Rituximab
Highest phase reached
Approved
Drug type
Antibody
First approval year
1997
- First approval year
- 1997
- Listing at source
- Listed
- Highest phase reached
- Approved
- Drug type
- Antibody
- Drug name
- Rituximab
- blitzima
- Blitzima
- mabthera
- Mabthera
- mabthera rituxan
- Mabthera rituxan
- ritemvia
- Ritemvia
- rituxan
- Rituxan
- rituximab component of rituxan hycela
- Rituximab component of rituxan hycela
- Rituzena (previously tuxella)
- rituzena previously tuxella
- rixathon
- Rixathon
- riximyo
- Riximyo
- ruxience
- Ruxience
- truxima
- Truxima
- 200 mg rituximab
- 2cda rituximab
- abp 798
- ABP 798
- ABP-798
- abp798
- ABP798
- bi 695500
- Bi 695500
- BI 695500
- BI 695500 [WHO-DD]
- bi 695500 who dd
- Bi-695500
- bi695500
- BI695500
- blitzima
- Blitzima
- CEEP-RITUXIMAB
- ct p10
- CT-P10
- gp 2013
- GP-2013
- gp2013
- Gp2013
- GP2013
And 161 more, listed on the interactive page.
- CAS registry numbers
- 174722-31-7
- ChEMBL ID
- CHEMBL1201576
- FDA ingredient codes (UNII)
- 4F4X42SYQ6
- L01FA01
- L01XC02
Sources for recorded values
- 121191
- 2105824
- Applicant
- GENENTECH
- Approval date
- 26 Nov 1997
- Application number
- BLA103705
- Status
- Authorised
- Status date
- 2 Jun 1998
- Authorisation date
- 2 Jun 1998
- Approved indications
- MabThera is indicated in adults for the following indications: Non Hodgkin’s lymphoma (NHL) MabThera is indicated for the treatment of previously untreated adult patients with stage III?IV follicular lymphoma in combination with chemotherapy. MabThera maintenance therapy is indicated for the treatment of adult follicular lymphoma patients responding to induction therapy. MabThera monotherapy is indicated for treatment of adult patients with stage III?IV follicular lymphoma who are chemoresistant or are in their second or subsequent relapse after chemotherapy. MabThera is indicated for the treatment of adult patients with CD20 positive diffuse large B cell non?Hodgkin’s lymphoma in combination with CHOP (cyclophosphamide, doxorubicin, vincristine, prednisolone) chemotherapy. MabThera in combination with chemotherapy is indicated for the treatment of paediatric patients (aged ? 6 months to < 18 years old) with previously untreated advanced stage CD20 positive diffuse large B-cell lymphoma (DLBCL), Burkitt lymphoma (BL)/Burkitt leukaemia (mature B-cell acute leukaemia) (BAL) or Burkitt-like lymphoma (BLL). Chronic lymphocytic leukaemia (CLL) MabThera in combination with chemotherapy is indicated for the treatment of patients with previously untreated and relapsed/refractory CLL. Only limited data are available on efficacy and safety for patients previously treated with monoclonal antibodies including MabThera or patients refractory to previous MabThera plus chemotherapy. Rheumatoid arthritis MabThera in combination with methotrexate is indicated for the treatment of adult patients with severe active rheumatoid arthritis who have had an inadequate response or intolerance to other disease?modifying anti?rheumatic drugs (DMARD) including one or more tumour necrosis factor (TNF) inhibitor therapies. MabThera has been shown to reduce the rate of progression of joint damage as measured by X?ray and to improve physical function, when given in combination with methotrexate. Granulomatosis with polyangiitis and microscopic polyangiitis MabThera, in combination with glucocorticoids, is indicated for the treatment of adult patients with severe, active granulomatosis with polyangiitis (Wegener’s) (GPA) and microscopic polyangiitis (MPA). MabThera, in combination with glucocorticoids, is indicated for the induction of remission in paediatric patients (aged ? 2 to < 18 years old) with severe, active GPA (Wegener’s) and MPA. Pemphigus vulgaris MabThera is indicated for the treatment of patients with moderate to severe pemphigus vulgaris (PV).
