Delgocitinib cream (Anzupgo) is now available within the US for adult patients living with moderate-to-severe chronic hand eczema (CHE).1
This announcement by LEO Pharma Inc. regarding delgocitinib cream’s availability within the US for adults with CHE follows their July 23, 2025, announcement of the topical medication’s US Food and Drug Administration (FDA) approval in this patient population. Delgocitinib cream is indicated for adults who have had an inadequate response to, or for whom, topical corticosteroids are not advisable.
“After successfully launching [delgocitinib] in several countries, we’re proud to now bring this innovation to adult patients with moderate-to-severe CHE in the United States,” Christophe Bourdon, chief executive officer of LEO Pharma, said in a statement.1 “The approval of [delgocitinib] reinforces our commitment to investing in difficult-to-treat skin diseases to deliver new treatments to patients where the need is greatest.”
CHE is an inflammatory skin condition characterized by key symptoms such as pruritus and pain. The disease appears on a patient’s hands and wrists, all of which can become irritated, red, thickened, swollen, blistered, or cracked as a result of CHE.
Delgocitinib cream itself is a topical, non-steroidal, pan-Janus kinase (JAK) inhibitor that functions as a targeted treatment option. Its current availability and approval by FDA officials had been based on data from the DELTA 1 and DELTA 2 clinical trial programs.
The treatment was assessed in adult patients during the phase 3 DELTA 1 and DELTA 2 studies, with almost 1000 participants evaluated in both studies. The DELTA investigators assessed treatment success at the 16-week mark using the Investigator’s Global Assessment (IGA-CHE TS), defined as clear or almost clear skin with a 2-point improvement from baseline at minimum. Their results showed delgocitinib outperformed the vehicle cream: in DELTA 1, they observed 20% versus 10% achieved treatment success, respectively.
In DELTA 2, rates of success were 29% versus 7%, respectively. DELTA investigators also highlighted significant improvements seen in pain and pruritus scores among subjects, with nearly half of those given delgocitinib reporting ≥4-point reductions compared with about a fifth of those on vehicle.
Long-term outcomes were confirmed through the DELTA 3 extension study, with investigators assessing more than 800 participants from the initial trials for up to 36 weeks of open-label treatment.2 Delgocitinib cream was shown to generally be well-tolerated, with COVID-19 and nasopharyngitis being observed among participants as the most common adverse events.
This analysis highlighted that patients who had already been treated with delgocitinib cream maintained or improved their treatment response, whereas subjects previously on vehicle showed substantial gains. These findings helped to reinforce both the durability and safety of delgocitinib in managing CHE prior to its recent approval.
References
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LEO Pharma. LEO Pharma Announces FDA Approval of ANZUPGO® (delgocitinib) Cream in the U.S. LEO Pharma. Published July 23, 2025. Accessed July 23, 2025. https://www.leo-pharma.com/media-center/news/2025-fda-approval.
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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. Journal of the American Academy of Dermatology. Published online March 11, 2025. Accessed September 8, 2025. doi: 10.1016/j.jaad.2025.03.008.