Elanco Secures Approval of Zenrelia™ (ilunocitinib) in the European Union (EU), Launching Innovative Canine Dermatology Treatment for Itchy Dogs

• The European Commission's Approval of Zenrelia reinforces safety and efficacy and further expands opportunities to treat itchy dogs around the world
• Launch to begin immediately with product in market before the end of Q3 2025

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.

ABOUT ELANCO
Elanco Animal Health Incorporated (NYSE: ELAN) is a global leader in animal health dedicated to innovating and delivering products and services to prevent and treat disease in farm animals and pets, creating value for farmers, pet owners, veterinarians, stakeholders and society as a whole. With 70 years of animal health heritage, we are committed to breaking boundaries and going beyond to help our customers improve the health of animals in their care, while also making a meaningful impact on our local and global communities. At Elanco, we are driven by our vision of Food and Companionship Enriching Life and our Elanco Healthy Purpose™ sustainability pillars – all to advance the health of animals, people, the planet and our enterprise. Learn more at www.elanco.com.

Cautionary Statement Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the federal securities laws, including, without limitation, statements concerning product approvals and launches. Forward-looking statements are based on our current expectations and assumptions regarding our business, the economy and other future conditions. Because forward-looking statements relate to the future, by their nature, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict. As a result, our actual results may differ materially from those contemplated by the forward-looking statements. Important risk factors that could cause actual results to differ materially from those in the forward-looking statements include regional, national or global political, economic, business, competitive, market and regulatory conditions, including whether and when regulatory reviews are completed and product approvals are received, our ability to manufacture and distribute product, competition with other canine dermatology products and additional factors that could cause actual results to differ materially from forward-looking statements described in the company's latest Form 10-K and Form 10-Qs filed with the Securities and Exchange Commission. We caution you against relying on any forward-looking statements, which should also be read in conjunction with the other cautionary statements that are included elsewhere in this press release. Any forward-looking statement made by us in this press release speaks only as of the date thereof. We undertake no obligation to publicly update or to revise any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law.

Investor Contact: Tiffany Kanaga (765) 740-0314 [email protected]
Media Contact: Season Solorio (765) 316-0233 [email protected]

SOURCE Elanco Animal Health