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adalimumab

Trade name: humira

mAbapproved

Approved

Dec 31, 2002

Adalimumab, sold under the brand name Humira and others, is a disease-modifying antirheumatic drug and monoclonal antibody used to treat rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis, plaque psoriasis, hidradenitis suppurativa, and uveitis. It is administered by subcutaneous injection. It works by inactivating tumor necrosis factor-alpha (TNFα). — Wikipedia

Clinical trial activity

466 trials · 333 clinical orgs · 13 marketing orgs

Phase 1
54
Phase 2
258
Phase 3
191
Phase 4
124

Earliest trial started Feb 1, 2000 (NCT00195702)

Timeline

2000s

  1. Jan 1, 2000

    Abbott — Earliest Phase 3 Sponsor(trial)

  2. Jan 1, 2002

    Abbott — Earliest Phase 2 Sponsor(trial)

  3. Dec 31, 2002

    Abbott — Earliest FDA Approval

  4. Dec 31, 2002

    Abbott — NDA Organization

  5. Dec 31, 2002

    AbbVie — Marketing Organization

  6. Dec 31, 2002

    AbbVie — NDA Secondary Org

  7. Jan 1, 2005

    Earliest Phase 1 Sponsor(trial)

2010s

  1. Sep 23, 2016

    Amgen — Marketing Organization

  2. Sep 23, 2016

    Amgen — NDA Secondary Org

  3. Aug 25, 2017

    Boehringer Ingelheim — Marketing Organization

  4. Aug 25, 2017

    Boehringer Ingelheim — NDA Secondary Org

  5. Oct 30, 2018

    Sandoz — Marketing Organization

  6. Oct 30, 2018

    Novartis — NDA Secondary Org

  7. Jul 23, 2019

    Samsung — Marketing Organization

  8. Jul 23, 2019

    Samsung — NDA Secondary Org

  9. Nov 15, 2019

    Pfizer — Marketing Organization

  10. Nov 15, 2019

    Pfizer — NDA Secondary Org

2020s

  1. Jul 6, 2020

    Mylan — Marketing Organization

  2. Jul 6, 2020

    Mylan — NDA Secondary Org

  3. Dec 17, 2021

    Coherus BioSciences — Marketing Organization

  4. Dec 17, 2021

    Coherus BioSciences — NDA Secondary Org

  5. Dec 13, 2022

    Fresenius — Marketing Organization

  6. Dec 13, 2022

    Fresenius — NDA Secondary Org

  7. May 23, 2023

    Celltrion — Marketing Organization

  8. May 23, 2023

    Celltrion — NDA Secondary Org

  9. Feb 23, 2024

    Alvotech — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedDec 31, 2002

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

  • abp 501
  • adalimumab
  • adalimumab
  • adalimumab
  • adalimumab
  • adalimumab
  • adalimumab
  • adalimumab
  • adalimumab
  • adalimumab-adaz
  • adalimumab-adbm
  • adalimumab-atto
  • adalimumab-atto
  • adalimumab-atto
  • adalimumab-atto
  • adalimumab-atto
  • adalimumab-atto
  • adalimumab (genetical recombination)
  • amjevita
  • d2e7
  • d2e7
  • humira
  • humira
  • humira
  • humira
  • ibi303
  • lu200134
  • lu-200134
  • msb11022
  • sb5
  • sb5

