Merck Animal Health Gains FDA Approval for NUMELVI Launching Spring 2026
Merck Animal Health won FDA approval for NUMELVI, the first second-generation JAK inhibitor for controlling pruritus in dogs aged six months and older, with spring 2026 nationwide rollout and extended shelf life. Merck also flagged early-stage hair-loss treatments and a promising HIV drug under evaluation.
1. FDA Clears NUMELVI for Canine Allergic Dermatitis
Merck Animal Health received FDA approval for NUMELVI (atinvicitinib tablets), the first second-generation Janus kinase inhibitor indicated to control pruritus associated with allergic dermatitis in dogs six months and older. The approval marks the introduction of a novel veterinary therapy expected to address up to 20% of skin disorder cases seen in general practice.
2. Product Profile and Commercial Readiness
NUMELVI offers once-daily dosing, with most dogs requiring only a half or full tablet from 4.4 pounds upward. The drug’s intrinsic stability removes the need for special packaging or film coating, delivering the longest shelf life among veterinary JAK inhibitors and enabling standard storage conditions.
3. Human Therapeutic Pipeline Highlights
Beyond animal health, Merck is exploring early-stage human therapeutics, including novel hair-loss treatments—the first in decades—and advancing a new HIV therapy that has shown promising clinical signals and drawn Wall Street attention despite limited disclosed data.