- Product number
- EMEA/H/C/000165
- Authorisation holder
- Roche Registration GmbH
- Priority medicines scheme
- No
- Generic
- No
- Biosimilar
- No
- Generic medicines
- 0
- Biosimilar medicines
- 6
- Advanced therapy
- No
- Conditional approval
- No
- Additional monitoring
- No
- Accelerated assessment
- No
- Exceptional circumstances
- No
Therapeutic areas
- Arthritis, Rheumatoid
- Leukemia, Lymphocytic, Chronic, B-Cell
- Lymphoma, Non-Hodgkin
European medicines record
- Patents
- 0
- Designations
- 5
- Earliest recorded loss of exclusivity
- 2 Dec 2028
- First in class
- No
- Fast track
- No
- Breakthrough designation
- Yes
- Orphan designation
- No
- Priority review
- Yes
- Orphan exclusivity
- No
- Accelerated approval
- No
- Availability
- Prescription only
- Boxed warning
- Yes
- Pharmacology name
- rituximab
- Type
- Antibody
- Drug name stem
- -mab
- Approval recorded by Guide to Pharmacology
- Yes
Administration routes
- Parenteral
- Mechanism
- B-lymphocyte antigen CD20 binding agent
- Action type
- BINDING_AGENT
- Target
- B-lymphocyte antigen CD20
- Protein identifier
- P11836
- Action
- Binding
- Action type
- Binding
- Target
- CD20 (membrane-spanning 4-domains, subfamily A, member 1)
- Gene symbol
- MS4A1
- Protein identifier
- P11836
- Median affinity
- 8.51
- Affinity units
- pKd
- Primary target
- Yes
Open Targets mechanisms
- Mechanism
- B-lymphocyte antigen CD20 binding agent
- Action type
- BINDING AGENT
- Target
- B-lymphocyte antigen CD20
- Condition
- Leukemia, Biphenotypic, Acute
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000094
- Subject identifier
- D015456
- Condition
- Leukemia, Lymphocytic, Chronic, B-Cell
- Highest recorded phase
- 4
- Condition identifier
- EFO:0000095
- Subject identifier
- D015451
- Condition
- Lymphoma, Follicular
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000096
- Subject identifier
- D008224
- Condition
- Carcinoma, Hepatocellular
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000182
- Subject identifier
- D006528
- Condition
- Hodgkin Disease
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000183
- Subject identifier
- D006689
- Condition
- Lymphoma, B-Cell, Marginal Zone
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000191
- Subject identifier
- D018442
- Condition
- Myelodysplastic Syndromes
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000198
- Subject identifier
- D009190
- Condition
- Neoplasms, Plasma Cell
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000200
- Subject identifier
- D054219
- Condition
- Leukemia, Biphenotypic, Acute
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000209
- Subject identifier
- D015456
- Condition
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
- Highest recorded phase
- 4
- Condition identifier
- EFO:0000220
- Subject identifier
- D054198
- Condition
- Leukemia, Myeloid, Acute
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000222
- Subject identifier
- D015470
- Condition
- Immunoblastic Lymphadenopathy
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000255
- Subject identifier
- D007119
- Condition
- Burkitt Lymphoma
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000309
- Subject identifier
- D002051
- Condition
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000339
- Subject identifier
- D015464
- Condition
- Crohn Disease
- Highest recorded phase
- 1
- Condition identifier
- EFO:0000384
- Subject identifier
- D003424
- Condition
- Melanoma
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000389
- Subject identifier
- D008545
- Condition
- Lymphoma, Large B-Cell, Diffuse
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000403
- Subject identifier
- D016403
- Condition
- Immune System Diseases
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000540
- Subject identifier
- D007154
- Condition
- Dermatomyositis
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000557
- Subject identifier
- D003882
- Condition
- Leukemia
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000565
- Subject identifier
- D007938
- Condition
- Lymphoma
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000574
- Subject identifier
- D008223
- Condition
- Neoplasms
- Highest recorded phase
- 4
- Condition identifier
- EFO:0000616
- Subject identifier
- D009369
- Condition
- Neuroblastoma
- Highest recorded phase
- 0.5
- Condition identifier
- EFO:0000621
- Subject identifier
- D009447
- Condition
- Mental Disorders
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000677
- Subject identifier
- D001523
- Condition
- Arthritis, Rheumatoid
- Highest recorded phase
- 4
- Condition identifier
- EFO:0000685
- Subject identifier
- D001172
And 127 more, listed on the interactive page.
