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Prescription medicine

Delgocitinib Brand names: Anzupgo

Delgocitinib (Anzupgo) is a prescription medicine with an FDA approval on record since 2025. No generic is listed in FDA's NDC Directory.

  • No generic listed

Check it at the source: the delgocitinib FDA label on DailyMed (effective July 10, 2026, LEO Pharma, Inc); the NDA 219155 record on Drugs@FDA; every delgocitinib label on DailyMed.

Highlights of the record

FDA label of July 10, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026

Used for

From the label: 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.

Forms and strengths

  • 20 mg/g

Cream.

On the market

Earliest approval on file
July 23, 2025 Anzupgo, Leo Pharma As; Drugs@FDA’s file, where older or withdrawn approvals can be missing
Generic approvals
No generic approved
Labelers listed (NDC)
1 of which 0 under generic applications, 1 under brand applications, repackagers included
Last listed patent
September 19, 2031 Anzupgo cream; not a generic launch date

Supply and safety

Pharmacy cost (NADAC)
Not in the survey
Shortage (FDA)
No current entry
Recalls by its makers (FDA)
No recall recorded
FAERS reports
233 through July 30, 2026

What is delgocitinib used for?

From the label: 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. Limitations of Use Use of ANZUPGO in combination with other JAK inhibitors or potent immunosuppressants is not recommended. 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.

Conditions named in the indications of delgocitinib's FDA labels, with every medicine labeled for each:

FDA pharmacologic class: Janus Kinase Inhibitor.

Source: FDA drug label (Anzupgo), LEO Pharma, Inc, effective July 10, 2026 (SPL set a59bf36e-6f04-4b47-b385-8040c95f040c), via openFDA; the full label on DailyMed

What does the patient leaflet for delgocitinib say first?

The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.

From the patient leaflet: What is the most important information I should know about ANZUPGO?

ANZUPGO may cause serious side effects, including: Serious Infections. ANZUPGO may increase your risk of infections. ANZUPGO contains delgocitinib. Delgocitinib belongs to a class of medicines called Janus kinase (JAK) inhibitors. JAK inhibitors are medicines that affect your immune system. JAK inhibitors can lower the ability of your immune system to fight infections. Some people have had serious infections while taking JAK inhibitors by mouth or applying on the skin, including tuberculosis (TB), and infections caused by bacteria, fungi, or viruses that can spread throughout the body. Some people have been hospitalized or died from these infections. ANZUPGO should not be used in people with an active, serious infection. You should not start using ANZUPGO if you have any kind of infection unless your healthcare provider tells you it is okay. You may be at a higher risk of developing shingles (herpes zoster) or eczema herpeticum (a blistery, painful skin rash) during treatment with ANZUPGO. Before starting ANZUPGO, tell your healthcare provider if you: are being treated for an infection have an infection that does not go away or that keeps coming back have TB or have been in close contact with someone with TB have had shingles (herpes zoster) have had hepatitis B or C think you have an infection or have symptoms of an infection such as: fever, sweating, or chills muscle aches cough or shortness of breath blood in your phlegm weight loss warm, red, or painful skin or sores on your body diarrhea or stomach pain burning when you urinate or urinating more often than usual feeling very tired After starting ANZUPGO, call your healthcare provider right away if you have any symptoms of an infection. […]

From the patient leaflet: How should I store ANZUPGO?

Store ANZUPGO at room temperature between 68°F to 77°F (20°C to 25°C). Do not freeze ANZUPGO. Keep ANZUPGO and all medicines out of the reach of children.

Source: FDA drug label (Anzupgo), LEO Pharma, Inc, effective July 10, 2026 (SPL set a59bf36e-6f04-4b47-b385-8040c95f040c), via openFDA; the full label on DailyMed

Is there a generic for delgocitinib (Anzupgo)?

No generic delgocitinib is approved (Drugs@FDA, October 8, 2026).

The Orange Book lists 1 patent for Anzupgo cream: the compound patent runs to September 19, 2031. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.

  • 2025 earliest approval on file
  • 2031 last listed patent

Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)

What does the delgocitinib label say about other medicines?

The delgocitinib label names 1 other medicine in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.

Medicine namedSectionWhat the label says
Methotrexatewarnings and precautionsIn a large, randomized, postmarketing safety trial of an oral JAK inhibitor in combination with methotrexate in rheumatoid arthritis (RA), patients 50 years of age and older with at least one cardiovascular risk factor, higher rates of all-cause mortality, including sudden cardiovascular death, major adverse …

Check delgocitinib against other medicines

Source: FDA drug label (Anzupgo), LEO Pharma, Inc, effective July 10, 2026 (SPL set a59bf36e-6f04-4b47-b385-8040c95f040c), via openFDA; the full label on DailyMed

What do FAERS reports show for delgocitinib?

The FDA Adverse Event Reporting System holds 233 reports that list delgocitinib among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 2 are coded as a death and 35 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.

The most reported reactions

  • Product Use In Unapproved Indication (a use or a product term, not a reaction)56
  • Pruritus (named in the label)26
  • Dermatitis Atopic25
  • Dermatitis20
  • Erythema (named in the label)20
  • Drug Ineffective (a use or a product term, not a reaction)18
  • Rash14
  • Eczema (a use or a product term, not a reaction)11

Side effects: the label's list and every FAERS reaction

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026

What else is labeled for the same conditions as delgocitinib?

6 other medicines are given the same way (topical) and in the same FDA class as delgocitinib or labeled mainly for the same use (eczema (atopic dermatitis)), the same class first. Eczema (atopic dermatitis) lists all 26 medicines labeled for it, by any route. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.

MedicineShared indicationGeneric labelers (topical)Pharmacy costShortage
RuxolitinibEczema (atopic dermatitis)none listed$34.01 per gram 1.5% creamNo current entry
OatmealEczema (atopic dermatitis)none listedn/aNo current entry
DesonideEczema (atopic dermatitis)12 labelers$0.252 per gram 0.05% creamNo current entry
PimecrolimusEczema (atopic dermatitis)2 labelers$3.31 per gram 1% creamNo current entry
CrisaboroleEczema (atopic dermatitis)none listed$11.68 per gram 2% ointmentNo current entry
DifamilastEczema (atopic dermatitis)none listedn/aNo current entry

Every medicine labeled for the same conditions as delgocitinib

Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)

What next?

Alternatives to delgocitinib
6 medicines for the same use
Other janus kinase inhibitors
the pharmacologic class, with prices and generics
Delgocitinib side effects
the label's list beside FAERS reports
Check an interaction
what two or more labels say about each other