GREENFIELD, Ind., July 24, 2025 /PRNewswire/ -- Elanco Animal Health Incorporated (NYSE:ELAN) announced today that Zenrelia™ (ilunocitinib) has received approval by the European Commission.

This approval by the EU reinforces Zenrelia's status as a highly effective, convenient, and safe once-daily oral JAK inhibitor. Zenrelia's approval represents a significant milestone in the EU canine dermatology market, offering a once-daily tablet solution for control pruritus (itching) associated with allergic dermatitis and control of atopic dermatitis in dogs at least 12 months of age.

"Our EU approval for Zenrelia is a pivotal achievement, making it our most rapidly expanding product and solidifying our position as a leader in pet health innovation," stated Dr. Ellen de Brabander, Executive Vice President of Innovation and Regulatory Affairs at Elanco. "We've seen remarkable results from our rigorous head-to-head study against the market leader and in real-world settings where Zenrelia is already approved and being used. We're excited to provide veterinarians across the EU with this impactful solution, offering relief to countless dogs suffering from itchy and inflamed skin."

Elanco is pleased the label is consistent with other markets outside North America where the product has already been approved. Zenrelia is available in Brazil, Canada, Japan and the United States, and the company expects additional approvals in key geographies.

"We're excited to bring Zenrelia to veterinarians and pet owners in Europe and provide a new solution to bring relief to itchy dogs, while changing the standard of care to a single daily dose," said Ramiro Cabral, Executive Vice President, Elanco International. "Our commercial teams are ready and product launch will begin immediately, with supply availability expected in the third quarter. Zenrelia joins our growing pet health portfolio in Europe, including AdTab, Credelio, Galliprant and others."

As part of the EU approval process, Elanco conducted a head-to-head non-inferiority study versus the marketplace incumbent, Apoquel. The randomized, double-blind study of 338 client-owned dogs with confirmed atopic dermatitis was conducted across 25 study sites in four countries. The study shows one daily dose of Zenrelia is at least as effective as the market incumbent JAK inhibitor at the primary end point on Day 28. The study is published in a leading peer-reviewed, international journal, Veterinary Dermatology: https://doi.org/10.1111/vde.13319.

Details on the marketing authorization will be shared on the European Commission website in the coming days.

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