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Drug

Delgocitinib

Approved · FDA / EMA
Emerging researchLate-stage development

Also known as Anzupgo, 1,6-DIAZASPIRO(3.4)OCTANE-1-PROPANENITRILE, 3-METHYL-.BETA.-OXO-6-(7H-PYRROLO(2,3-D)PYRIMIDIN-4-YL)-, (3S,4R)-.

RxNorm2721163ChEMBLCHEMBL4297507UNII9L0Q8KK220
1
Research papers
3
Active clinical trials
3
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

A Pilot Study to Assess Safety and Biomarker Responses of Delgocitinib (JAK1,2,3/TYK2 Inhibitor) in Central Centrifugal Cicatricial Alopecia and Lichen Planopilaris

Clinical trial2026-07-10Results expected Q2 2027 · ClinicalTrials.gov

Label change: DELGOCITINIB (NDA219155)

Regulatory2026-06-30FDA

Phase 2 Open Label Trial of Delgocitinib 20 mg/g Cream in Subjects With Frontal Fibrosing Alopecia (FFA)

Clinical trial2026-06-26Results expected Q4 2027 · ClinicalTrials.gov

A Phase 3, Double-blinded, Vehicle-controlled Trial to Investigate the Efficacy and Safety of Twice Daily Delgocitinib Cream in Adult Participants With Lichen Sclerosus During a 12-Week Initial Treatment Period Followed by a 40-Week Continuation Treatment Period

Clinical trial2026-06-09Results expected Q1 2028 · ClinicalTrials.gov

A Phase 3 Clinical Trial to Evaluate Efficacy and Safety of Twice-daily Applications of Delgocitinib Cream 20 mg/g Compared With Cream Vehicle for a 16-week Treatment Period in Adolescents 12-17 Years of Age With Moderate to Severe Chronic Hand Eczema (DELTA TEEN)

Clinical trial2026-05-04Results posted · ClinicalTrials.gov

A Phase 3 Trial to Evaluate Efficacy, Safety, and Pharmacokinetics of Twice-Daily Applications of Delgocitinib Cream 20 mg/g in Chinese Adults and Adolescents (12-17 Years of Age) With Moderate to Severe Chronic Hand Eczema

Clinical trial2025-09-12Completed · ClinicalTrials.gov

Approval: DELGOCITINIB (NDA219155)

Regulatory2025-07-23FDA

A 24 Week, Randomised, Assessor Blinded, Active-controlled, Parallel Group, Phase 3, 2 Arm Trial to Compare the Efficacy and Safety of Delgocitinib Cream 20 mg/g Twice-daily With Alitretinoin Capsules Once-daily in Adult Participants With Severe Chronic Hand Eczema

Clinical trial2025-05-09Results posted · ClinicalTrials.gov

Efficacy and safety of topical delgocitinib cream versus oral alitretinoin capsules in adults with severe chronic hand eczema (DELTA FORCE): a 24-week, randomised, head-to-head, phase 3 trial.

Research2025-04-16Lancet (London, England)

A Phase 3 Extension Trial of DELTA 1 and DELTA 2 to Evaluate the Long-term Safety of a Twice-daily Treatment With Delgocitinib Cream 20 mg/g as Needed for up to 36 Weeks in Adult Subjects With Chronic Hand Eczema (DELTA 3)

Clinical trial2025-04-08Results posted · ClinicalTrials.gov

Approval: Anzupgo (EMA)

Regulatory2024-09-19EMA

A Phase 1 Clinical Trial to Evaluate the Pharmacokinetics of Twice-daily Applications of Delgocitinib Cream 20 mg/g for 1 Week in Adult Subjects With Moderate to Severe Chronic Hand Eczema.

Clinical trial2022-11-22Completed · ClinicalTrials.gov

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Delgocitinib
Aliases & brands
Anzupgo1,6-DIAZASPIRO(3.4)OCTANE-1-PROPANENITRILE, 3-METHYL-.BETA.-OXO-6-(7H-PYRROLO(2,3-D)PYRIMIDIN-4-YL)-, (3S,4R)-
RxNorm CUI
2721163
ChEMBL ID
CHEMBL4297507
UNII
9L0Q8KK220
Regulatory jurisdictions
emafda

Regulatory timeline

3 events

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Approval / market entry confirmed across FDA and EMA (2024-09-19 → 2025-07-23)
Earliest approval
2024-09-19
Latest approval
2025-07-23
Authorities
FDA · EMA
Total events
3
fdaU.S. Food and Drug Administration· 2 events
2026-06-30Label change
Label change: DELGOCITINIB (NDA219155)
Evidence ↗
2025-07-23ApprovalMulti-authority
Approval: DELGOCITINIB (NDA219155)
Evidence ↗
emaEuropean Medicines Agency· 1 event
2024-09-19ApprovalMulti-authority
Approval: Anzupgo (EMA)

Indication: Anzupgo is indicated for the treatment of moderate to severe chronic hand eczema (CHE)

Evidence ↗

Data from the U.S. Food and Drug Administration (U.S. Food and Drug Administration), public domain (CC0).