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07061574Phase 1/Phase 2 (Phase 2)Dec 15, 2026City of Hope National Medical Center, Jaeb Center for Health Research
NCT07268534Phase 2Apr 1, 2026Assistance Publique - Hôpitaux de Paris
NCT06996652Phase 2Jan 31, 2026National Institute on Aging (NIA), The Marcus Foundation, Yale University
NCT07258641Phase 1/Phase 2 (Phase 2)Jan 15, 2026University of Groningen
NCT07138898Phase 2Sep 30, 2025New York University
NCT07151937Phase 2Sep 30, 2025Almirall
NCT06941376Phase 2Aug 1, 2025University of Pennsylvania
NCT06926478Phase 1Aug 1, 2025Harvard University
NCT07128472N/AAug 1, 2025South Valley University
NCT07013838Phase 4Jun 15, 2025Chinese Academy of Medical Sciences, Chinese SLE Treatment And Research Group
NCT06390436Phase 4Mar 31, 2025Government of France, University of Lyon
NCT07181694Phase 1Mar 12, 2025Biocad
NCT06833112Phase 4Feb 28, 2025Guizhou Medical University
NCT07147257Phase 1Feb 12, 2025Government of China
NCT06742606Early Phase 1 (Phase 1)Jan 15, 2025Ain Shams University
NCT06729463N/ADec 1, 2024South Valley University
NCT06849908Phase 2Nov 8, 2024Chinese Academy of Medical Sciences
NCT06440629Phase 4Aug 20, 2024Betanien Hospital, Carol Davila University of Medicine and Pharmacy, Diakonhjemmet Hospital, Drammen sykehus, Haugesund Hospital, Helse Møre og Romsdal HF, Hospital of Southern Norway Trust, Karolinska Institute, Lillehammer Hospital for Rheumatic Diseases, Martina Hansen's Hospital, Medical University of Vienna, Nordland Hospital, Norwegian University of Science and Technology, South-Eastern Norway Regional Health Authority, University Hospital of North Norway, University of Bergen, University of Gothenburg, University of London, University of Oslo, University of Stavanger, Vestre Viken Ringerike Sykehus
NCT06640517Phase 3Aug 8, 2024Biocad
NCT06527534Phase 4Jul 15, 2024University of Verona
Showing 20 of 466 trials
Page 1 / 24

Organizations

Research & Development (333)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
AbbottFor profit1016852000
AbbVieFor profit725852000
EisaiFor profit15032003
Boehringer IngelheimFor profit121132011
PfizerFor profit10952007
Eli LillyFor profit9722011
University of CopenhagenAcademic/Hospital9832004
Assistance Publique - Hôpitaux de ParisAcademic/Hospital7622007
University of ParisAcademic/Hospital7632004
AlvotechFor profit6622018
AmgenFor profit6622013
Bristol-Myers SquibbFor profit6332009
RocheFor profit6432006
SamsungFor profit6642014
Wake Forest UniversityAcademic/Hospital6332008
BiocadFor profit5522015
CelltrionFor profit5522018
Chinese Academy of Medical SciencesAcademic/Hospital5322021
InnovadermFor profit5522007
TakedaFor profit5442015
333 organizations
Page 1 / 17

Marketing (22)

OrganizationOrg typeRelationshipDate
AbbVieFor profitMKTGDec 31, 2002
AbbVieFor profitNDA2Dec 31, 2002
AbbottFor profitNDADec 31, 2002
AlvotechFor profitMKTGFeb 23, 2024
AmgenFor profitMKTGSep 23, 2016
AmgenFor profitNDA2Sep 23, 2016
Boehringer IngelheimFor profitMKTGAug 25, 2017
Boehringer IngelheimFor profitNDA2Aug 25, 2017
CelltrionFor profitMKTGMay 23, 2023
CelltrionFor profitNDA2May 23, 2023
Coherus BioSciencesFor profitMKTGDec 17, 2021
Coherus BioSciencesFor profitNDA2Dec 17, 2021
FreseniusFor profitMKTGDec 13, 2022
FreseniusFor profitNDA2Dec 13, 2022
MylanFor profitMKTGJul 6, 2020
MylanFor profitNDA2Jul 6, 2020
NovartisFor profitNDA2Oct 30, 2018
PfizerFor profitMKTGNov 15, 2019
PfizerFor profitNDA2Nov 15, 2019
SamsungFor profitMKTGJul 23, 2019
SamsungFor profitNDA2Jul 23, 2019
SandozFor profitMKTGOct 30, 2018