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elotuzumab

Trade name: empliciti

mAbapprovedOrphan Drug FDABreakthrough Therapy FDA

Approved

Nov 30, 2015

Elotuzumab, sold under the brand name Empliciti, is a humanized IgG1 monoclonal antibody medication used in combination with lenalidomide and dexamethasone, for adults that have received 1 to 3 prior therapies for the treatment of multiple myeloma. It is also indicated for adult patients in combination with pomalidomide and dexamethasone, who have received 2 prior therapies including lenalidomide and a protease inhibitor. Administration of elotuzumab is done intravenously. Each intravenous injection of elotuzumab should be premedicated with dexamethasone, diphenhydramine, ranitidine and acetaminophen. It is being developed by Bristol Myers Squibb and AbbVie. — Wikipedia

Clinical trial activity

65 trials · 62 clinical orgs · 1 marketing orgs

Phase 1
17
Phase 2
50
Phase 3
13
Phase 4
0

Earliest trial started Dec 1, 2006 (NCT00425347)

Timeline

2000s

  1. Jan 1, 2006

    Earliest Phase 1 Sponsor(trial)

  2. Jan 1, 2008

    Earliest Phase 2 Sponsor(trial)

2010s

  1. Jan 1, 2011

    Bristol-Myers Squibb — Earliest Phase 3 Sponsor(trial)

  2. Sep 1, 2011

    Orphan Drug Designation

  3. Nov 30, 2015

    Bristol-Myers Squibb — Earliest FDA Approval

  4. Nov 30, 2015

    Bristol-Myers Squibb — NDA Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedBreakthroughNov 30, 2015

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

  • bms-901608
  • bms-901608
  • elotuzumab
  • elotuzumab
  • elotuzumab
  • elotuzumab
  • elotuzumab
  • elotuzumab
  • elotuzumab
  • elotuzumab
  • elotuzumab
  • empliciti
  • empliciti
  • empliciti
  • huluc63
  • huluc63
  • huluc63
  • huluc63
  • huluc63
  • immunoglobulin g1, anti-(human protein cs1) (human-mouse huluc63 heavy chain), disulfide with human-mouse huluc63 kappa-chain, dimer
  • immunoglobulin g1, anti-(human slam family member 7 (cd2-like receptor activating cytotoxic cells, cd319 antigen)), humanized mouse monoclonal huluc63 gamma-1 heavy chain (222-214')-disulfide with humanized mouse monoclonal huluc63 kappa light chain (228-228'';231-231'')-bisdisulfide dimer
  • pdl-063

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT06785415Phase 1/Phase 2 (Phase 2)Mar 3, 2025Mayo Clinic
NCT06518551Phase 1/Phase 2 (Phase 2)Nov 1, 2024Bristol-Myers Squibb, Celgene, Harvard University
NCT06232707Phase 3May 3, 2024Bristol-Myers Squibb, Celgene
NCT06158841Phase 3Apr 26, 2024AbbVie
NCT06208150Phase 3Jan 22, 2024—
NCT05981209Phase 1Dec 31, 2023Ohio State University
NCT06152575Phase 3Dec 18, 2023Pfizer
NCT05730036Phase 3Sep 18, 2023Regeneron
NCT05675319Phase 3Mar 3, 2023Gemeinsamer Bundesausschuss, Staburo GmbH, University of Hamburg
NCT05560399Early Phase 1 (Phase 1)Oct 15, 2022Bristol-Myers Squibb, Icahn School of Medicine at Mount Sinai, Multiple Myeloma Research Consortium
NCT05170789Phase 2Apr 27, 2022Karyopharm Therapeutics Inc, Tulane University
NCT04835129Phase 2Jan 31, 2022Medical College of Wisconsin
NCT05002816Phase 1/Phase 2 (Phase 2)Nov 30, 2021GlaxoSmithKline, Yale University
NCT05028348Phase 3Oct 31, 2021European Myeloma Network, Karyopharm Therapeutics Inc
NCT04918147Phase 2Oct 13, 2021Bristol-Myers Squibb, Harvard University, National Institute of Allergy and Infectious Diseases (NIAID), Rho, Inc.
NCT04517851Phase 1Feb 1, 2021University of Texas at Houston
NCT04584307Phase 2Dec 31, 2020Big Ten Cancer Research Consortium, Bristol-Myers Squibb, University of Wisconsin
NCT04614636Phase 1Nov 30, 2020Fate Therapeutics
NCT04150965Phase 1/Phase 2 (Phase 2)Dec 1, 2019Antengene Corporation, Bristol-Myers Squibb, Emory University, Hackensack University Medical Center, Harvard University, Icahn School of Medicine at Mount Sinai, Memorial Sloan-Kettering Cancer Center, Monopar Therapeutics, Multiple Myeloma Research Consortium, University of California, San Francisco, University of Michigan, University of Texas, Galveston, Wake Forest University, Washington University in St. Louis
NCT03227432Phase 2Dec 31, 2018Bristol-Myers Squibb, Harvard University
Showing 20 of 65 trials
Page 1 / 4

Organizations

Research & Development (62)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Bristol-Myers SquibbFor profit421842008
AbbVieFor profit13242008
CelgeneFor profit8132013
Harvard UniversityAcademic/Hospital8522006
Icahn School of Medicine at Mount SinaiAcademic/Hospital4332015
Multiple Myeloma Research ConsortiumAcademic/Hospital4122016
Hoosier Cancer Research NetworkAcademic/Hospital3312017
National Cancer Institute (NCI)Government3012012
University of Texas at HoustonAcademic/Hospital3322013
AbbottFor profit2122008
AmgenFor profit2012017
Karyopharm Therapeutics IncFor profit2022021
Mayo ClinicAcademic/Hospital2212018
Wake Forest UniversityAcademic/Hospital2112017
Washington University in St. LouisAcademic/Hospital2112017
Wayne State UniversityAcademic/Hospital2122006
Adknoma Health ResearchFor profit1012017
Altor BioscienceFor profit1012017
Antengene CorporationFor profit1012019
Assistance Publique - Hôpitaux de ParisAcademic/Hospital1112018
62 organizations
Page 1 / 4

Marketing (1)

OrganizationOrg typeRelationshipDate
Bristol-Myers SquibbFor profitNDANov 30, 2015