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Drug

Dupilumab

Approved · FDA / EMA
ClassInterleukin-4 receptor subunit alpha antagonistEmerging researchLate-stage developmentCooling momentum

Also known as Dupixent.

12
Research papers
55
Active clinical trials
IL4R
Primary target
35
Regulatory events
Latest activity
beta

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

Profile

Identifiers & mechanism

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

Canonical name
Dupilumab
Aliases & brands
Dupixent
RxNorm CUI
1876376
ChEMBL ID
CHEMBL2108675
ATC codes
D11AH05
UNII
420K487FSG
Primary mechanism
Interleukin-4 receptor subunit alpha antagonist
Regulatory jurisdictions
emamhrafda

Pharmacology & targets

1 target

Known molecular targets and mechanisms supported by curated pharmacology databases.

ANTAGONISTInterleukin-4 receptor subunit alpha antagonist

Regulatory timeline

35 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 (2017-03-282019-03-11)
Earliest approval
2017-03-28
Latest approval
2026-04-22
Authorities
FDA · EMA · MHRA
Total events
35
fdaU.S. Food and Drug Administration· 33 events
2026-07-15Label change
Label change: DUPILUMAB (BLA761055)
Evidence ↗
2026-04-22Indication expansion
Indication expansion: DUPILUMAB (BLA761055)
Evidence ↗
2026-04-16Label change
Label change: DUPILUMAB (BLA761055)
Evidence ↗
emaEuropean Medicines Agency· 1 event
2017-09-26ApprovalMulti-authority
Approval: Dupixent (EMA)
Indication: Atopic dermatitis Adults and adolescents Dupixent is indicated for the treatment of moderate-to-severe atopic dermatitis in adults and adolescents 12 years and older who areShow full indication

Atopic dermatitis Adults and adolescents Dupixent is indicated for the treatment of moderate-to-severe atopic dermatitis in adults and adolescents 12 years and older who are candidates for systemic therapy. Children 6 months to 11 years of age Dupixent is indicated for the treatment of severe atopic dermatitis in children 6 months to 11 years old who are candidates for systemic therapy. Asthma Adults and adolescents Dupixent is indicated in adults and adolescents 12 years and older as add-on maintenance treatment for severe asthma with type 2 inflammation characterised by raised blood eosinophils and/or raised fraction of exhaled nitric oxide (FeNO), see section 5.1, who are inadequately controlled with high dose inhaled corticosteroids (ICS) plus another medicinal product for maintenance treatment. Children 6 to 11 years of age Dupixent is indicated in children 6 to 11 years old as add-on maintenance treatment for severe asthma with type 2 inflammation characterised by raised blood eosinophils and/or raised fraction of exhaled nitric oxide (FeNO), who are inadequately controlled with medium to high dose inhaled corticosteroids (ICS) plus another medicinal product for maintenance treatment. Chronic rhinosinusitis with nasal polyposis (CRSwNP) Dupixent is indicated as an add-on therapy with intranasal corticosteroids for the treatment of adults with severe CRSwNP for whom therapy with systemic corticosteroids and/or surgery do not provide adequate disease control. Prurigo Nodularis (PN) Dupixent is indicated for the treatment of adults with moderate-to-severe prurigo nodularis (PN) who are candidates for systemic therapy. Eosinophilic esophagitis (EoE) Dupixent is indicated for the treatment of eosinophilic esophagitis in adults, adolescents and children aged 1 year and older, weighing at least 15 kg, who are inadequately controlled by, are intolerant to, or who are not candidates for conventional medicinal therapy. Chronic obstructive pulmonary disease (COPD) Dupixent is indicated in adults as add-on maintenance treatment for uncontrolled chronic obstructive pulmonary disease (COPD) characterised by raised blood eosinophils on a combination of an inhaled corticosteroid (ICS), a long-acting beta2-agonist (LABA), and a long-acting muscarinic antagonist (LAMA), or on a combination of a LABA and a LAMA if ICS is not appropriate. Chronic Spontaneous Urticaria (CSU) Dupixent is indicated for the treatment of moderate to severe chronic spontaneous urticaria in adults, adolescents and children (2 years and above) patients with inadequate response to H1 antihistamines and who are naive to anti-IgE therapy for CSU.

Evidence ↗
mhraMedicines and Healthcare products Regulatory Agency· 1 event
2022-11-29Safety communicationSafety
Drug Safety Update: Dupilumab (Dupixent▼): risk of ocular adverse reactions and need for prompt management
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.

Contains public sector information from the Medicines and Healthcare products Regulatory Agency (MHRA) licensed under the Open Government Licence (OGL v3).

Clinical trials

146 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
146
registered trials across all phases
LATEST COMPLETION 2025
55
Active studies
34
Recruiting
83
Late-stage (III+)
74
Completed
17
Discontinued
PHASE DISTRIBUTIONn = 146
Early Phase 14Phase 111Phase 1 / 23Phase 245Phase 2 / 33Phase 333Phase 444Phase N / A3

Late-stage studies

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

Recent completions

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

Research activity

12 papers

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

Publications over time
20142024
Most influential
Recent papers
Major research themes4
Antibodies, Monoclonal1Dermatitis, Atopic1Patient Reported Outcome Measures1Quality of Life1
Journals, researchers & institutions
Top journals
  • The New England journal of medicine4
  • Journal of the American Academy of Dermatology2
  • Lancet (London, England)2
  • JAMA1
  • medRxiv : the preprint server for health sciences1
  • Nature communications1
Leading researchers
  • Pirozzi G9
  • Stahl N7
  • Yancopoulos GD7
  • Graham NM6
  • Ardeleanu M5
  • Bieber T4
  • Eckert L4
  • Hamilton JD4
Leading institutions
free-text, unnormalised
  • Oregon Health and Science University3
  • Center for Public Health Genomics and Department of Public Health Sciences2
  • Charité University2
  • Oregon Medical Research Center2
  • University of Bonn2
  • University of Rochester Medical Center2
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.