- Condition identifier
- EFO_0000095
- Condition identifier
- EFO_0000096
- Highest recorded phase
- 3
- Condition identifier
- EFO_0000182
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000183
- Highest recorded phase
- 3
- Condition identifier
- EFO_0000191
- Highest recorded phase
- 3
- Condition identifier
- EFO_0000220
- Condition identifier
- EFO_0000274
- Condition identifier
- EFO_0000275
- Condition identifier
- EFO_0000309
- Highest recorded phase
- 3
- Condition identifier
- EFO_0000389
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000403
- Condition identifier
- EFO_0000540
- Highest recorded phase
- 3
- Condition identifier
- EFO_0000565
- Highest recorded phase
- 3
- Condition identifier
- EFO_0000574
- Highest recorded phase
- 3
- Condition identifier
- EFO_0000616
- Condition identifier
- EFO_0000638
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000677
- Highest recorded phase
- 3
- Condition identifier
- EFO_0000685
- Condition identifier
- EFO_0000699
- Condition identifier
- EFO_0000717
- Condition identifier
- EFO_0000729
- Condition identifier
- EFO_0000763
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000768
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000769
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000772
- Highest recorded phase
- 2
And 296 more, listed on the interactive page.
Warnings
- Warning
- Black Box Warning
- Effect
- infectious disease
Open Targets warnings
- Warning
- Black Box Warning
- Effect
- infectious disease
- Country
- United States
- Event
- abdominal discomfort
- Reports
- 3,018
- Reporting signal score
- 2,696.58
- Event
- alopecia
- Reports
- 3,227
- Reporting signal score
- 3,025.93
- Event
- anti-cyclic citrullinated peptide antibody positive
- Reports
- 1,115
- Reporting signal score
- 3,134.95
- Event
- arthralgia
- Reports
- 4,067
- Reporting signal score
- 1,256.62
- Event
- arthropathy
- Reports
- 2,311
- Reporting signal score
- 2,961.24
- Event
- diffuse large b-cell lymphoma recurrent
- Reports
- 513
- Reporting signal score
- 1,441
- Event
- discomfort
- Reports
- 1,245
- Reporting signal score
- 1,339.84
- Event
- drug intolerance
- Reports
- 4,439
- Reporting signal score
- 5,244.43
- Event
- duodenal ulcer perforation
- Reports
- 550
- Reporting signal score
- 1,273.81
- Event
- febrile neutropenia
- Reports
- 3,445
- Reporting signal score
- 4,198.89
- Event
- glossodynia
- Reports
- 1,911
- Reporting signal score
- 4,238.38
- Event
- hand deformity
- Reports
- 1,778
- Reporting signal score
- 4,526.58
- Event
- helicobacter infection
- Reports
- 649
- Reporting signal score
- 1,276.56
- Event
- hepatic enzyme increased
- Reports
- 1,913
- Reporting signal score
- 1,640.3
- Event
- hypersensitivity
- Reports
- 2,598
- Reporting signal score
- 1,240.63
- Event
- hypogammaglobulinaemia
- Reports
- 831
- Reporting signal score
- 1,803.77
- Event
- infection
- Reports
- 3,104
- Reporting signal score
- 2,474.74
- Event
- infusion related reaction
- Reports
- 4,090
- Reporting signal score
- 6,085.05
- Event
- joint swelling
- Reports
- 3,622
- Reporting signal score
- 3,947.32
- Event
- loss of personal independence in daily activities
- Reports
- 1,152
- Reporting signal score
- 1,496.58
- Event
- musculoskeletal stiffness
- Reports
- 1,725
- Reporting signal score
- 1,172.25
- Event
- neutropenia
- Reports
- 3,608
- Reporting signal score
- 2,249.69
- Event
- pain
- Reports
- 5,694
- Reporting signal score
- 2,186.56
- Event
- pemphigus
- Reports
- 2,429
- Reporting signal score
- 6,728.46
- Event
- pericarditis
- Reports
- 1,106
- Reporting signal score
- 1,833.17
And 10 more, listed on the interactive page.
