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alemtuzumab

Trade name: campath

mAbapprovedOrphan Drug FDA

Approved

May 7, 2001

Alemtuzumab, sold under the brand names Campath and Lemtrada among others, is a medication used to treat chronic lymphocytic leukemia and multiple sclerosis. In chronic lymphocytic leukemia, it has been used as both a first line and second line treatment. It is given by injection into a vein. — Wikipedia

Clinical trial activity

305 trials · 180 clinical orgs · 2 marketing orgs

Phase 1
88
Phase 2
208
Phase 3
27
Phase 4
21

Earliest trial started Dec 31, 1991

Timeline

1990s

  1. Jan 1, 1991

    Earliest Phase 1 Sponsor

  2. Oct 20, 1997

    Orphan Drug Designation

  3. Jan 1, 1999

    Earliest Phase 2 Sponsor(trial)

2000s

  1. Jan 1, 2001

    Genzyme — Earliest Phase 3 Sponsor(trial)

  2. May 7, 2001

    Millennium Pharmaceuticals — Earliest FDA Approval

  3. May 7, 2001

    Millennium Pharmaceuticals — NDA Organization

  4. May 7, 2001

    Genzyme — Marketing Organization

  5. May 7, 2001

    Genzyme — NDA Secondary Org

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedAcceleratedMay 7, 2001

Chemistry & pharmacology

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

Oral

No

Parenteral

Yes

Topical

No

Black box warning

Sources

Also known as

  • alemtuzumab
  • alemtuzumab
  • alemtuzumab
  • alemtuzumab
  • alemtuzumab
  • alemtuzumab
  • alemtuzumab
  • alemtuzumab
  • alemtuzumab
  • campath
  • campath
  • campath
  • campath
  • campath
  • campath
  • campath
  • campath 1g
  • campath-1g
  • campath-1-g
  • campath 1h
  • campath-1h
  • campath-1h
  • campath-1h
  • campath 1m
  • campath-1m
  • campath mabcampath, lemtrada
  • humanized anti-cd52
  • ldp-03
  • lemtrada
  • lemtrada
  • mabcambath
  • mabcampath
  • monoclonal antibody campath-1h

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT06959771Phase 1/Phase 2 (Phase 2)Jul 16, 2025National Institute of Allergy and Infectious Diseases (NIAID)
NCT07015684Phase 1Apr 28, 2025Actinium Pharmaceuticals, Columbia University
NCT06872333Phase 2Nov 19, 2024University of Minnesota
NCT06084780Phase 2Apr 30, 2024Case Western Reserve University
NCT06358638Phase 2Apr 3, 2024Doris Duke Charitable Foundation, Georgetown University, Janssen Pharmaceutica NV, Northwestern University, Ohio State University, University of Calgary, University of Toronto, Yeshiva University
NCT05501756Phase 2Nov 30, 2022University of Cincinnati
NCT05607420Phase 1/Phase 2 (Phase 2)Nov 1, 2022Cellectis S.A., Harvard University
NCT05384756Phase 1Jul 13, 2022City of Hope National Medical Center, National Cancer Institute (NCI)
NCT05463133Phase 1/Phase 2 (Phase 2)Jul 8, 2022National Institute of Allergy and Infectious Diseases (NIAID)
NCT05357482Phase 1/Phase 2 (Phase 2)May 12, 2022National Heart, Lung, and Blood Institute (NHLBI)
NCT04971005Phase 2Aug 27, 2021CTC Bio, Inc., Neovii Biotech, University of Hamburg
NCT04362293Phase 2Apr 30, 2020St. Jude Children's Hospital
NCT04339777Phase 2Apr 23, 2020National Cancer Institute (NCI)
NCT04232085Phase 2Jan 6, 2020Johns Hopkins University
NCT04154735Phase 2Nov 30, 2019Northwestern University
NCT03989466Phase 1Oct 31, 2019University of Texas at Houston
NCT03910452Early Phase 1 (Phase 1)Jul 5, 2019National Institute of Allergy and Infectious Diseases (NIAID)
NCT04018937Phase 2Mar 22, 2019Emory University
NCT03821610Phase 2Nov 22, 2018University of Birmingham, University of Bristol
NCT03653338Phase 1/Phase 2 (Phase 2)Sep 30, 2018University of Pittsburgh
Showing 20 of 305 trials
Page 1 / 16

Organizations

Research & Development (180)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
National Cancer Institute (NCI)Government331332000
GenzymeFor profit321652000
BayerFor profit29152002
Baylor UniversityAcademic/Hospital222132000
University of Texas at HoustonAcademic/Hospital171732001
University of MinnesotaAcademic/Hospital161642000
Methodist Cancer Center, Houston, TexasAcademic/Hospital14032000
National Heart, Lung, and Blood Institute (NHLBI)Government131122001
Harvard UniversityAcademic/Hospital11822002
National Institute of Allergy and Infectious Diseases (NIAID)Government111022004
Northwestern UniversityAcademic/Hospital11942000
German CLL Study GroupAcademic/Hospital8712000
University of PittsburghAcademic/Hospital8822007
Columbia UniversityAcademic/Hospital7622004
Mayo ClinicAcademic/Hospital7722004
University of ChicagoAcademic/Hospital7532001
University of WisconsinAcademic/Hospital7732000
Immune Tolerance NetworkAcademic/Hospital6022003
University of WashingtonAcademic/Hospital6512001
NovartisFor profit5422005
180 organizations
Page 1 / 9

Marketing (3)

OrganizationOrg typeRelationshipDate
GenzymeFor profitMKTGMay 7, 2001
GenzymeFor profitNDA2May 7, 2001
Millennium PharmaceuticalsFor profitNDAMay 7, 2001