Last update 10 Jul 2026

Rituximab

Overview

Basic Info

Drug Type
Monoclonal antibody
Synonyms
IDEC-C2B8-anti-CD20, Ristova, Rituximab (Genetical Recombination)
+ [16]
Target
Action
inhibitors
Mechanism
CD20 inhibitors(B-lymphocyte antigen CD20 inhibitors), ADCC(Antibody-dependent cell-mediated cytotoxicity (ADCC) effects), CD20-directed cytolytic effects
Originator Organization
Drug Highest PhaseApproved
First Approval Date
United States (26 Nov 1997),
RegulationOrphan Drug (United States), Orphan Drug (European Union), Orphan Drug (Japan)
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Structure/Sequence

External Link

KEGGWikiATCDrug Bank
D02994Rituximab

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Autoimmune Haemolytic Anaemias
Japan
19 Feb 2026
Cardiac transplant rejection
Japan
22 Dec 2023
Liver transplant rejection
Japan
22 Dec 2023
Lung transplant rejection
Japan
22 Dec 2023
Rejection of pancreas transplant
Japan
22 Dec 2023
Renal transplant rejection
Japan
22 Dec 2023
Small intestine transplantation rejection
Japan
22 Dec 2023
Lupus Nephritis
Japan
23 Aug 2023
Neuromyelitis Optica
Japan
20 Jun 2022
Pemphigus and Fogo Selvagem
Japan
24 Dec 2021
Pemphigus Vulgaris, Familial
Japan
24 Dec 2021
Thrombotic Thrombocytopenic Purpura, Acquired
Japan
21 Feb 2020
CD20 Positive B-Cell Chronic Lymphocytic Leukemia
Japan
26 Mar 2019
Lymphoid Leukemia
Japan
26 Mar 2019
Lymphoid Leukemia
Japan
26 Mar 2019
Chronic idiopathic thrombocytopenic purpura
Japan
26 Jun 2017
Purpura, Thrombocytopenic
Japan
26 Jun 2017
Purpura, Thrombocytopenic
Japan
26 Jun 2017
Nephrotic Syndrome
Japan
29 Aug 2014
Nephrotic Syndrome
Japan
29 Aug 2014
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Refractory Grade 3a Follicular LymphomaPhase 3
United States
05 Feb 2024
Refractory Grade 3a Follicular LymphomaPhase 3
China
05 Feb 2024
Refractory Grade 3a Follicular LymphomaPhase 3
Japan
05 Feb 2024
Refractory Grade 3a Follicular LymphomaPhase 3
Australia
05 Feb 2024
Refractory Grade 3a Follicular LymphomaPhase 3
Belgium
05 Feb 2024
Refractory Grade 3a Follicular LymphomaPhase 3
Brazil
05 Feb 2024
Refractory Grade 3a Follicular LymphomaPhase 3
Bulgaria
05 Feb 2024
Refractory Grade 3a Follicular LymphomaPhase 3
Canada
05 Feb 2024
Refractory Grade 3a Follicular LymphomaPhase 3
Croatia
05 Feb 2024
Refractory Grade 3a Follicular LymphomaPhase 3
Czechia
05 Feb 2024
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Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
69
wuxvckpvyg = nqnfopzgbi nnhpcltbny (mtyhnhcxcs, rnjemnaiea - hjnxgefufw)
-
10 Jul 2026
wuxvckpvyg = akvednxlds nnhpcltbny (mtyhnhcxcs, znicnfncvc - uissvqvdzi)
Phase 3
110
fccmwsppht(woupohqzkr) = yxtqdbppfn kguzmumnwe (rkldlotdul )
Negative
11 Jun 2026
Placebo
fccmwsppht(woupohqzkr) = svkwtdhdkp kguzmumnwe (rkldlotdul )
Not Applicable
15
pxqvupkzkv(gqdzpapnkz) = adypzejiut xsfnjlcrbq (vvykkgqpkq )
Positive
11 Jun 2026
Phase 2
Sjogren's Syndrome
gene expression signatures
37
tapxjqjozb(lcvbyzwels) = nxwdzmtxhy yjlcpvtswm (ldeiiybprc )
Positive
11 Jun 2026
Not Applicable
34
onbjckvdzi(tikdtgghai) = pwafmegjvm sifbhkiysx (kbnefebazk )
Positive
11 Jun 2026
Not Applicable
44
sfynuszzue(iytdacplry) = cgszfrpdtp hkwhalgkhe (odvfpuyavd )
Positive
11 Jun 2026
Not Applicable
176
szmigsjije(lqfrehqdnr) = Drug survival was similar for first-line users, but second-line belimumab users had higher drug survival compared with rituximab (HR 1.34, 95% CI 1.02-1.77) kbffuhdret (kpgstoaovq )
Positive
11 Jun 2026
Not Applicable
769
(Rheumatoid Arthritis)
atrqcjgygn(whtozewkwp) = rkgpdfnsay shtdgsmcwb (gnokhekunf )
Positive
11 Jun 2026
Not Applicable
187
Rituximab ± any DMARD
zuodybsvbs(ligkekaqmj) = uemwkklwkh qhwxfcssqh (erftbjchqa )
Positive
11 Jun 2026
Cyclophosphamide ± any DMARD
zuodybsvbs(ligkekaqmj) = dvtmupfbag qhwxfcssqh (erftbjchqa )
Not Applicable
167
Rituximab ± glucocorticoids
yeqhvrhvpj(otxjfasugl) = bpusxotzbd ylsndbjzmx (pumcyjbbzb )
Positive
11 Jun 2026
yeqhvrhvpj(otxjfasugl) = ddomnvxnau ylsndbjzmx (pumcyjbbzb )
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Core Patent

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Clinical Trial

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Approval

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Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.
Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

Regulation

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