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efalizumab

Trade name: Raptiva

mAbwithdrawn

Approved

Oct 27, 2003

Efalizumab is a formerly available medication designed to treat autoimmune diseases, originally marketed to treat psoriasis. As implied by the suffix -zumab, it is a recombinant humanized monoclonal antibody administered once weekly by subcutaneous injection. Efalizumab binds to the CD11a subunit of lymphocyte function-associated antigen 1 and acts as an immunosuppressant by inhibiting lymphocyte activation and cell migration out of blood vessels into tissues. Efalizumab was associated with fatal brain infections and was withdrawn from the market in 2009. — Wikipedia

Clinical trial activity

39 trials · 26 clinical orgs · 1 marketing orgs

Phase 1
11
Phase 2
18
Phase 3
8
Phase 4
11

Earliest trial started Feb 1, 2001 (NCT00096980)

Timeline

2000s

  1. Jan 1, 2002

    Earliest Phase 2 Sponsor(trial)

  2. Jan 1, 2002

    Genentech — Earliest Phase 3 Sponsor(trial)

  3. Jan 1, 2003

    Earliest Phase 1 Sponsor(trial)

  4. Oct 27, 2003

    Genentech — Earliest FDA Approval

  5. Oct 27, 2003

    Genentech — NDA Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • withdrawnOct 27, 2003

Chemistry & pharmacology

Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Parenteral
Multi-specific
No

Oral

No

Parenteral

Yes

Topical

No

Sources

Also known as

  • anti alphal integrin
  • anti-cd11a
  • anti-cd11a
  • anticd11 alpha
  • efalizumab
  • efalizumab
  • efalizumab
  • efalizumab
  • efalizumab
  • efalizumab
  • efalizumab
  • efalizumab
  • efalizumab
  • hu1124
  • hu1124
  • hu1124
  • raptiva
  • raptiva
  • raptiva
  • raptiva
  • raptiva
  • xanelim

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT00777400Phase 1/Phase 2 (Phase 2)Dec 1, 2008Genentech, University of California, San Francisco
NCT00737763Phase 2Oct 1, 2008Emory University, Genentech, Juvenile Diabetes Research Foundation
NCT00707070Phase 4Sep 1, 2008University of Verona
NCT00972543Phase 4Sep 1, 2008Merck KGaA, Merck Serono
NCT00729768Phase 2/Phase 3 (Phase 3)Aug 2, 2008Genentech
NCT00746980Phase 2Aug 1, 2008Genentech, Northwestern University
NCT00739882Phase 4Apr 1, 2008Merck KGaA, Merck Serono
NCT00676559Phase 1Apr 1, 2008Genentech, Johns Hopkins University, Juvenile Diabetes Research Foundation
NCT00726466Phase 1Mar 1, 2008Genentech, Vitreous -Retina- Macula Consultants of New York (VRMNY)
NCT00669214Phase 4Feb 1, 2008Genentech
NCT00697593Phase 4Jan 1, 2008Merck KGaA, Merck Serono
NCT00672204Phase 1/Phase 2 (Phase 2)Nov 1, 2007Juvenile Diabetes Research Foundation, University of Minnesota
NCT00472082Phase 1/Phase 2 (Phase 2)May 1, 2007Emory University, Genentech
NCT00368654Phase 1/Phase 2 (Phase 2)Jan 1, 2007Genentech, University of California, Davis
NCT00489216N/ADec 1, 2006Genentech, University of North Carolina at Chapel Hill
NCT00344448Phase 2Jun 1, 2006National Institute of Dental and Craniofacial Research (NIDCR), National Institutes of Health (NIH)
NCT00336973Phase 4May 1, 2006Genentech
NCT00312026Phase 4Mar 30, 2006Genentech
NCT00302445Phase 4Mar 1, 2006Derm Research, PLLC, Genentech
NCT00308204Phase 2Mar 1, 2006University of Rochester
Showing 20 of 39 trials
Page 1 / 2

Organizations

Research & Development (26)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
GenentechFor profit231052001
Merck KGaAFor profit7722003
Juvenile Diabetes Research FoundationAcademic/Hospital4022005
Merck SeronoFor profit4022004
Emory UniversityAcademic/Hospital3312005
Sponsor GmbHAcademic/Hospital3022003
XomaFor profit2222002
Derm Research, PLLCFor profit1112006
Johns Hopkins UniversityAcademic/Hospital1112008
National Eye Institute (NEI)Government1112006
National Institute of Dental and Craniofacial Research (NIDCR)Government1112006
National Institutes of Health (NIH)Government1012006
New York UniversityAcademic/Hospital1112005
Northwestern UniversityAcademic/Hospital1112008
Oregon Health and Science UniversityAcademic/Hospital1112005
Rockefeller UniversityAcademic/Hospital1112003
Rutgers UniversityAcademic/Hospital1012005
University of California, DavisAcademic/Hospital1112007
University of California, San FranciscoAcademic/Hospital1112008
University of Medicine and Dentistry of New JerseyAcademic/Hospital1112005
26 organizations
Page 1 / 2

Marketing (1)

OrganizationOrg typeRelationshipDate
GenentechFor profitNDAOct 27, 2003