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infliximab

Trade name: remicade

mAbapprovedCOVID-19Orphan Drug FDA

Approved

Aug 24, 1998

Infliximab, a chimeric monoclonal antibody, sold under the brand name Remicade among others, is a medication used to treat a number of autoimmune diseases. This includes Crohn's disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriasis, psoriatic arthritis, and Behçet's disease. It is given by slow injection into a vein, typically at six- to eight-week intervals. — Wikipedia

Clinical trial activity

318 trials · 279 clinical orgs · 6 marketing orgs

Phase 1
34
Phase 2
159
Phase 3
106
Phase 4
96

Earliest trial started Jun 1, 1995 (NCT00269854)

Timeline

1990s

  1. Jan 1, 1995

    Centocor — Earliest Phase 2 Sponsor(trial)

  2. Nov 14, 1995

    Orphan Drug Designation

  3. Jan 1, 1996

    Centocor — Earliest Phase 3 Sponsor(trial)

  4. Aug 24, 1998

    Johnson and Johnson — Earliest FDA Approval

  5. Aug 24, 1998

    Centocor — Marketing Organization

  6. Aug 24, 1998

    Johnson and Johnson — NDA Secondary Org

  7. Aug 24, 1998

    Johnson and Johnson — NDA Organization

2000s

  1. Jan 1, 2003

    Earliest Phase 1 Sponsor(trial)

2010s

  1. Apr 5, 2016

    Celltrion — Marketing Organization

  2. Apr 5, 2016

    Celltrion — NDA Secondary Org

  3. Apr 21, 2017

    Samsung — Marketing Organization

  4. Apr 21, 2017

    Samsung — NDA Secondary Org

  5. Dec 13, 2017

    Pfizer — Marketing Organization

  6. Dec 13, 2017

    Pfizer — NDA Secondary Org

  7. Dec 6, 2019

    Amgen — Marketing Organization

  8. Dec 6, 2019

    Amgen — NDA Secondary Org

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedAcceleratedAug 24, 1998

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 710
  • bay 103356
  • bay-103356
  • bay-103356
  • bay w 3356
  • bay-w 3356
  • bay-w-3356
  • bms-224819
  • ca2
  • ca2
  • ca2
  • cdp 571
  • cdp-571
  • cdp-571
  • ct-p13
  • humicade
  • humicade
  • inflectra
  • inflectra
  • inflectra
  • inflectra
  • inflectra
  • infliximab
  • infliximab
  • infliximab
  • infliximab
  • infliximab
  • infliximab
  • infliximab
  • infliximab
  • infliximab-abda
  • infliximab-dyyb
  • infliximab-dyyb
  • infliximab-qbtx
  • remicade
  • remicade
  • remicade
  • remicade
  • remsima
  • remsima
  • teneliximab
  • tumor necrosis factor alpha antibodieas

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07257068N/AApr 14, 2026University of Texas at Houston
NCT07297069Phase 2Jan 1, 2026Asian Institute of Gastroenterology
NCT07176754N/AOct 1, 2025Central South University, Guangxi Medical University, Nanjing Medical University, Peking University, Shandong University, Sichuan University, Wuhan University, Xinjiang Medical University
NCT07138898Phase 2Sep 30, 2025New York University
NCT06941376Phase 2Aug 1, 2025University of Pennsylvania
NCT07149441N/AAug 1, 2025Huazhong University of Science and Technology
NCT06839820N/AFeb 1, 2025Oslo Metropolitan University
NCT06646016Phase 2Jan 31, 2025Mallinckrodt
NCT06758024N/AJan 24, 2025Pontificia Universidad Catolica de Chile, Universidad de la Frontera, University of Chile
NCT06738719Phase 3Jan 20, 2025Celltrion
NCT06614387Phase 3Oct 1, 2024Children's Memorial Health Institute, Poland
NCT06136546Phase 2Sep 1, 2024Harvard University
NCT06453317Phase 2Jul 31, 2024Government of Poland, K. Marcinkowski University of Medical Sciences, Medical University of Lodz, Poznan University
NCT06274294Phase 3Jul 10, 2024CHU AMBROISE PARE
NCT05823532Phase 4Jan 31, 2024Emory University, National Institute of Mental Health (NIMH)
NCT06113913Phase 4Jan 31, 2024Belgian Inflammatory Bowel Disease Research and Development (BIRD) VZW, Celltrion
NCT06591273Phase 1/Phase 2 (Phase 2)Nov 6, 2023Services Institute of Medical Sciences, Pakistan
NCT05928039Phase 4Oct 25, 2023Robarts Clinical Trials, University of Calgary
NCT06064864N/AOct 9, 2023Kyung Hee University, Kyungpook University, Seoul National University, Sungkyunkwan University, University of Ulsan, Yonsei University
NCT06051253Phase 4Oct 2, 2023University of Ulsan
Showing 20 of 318 trials
Page 1 / 16

Organizations

Research & Development (279)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
CentocorFor profit462751995
MerckFor profit282732003
CelltrionFor profit161242010
Johnson and JohnsonFor profit8822007
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives (GETAID)Academic/Hospital7632005
Mitsubishi TanabeFor profit7712005
Schering-PloughFor profit7022001
Emory UniversityAcademic/Hospital6622005
Harvard UniversityAcademic/Hospital6622010
PfizerFor profit6242012
Sun Yat-Sen UniversityAcademic/Hospital6622008
Fudan UniversityAcademic/Hospital5522013
Icahn School of Medicine at Mount SinaiAcademic/Hospital5332009
Janssen Pharmaceutica NVFor profit5122010
National Cancer Institute (NCI)Government5132002
Assistance Publique - Hôpitaux de ParisAcademic/Hospital4422007
Jiao Tong UniversityAcademic/Hospital4132010
Katholieke Universiteit LeuvenAcademic/Hospital4432004
National Institute of Allergy and Infectious Diseases (NIAID)Government4412006
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)Government4322000
279 organizations
Page 1 / 14

Marketing (12)

OrganizationOrg typeRelationshipDate
AmgenFor profitMKTGDec 6, 2019
AmgenFor profitNDA2Dec 6, 2019
CelltrionFor profitMKTGApr 5, 2016
CelltrionFor profitNDA2Apr 5, 2016
CelltrionFor profitSYNOct 20, 2023
CentocorFor profitMKTGAug 24, 1998
Johnson and JohnsonFor profitNDA2Aug 24, 1998
Johnson and JohnsonFor profitNDAAug 24, 1998
PfizerFor profitMKTGDec 13, 2017
PfizerFor profitNDA2Dec 13, 2017
SamsungFor profitMKTGApr 21, 2017
SamsungFor profitNDA2Apr 21, 2017