Product Dossier

ANZUPGO

Product Dossier for ANZUPGO (delgocitinib, LEO Pharma). ARTG record, PBS listing, PBAC outcomes, AusPAR — compiled by arcimedes.

What it is

ANZUPGO is a cream containing 20 mg of delgocitinib per gram . Delgocitinib is a pan Janus kinase (JAK) inhibitor that targets the activity of all four members of the JAK family of enzymes consisting of JAK1, JAK2, JAK3, and tyrosine kinase 2 (TYK2) . In human cellular studies, inhibition of the JAK-STAT pathway by delgocitinib attenuates the signalling of several pro-inflammatory cytokines, downregulating the immune and inflammatory responses in cells of relevance to chronic hand eczema pathology .

Approved indications

— Treatment of moderate to severe chronic hand eczema in adults for whom topical corticosteroids are inadequate or inappropriate .

Dosing overview

A thin layer of ANZUPGO should be applied twice daily to the affected skin of the hands and wrists until the skin is clear or almost clear . It is recommended to apply the cream at regular intervals, approximately 12 hours apart . In the event of recurrence of the signs and symptoms of chronic hand eczema (flares), twice daily treatment of the affected areas should be re-initiated as needed . Treatment should be discontinued if no improvement is seen after 12 weeks of continuous treatment .

Key safety warnings

Non-melanoma skin cancer, predominantly basal cell carcinoma, has been reported in patients treated with topical JAK inhibitors . Periodic skin examination of the application site is recommended for all patients, particularly those with risk factors for skin cancer . Application site reactions (including application site pain, application site paraesthesia, application site pruritus, and application site erythema) were reported in 1.0% of patients treated with delgocitinib cream compared with 2.5% of patients treated with vehicle cream . The majority of application site reactions were mild in severity with no serious or severe events being reported . This medicinal product is subject to additional monitoring in Australia, which will allow quick identification of new safety information .

Contraindications

Hypersensitivity to the active substance or to any of the excipients .

Regulatory history

ANZUPGO was approved by the TGA on 27 August 2025 for the treatment of moderate to severe chronic hand eczema in adults for whom topical corticosteroids are inadequate or inappropriate . This decision followed an evaluation through the TGA's Comparable Overseas Regulator B process . ANZUPGO delgocitinib 20 mg/g cream was first listed on the ARTG on 5 September 2025 .

AusPAR (TGA)