- NCT00001563
- NCT00036855
- NCT00049036
- NCT00126243
- NCT00310128
- NCT00001586
- NCT00003204
- NCT00012298
- NCT00017381
- NCT00022971
- NCT00060684
- NCT00071396
- NCT00078234
- NCT00079443
- NCT00086203
- NCT00090051
- NCT00098488
- NCT00098670
- NCT00119392
- NCT00131313
- NCT00143065
- NCT00201682
- NCT00201721
- NCT00254163
- NCT00254410
And 1,384 more, listed on the interactive page.
- Dose
- 375 mg/m2
- Route
- Intravenous
- How often
- Every 4 weeks
- Administer only as an intravenous infusion
- Do not administer as an intravenous push or bolus
- Prodrug
- No
- Chirality
- Single enantiomer
- Inorganic
- No
- Natural product
- No
- Component
- Sequence
- Type
- Protein
- Sequence
- QIVLSQSPAILSASPGEKVTMTCRASSSVSYIHWFQQKPGSSPKPWIYATSNLASGVPVRFSGSGSGTSYSLTISRVEAEDAATYYCQQWTSNPPTFGGGTKLEIKRTVAAPSVFIFPPSDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQESVTEQDSKDSTYSLSSTLTLSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC
- Component
- Sequence
- Type
- Protein
- Sequence
- QVQLQQPGAELVKPGASVKMSCKASGYTFTSYNMHWVKQTPGRGLEWIGAIYPGNGDTSYNQKFKGKATLTADKSSSTAYMQLSSLTSEDSAVYYCARSTYYGGDWYFNVWGAGTTVTVSAASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSSGLYSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKKVEPKSCDKTHTCPPCPAPELLGGPSVFLFPPKPKDTLMISRTPEVTCVVVDVSHEDPEVKFNWYVDGVEVHNAKTKPREEQYNSTYRVVSVLTVLHQDWLNGKEYKCKVSNKALPAPIEKTISKAKGQPREPQVYTLPPSRDELTKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSKLTVDKSRWQQGNVFSCSVMHEALHNHYTQKSLSLSPGK
- 0069-0238
- 0069-0249
- 50242-051
- 50242-053
- 50242-108
- 50242-109
- 55513-224
- 55513-326
- 63459-103
- 63459-104
Related records
Trials (2,115)
- [CREMA]Combination of R-M Followed by R-A in Elderly Patients With Primary CNS Lymphoma
- 131I-rituximab for Relapsed or Refractory Follicular or Mantle Cell Lymphoma
- 131I-rituximab for Relapsed or Refractory Marginal Zone B-cell Lymphoma
- 17-N-Allylamino-17-Demethoxygeldanamycin With or Without Rituximab in Treating Patients With Relapsed B-Cell Chronic Lymphocytic Leukemia or Prolymphocytic Leukemia
- A Clinical Study of Hanlikang and BTK Inhibitors in the Treatment of Newly Diagnosed Mantle Cell Lymphoma
- A Clinical Study of Zilovertamab Vedotin (MK-2140) Plus Rituximab Plus Cyclophosphamide, Doxorubicin, and Prednisone (R-CHP) Versus Polatuzumab Vedotin Plus R-CHP in People With Diffuse Large B-cell Lymphoma (DLBCL) (MK-2140-011/waveLINE-011)
- A Clinical Study Using MEDI-551 in Adult Participants With Relapsed or Refractory Advanced B-Cell Malignancies
- A Clinical Trial of MK-1045 and Rituximab in People With Follicular Lymphoma (MK-1045-007)
- A Clinical Trial to Evaluate the Efficacy and Safety of TQB3909 Tablets Versus Investigator's Choice in the Treatment of Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL)
