Wednesday, July 8, 2026

Drug profile · INN

dupilumab

dupilumab (DUPIXENT) is a interleukin-4 receptor subunit alpha antagonist. Associated with Sanofi-aventis Healthcare Pty Ltd. Route of administration: injection. Current US regulatory status: approved.

FDA: approved EMA: approved TGA: approved PMDA: approved NMPA: clinical trials Dermatologicals (D11) D11AH05
US status approved
Patents linked 0
Pipeline programs 76
News articles 3
Drug details — dupilumab

Quick answer

dupilumab (DUPIXENT) is a interleukin-4 receptor subunit alpha antagonist. Associated with Sanofi-aventis Healthcare Pty Ltd. Route of administration: injection. Current US regulatory status: approved.

Key facts

INN dupilumab
Brand DUPIXENT
Mechanism Interleukin-4 receptor subunit alpha antagonist
Target Interleukin-4 receptor subunit alpha
Therapeutic class Dermatologicals (D11)
Route INJECTION
Formulation INJECTABLE
ATC code D11AH05

Mechanism of action

Interleukin-4 receptor subunit alpha antagonist

Primary target: Interleukin-4 receptor subunit alpha

Approval history

Authority Status Date
FDA approved
EMA approved
TGA approved
PMDA approved
NMPA clinical trials

Recent coverage

Pipeline programs

  1. Dupilumab Phase 3 · Regeneron UK · Wheezing
  2. Dupilumab Phase 3 · Regeneron UK · Eosinophilic Esophagitis (EoE)
  3. Dupilumab Phase 3 · Regeneron UK · Prurigo Nodularis
  4. Dupilumab Phase 3 · Regeneron UK · Lichen Simplex Chronicus
  5. Dupilumab Prefilled Syringe Phase 3 · Regeneron UK · Asthma Control
  6. Dupilumab SAR231893 Phase 3 · Regeneron UK · Chronic Spontaneous Urticaria
  7. Dupilumab SAR231893 Phase 3 · Regeneron UK · Asthma
  8. Dupilumab SAR231893 Phase 3 · Regeneron UK · Allergic Fungal Rhinosinusitis

Related & competitor drugs

  1. beremagene geperpavec Dermatologicals (D03)
  2. imiquimod Dermatologicals (D06)
  3. lebrikizumab Dermatologicals (D11)
  4. retapamulin Dermatologicals (D06)
  5. tacrolimus Dermatologicals (D11)
  6. tirbanibulin Dermatologicals (D06)

Frequently asked questions

What is dupilumab?

dupilumab (DUPIXENT) is a interleukin-4 receptor subunit alpha antagonist. Associated with Sanofi-aventis Healthcare Pty Ltd. Route of administration: injection. Current US regulatory status: approved.

What is the brand name for dupilumab?

DUPIXENT is a marketed brand name for dupilumab. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of dupilumab?

dupilumab has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.