Quick answers
- What is Delgocitinib used for?
- The FDA-approved label (Anzupgo, LEO Pharma, Inc, July 10, 2026) says: “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. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Delgocitinib have a boxed warning?
- No. None of the 1 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Delgocitinib?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Delgocitinib been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Delgocitinib?
- 1 company lists prescription products of Delgocitinib in the FDA NDC Directory, including LEO Pharma Inc..
What Delgocitinib is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
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. …
— FDA label: Anzupgo, LEO Pharma, Inc, effective July 10, 2026. Read the full label on DailyMed →
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
Forms and how it is given
| Dosage forms | Cream |
|---|---|
| Route | Topical |
| Prescription products | 1 in the FDA NDC Directory |
| Brand names | Anzupgo |
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- LEO Pharma Inc.1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA219155 ANZUPGO | Leo Pharma As | July 23, 2025 | 1, latest June 30, 2026 2026: Labeling |
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 2721167, 2721172 |
|---|---|
| SPL set ID of the quoted label | a59bf36e-6f04-4b47-b385-8040c95f040c |
| FDA labels (SPL) | 1 |
| FDA applications | NDA219155 |
| Active ingredients (FDA) | DELGOCITINIB |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Anzupgo, LEO Pharma, Inc, effective July 10, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →