Brand Name
Anzupgo
Generic Name
Delgocitinib
View Brand Information FDA approval date: July 24, 2025
Classification: Janus Kinase Inhibitor
Form: Cream
What is Anzupgo (Delgocitinib)?
ANZUPGO is indicated for the topical treatment of moderate to severe chronic hand eczema in adults who have had an inadequate response to, or for whom topical corticosteroids are not advisable. ANZUPGO is a Janus kinase inhibitor indicated for the topical treatment of moderate to severe chronic hand eczema 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. Limitations of Use Use of ANZUPGO in combination with other JAK inhibitors or potent immunosuppressants is not recommended.
Approved To Treat
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A Proof-of-concept Phase 2a, Double-blind, 2-arm Trial to Investigate the Efficacy and Safety of Twice Daily Delgocitinib Cream 20 mg/g Compared With Cream Vehicle During a 16-week Treatment Period in Adult Subjects With Mild to Severe Palmoplantar Pustulosis
Summary: The main objective of the study is to evaluate the efficacy of twice daily applications of delgocitinib cream 20 mg/g compared with cream vehicle in the treatment of adult participants with mild to severe palmoplantar pustulosis (PPP). Total study duration for each participants will be approximately 18 weeks, for an approximate total of 9 visits.
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Brand Information
Anzupgo (delgocitinib)
1INDICATIONS 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.
2DOSAGE FORMS AND STRENGTHS
Cream, 2%: Each gram of ANZUPGO cream contains 20 mg of delgocitinib in a white to slightly brown cream.
3CONTRAINDICATIONS
None
4DESCRIPTION
ANZUPGO (delgocitinib) cream is a white to slightly brown cream for topical use and contains delgocitinib as the active ingredient.
Delgocitinib is a white to almost white powder. Delgocitinib is slightly soluble in aqueous solutions at pH 5.0. The pKa of delgocitinib is 5.5.
Delgocitinib is a Janus kinase (JAK) inhibitor [JAK1, JAK2, JAK3, and tyrosine kinase 2 (TYK2)] with the chemical name 3-[(3S,4R)-3-Methyl- 6-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-1,6-diazaspiro[3.4]octan-1-yl]-3- oxopropanenitrile.
The molecular formula is C
Each gram of ANZUPGO contains 20 mg of delgocitinib. Inactive ingredients include benzyl alcohol, butylated hydroxyanisole, cetostearyl alcohol, citric acid monohydrate, edetate disodium, hydrochloric acid, mineral oil, polyoxyl 20 cetostearyl ether, and purified water.
5CLINICAL STUDIES
The efficacy of ANZUPGO was evaluated in two randomized, double-blind, vehicle-controlled, 16-week trials (TRIAL 1 [NCT04871711] and TRIAL 2 [NCT04872101]) which enrolled a total of 960 adult subjects with moderate to severe CHE who had a history of inadequate response to, or for whom topical corticosteroids were not advisable. All subjects who completed TRIAL 1 and TRIAL 2 were eligible to enroll into a long-term extension trial (TRIAL 3 [NCT04949841]).
Disease severity of enrolled subjects was defined using the Investigator's Global Assessment for chronic hand eczema (IGA-CHE) score and the Hand Eczema Symptom Diary (HESD) itch score (weekly average). The IGA-CHE is the investigator's overall assessment of chronic hand eczema at a given time point on a scale ranging from 0 (clear) to 4 (severe). The HESD itch score assesses disease severity of pruritus using a scale ranging from 0 (no symptoms) to 10 (severe symptoms). Subjects enrolled in these three trials had an IGA-CHE score of 3 or 4 (moderate or severe, respectively) and a HESD itch score (weekly average) of ≥ 4 points at baseline.
Across all treatment groups in TRIAL 1 and TRIAL 2, the mean age of enrolled subjects was 44.1 years, and 8% of subjects were 65 years of age or older, 64% were female, 90% were White, 4% were Asian, and 1% were Black. For ethnicity, 94% of subjects identified as not Hispanic or Latino and 3% of subjects identified as Hispanic or Latino. The primary classifications of CHE by subtype were atopic hand eczema (35.9%), hyperkeratotic eczema (21.5%), irritant contact dermatitis (19.6%), allergic contact dermatitis (13.9%), vesicular hand eczema (9.1%), and contact urticaria/protein contact dermatitis (0.1%). Across all trial arms, 28% of subjects were diagnosed with two or more overlapping CHE subtypes.
The HESD itch score is a weekly average of daily itch severity on an 11-point scale from 0-10 that assesses the maximal intensity of pruritus in the last 24 hours with 0 being no pruritus and 10 being the worst pruritus. The HESD pain score is a weekly average of daily pain severity on an 11-point scale from 0-10 that assesses the maximal intensity of pain in the last 24 hours with 0 being no pain and 10 being the worst pain. In these trials, 28% of subjects had a baseline IGA-CHE score of 4 (severe CHE). The mean baseline HESD itch and pain scores were 7.1 and 6.7, respectively.
In both trials, subjects applied either topical ANZUPGO or vehicle twice daily to affected areas on the hands and wrists for 16 weeks. The primary efficacy endpoint was the proportion of subjects who achieved IGA-CHE treatment success (IGA-CHE TS) at Week 16, defined as a score of 0 (clear) or 1 (almost clear) with at least a 2-point improvement from baseline. Table 2 describes the efficacy results at Week 16 in TRIAL 2. Figure 1 describes the proportion of subjects who achieve IGA-CHE TS during the 16-week treatment period in TRIAL 1 and TRIAL 2. Figures 2 and 3 describe the proportion of subjects who achieved HESD itch ≥ 4-point improvement and HESD pain ≥ 4-point improvement during the 16-week treatment period in TRIAL 1 and TRIAL 2.
