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Rituximab

Generic Name
Rituximab
Brand Names
MabThera, Riabni, Rituxan, Rituxan Hycela, Ruxience, Truxima, Blitzima, Rixathon, Riximyo, Ituxredi
Drug Type
Biotech
CAS Number
174722-31-7
Unique Ingredient Identifier
4F4X42SYQ6

Overview

Rituximab is a genetically engineered chimeric murine/human monoclonal antibody directed against the CD20 antigen found on the surface of normal and malignant B lymphocytes. The antibody is an IgG1 kappa immunoglobulin containing murine light and heavy-chain variable region sequences and human constant region sequences , . It was originally approved by the U.S. FDA in 1997 as a single agent to treat patients with B-cell Non-Hodgkin's Lymphoma (NHL) , however, has now been approved for a variety of conditions . On November 28, 2018, the US FDA approved Truxima, the first biosimilar to Rituxan (Rituximab) .

Indication

Rituximab is indicated for the treatment of adult patients with relapsed or refractory, low-grade or follicular, CD20-positive, B-cell non-Hodgkin’s Lymphoma (NHL) as a single agent. Also, it is indicated for the treatment of adult patients with previously untreated follicular, CD20-positive, B-cell NHL in combination with first line chemotherapy and, in patients achieving a complete or partial response to a rituximab product in combination with chemotherapy, as single-agent maintenance therapy. Additionally, rituximab is indicated for the treatment of adult patients with non-progressing (including stable disease), low-grade, CD20-positive, B-cell NHL as a single agent after first-line cyclophosphamide, vincristine, and prednisone (CVP) chemotherapy; and previously untreated diffuse large B-cell, CD20-positive NHL in combination with cyclophosphamide, doxorubicin, vincristine, prednisone (CHOP) or other anthracycline-based chemotherapy regimens. Rituximab, in combination with fludarabine and cyclophosphamide (FC), is indicated for the treatment of adult patients with previously untreated and previously treated CD20-positive chronic lymphocytic leukemia (CLL). In combination with methotrexate, rituximab is indicated for the treatment of adult patients with moderately-to severely-active rheumatoid arthritis who have had an inadequate response to one or more TNF antagonist therapies. Additionally, rituximab, in combination with glucocorticoids, is indicated for the treatment of adult and pediatric patients 2 years of age and older with Granulomatosis with Polyangiitis (GPA) (Wegener’s Granulomatosis) and Microscopic Polyangiitis (MPA). RITUXAN (rituximab injection for intravenous use) is indicated for the treatment of pediatric patients aged 6 months and older with previously untreated, advanced stage, CD20-positive diffuse large B-cell lymphoma (DLBCL), Burkitt lymphoma (BL), Burkitt-like lymphoma (BLL) or mature B-cell acute leukemia (B-AL) in combination with chemotherapy; as well as the treatment of adult patients with moderate to severe pemphigus vulgaris. These indications for RITUXAN are not included in the labels of rituximab biosimilar products (rituximab-arrx, rituximab-abbs, rituximab-pvvr). The combination product RITUXAN HYCELA (rituximab and hyaluronidase human injection, for subcutaneous use) is not indicated for the treatment of non-malignant conditions.

Associated Conditions

  • Active, Moderate to Severe Rheumatoid Arthritis
  • Chronic Lymphocytic Leukemia
  • Diffuse Large B-Cell Lymphoma (DLBCL)
  • Follicular Non-Hodgkin's Lymphoma
  • Granulomatosis With Polyangiitis
  • Microscopic Polyangiitis (MPA)
  • Advanced Burkitt Lymphoma (BL)
  • Advanced Burkitt-like lymphoma
  • Advanced Diffuse Large B-Cell Lymphoma (DLBCL)
  • Advanced Mature B-cell type acute leukaemia
  • Moderate Pemphigus Vulgaris (PV)
  • Non-progressive Low Grade Non-Hodgkin's Lymphoma (NHL)
  • Refractory Low Grade Non-Hodgkin's Lymphoma (NHL)
  • Refractory follicular B-cell non-Hodgkin's lymphoma
  • Relapsed Low Grade Non-Hodgkin's Lymphoma (NHL)
  • Relapsed follicular B-cell non-Hodgkin's lymphoma
  • Severe Pemphigus Vulgaris (PV)

Clinical Trials

Title
Posted
Study ID
Phase
Status
Sponsor
2025/07/18
Not Applicable
Recruiting
Imbioray (Hangzhou) Biomedicine Co., Ltd.
2025/07/17
Not Applicable
Active, not recruiting
Tang-Du Hospital
2025/07/04
Not Applicable
Not yet recruiting
Ostfold Hospital Trust
2025/07/03
Not Applicable
Completed
Wuhan Children's Hospital
2025/06/27
Not Applicable
Recruiting
Pirogov Russian National Research Medical University
2025/06/25
Phase 2
Completed
Shereen Medhat Mohammed Elsayed Nassar
2025/06/24
Phase 2
Not yet recruiting
2025/06/19
Phase 2
Not yet recruiting
Shanghai JMT-Bio Inc.
2025/06/11
Phase 2
Not yet recruiting
Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
2025/06/08
Phase 4
Not yet recruiting

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
Cephalon, Inc.
63459-104
INTRAVENOUS
10 mg in 1 mL
11/2/2022
Pfizer Laboratories Div Pfizer Inc
0069-0238
INTRAVENOUS
100 mg in 10 mL
10/30/2023
Amgen Inc
55513-224
INTRAVENOUS
100 mg in 10 mL
6/16/2025
Cephalon, Inc.
63459-103
INTRAVENOUS
10 mg in 1 mL
11/2/2022
Genentech, Inc.
50242-109
SUBCUTANEOUS
120 mg in 1 mL
11/16/2022
Genentech, Inc.
50242-051
INTRAVENOUS
10 mg in 1 mL
6/6/2023
Genentech, Inc.
50242-053
INTRAVENOUS
10 mg in 1 mL
6/6/2023
Genentech, Inc.
50242-108
SUBCUTANEOUS
120 mg in 1 mL
11/16/2022
Amgen Inc
55513-326
INTRAVENOUS
500 mg in 50 mL
6/16/2025
Pfizer Laboratories Div Pfizer Inc
0069-0249
INTRAVENOUS
500 mg in 50 mL
10/30/2023

HSA Drug Approvals

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
Rituximab Injection
国药准字S20201002
生物制品
注射剂
4/15/2020
Rituximab Injection
国药准字SJ20160029
生物制品
注射剂
3/26/2021
Rituximab Injection
国药准字SJ20160031
生物制品
注射剂
3/26/2021
Rituximab Injection
国药准字S20190021
生物制品
注射剂
12/18/2023
Rituximab Injection
国药准字S20240008
生物制品
注射剂
3/19/2024
Rituximab Injection
国药准字SJ20160030
生物制品
注射剂
3/26/2021
Rituximab Injection
国药准字S20230033
生物制品
注射剂
5/26/2023
Rituximab Injection
国药准字S20200022
生物制品
注射剂
9/30/2020
Rituximab Injection
国药准字SJ20170002
生物制品
注射剂
3/26/2021
MabThera sc
国药准字SJ20240013
生物制品
注射剂
4/2/2024

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