the highest standards as we progress toward a product development meeting to refine our proposed plan and schedule.”
Building on foundational research, the announcement follows promising in vitro data presented by Lupvindol at the International Cannabinoid Research Society (ICRS) 2025 Symposium in July. The studies evaluated the therapeutic potential of CBD-corticosteroid combinations on osteoarthritis-related cell lines, demonstrating reduced cytotoxicity, enhanced anti-inflammatory effects, and lower levels of pro-inflammatory cytokines and cartilage-degrading enzymes compared to corticosteroid alone.
“Opening an INAD with the FDA is a huge accomplishment, and we’re thrilled to explore a groundbreaking therapy that could redefine how we help dogs with IBD heal, thrive, and live better lives,” said Tim Lefever, Vice President of R&D at Lupvindol Biosciences. “Building on our successful in vitro research presented at ICRS 2025, which showed the combination’s ability to attenuate corticosteroid toxicity while enhancing cytokine modulation and joint-protective effects at lower doses, this step allows us to advance toward real-world validation. Our patented fixed-dose combination therapy seeks to offer the efficacy pet owners can rely on with the improved safety they should expect.”
“I’m delighted to congratulate our exceptional team on this achievement,” said Hunter Land, PhD, Chief Executive Officer of Lupvindol Biosciences. “This milestone brings us closer to realizing our vision of harnessing the power of corticosteroids without the burdensome side effects, paving the way for safer, more effective treatments in veterinary medicine and setting the stage for broader innovations across animal health.”
Lupvindol’s veterinary-first strategy leverages accelerated regulatory pathways to de-risk development, with plans to use canine data to inform future human applications in inflammation and autoimmune disorders, while continuing to expand its pipeline of solutions for diverse veterinary needs. The company will now focus on protocol submissions and a product development meeting with the FDA.
For more information, visit www.lupvindol.com.
About Lupvindol Biosciences Ltd.
Lupvindol Biosciences is a clinical-stage biopharmaceutical company developing patented fixed-dose combination therapies that reduce steroid dosing for maximum efficacy and safety in treating inflammation and pain. With a focus on veterinary health as a gateway to human therapeutics and ongoing advancements in multiple animal indications, Lupvindol aims to address unmet needs in conditions like IBD and osteoarthritis. The company is headquartered in the UK with a global team of experts in cannabinoid and pharmaceutical development.
Media Contact:
Mark Rogers mr@lupvindol.com 1-833-380-5324 or +44 (0) 7894 706040
Forward-Looking Statements:
This press release contains forward-looking statements regarding Lupvindol’s investigational therapy, including potential benefits, regulatory progress, and future studies. These statements are based on current expectations and involve risks and uncertainties. Actual results may differ materially. The therapy is investigational and has not been approved by the FDA or any regulatory authority.
