RITUXAN (rituximab)
RITUXAN is indicated for the treatment of Non-Hodgkin's Lymphoma; Diffuse Large B-Cell Lymphoma; Burkitt Lymphoma; Mature B-Cell Acute Leukemia; Chronic Lymphocytic Leukemia; Rheumatoid Arthritis.
How RITUXAN Works
Rituximab is a monoclonal antibody designed to target the CD20 antigen, which is expressed on the surface of pre-B and mature B-lymphocytes. Upon binding to this antigen, the drug mediates B-cell lysis through mechanisms such as complement-dependent cytotoxicity and antibody-dependent cell-mediated cytotoxicity. In autoimmune conditions, depleting B-cells helps interrupt the inflammatory process by reducing autoantibody production, antigen presentation, and proinflammatory cytokine production.
Development Insights
Details
- Status
- Prescription
- First Approved
- 1997-11-26
- Patent Cliff
- 2018
- Revenue
- $375M (Q4-2025)
- Routes
- INTRAVENOUS
- Dosage Forms
- SOLUTION
RITUXAN Approval History
What RITUXAN Treats
6 indicationsRITUXAN is approved for 6 conditions since its original approval in 1997. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Non-Hodgkin's Lymphoma
- Diffuse Large B-Cell Lymphoma
- Burkitt Lymphoma
- Mature B-Cell Acute Leukemia
- Chronic Lymphocytic Leukemia
- Rheumatoid Arthritis
RITUXAN Boxed Warning
FATAL INFUSION-RELATED REACTIONS, SEVERE MUCOCUTANEOUS REACTIONS, HEPATITIS B VIRUS REACTIVATION and PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY WARNING: FATAL INFUSION-RELATED REACTIONS, SEVERE MUCOCUTANEOUS REACTIONS, HEPATITIS B VIRUS REACTIVATION and PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY See full prescribing information for complete boxed warning. Fatal infusion-related reactions within 24 hours of RITUXAN infusion; approximately 80% of fatal reactions occurred with first infusion. Monit...
WARNING: FATAL INFUSION-RELATED REACTIONS, SEVERE MUCOCUTANEOUS REACTIONS, HEPATITIS B VIRUS REACTIVATION and PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY WARNING: FATAL INFUSION-RELATED REACTIONS, SEVERE MUCOCUTANEOUS REACTIONS, HEPATITIS B VIRUS REACTIVATION and PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY See full prescribing information for complete boxed warning. Fatal infusion-related reactions within 24 hours of RITUXAN infusion; approximately 80% of fatal reactions occurred with first infusion. Monitor patients and discontinue RITUXAN infusion for severe reactions ( 5.1 ). Severe mucocutaneous reactions, some with fatal outcomes ( 5.2 ). Hepatitis B virus (HBV) reactivation, in some cases resulting in fulminant hepatitis, hepatic failure, and death ( 5.3 ). Progressive multifocal leukoencephalopathy (PML) resulting in death ( 5.4 ). Infusion-Related Reactions RITUXAN administration can result in serious, including fatal, infusion-related reactions. Deaths within 24 hours of RITUXAN infusion have occurred. Approximately 80% of fatal infusion reactions occurred in association with the first infusion. Monitor patients closely. Discontinue RITUXAN infusion for severe reactions and provide medical treatment for Grade 3 or 4 infusion-related reactions [see Warnings and Precautions (5.1) , Adverse Reactions (6.1) ]. Severe Mucocutaneous Reactions Severe, including fatal, mucocutaneous reactions can occur in patients receiving RITUXAN [see Warnings and Precautions (5.2) ] . Hepatitis B Virus (HBV) Reactivation HBV reactivation can occur in patients treated with RITUXAN, in some cases resulting in fulminant hepatitis, hepatic failure, and death. Screen all patients for HBV infection before treatment initiation, and monitor patients during and after treatment with RITUXAN. Discontinue RITUXAN and concomitant medications in the event of HBV reactivation [see Warnings and Precautions (5.3) ] . Progressive Multifocal Leukoencephalopathy (PML), including fatal PML, can occur
RITUXAN Target & Pathway
ProTarget
A protein found on the surface of B-cells but not stem cells or plasma cells. Anti-CD20 antibodies deplete B-cells, making them effective in B-cell cancers and autoimmune diseases where B-cells drive pathology.
