Delgocitinib Now Available in the US for CHE

LEO Pharma's delgocitinib cream (Anzupgo) is now available for clinicians to prescribe in the US for adult patients with moderate to severe chronic hand eczema (CHE), according to an exclusive statement from a LEO Pharma spokesperson.

The FDA approved delgocitinib on July 23, 2025, for patients with CHE who have not responded adequately to prior topical corticosteroids or for whom corticosteroid use is not advisable. The approval makes delgocitinib cream the first and only approved therapy in the US for CHE in adults.¹

The approval of the steroid-free, topical pan-JAK inhibitor is supported by positive data from the phase 3 DELTA 1 (NCT04871711) and DELTA 2 (NCT04872101) clinical trials.² These randomized, double-blind, vehicle-controlled studies enrolled a total of 960 adult patients with CHE to assess the cream’s safety and efficacy over 16 weeks.

The primary measure of success was achieving an Investigator’s Global Assessment for CHE Treatment Success (IGA-CHE TS)—a score of 0 (clear) or 1 (almost clear) with at least a 2-point improvement from baseline.

In DELTA 1, 20% of patients treated with delgocitinib reached this end point, compared to 10% in the vehicle group. In DELTA 2, 29% of delgocitinib-treated patients achieved success versus just 7% using vehicle cream. Both results were statistically significant, supporting the efficacy of delgocitinib in achieving visible skin improvement.

"It is truly exciting that topical delgocitinib is now FDA-approved in the United States for patients suffering from chronic hand eczema," said Christopher Bunick, MD, PhD, associate professor of dermatology at Yale School of Medicine in New Haven, Connecticut, and editor in chief of Dermatology Times, in a previous statement. "Delgocitinib represents the first approved medication specifically indicated for chronic hand eczema of all subtypes. This is a tremendous win for CHE patients who need a highly efficacious non-steroidal therapy they can use safely."

Additional data on delgocitinib from the DELTA 3 (NCT04949841) open-label extension trial highlights a favorable safety profile, with no increase in adverse events compared to earlier trials and most events being mild or moderate in nature. The most commonly reported issues were COVID-19 and upper respiratory infections. Tolerability improved over time, and nearly half of previously treated patients maintained IGA-CHE 0/1 responses. More than half of the patients who had received placebo in prior trials also achieved significant improvements. Sustained reductions in disease severity scores (HECSI and HESD) were observed, and among those who reinitiated treatment after symptom recurrence, over 80% regained disease control within a median of 8 weeks.³

For more information on a timeline of events for delgocitinib's approval, click here.

References

1. Anzupgo (delgocitinib) cream is now the first and only FDA-approved treatment for moderate-to-severe chronic hand eczema (CHE) in adults. News release. LEO Pharma Inc. 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
2. Bissonnette R, Warren RB, Pinter A, et al. Efficacy and safety of delgocitinib cream in adults with moderate to severe chronic hand eczema (DELTA 1 and DELTA 2): results from multicentre, randomised, controlled, double-blind, phase 3 trials. Lancet. 2024;404(10451):461-473. doi:10.1016/S0140-6736(24)01027-4
3. Gooderham M, Molin S, Bissonnette R, et al. Long-term safety and efficacy of delgocitinib cream for up to 52 weeks in adults with chronic hand eczema: results of the phase 3 open-label extension DELTA 3 trial following the DELTA 1 and 2 trials. J Am Acad Dermatol. doi:10.1016/j.jaad.2025.03.008