Elanco Secures Approval of Zenrelia™ (ilunocitinib) in the European Union (EU), Launching Innovative Canine Dermatology Treatment for Itchy Dogs
Elanco Animal Health (NYSE:ELAN) has received European Commission approval for Zenrelia™ (ilunocitinib), a once-daily oral JAK inhibitor for treating itching associated with allergic dermatitis and atopic dermatitis in dogs aged 12 months and older.
The approval follows a successful head-to-head study against market incumbent Apoquel, involving 338 dogs across 25 study sites in four countries, demonstrating Zenrelia's non-inferiority. The product is already available in Brazil, Canada, Japan, and the United States, with launch in EU markets expected before the end of Q3 2025.
Elanco Animal Health (NYSE:ELAN) ha ottenuto l'approvazione della Commissione Europea per Zenrelia™ (ilunocitinib), un inibitore orale JAK da assumere una volta al giorno per il trattamento del prurito associato alla dermatite allergica e alla dermatite atopica nei cani di età pari o superiore a 12 mesi.
L'approvazione segue uno studio comparativo diretto contro il prodotto leader di mercato Apoquel, che ha coinvolto 338 cani in 25 centri di studio in quattro paesi, dimostrando la non inferiorità di Zenrelia. Il prodotto è già disponibile in Brasile, Canada, Giappone e Stati Uniti, con il lancio previsto nei mercati dell'UE entro la fine del terzo trimestre 2025.
Elanco Animal Health (NYSE:ELAN) ha recibido la aprobación de la Comisión Europea para Zenrelia™ (ilunocitinib), un inhibidor oral de JAK de una vez al día para tratar la picazón asociada con dermatitis alérgica y dermatitis atópica en perros de 12 meses o más.
La aprobación sigue a un exitoso estudio comparativo directo contra Apoquel, líder del mercado, que involucró a 338 perros en 25 sitios de estudio en cuatro países, demostrando la no inferioridad de Zenrelia. El producto ya está disponible en Brasil, Canadá, Japón y Estados Unidos, y se espera su lanzamiento en los mercados de la UE antes de finales del tercer trimestre de 2025.
Elanco Animal Health (NYSE:ELAN)는 12개월 이상 된 개들의 알레르기 피부염 및 아토피 피부염과 관련된 가려움증 치료를 위한 하루 한 번 복용하는 경구용 JAK 억제제인 Zenrelia™ (일루노시티닙)에 대해 유럽연합 집행위원회의 승인을 받았습니다.
이번 승인은 4개국 25개 연구기관에서 338마리의 개를 대상으로 시장 선도 제품인 Apoquel과 직접 비교한 대조 연구에서 Zenrelia의 비열등성이 입증된 결과를 바탕으로 합니다. 이 제품은 이미 브라질, 캐나다, 일본, 미국에서 판매 중이며, 2025년 3분기 말 이전에 EU 시장에 출시될 예정입니다.
Elanco Animal Health (NYSE:ELAN) a obtenu l'approbation de la Commission européenne pour Zenrelia™ (ilunocitinib), un inhibiteur oral de JAK à prise quotidienne unique destiné au traitement des démangeaisons associées à la dermatite allergique et à la dermatite atopique chez les chiens âgés de 12 mois et plus.
Cette approbation fait suite à une étude comparative directe réussie contre Apoquel, leader du marché, impliquant 338 chiens répartis sur 25 sites d'étude dans quatre pays, démontrant la non-infériorité de Zenrelia. Le produit est déjà disponible au Brésil, au Canada, au Japon et aux États-Unis, avec un lancement prévu sur les marchés de l'UE avant la fin du troisième trimestre 2025.
Elanco Animal Health (NYSE:ELAN) hat die Zulassung der Europäischen Kommission für Zenrelia™ (Ilunocitinib) erhalten, einen einmal täglich oral einzunehmenden JAK-Inhibitor zur Behandlung von Juckreiz im Zusammenhang mit allergischer Dermatitis und atopischer Dermatitis bei Hunden ab 12 Monaten.
Die Zulassung folgt auf eine erfolgreiche direkte Vergleichsstudie gegen den Marktführer Apoquel, an der 338 Hunde an 25 Studienstandorten in vier Ländern teilnahmen und die die Nicht-Unterlegenheit von Zenrelia nachwies. Das Produkt ist bereits in Brasilien, Kanada, Japan und den USA erhältlich, mit einer Markteinführung in der EU vor Ende des dritten Quartals 2025 wird gerechnet.
- European Commission approval expands market reach for Zenrelia
- Successful head-to-head study against market leader demonstrates product efficacy
- Immediate launch with Q3 2025 market availability strengthens competitive position
- Product already successfully launched in multiple major markets including US, Japan, Brazil, and Canada
- None.
Insights
Elanco's EU approval for Zenrelia expands market reach for this fast-growing JAK inhibitor, strengthening its pet health portfolio against competitors.
The European Commission's approval of Zenrelia (ilunocitinib) represents a significant expansion of Elanco's dermatology portfolio in the lucrative EU pet health market. This once-daily oral JAK inhibitor for canine allergic dermatitis joins Elanco's existing products already available in Brazil, Canada, Japan, and the United States, with more approvals anticipated.
The timing is particularly strategic - with product launch beginning immediately and availability expected before the end of Q3 2025, Elanco is positioned to capture market share quickly. The company conducted a head-to-head non-inferiority study against Apoquel (the current market leader), demonstrating comparable efficacy at the 28-day primary endpoint. This published clinical validation strengthens Zenrelia's competitive positioning against established treatments.
Most notably, the once-daily dosing represents a convenience advantage over competitors requiring multiple daily doses, potentially improving compliance and treatment outcomes. This approval further diversifies Elanco's EU pet health portfolio that includes AdTab, Credelio, and Galliprant, strengthening its position in the growing pet therapeutics market.
The designation of Zenrelia as Elanco's "most rapidly expanding product" signals its importance to the company's growth strategy. With allergic dermatitis affecting a significant percentage of dogs globally, this EU approval opens access to millions of potential patients across a major market, representing substantial revenue potential for Elanco's pet health division.
- 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
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
"We're excited to bring Zenrelia to veterinarians and pet owners in
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 tiffany.kanaga@elancoah.com
Media Contact: Season Solorio (765) 316-0233 season.solorio@elancoah.com
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SOURCE Elanco Animal Health
FAQ
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