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rituximab

Trade name: rituxan

mAbapprovedOrphan Drug FDA

Approved

Nov 26, 1997

Rituximab, sold under the brand name Rituxan among others, is a monoclonal antibody medication used to treat certain autoimmune diseases and types of cancer. It is used for non-Hodgkin lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis, granulomatosis with polyangiitis, idiopathic thrombocytopenic purpura, pemphigus vulgaris, myasthenia gravis and Epstein–Barr virus-positive mucocutaneous ulcers. It is given by slow intravenous infusion. — Wikipedia

Clinical trial activity

2,179 trials · 933 clinical orgs · 6 marketing orgs

Phase 1
511
Phase 2
1680
Phase 3
471
Phase 4
86

Earliest trial started Apr 30, 1993 (NCT00001337)

Timeline

1990s

  1. Jan 1, 1993

    Earliest Phase 2 Sponsor(trial)

  2. Jun 13, 1994

    Orphan Drug Designation

  3. Jan 1, 1995

    Earliest Phase 3 Sponsor(trial)

  4. Jan 1, 1997

    Earliest Phase 1 Sponsor(trial)

  5. Nov 26, 1997

    Genentech — Earliest FDA Approval

  6. Nov 26, 1997

    Genentech — Marketing Organization

  7. Nov 26, 1997

    Genentech — NDA Secondary Org

  8. Nov 26, 1997

    Genentech — NDA Organization

2000s

  1. Feb 19, 2002

    IDEC — NDA Secondary Org

2010s

  1. Jun 22, 2017

    Roche — NDA Secondary Org

  2. Nov 28, 2018

    Celltrion — Marketing Organization

  3. Nov 28, 2018

    Celltrion — NDA Secondary Org

  4. Jul 23, 2019

    Pfizer — Marketing Organization

  5. Jul 23, 2019

    Pfizer — NDA Secondary Org

2020s

  1. Dec 17, 2020

    Amgen — Marketing Organization

  2. Dec 17, 2020

    Amgen — NDA Secondary Org

Indications

Approved for

Studied for

Mechanism of action

Combination products

Approval history

  • approvedNov 26, 1997

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 798
  • acellbia
  • anticd20
  • aurixim
  • chimeric anti-cd20 monoclonal antibody
  • cmab304
  • drl_ri
  • ib301
  • ibi301
  • idec-102
  • idec-c2b8
  • jhl1101
  • mabthera
  • mabthera
  • mabthera
  • mabthera rituxan
  • r-105 idec-102
  • rg-105
  • ritixumab
  • rituxan
  • rituxan
  • rituxan
  • rituxan
  • rituxan
  • rituximab
  • rituximab
  • rituximab
  • rituximab
  • rituximab
  • rituximab
  • rituximab
  • rituximab
  • rituximab
  • rituximab
  • rituximab
  • rituximab-abbs
  • t-cells rituximab + il-2
  • tl011
  • ub-921

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT06965114Phase 1/Phase 2 (Phase 2)Jun 27, 2026National Cancer Institute (NCI), Ohio State University
NCT07257055Phase 2May 12, 2026University of Texas at Houston
NCT07220187Phase 3May 2, 2026National Cancer Institute (NCI), SWOG Cancer Research Network
NCT07224100Phase 2May 1, 2026Takeda, University of Washington
NCT07294677Phase 1/Phase 2 (Phase 2)Mar 17, 2026University of Chicago
NCT07226843Phase 1Feb 28, 2026Eli Lilly
NCT07222631Phase 1/Phase 2 (Phase 2)Feb 28, 2026University of California, San Diego
NCT07137481Phase 2Feb 28, 2026University of Texas at Houston
NCT07231250Phase 2Jan 15, 2026Sun Yat-Sen University
NCT07261215Phase 2Jan 14, 2026China Academy of Chinese Medical Sciences
NCT07299331N/AJan 1, 2026Zhengzhou University
NCT07097363Phase 2Jan 1, 2026AbbVie, University of Washington
NCT07297563Phase 2Dec 31, 2025China Academy of Chinese Medical Sciences
NCT07225439Phase 1Dec 31, 2025Case Western Reserve University, Incyte
NCT07259122Phase 2Dec 30, 2025China Academy of Chinese Medical Sciences
NCT06522386Phase 2Dec 1, 2025University of Texas at Houston
NCT07010302Phase 4Nov 30, 2025Harvard University, Humboldt University, Patient-Centered Outcomes Research Institute
NCT07234019Phase 2Nov 30, 2025China Academy of Chinese Medical Sciences
NCT07255963Phase 2Nov 30, 2025Soochow University
NCT07187960Phase 3Nov 30, 2025Government of China
Showing 20 of 2,179 trials
Page 1 / 109

Organizations

Research & Development (933)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
National Cancer Institute (NCI)Government31811641993
RocheFor profit1669951997
University of Texas at HoustonAcademic/Hospital14714041998
GenentechFor profit1372551998
Harvard UniversityAcademic/Hospital725752002
CelgeneFor profit701732004
Chinese Academy of Medical SciencesAcademic/Hospital533452009
Mayo ClinicAcademic/Hospital523441997
Cornell UniversityAcademic/Hospital483841998
University of WashingtonAcademic/Hospital463742000
Jiao Tong UniversityAcademic/Hospital413142009
BiogenFor profit37851995
Millennium PharmaceuticalsFor profit361142004
Sun Yat-Sen UniversityAcademic/Hospital362842006
The Lymphoma Study AssociationAcademic/Hospital301721999
AbbVieFor profit29832009
Fudan UniversityAcademic/Hospital262052007
Ohio State UniversityAcademic/Hospital251141998
Johns Hopkins UniversityAcademic/Hospital241842001
Johnson and JohnsonFor profit24832006
933 organizations
Page 1 / 47

Marketing (12)

OrganizationOrg typeRelationshipDate
AmgenFor profitMKTGDec 17, 2020
AmgenFor profitNDA2Dec 17, 2020
CelltrionFor profitMKTGNov 28, 2018
CelltrionFor profitNDA2Nov 28, 2018
GenentechFor profitMKTGNov 26, 1997
GenentechFor profitSYNJun 22, 2017
GenentechFor profitNDA2Nov 26, 1997
GenentechFor profitNDANov 26, 1997
IDECFor profitNDA2Feb 19, 2002
PfizerFor profitMKTGJul 23, 2019
PfizerFor profitNDA2Jul 23, 2019
RocheFor profitNDA2Jun 22, 2017