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daclizumab

Trade name: Zenapax

mAbapprovedOrphan Drug FDA

Approved

Dec 10, 1997

Daclizumab is a therapeutic humanized monoclonal antibody which was used for the treatment of adults with relapsing forms of multiple sclerosis (MS). Daclizumab works by binding to CD25, the alpha subunit of the IL-2 receptor of T-cells. — Wikipedia

Clinical trial activity

78 trials · 101 clinical orgs · 3 marketing orgs

Phase 1
15
Phase 2
51
Phase 3
14
Phase 4
17

Earliest trial started Jul 1, 1995 (NCT00002681)

Timeline

1990s

  1. Mar 5, 1993

    Orphan Drug Designation

  2. Jan 1, 1995

    Earliest Phase 1 Sponsor(trial)

  3. Dec 10, 1997

    Roche — Earliest FDA Approval

  4. Dec 10, 1997

    Roche — NDA Secondary Org

  5. Dec 10, 1997

    Roche — NDA Organization

  6. Jan 1, 1999

    Earliest Phase 2 Sponsor(trial)

2000s

  1. Jan 1, 2000

    Roche — Earliest Phase 3 Sponsor(trial)

2010s

  1. May 27, 2016

    Biogen — Marketing Organization

  2. May 27, 2016

    Biogen-IDEC — NDA Secondary Org

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedDec 10, 1997

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

  • anti-il-2r
  • anti-il2r ab
  • cd25 monoclonal antibody
  • dacliximab
  • dacliximab
  • daclizumab
  • daclizumab
  • daclizumab
  • daclizumab
  • daclizumab
  • daclizumab
  • daclizumab
  • daclizumab
  • daclizumab beta
  • dalclizumab
  • immunoglobulin g 1, (human-mouse monoclonal 1h4 gamma-chain, anti-human interleukin 2 receptor), disulfide with human-mouse monoclonal clone 1h4 light chain, dimer
  • ro 24-7375
  • ro-24-7375
  • ro-24-7375
  • zenapax
  • zenapax
  • zenapax
  • zenapax
  • zinbryta
  • zinbryta
  • zinbryta
  • zinbryta
  • zinbryta

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT06880419Phase 2Mar 31, 2025China Academy of Chinese Medical Sciences
NCT07029958Phase 4Nov 12, 2024Capital Medical University
NCT06657391Phase 2Oct 1, 2024Hacettepe University
NCT06364319Phase 4Apr 15, 2024Peking University
NCT02881567Phase 3Apr 18, 2017AbbVie, Biogen
NCT02241018Phase 2/Phase 3 (Phase 3)Sep 1, 2014Guangzhou Medical University, Huazhong University of Science and Technology, Peking University, People's Liberation Army of China, Shantou University, Southern Medical University, Sun Yat-Sen University
NCT01929746Phase 1Oct 1, 2013AbbVie, Biogen
NCT01797965Phase 3Feb 1, 2013AbbVie, Biogen
NCT01462318Phase 3Nov 1, 2011Biogen
NCT01418430Phase 4Aug 16, 2011University of London
NCT01143441Phase 1May 13, 2010National Institute of Neurological Disorders and Stroke (NINDS)
NCT01064401Phase 3May 1, 2010AbbVie, Biogen
NCT01051349Phase 2Mar 1, 2010AbbVie, Biogen
NCT00859131N/AMar 1, 2009Genzyme, Medical University of South Carolina, University of South Carolina
NCT00870740Phase 2Feb 1, 2009AbbVie, Biogen
NCT00790439Phase 2Jul 1, 2008National Institute of Allergy and Infectious Diseases (NIAID), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Uppsala University
NCT00390221Phase 2Feb 1, 2008AbbVie, Biogen
NCT00626015Phase 1Mar 1, 2007Duke University, National Cancer Institute (NCI)
NCT00468117Phase 3Jan 1, 2007Harvard University, National Institute of Allergy and Infectious Diseases (NIAID), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NCT00468442Phase 2Nov 1, 2006National Institute of Allergy and Infectious Diseases (NIAID), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), University of Pennsylvania
Showing 20 of 78 trials
Page 1 / 4

Organizations

Research & Development (101)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
RocheFor profit14631999
National Institute of Allergy and Infectious Diseases (NIAID)Government11942001
BiogenFor profit8832008
National Eye Institute (NEI)Government8821996
AbbVieFor profit7032008
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Government6122003
Facet BiotechFor profit5211997
National Institutes of Health (NIH)Government5211999
University of MiamiAcademic/Hospital5422002
National Cancer Institute (NCI)Government4131995
AstellasFor profit3222002
Harvard UniversityAcademic/Hospital3121995
National Institute of Neurological Disorders and Stroke (NINDS)Government3321999
University of AlbertaAcademic/Hospital3022001
University of California, San FranciscoAcademic/Hospital3022002
University of CincinnatiAcademic/Hospital3121999
Baylor UniversityAcademic/Hospital2222002
Duke UniversityAcademic/Hospital2222006
Mayo ClinicAcademic/Hospital2022002
Medical University of South CarolinaAcademic/Hospital2022002
101 organizations
Page 1 / 6

Marketing (4)

OrganizationOrg typeRelationshipDate
BiogenFor profitMKTGMay 27, 2016
Biogen-IDECFor profitNDA2May 27, 2016
RocheFor profitNDA2Dec 10, 1997
RocheFor profitNDADec 10, 1997