Merck Animal Health announced that the U.S. Food and Drug Administration approved NUMELVI on February 25, 2026. NUMELVI is a second‑generation Janus kinase (JAK) inhibitor that treats pruritus associated with allergic dermatitis in dogs. It is the first second‑generation JAK inhibitor cleared for veterinary use; earlier JAK inhibitors such as oclacitinib (Apoquel) and ilunocitinib (Zenrelia) were approved in prior years.
The drug is indicated for dogs six months and older, with a minimum weight of 4.4 pounds. It offers a convenient dosing schedule—either a full tablet or a half tablet—without the need to adjust vaccination schedules, making it a user‑friendly option for veterinary practices.
NUMELVI is expected to launch in the spring of 2026. The companion‑animal therapeutics market is projected to grow at a compound annual growth rate of 10.6% from 2026 to 2033, reaching an estimated $56.41 billion by 2033. Canine allergic dermatitis accounts for up to 20% of veterinary visits, underscoring a sizable addressable market for a high‑margin treatment such as NUMELVI.
The approval diversifies Merck’s portfolio beyond its core oncology and vaccine businesses and provides a new revenue stream that can help offset the 2028 Keytruda patent cliff. Merck Animal Health’s 2024 sales totaled $5.9 billion, a 4% increase from the prior year, driven by higher pricing and strong demand for core products. NUMELVI adds a high‑margin niche that aligns with the company’s strategy to strengthen its animal‑health segment against competitors such as Zoetis.
"Merck Animal Health is proud to introduce NUMELVI, our latest advancement geared at rapidly controlling pruritus associated with allergic dermatitis," said Christine McKinney, DVM, DACVD, Senior Professional Services Veterinarian. "With more than 70 years of innovation and commitment to animal health, we are confident that NUMELVI will offer veterinary professionals a groundbreaking, first‑of‑its‑kind solution aimed at improving the health and well-being of dogs—from as young as six months to mature dogs—and ultimately providing peace of mind for the people who care for them." Tim Kowalski, Distinguished Scientist, Discovery Research, added, "NUMELVI, a second‑generation JAK inhibitor, is the first of its kind to enter the market in veterinary medicine, giving it a unique profile compared with other JAK inhibitors. Second‑generation JAK inhibitors are already considered the standard of care in human health, and NUMELVI brings that same advanced approach to veterinary medicine."
The approval comes at a time when Merck’s broader business is under scrutiny for the impending Keytruda patent cliff. While no specific market reaction data for NUMELVI is available, analysts have noted Merck’s strategic positioning and the company’s focus on high‑margin, high‑growth niches as positive indicators for its long‑term outlook.
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