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

10 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
10
registered trials across all phases
LATEST COMPLETION 2025
3
Active studies
3
Recruiting
5
Late-stage (III+)
7
Completed
PHASE DISTRIBUTIONn = 10
Early Phase 11Phase 12Phase 22Phase 35

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

A Phase 3, Double-blinded, Vehicle-controlled Trial to Investigate the Efficacy and Safety of Twice Daily Delgocitinib Cream in Adult Participants With Lichen Sclerosus During a 12-Week Initial Treatment Period Followed by a 40-Week Continuation Treatment Period

RecruitingPH IIILEO Pharman=6522028

A Phase 3 Trial to Evaluate Efficacy, Safety, and Pharmacokinetics of Twice-Daily Applications of Delgocitinib Cream 20 mg/g in Chinese Adults and Adolescents (12-17 Years of Age) With Moderate to Severe Chronic Hand Eczema

CompletedPH IIILEO Pharman=3622025

A Phase 3 Clinical Trial to Evaluate Efficacy and Safety of Twice-daily Applications of Delgocitinib Cream 20 mg/g Compared With Cream Vehicle for a 16-week Treatment Period in Adolescents 12-17 Years of Age With Moderate to Severe Chronic Hand Eczema (DELTA TEEN)

CompletedPH IIILEO Pharman=982024

A 24 Week, Randomised, Assessor Blinded, Active-controlled, Parallel Group, Phase 3, 2 Arm Trial to Compare the Efficacy and Safety of Delgocitinib Cream 20 mg/g Twice-daily With Alitretinoin Capsules Once-daily in Adult Participants With Severe Chronic Hand Eczema

CompletedPH IIILEO Pharman=5132023

A Phase 3 Extension Trial of DELTA 1 and DELTA 2 to Evaluate the Long-term Safety of a Twice-daily Treatment With Delgocitinib Cream 20 mg/g as Needed for up to 36 Weeks in Adult Subjects With Chronic Hand Eczema (DELTA 3)

CompletedPH IIILEO Pharman=8012023

Recent completions

Trials that read out recently, adding to the completed evidence base.

A Phase 3 Trial to Evaluate Efficacy, Safety, and Pharmacokinetics of Twice-Daily Applications of Delgocitinib Cream 20 mg/g in Chinese Adults and Adolescents (12-17 Years of Age) With Moderate to Severe Chronic Hand Eczema

CompletedPH IIILEO Pharman=3622025

A Phase 3 Clinical Trial to Evaluate Efficacy and Safety of Twice-daily Applications of Delgocitinib Cream 20 mg/g Compared With Cream Vehicle for a 16-week Treatment Period in Adolescents 12-17 Years of Age With Moderate to Severe Chronic Hand Eczema (DELTA TEEN)

CompletedPH IIILEO Pharman=982024

A 24 Week, Randomised, Assessor Blinded, Active-controlled, Parallel Group, Phase 3, 2 Arm Trial to Compare the Efficacy and Safety of Delgocitinib Cream 20 mg/g Twice-daily With Alitretinoin Capsules Once-daily in Adult Participants With Severe Chronic Hand Eczema

CompletedPH IIILEO Pharman=5132023

A Phase 3 Extension Trial of DELTA 1 and DELTA 2 to Evaluate the Long-term Safety of a Twice-daily Treatment With Delgocitinib Cream 20 mg/g as Needed for up to 36 Weeks in Adult Subjects With Chronic Hand Eczema (DELTA 3)

CompletedPH IIILEO Pharman=8012023

A Phase 1 Clinical Trial to Evaluate the Pharmacokinetics of Twice-daily Applications of Delgocitinib Cream 20 mg/g for 1 Week in Adult Subjects With Moderate to Severe Chronic Hand Eczema.

CompletedPH ILEO Pharman=152022

A Phase 1 Clinical Trial to Evaluate QTcF Prolongation and Proarrhythmic Potential of the Non Antiarrhythmic Drug Delgocitinib Following Oral Administration in Healthy Subjects

CompletedPH ILEO Pharman=402022

Research activity

1 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Major research themes5
Alitretinoin1Dermatologic Agents1Eczema1Hand Dermatoses1Pyrroles1
Journals, researchers & institutions
Top journals
  • Lancet (London, England)1
Leading researchers
  • Bauer A1
  • Costanzo A1
  • Giménez-Arnau AM1
  • Legat FJ1
  • Lynde C1
  • Mellerup N1
  • Østerdal ML1
  • Pinter A1
Leading institutions
free-text, unnormalised
  • Goethe-Universität Frankfurt am Main1
  • Hospital Del Mar Research Institute1
  • Hospital General Universitario Dr Balmis1
  • Humanitas University1
  • Lynde Institute for Dermatology and Lynderm Research1
  • Medical University of Graz1
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.