News|Slideshows|August 7, 2025

Delgocitinib: Clinical Timeline and Approval

Author(s)Maddi Hebebrand, MC, Associate Editor

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Key Takeaways

Delgocitinib cream, Anzupgo, is FDA-approved for moderate-to-severe chronic hand eczema in adults, marking a significant treatment milestone.
Phase 3 trials (DELTA 1 and DELTA 2) confirmed the cream's efficacy and safety in managing chronic hand eczema.
A phase 2b trial demonstrated improvements in health-related quality of life for patients using delgocitinib cream.
The DELTA 3 trial validated the long-term safety and efficacy of delgocitinib cream over a 52-week period.

The drug’s approval in August 2025 follows robust efficacy and safety results from the DELTA 1, 2, and 3 clinical trials.

References

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 August 7, 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
Buhl T, Bauer A, Ehst BD, et al. Health-related quality of life in chronic hand eczema in a phase 2b trial of delgocitinib cream. Dermatol Ther (Heidelb). 2025 May;15(5):1181-1193. doi: 10.1007/s13555-025-01384-4. Epub 2025 Apr 5. PMID: 40186746; PMCID: PMC12033156.
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
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. Published online March 11, 2025. doi:10.1016/j.jaad.2025.03.008

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