
News|Slideshows|August 7, 2025
Delgocitinib: Clinical Timeline and Approval
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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.
The drug’s approval in August 2025 follows robust efficacy and safety results from the DELTA 1, 2, and 3 clinical trials.
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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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