RITUXAN Biosimilars
3 FDA-approvedThese 3 alternatives require prescriber approval to substitute for RITUXAN.
What are biosimilars? Lower-cost alternatives to RITUXAN with no clinically meaningful differences.
Auto-substitute OK = FDA "interchangeable" designation — pharmacist can switch without calling the doctor.
RITUXAN Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in RITUXAN's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications RITUXAN treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to RITUXAN
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
986 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT04759586 | NCI-2021-01071 NCI-2021-01071, ANHL1931 | Ph 3 | active not recruiting | Nivolumab in Combination With Chemo-Immunotherapy for the Treatment of Newly Diagnosed Primary Mediastinal B-Cell Lymphoma |
| NCT05886036 | NCI-2023-04108 NCI-2023-04108, 10590 | Ph 2 | recruiting | Comparing the Effectiveness of the Immunotherapy Agents Rituximab or Mosunetuzumab in Patients With Nodular Lymphocyte-Predominant Hodgkin Lymphoma, NORM Trial |
| NCT04840602 | NCI-2021-02851 NCI-2021-02851, S2005 | Ph 2 | recruiting | Testing the Combination of Venetoclax and Rituximab, in Comparison to the Usual Treatment (Ibrutinib Plus Rituximab or Zanubrutinib Alone) for Waldenstrom's Macroglobulinemia/Lymphoplasmacytic Lymphoma |
| NCT07583810 | 260148 NCI-2026-03180, 260148 | Ph 2 | not yet recruiting | Non-covalent BTK Inhibitor Nemtabrutinib in Combination With the CD20 Monoclonal Antibody Rituximab for the Treatment of Marginal Zone Lymphoma |
| NCT06965114 | NCI-2025-03281 NCI-2025-03281, 10664 | Ph 1, Ph 2 | recruiting | Testing the Combination of Anti-cancer Drugs, Tovorafenib Plus Rituximab, in Patients With Hairy Cell Leukemia |
| NCT02160015 | NCI-2014-01157 NCI-2014-01157, 2015-00531 | Ph 1 | active not recruiting | Lenalidomide, Ibrutinib, and Rituximab in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma That Is Metastatic or Cannot Be Removed by Surgery |
| NCT07104032 IGNITE | ONO-4059-17 | Ph 3 | recruiting | IGNITE: Study of Tirabrutinib vs Rituximab/Temozolomide for Relapsed/Refractory Primary Central Nervous System Lymphoma (PCNSL) |
| NCT03321643 | NCI-2017-01957 NCI-2017-01957, PHI-96 | Ph 1 | active not recruiting | Testing the Addition of an Immunotherapy Agent, Atezolizumab, When Given With the Usual Chemo-Immunotherapy Drug Combination (Rituximab Plus Gemcitabine and Oxaliplatin) for Relapsed/Refractory (That Has Come Back or Not Responded to Treatment) Transformed Diffuse Large B-Cell Lymphoma |
| NCT03808610 | 2016-0629 NCI-2018-03360, 2016-0629 | Ph 1, Ph 2 | terminated | Low-Intensity Chemotherapy and Venetoclax in Treating Patients With Relapsed or Refractory B- or T-Cell Acute Lymphoblastic Leukemia |
| NCT03984448 | NCI-2019-03711 NCI-2019-03711, A051701 | Ph 2, Ph 3 | active not recruiting | Testing the Addition of a New Anti-cancer Drug, Venetoclax, to Usual Chemotherapy for High Grade B-cell Lymphomas |
| NCT06655896 | CYTB323K12201 2023-510380-34-00 | Ph 2 | recruiting | Phase 2 Study Evaluating Rapcabtagene Autoleucel in Participants With Diffuse Cutaneous Systemic Sclerosis |
| NCT07444710 | NCI-2026-01137 NCI-2026-01137, PHI-158 | Ph 1 | not yet recruiting | Testing the Addition of an Anti-Cancer Drug, Glofitamab, to the Usual Chemotherapy Treatment (Alternating R-CHOP/R-DHAP) for Previously Untreated Mantle Cell Lymphoma |
