LAUNCH ALERT: FDA Approves Anzupgo (Delgocitinib) Cream for Moderate-to-Severe Chronic Hand Eczema in Adults

Update (September 2025): Anzupgo is now commercially available and can be prescribed in the United States. Following FDA approval in July 2025, the therapy has officially entered the market and is accessible to clinicians for eligible patients.  

Watch as James Q. Del Rosso, DO, reviews clinical trial data, mechanism of action, safety, and more. 

The US Food and Drug Administration has approved Anzupgo (delgocitinib) cream (20 mg/g) for the treatment of moderate-to-severe chronic hand eczema (CHE) in adults who are not adequately controlled with topical corticosteroids or for whom such treatment is not advisable. This represents the first FDA-approved therapy specifically indicated for CHE. 

Mechanism of action 

Anzupgo is a topical pan-Janus kinase (JAK) inhibitor, targeting JAK1, JAK2, JAK3, and tyrosine kinase 2. It modulates multiple cytokine signaling pathways involved in the pathophysiology of CHE via inhibition of the JAK-STAT pathway, with topical administration limiting systemic exposure. 

Clinical trial insights 

FDA approval was supported by results from two identical randomized, double-blind, vehicle-controlled trials (DELTA 1 and DELTA 2) involving 960 adults with moderate-to-severe CHE. 

• Primary endpoint: Investigator’s Global Assessment for Chronic Hand Eczema Treatment Success (IGA-CHE TS) at Week 16:
  • DELTA 1: 20% with Anzupgo vs 10% with vehicle (p=0.006)
  • DELTA 2: 29% with Anzupgo vs 7% with vehicle (p<0.0001)
• Key secondary endpoint (≥4-point reduction in severity of itch and pain as measured by the Hand Eczema Symptom Diary):
  • Itch: 47% of Anzupgo-treated patients in both DELTA 1 and DELTA 2 achieved this reduction at Week 16, vs 23% and 20% with cream vehicle (p<0.0001).
  • Pain: 49% of Anzupgo-treated patients in both trials achieved this reduction at Week 16, vs 28% and 23% with cream vehicle (p<0.0001). 

Safety profile 

The safety profile of Anzupgo was comparable to that of vehicle. Adverse events occurring in ≤ 1% of patients included application site pain, paresthesia, erythema, pruritus, and bacterial skin infections. 

Patients completing 16 weeks of treatment in the DELTA 1 and DELTA 2 trials were eligible to enter DELTA 3, a 36-week open-label extension assessing long-term safety. 

Product availability 

Anzupgo has been launched in multiple international markets and is expected to be made available in the US soon.