European Commission approves Zenrelia

This week, Elanco Animal Health Incorporated announced that its ilunocitinib tablets (Zenrelia; Elanco Animal Health) have received approval from the European Commission (EU). The approval for the once-daily Janus kinase (JAK) Inhibitor means that the treatment will hit the EU canine dermatology market to help canine patients with pruritus associated with allergic dermatitis and control atopic dermatitis in canine patients 12 months and older.

“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,” Ellen de Brabander, PhD, executive vice president of innovation and regulatory affairs at Elanco, said in an organizational release.¹

“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,” she said. 

According to the organizational release, Elanco conducted a head-to-head noninferiority study vs the market incumbent, oclacitinib tablets (Apoquel; Zoetis), as part of the approval process.¹ The study was randomized, double-blind, and consisted of 338 client-owned dogs confirmed with atopic dermatitis, and it took place in 25 study sites across 4 countries. The results of the show demonstrated that 1 daily dose of Zenrelia is at least as effective as the market incumbent JAK inhibitor on the primary end point on day 28.²

With this approval, Elanco’s Zenrelia is now available in the United Kingdom, Brazil, Canada, Japan, and the US, but the company is expecting additional approvals in key geographies. Elanco also stated in the release that the details for the marketing authorization will be shared on the European Commission website in the next few days.

“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,” Ramiro Cabral, DVM, executive vice president of Elanco International, stated in the release.¹ “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.”

Zenrelia is expected to launch immediately in the market before the end of Q3 2025.

References

1. Elanco secures approval of Zenrelia (ilunocitinib) in the European Union (EU), launching innovative canine dermatology treatment for itchy dogs. News release. Elanco Animal Health Incorporated. July 24, 2025. Accessed July 28, 2025. https://www.elanco.com/us/newsroom/press-releases/elanco-secures-approval-of-zenreliatm-ilunocitinib-in-the-european-union-eu-launching-innovative-canine-dermatology-treatment-for-itchy-dogs
2. Forster S, Boegel A, Despa S, Trout C, King S. Comparative efficacy and safety of ilunocitinib and oclacitinib for the control of pruritus and associated skin lesions in dogs with atopic dermatitis. Veterinary Dermatol. 2025;36(2):165-176. doi:10.1111/vde.13319