Anzupgo Available for Prescribing Today

The US Food and Drug Administration (FDA) recently approved delgocitinib cream (Anzupgo, LEO Pharma), as the first and only treatment indicated for moderate-to-severe chronic hand eczema (CHE) in adults. This approval provides clinicians with a novel, nonsteroidal topical therapeutic option—available to prescribe September 8, 2025—for patients who have historically relied on topical corticosteroids with variable efficacy and tolerability.

Delgocitinib is a topical pan-Janus kinase (JAK) inhibitor that acts by inhibiting JAK-1, JAK-2, JAK-3, and TYK-2 pathways, thereby suppressing multiple cytokine-driven inflammatory mechanisms implicated in CHE. Its broad activity across JAK family members distinguishes it from other selective JAK inhibitors.

FDA approval was supported by 2 pivotal phase 3 clinical trials (DELTA 1 and DELTA 2) enrolling nearly 1600 adult patients with moderate-to-severe CHE. In both randomized, double-blind, vehicle-controlled studies, delgocitinib cream demonstrated statistically significant improvement in disease severity. The primary endpoint—an Investigator’s Global Assessment score of 0 (clear) or 1 (almost clear) with a 2-point or greater reduction at week 16—was achieved by significantly more patients using delgocitinib vs the vehicle. Secondary endpoints included improvements in patient-reported outcomes, such as itch and pain scores measured through the Hand Eczema Symptom Diary, which also favored delgocitinib.

Delgocitinib cream was reported to be well tolerated in clinical development. The most common adverse events were application-site reactions, which occurred at low frequency and were generally mild. Importantly, delgocitinib does not have a black box warning. 

For practicing dermatologists, delgocitinib cream represents a first-in-class, nonsteroidal, topical JAK inhibitor specifically approved for CHE. Its demonstrated efficacy in reducing both clinical severity and patient-reported symptoms offers a valuable option for patients with refractory or steroid-ineligible disease. The approval highlights the importance of recognizing and treating CHE as a chronic, burdensome condition with limited prior FDA-approved therapies.

Reference
ANZUPGO (delgocitinib) cream is now the first and only FDA-approved treatment for moderate-to-severe chronic hand eczema (CHE) in adults. Business Wire. Published July 23, 2025. Accessed September 8, 2025. https://www.businesswire.com/news/home/20250723115252/en/ANZUPGO-delgocitinib-Cream-Is-Now-the-First-and-Only-FDA-Approved-Treatment-for-Moderate-to-Severe-Chronic-Hand-Eczema-CHE-in-Adults