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dupilumab

Trade name: dupixent

mAbapprovedBreakthrough Therapy FDA

Approved

Mar 28, 2017

Dupilumab, sold under the brand name Dupixent, is a monoclonal antibody blocking interleukin 4 and interleukin 13 receptor signalling, used for allergic diseases such as atopic dermatitis (eczema), asthma and nasal polyps which result in chronic sinusitis. It is also used for the treatment of eosinophilic esophagitis, prurigo nodularis and chronic obstructive pulmonary disease. — Wikipedia

Clinical trial activity

198 trials · 100 clinical orgs · 1 marketing orgs

Phase 1
24
Phase 2
105
Phase 3
57
Phase 4
56

Earliest trial started Oct 1, 2009 (NCT01015027)

Timeline

2000s

  1. Jan 1, 2009

    Regeneron — Earliest Phase 1 Sponsor(trial)

2010s

  1. Jan 1, 2011

    Earliest Phase 2 Sponsor(trial)

  2. Jan 1, 2013

    Regeneron — Earliest Phase 3 Sponsor(trial)

  3. Mar 28, 2017

    Regeneron — Earliest FDA Approval

  4. Mar 28, 2017

    Regeneron — Marketing Organization

  5. Mar 28, 2017

    Regeneron — NDA Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedPriority reviewBreakthroughMar 28, 2017

Chemistry & pharmacology

Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Parenteral
Availability
Prescription Only
Multi-specific
No

Oral

No

Parenteral

Yes

Topical

No

First in class

Sources

Also known as

  • dupilumab
  • dupilumab
  • dupilumab
  • dupilumab
  • dupilumab
  • dupilumab
  • dupilumab
  • dupixent
  • regn668
  • regn668
  • regn-668
  • sar231893
  • sar231893

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07309614Phase 3Jan 31, 2026Government of Canada, Regeneron, Sanofi, University of Oxford, University of Sherbrooke, University of Western Australia
NCT07112378Phase 3Jan 13, 2026Regeneron, Sanofi
NCT07277322Phase 1/Phase 2 (Phase 2)Dec 15, 2025Coherus Oncology, Inc., Icahn School of Medicine at Mount Sinai
NCT07187089Phase 4Nov 11, 2025Regeneron, Sanofi
NCT07053423Phase 4Sep 22, 2025Regeneron, Sanofi
NCT07091175Phase 2Aug 1, 2025Government of Singapore, KK Women's and Children's Hospital, National University of Singapore
NCT06868212Phase 3Jul 11, 2025Novartis
NCT07027527Phase 1Jun 4, 2025Apogee Therapeutics, Inc.
NCT06884891Phase 3Apr 30, 2025Qilu Pharmaceutical Co., Ltd.
NCT07268313Phase 4Apr 3, 2025University of Copenhagen
NCT06881251Phase 2Feb 26, 2025—
NCT06743581N/AFeb 1, 2025University of Montreal
NCT06465732Phase 4Jan 31, 2025Zhejiang University
NCT06705387Phase 2Dec 31, 2024National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), University of Colorado, Denver
NCT06687967Phase 3Dec 20, 2024Regeneron, Sanofi
NCT06687980Phase 3Dec 20, 2024Regeneron, Sanofi
NCT06226610Phase 2Dec 1, 2024Northeast Ohio Medical University, Ohio State University, Regeneron
NCT06637306Early Phase 1 (Phase 1)Dec 1, 2024Icahn School of Medicine at Mount Sinai
NCT06477653Phase 2Nov 17, 2024National Institute of Allergy and Infectious Diseases (NIAID)
NCT06665971Phase 4Nov 10, 2024Regeneron, University of California, San Diego
Showing 20 of 198 trials
Page 1 / 10

Organizations

Research & Development (100)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
RegeneronFor profit1194452009
SanofiFor profit1005152009
Icahn School of Medicine at Mount SinaiAcademic/Hospital8832018
National Institute of Allergy and Infectious Diseases (NIAID)Government7522018
Harvard UniversityAcademic/Hospital6532018
AbbVieFor profit4412019
Johns Hopkins UniversityAcademic/Hospital3322019
Mayo ClinicAcademic/Hospital3232020
Stanford UniversityAcademic/Hospital3322018
University of California, San DiegoAcademic/Hospital3222022
University of California, San FranciscoAcademic/Hospital3312018
University of MichiganAcademic/Hospital3312022
University of RochesterAcademic/Hospital3222018
University of VirginiaAcademic/Hospital3332020
Erasmus University RotterdamAcademic/Hospital2122021
Government of RussiaGovernment2212021
Humboldt UniversityAcademic/Hospital2212018
Northwestern UniversityAcademic/Hospital2222021
PfizerFor profit2212018
Qilu Pharmaceutical Co., Ltd.For profit2222024
100 organizations
Page 1 / 5

Marketing (2)

OrganizationOrg typeRelationshipDate
RegeneronFor profitMKTGMar 28, 2017
RegeneronFor profitNDAMar 28, 2017