Delgocitinib

What is delgocitinib?

Delgocitinib is a pan-Janus kinase (JAK) inhibitor that targets all members of the JAK family (JAK1, JAK2, JAK3, and TYK2), thereby suppressing multiple cytokine-driven immune and inflammatory responses.

Topical formulations of delgocitinib are approved in some countries for the treatment of chronic hand eczema (CHE) and atopic dermatitis.

What is delgocitinib used for?

Chronic hand eczema

Topical delgocitinib 20 mg/g (0.2%) cream (Anzupgo®) is approved for the treatment of moderate-to-severe chronic hand eczema in adults for whom topical corticosteroids are inadequate or inappropriate.

• The European Medicines Agency (EMA) first approved delgocitinib cream in 2024, followed by the United States Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA) in 2025.
• Delgocitinib cream is the first FDA-approved non-steroidal treatment for CHE.

Atopic dermatitis

Topical delgocitinib 0.25% and 0.5% ointment (Corectim ®) is approved in Japan for the treatment of atopic dermatitis in adults and paediatric patients (≥6 months) — however, this is not approved outside of Japan.

What are the contraindications and precautions with delgocitinib?

Contraindications (for topical route)

Hypersensitivity to delgocitinib or any of its excipients.

Precautions (for topical route)

• Active or serious infection eg, tuberculosis, hepatitis B and C — avoid use
• Concurrent use with other JAK inhibitors or potent immunosuppressants — lack of safety data; use not recommended
• Pregnancy — lack of safety data
• Paediatric population (≤18 years old) — lack of safety data

Immunisations

Before commencing topical delgocitinib treatment, patients should complete all age-appropriate vaccinations as per immunisation guidelines, including herpes zoster vaccination.

Live vaccinations should be avoided immediately prior to, during, and shortly after treatment.

Dose and application

Delgocitinib cream is applied twice daily in a thin layer to clean, dry, affected skin of the hands and wrists. The recommended dosage limit is no more than 30 g per two weeks or 60 g per month.

It is for topical use only, and patients must avoid contact with the eyes, mouth, vagina, or other mucous membranes. Rinse thoroughly with water if contact with mucous membranes occurs.

Monitoring

It is recommended to monitor for the development of signs and symptoms of infection during and after treatment. If a patient develops a serious infection, delgocitinib treatment should be interrupted and only resumed once the infection resolves or is adequately treated.

What are the benefits of delgocitinib?

Efficacy

Evidence for topical delgocitinib in the treatment of chronic hand eczema is supported by two large, phase 3, double-blind, randomised controlled trials (RCTs): DELTA 1 and DELTA 2. Patients were randomised to apply delgocitinib 20 mg/gram cream or a vehicle cream twice daily for 16 weeks:

• Significantly more patients in the delgocitinib group met the primary outcome measure compared to the vehicle group (24.3% vs 8.4%; p<0.001).
  • The primary endpoint was defined as an IGA-CHE (Investigator Global Assessment of Chronic Hand Eczema) score of 0/1 (clear or almost clear) with ≥2-step improvement from baseline at week 16.
• The delgocitinib group were also more likely to achieve the secondary outcome measures:
  • HECSI-90 (≥90% improvement in Hand Eczema Severity Index) — 30.3% vs. 10.6%; p<0.001
  • DLQI (Dermatology Life Quality Index) ≥4-point improvement — 73.3% vs. 47.8%; p<0.001.
• Efficacy was maintained up to 52 weeks in a 36-week extension trial (DELTA 3).

In a head-to-head trial (DELTA FORCE) against oral alitretinoin in patients with refractory severe CHE, topical delgocitinib demonstrated superior efficacy and fewer side effects.

Safety benefits

• Delgocitinib cream is generally well tolerated, and it maintained a favourable safety profile throughout a 36-week extension trial.
• Unlike other topical JAK inhibitors, delgocitinib cream does not carry any black-box warnings (eg, thromboembolism, major adverse cardiac events, malignancy), reflecting a lower risk profile.
• It can be used during breastfeeding (care should be taken to avoid direct contact with the nipple or surrounding area after application to the hands and/or wrists).

Other benefits

• Symptom improvement was often seen within the first few weeks of therapy, with maximal benefits typically occurring at around 16 weeks.
• Delgocitinib provides a steroid-free topical treatment option for severe chronic hand eczema.
• Delgocitnib cream does not require regular laboratory monitoring of blood counts or liver function.

What are the disadvantages of delgocitinib?

• It is significantly more expensive than topical steroids.
• Like other topical therapies for hand eczema, symptoms often return after discontinuation of delgocitinib treatment.

What are the side effects and risks of delgocitinib?

In clinical trials, most adverse events were mild or moderate and considered unrelated to treatment. A 36-week extension trial found no new safety concerns.

Common side effects

• Application site reactions
  • Pain
  • Paresthesia
  • Pruritus
  • Erythema
  • Folliculitis
  • Acne
• Bacterial skin infections eg, finger cellulitis, paronychia

Rare and serious risks

• Delgocitinib cream may increase the risk of serious infection — eczema herpeticum was observed in one treated subject.
• Non-melanoma skin cancer has been reported in patients treated with delgocitinib cream and other topical JAK inhibitors. Periodic skin checks should be considered.

Approved datasheets are the official source of information for medicines, including approved uses, doses, and safety information. Check the individual datasheet in your country for information about medicines.

We suggest you refer to your national drug approval agency such as the Australian Therapeutic Goods Administration (TGA), US Food and Drug Administration (FDA), UK Medicines and Healthcare products regulatory agency (MHRA) / emc, and NZ Medsafe, or a national or state-approved formulary eg, the New Zealand Formulary (NZF) and New Zealand Formulary for Children (NZFC) and the British National Formulary (BNF) and British National Formulary for Children (BNFC).