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.
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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.
Limitations of Use
Use of ANZUPGO in combination with other JAK inhibitors or potent immunosuppressants is not recommended.
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 1 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
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
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
6HOW SUPPLIED/STORAGE AND HANDLING
How Supplied
ANZUPGO is a white to slightly brown cream containing 2% delgocitinib (each gram contains 20 mg of delgocitinib) and is supplied in the following package:
- 30 g laminated tubes: NDC 50222-280-30
7PATIENT COUNSELING INFORMATION
Advise patients to read the FDA-approved patient labeling (Patient Information).
Administration Instructions
Advise patients that ANZUPGO is for topical use only and is not for ophthalmic, oral, or intravaginal use
Advise patients to limit treatment to 30 grams per 2 weeks or 60 grams per month.
Instruct patients to clean and dry affected areas prior to applying ANZUPGO. Instruct patients to apply ANZUPGO, twice daily, to affected areas only on the hands and wrists, and avoid contact with eyes, mouth, or other mucous membranes
Serious Infections
Inform patients that ANZUPGO may lower the ability of their immune system to fight infections and to contact their healthcare provider immediately if they develop any signs or symptoms of infection
Non-melanoma Skin Cancers
Inform patients that ANZUPGO may increase the risk of developing non-melanoma skin cancers. Inform patients that periodic skin examinations should be performed while using ANZUPGO. Instruct patients to inform their healthcare provider if they have ever had any type of cancer. Advise patients to avoid sunlamps and minimize exposure to sunlight by wearing sun-protective clothing or using broad-spectrum sunscreen
Immunizations
Advise patients treated with ANZUPGO to avoid use of live vaccines immediately prior to, during, and immediately after treatment
Lactation
Advise breastfeeding women to avoid direct contact with the nipple and surrounding area immediately after applying ANZUPGO to the hands and/or wrists to minimize infant exposure
8PRINCIPAL DISPLAY PANEL - 30 g Tube Carton
Anzupgo
LEO
For Topical Use Only
NDC 50222-280-30
30 g