Figure 1: Proportion of Adult Subjects with Moderate to Severe CHE who Achieved IGA-CHE Treatment Success (0 or 1 with ≥2-point improvement from baseline) Over Time in TRIAL 1 and TRIAL 2
Point symbols are the multiplicity controlled timepoints.
Figure 2: Proportion of Adult Subjects with Moderate to Severe CHE who Achieved HESD Itch ≥ 4-point Improvement Over Time in TRIAL 1 and TRIAL 2
Based on the number of subjects whose weekly average baseline value was ≥ 4 (scale from 0-10).
Point symbols are the multiplicity controlled timepoints.
Figure 3: Proportion of Adult Subjects with Moderate to Severe CHE who Achieved HESD Pain ≥ 4-point Improvement Over Time in TRIAL 1 and TRIAL 2
Based on the number of subjects whose weekly average baseline value was ≥ 4 (scale from 0-10).
Point symbols are the multiplicity controlled timepoints.
6PATIENT COUNSELING INFORMATION
Advise patients to read the FDA-approved patient labeling (Patient Information).
7MEDICATION GUIDE ANZUPGO®(an zup goe) (delgocitinib) cream
Important: ANZUPGO is for use on the skin (topical use) only. Do not use ANZUPGO in or on your eyes, mouth, or vagina.
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.
- 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:
ANZUPGO can make you more likely to get infections or make worse any infections that you have. If you get a serious infection, your healthcare provider may stop your treatment with ANZUPGO until your infection is controlled. - Non-melanoma skin cancer. ANZUPGO may increase your risk of certain non-melanoma skin cancers. Your healthcare provider will regularly check your skin during your treatment with ANZUPGO.
- Avoid sunlamps and limit the amount of time you spend in the sunlight. Wear protective clothing when you are in the sun or use a broad-spectrum sunscreen.
- Tell your healthcare provider if you have ever had any type of cancer.
- Potential risks from Janus kinase (JAK) inhibition. It is not known whether using ANZUPGO has the same risks as taking other oral or topical JAK inhibitors. Increased risk of death (all causes) has happened in people who were 50 years of age and older with at least 1 heart disease (cardiovascular) risk factor who were taking a JAK inhibitor used to treat rheumatoid arthritis (RA) compared to people taking another medicine in a class of medicines called TNF blockers. ANZUPGO is not for use in people with RA. Other oral or topical JAK inhibitors have also caused increased cholesterol.
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What is ANZUPGO?
ANZUPGO is a prescription medicine used on the skin (topical) to treat moderate to severe chronic hand eczema in adults who are not well-controlled with, or cannot use topical corticosteroids.
The use of ANZUPGO along with other JAK inhibitors or strong immunosuppressants is not recommended.
It is not known if ANZUPGO is safe and effective in children.
Before using ANZUPGO, tell your healthcare provider about all your medical conditions, including if you:
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- have an infection
- have recently received or are scheduled to receive a vaccine. People who use ANZUPGO should not receive live vaccines right before starting, during treatment, or right after treatment with ANZUPGO.
- are pregnant or plan to become pregnant. It is not known if ANZUPGO will harm your unborn baby.
- are breastfeeding or plan to breastfeed. It is not known if ANZUPGO passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby during treatment with ANZUPGO.
Tell your healthcare provider about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
How should I use ANZUPGO?
- ANZUPGO is for use on the skin of your hands and wrists only. Do not use ANZUPGO in or on your eyes, mouth, vagina or other mucous membranes. If contact with mucous membranes happens, rinse well with water.
- Use ANZUPGO exactly as your healthcare provider tells you to use it.
- Clean and dry skin of the affected areas before applying ANZUPGO.
- Apply a thin layer of ANZUPGO 2 times each day to affected areas on your hands and wrists. Do not use more than 30 grams in 2 weeks or 60 grams in a month.
- If someone else applies ANZUPGO for you, they should wash their hands after applying ANZUPGO.
What are the possible side effects of ANZUPGO?
ANZUPGO may cause serious side effects, including:
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The most common side effects of ANZUPGO include:
- application site reactions, including pain, tingling, itching, and redness
- bacterial skin infections, including finger cellulitis, and nail infections
- low white blood cells
These are not all of the possible side effects of ANZUPGO.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
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.
General information about the safe and effective use of ANZUPGO.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use ANZUPGO for a condition for which it was not prescribed. Do not give ANZUPGO to other people, even if they have the same symptoms you have. It may harm them. You can ask your pharmacist or healthcare provider for information about ANZUPGO that is written for health professionals.
What are the ingredients in ANZUPGO?
Active ingredient: delgocitinib
Inactive ingredients: benzyl alcohol, butylated hydroxyanisole, cetostearyl alcohol, citric acid monohydrate, edetate disodium, hydrochloric acid, mineral oil, polyoxyl 20 cetostearyl ether, and purified water.
Manufactured by:
Distributed by:
ANZUPGO
For more information about ANZUPGO, go to www.ANZUPGO.com or call 1-877-494-4536.
This Medication Guide has been approved by the U.S. Food and Drug Administration.
Issued: 7/2025
LEO®
075997
8PRINCIPAL DISPLAY PANEL - 30 g Tube Carton
Anzupgo
LEO
For Topical Use Only
NDC 50222-280-30
30 g
