Delgocitinib Cream Becomes First, Only Approved Treatment for Moderate-to-Severe Chronic Hand Eczema

The FDA approved delgocitinib (Anzupgo; LEO Pharma) cream 20 mg/g for the topical treatment of moderate-to-severe chronic hand eczema (CHE) in adults for whom topical corticosteroids are not advisable or those that have had an inadequate response to such treatments, according to a news release from LEO Pharma.¹

Chronic hand eczema presents major, daily hurdles to individuals impacted. | Image Credit: © Ольга Тернавская - stock.adobe.com

Clinical Efficacy of Delgocitinib in DELTA Trials

The approval is a watershed moment for this population, as delgocitinib becomes the first and only FDA-approved treatment specifically for patients with CHE in the United States. It follows the FDA’s acceptance of a new drug application for the agent in September 2024 and is based on positive results from the DELTA 1 and DELTA 2 clinical trials, the results of which were featured in The Lancet.^1-3

In those trials, which enrolled 487 and 473 individuals, respectively, patients treated with delgocitinib had successful improvements in Investigator’s Global Assessment for CHE (IGA-CHE), with more patients achieving scores of 0—for clear skin—or 1—for almost clear skin—compared with those treated with a cream vehicle. Importantly, the proportion of patients reporting adverse events was similar between the delgocitinib and cream vehicle cohorts in both DELTA 1 and DELTA 2.^2,4

“Overall, delgocitinib cream showed superior efficacy versus cream vehicle and was well tolerated over 16 weeks,” the DELTA investigators wrote in their interpretation of the findings. “These results support the clinical benefit of delgocitinib cream as a potential treatment option for patients with moderate to severe chronic hand eczema.”⁴

Need for Treatments in Chronic Hand Eczema

There is a major need for effective treatments for CHE. Not only did patients have a lack of treatment options prior to delgocitinib’s approval, but CHE exerts a unique, consistent burden that gives patients little to no reprieve from the condition. CHE is an inflammatory disease that impacts the hands and wrists, with patients typically reporting symptoms of itching, pain, scaling, erythema, edema, and fissures on impacted areas. Its chronic nature is defined as such if the condition lasts for 3 or more months or relapses twice or more within a year.^1,3

Critically, research indicates that 70% of individuals with severe CHE report difficulties in performing everyday activities and disruptions in their daily lives because of the condition. It’s relatively common among the general population—impacting an estimated 1 in 10 adults globally—making it even more imperative that effective treatments such as delgocitinib can be researched, approved, and successfully disseminated to those that need it most.^1,3

Delgocitinib is a steroid-free, topical pan-Janus kinase (JAK) inhibitor. By specifically inhibiting the activity of JAK1, JAK2, JAK3, and tyrosine kinase 2, delgocitinib can suppress inflammatory responses that are key to flares of CHE. According to the news release, delgocitinib is now the first and only topical pan-JAK inhibitor available on the US market.¹

Pharmacists Can Counsel Patients on Delgocitinib Use

Pharmacists stand to play a key role in ensuring that patients with CHE are aware of delgocitinib’s FDA approval and, once the product begins to be manufactured and disseminated to consumers, are given assistance in acquiring the medication. Because they see patients more often than a primary care physician or dermatologist, they are in a unique position to monitor the onset and flare-ups of CHE and recommend relevant management strategies.

Once delgocitinib is available for prescribing, dermatologists will rely on pharmacists to procure the medication and ensure it gets into the hands of the patient. Furthermore, pharmacists should be sure to educate themselves on the application of delgocitinib so patients can reach out to them—rather than a difficult-to-reach dermatologist—for any questions regarding use of the medication.

REFERENCES

1. LEO Pharma. LEO Pharma Announces FDA Approval of ANZUPGO® (delgocitinib) Cream in the U.S.. News Release. Released July 23, 2025. Accessed July 24, 2025. https://www.leo-pharma.com/media-center/news/2025-fda-approval

2. Ferruggia K. Delgocitinib could aid adults with moderate to severe chronic hand eczema. Pharmacy Times. Published July 25, 2024. Accessed July 24, 2025. https://www.pharmacytimes.com/view/delgocitinib-could-aid-adults-with-moderate-to-severe-chronic-hand-eczema

3. Ferruggia K. FDA accepts new drug application for delgocitinib cream to treat chronic hand eczema. Pharmacy Times. Published September 23, 2024. Accessed July 24, 2025. https://www.pharmacytimes.com/view/fda-accepts-new-drug-application-for-delgocitinib-cream-to-treat-chronic-hand-eczema

4. 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. The Lancet. 2024;404(10451):461-473. doi:10.1016/S0140-6736(24)01027-4