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FDA Approves Anzupgo (delgocitinib) for Moderate to Severe Chronic Hand EczemaFDA approves new cream Anzupgo for chronic hand eczema in adults.

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Key Takeaway
Consider Anzupgo as a topical JAK inhibitor option for adults with moderate to severe chronic hand eczema inadequately controlled by topical corticosteroids.

The FDA has approved Anzupgo (delgocitinib) cream for the topical treatment of moderate to severe chronic hand eczema (CHE) in adults who have had an inadequate response to topical corticosteroids or for whom such therapy is not advisable. Anzupgo is a Janus kinase (JAK) inhibitor and represents a new nonsteroidal topical option for this often difficult-to-treat condition. The approval was supported by two randomized, double-blind, vehicle-controlled trials (TRIAL 1 and TRIAL 2) involving 960 adults with moderate to severe CHE. In TRIAL 2, 29% of patients treated with Anzupgo achieved treatment success (clear or almost clear skin with at least a 2-point improvement on the Investigator's Global Assessment for CHE) at week 16, compared with 7% for vehicle. The most common adverse events included nasopharyngitis and headache. Anzupgo is for topical use only and should not be used in combination with other JAK inhibitors or potent immunosuppressants.

Clinical Details (Mechanism · Dosing · Trial Data · Warnings)
Mechanism of Action

Delgocitinib is a Janus kinase (JAK) inhibitor. The mechanism of action in chronic hand eczema is not fully characterized, but it is thought to involve inhibition of JAK-STAT signaling pathways that mediate inflammation.

Indication & Patient Population

Anzupgo is indicated for the topical treatment of moderate to severe chronic hand eczema (CHE) in adults who have had an inadequate response to, or for whom topical corticosteroids are not advisable. Limitations of Use: Use of Anzupgo in combination with other JAK inhibitors or potent immunosuppressants is not recommended.

Dosing & Administration

Apply a thin layer of Anzupgo twice daily to affected areas only on the hands and wrists. Do not use more than 30 grams per 2 weeks or 60 grams per month. For topical use only. Not for oral, ophthalmic, or intravaginal use. Avoid contact with eyes, mouth, or other mucous membranes. If contact occurs, rinse thoroughly with water. Complete any necessary immunizations, including herpes zoster vaccination, prior to treatment.

Key Clinical Trial Data

Efficacy was evaluated in two randomized, double-blind, vehicle-controlled 16-week trials (TRIAL 1 and TRIAL 2) enrolling 960 adults with moderate to severe CHE and inadequate response to topical corticosteroids. The primary endpoint was the proportion of subjects achieving IGA-CHE treatment success (score of 0 or 1 with ≥2-point improvement) at week 16. In TRIAL 1, 20% of Anzupgo-treated subjects achieved success vs 10% with vehicle (difference 10%, 95% CI 4% to 16%). In TRIAL 2, 29% vs 7% (difference 22%, 95% CI 16% to 29%). Secondary endpoints included ≥4-point improvement in HESD itch score: TRIAL 1: 47% vs 23% (difference 24%, 95% CI 16% to 33%); TRIAL 2: 47% vs 20% (difference 27%, 95% CI 19% to 35%).

Warnings & Contraindications

Not reported in label.

Place in Therapy

Anzupgo provides a topical JAK inhibitor option for adults with moderate to severe chronic hand eczema who have not responded adequately to topical corticosteroids or for whom such therapy is not advisable. It should not be used in combination with other JAK inhibitors or potent immunosuppressants.

The U.S. Food and Drug Administration has approved a new prescription cream called Anzupgo (delgocitinib) for adults with moderate to severe chronic hand eczema. This condition causes red, itchy, and painful hands that can be hard to treat. Anzupgo is a type of medicine called a JAK inhibitor, and it works by blocking certain signals in the body that cause inflammation. It is meant for people who have not gotten better with topical steroids or who cannot use them.

In two large studies, about 29% of people using Anzupgo saw their skin become clear or almost clear after 16 weeks, compared to 7% of those using a cream without medicine. The most common side effects were cold-like symptoms and headache. Anzupgo is for use on the skin only and should not be used with other JAK inhibitors or strong immune-suppressing medicines.

This approval gives patients a new nonsteroidal option for a condition that can be frustrating to manage. However, it is not a cure, and results vary. If you have chronic hand eczema, talk to your doctor to see if Anzupgo might be right for you. Your doctor can help you understand the benefits and risks based on your personal health history.

What this means for you:
Anzupgo is a new nonsteroidal cream for chronic hand eczema; talk to your doctor if it might help you.

Study Details

Study typeFda approval
PublishedJul 2025
View Original Abstract ↓
1 INDICATIONS AND USAGE ANZUPGO is indicated for the topical treatment of moderate to severe chronic hand eczema (CHE) in adults who have had an inadequate response to, or for whom topical corticosteroids are not advisable. ANZUPGO is a Janus kinase (JAK) inhibitor indicated for the topical treatment of moderate to severe chronic hand eczema (CHE) in adults who have had an inadequate response to, or for whom topical corticosteroids are not advisable. ( 1 ) Limitations of Use: Use of ANZUPGO in combination with other JAK inhibitors or potent immunosuppressants is not recommended. ( 1 ) Limitations of Use Use of ANZUPGO in combination with other JAK inhibitors or potent immunosuppressants is not recommended.
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