- A Combination of Acalabrutinib With R-CHOP in Subjects With Previously Untreated Non-GCB DLBCL (ACE-LY-312)
- A Combination of Rituximab and CC-99282 as Front-line Therapy for Older Frail Patients With Diffuse Large B-cells Non-Hodgkin Lymphoma Evaluated With a Simplified Geriatric Assessment (sGA): a Phase II Study of the Fondazione Italiana Linfomi (FIL)
- A Comparison of Three Chemotherapy Regimens for the Treatment of Patients With Newly Diagnosed Mantle Cell Lymphoma
- A Dose Finding and Safety Study of CC-220, Alone and in Combination With an Anti-CD20 Monoclonal Antibody (mAb) in Subjects With Relapsed or Refractory Lymphomas
- A Dose Study of Doxil in a Dose Dense, 14 Day CDOP/Rituximab Regimen for Patients With Diffuse Large B-Cell Non-Hodgkin Lymphoma (NHL)> 60 Years or With Compromised Cardiac Status.
- A Dose-escalating Pilot Study of Orelabrutinib for Newly-diagnosed PCNSL
- A Double-blind, Randomized Controlled Study in CD20-positive Diffuse B Cell Non-Hodgkin's Lymphoma Subjects
- A Global Phase 3 Study of Orelabrutinib+BR Vs.BR in Pts with TN MCL
- A Global Study of Novel Agents in Paediatric and Adolescent Relapsed and Refractory B-cell Non-Hodgkin Lymphoma
- A MultiCenter Study of Combined PEX, Rituximab, and Steroids in Acute Idiopathic Pulmonary Fibrosis Exacerbations
- A Multicenter, Prospective Clinical Trial With a Concurrent Control Evaluating Methotrexate Combined With Rituximab,Sintilimab and Pirtobrutinib vs. Investigator-Selected Standard of Care in Treatment-Naive PCNSL
Approved for (13)
- Acute lymphoblastic leukemia
- B-cell chronic lymphocytic leukemia
- Cancer
- Childhood acute lymphoblastic leukemia
- Granulomatosis with polyangiitis
- Lymphoblastic lymphoma
- Microscopic polyangiitis
- Neoplasm
- Non-Hodgkin lymphoma
- Pemphigus
- Pemphigus vulgaris
- Rheumatoid arthritis
- Vasculitis
In development for (141)
- Acute leukemia of ambiguous lineage Phase 2
- Acute myeloid leukemia Phase 2
- AIDS Phase 2
- Anaplastic large cell lymphoma Phase 2
- Angioimmunoblastic T-cell lymphoma Phase 2
- Ankylosing spondylitis Phase 2
- Anti-neutrophil antibody associated vasculitis Phase 3
- Aplastic anemia Phase 2
- Autoimmune disease Phase 1
- Autoimmune hemolytic anemia Phase 3
- Autoimmune polyendocrinopathy Phase 2
- Autoimmune thrombocytopenic purpura Phase 3
- B-cell acute lymphoblastic leukemia Phase 2
- B-cell non-Hodgkin lymphoma Phase 2
- Behcet disease Phase 2
- Blast phase chronic myelogenous leukemia, BCR-ABL1 positive Phase 2
- Breast neoplasm Phase 2
- Bullous pemphigoid Phase 3
- Burkitt lymphoma Phase 3
- Castleman disease Phase 2
Other linked conditions (4)
- Atopic eczema
- Atrial fibrillation
- Idiopathic membranous glomerulonephritis
- Lymphoma, non-Hodgkin, familial
Targets (1)
- MS4A1 B-lymphocyte antigen CD20 binding agent