| NCT04799275 | NCI-2020-01256 NCI-2020-01256, S1918 | Ph 2, Ph 3 | active not recruiting | Testing CC-486 (Oral Azacitidine) Plus the Standard Drug Therapy in Patients 75 Years or Older With Newly Diagnosed Diffuse Large B Cell Lymphoma |
| NCT06337318 | NCI-2024-02361 NCI-2024-02361, S2308 | Ph 3 | recruiting | Comparing Rituximab and Mosunetuzumab Drug Treatments for People With Low Tumor Burden Follicular Lymphoma |
| NCT07226843 | 27804 J6Y-OX-JBFA, 2025-523601-16-00 | Ph 1 | recruiting | A Study of LY4584180 in Adult Participants With Previously Treated Blood Cancers |
| NCT06738368 | RG1124788 NCI-2024-09417, FHIRB0020869 | Ph 2 | recruiting | Etoposide, Prednisone, Vincristine, Cyclophosphamide, and Doxorubicin (DA-EPOCH) With or Without Rituximab Plus Recombinant Erwinia Asparaginase (JZP458) for the Treatment of Newly Diagnosed Ph Negative B-Acute Lymphoblastic Leukemia or T Acute Lymphoblastic Leukemia |
| NCT01419561 | 110220 11-C-0220 | Ph 2 | recruiting | Natural History Study of the KSHV Inflammatory Cytokine Syndrome (KICS) |
| NCT02970318 results posted | ACE-CL-309 2015-004454-17 | Ph 3 | active not recruiting | A Study of Acalabrutinib vs Investigator's Choice of Idelalisib Plus Rituximab or Bendamustine Plus Rituximab in R/R CLL |
| NCT06943872 | BGB-11417-303 2024-517131-52-00, CLL-RR1 | Ph 3 | recruiting | A Study to Investigate Progression-Free Survival With Sonrotoclax Plus Obinutuzumab Or Sonrotoclax Plus Rituximab Compared With Venetoclax Plus Rituximab Treatment In Patients With Relapsed and/or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CELESTIAL-RRCLL) |
| NCT06230224 OLYMPIA-4 | R1979-HM-2299 2022-502783-21-00 | Ph 3 | active not recruiting | A Trial to Learn How Effective and Safe Odronextamab is Compared to Standard of Care for Adult Participants With Previously Treated Aggressive B-cell Non-Hodgkin Lymphoma |
| NCT06846671 CaDAnCe-302 | BGB-16673-302 2024-518893-15-00 | Ph 3 | recruiting | A Study of BGB-16673 Compared to Investigator's Choice in Participants With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Previously Exposed to Both Bruton Tyrosine Kinase (BTK) and B-cell Leukemia/Lymphoma 2 Protein (BCL2) Inhibitors |
| NCT05100862 MAHOGANY | BGB-3111-308 CTR20232545, 2022-502548-12-00 | Ph 3 | recruiting | A Study of Zanubrutinib Plus Anti-CD20 Versus Lenalidomide Plus Rituximab in Participants With Relapsed/Refractory Follicular or Marginal Zone Lymphoma |
| NCT05453500 | RG1122464 NCI-2022-05225, 11008 | Ph 2 | active not recruiting | Chemotherapy (DA-EPOCH+/-R) and Targeted Therapy (Tafasitamab) for the Treatment of Newly-Diagnosed Philadelphia Chromosome Negative B Acute Lymphoblastic Leukemia |
| NCT06970743 CaDAnCe-303 | BGB-16673-303 | Ph 3 | recruiting | A Study of BGB-16673 Compared to Investigator's Choice in Participants With Relapsed/Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Previously Exposed to Covalent Bruton Tyrosine Kinase (BTK) Inhibitors |
| NCT07578077 | 25448 NCI-2026-02921, 25448 | Ph 1, Ph 2 | not yet recruiting | Golcadomide in Combination With Rituximab for the Treatment of Patients With Relapsed or Refractory Mantle Cell Lymphoma |
| NCT05947851 | 1026-010 MK-1026-010, BELLWAVE-010 | Ph 3 | recruiting | A Study of Nemtabrutinib Plus Venetoclax vs Venetoclax + Rituximab (VR) in Second-line (2L) + Relapsed/Refractory (R/R) Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) (MK-1026-010/BELLWAVE-010). |
| NCT03150693 | A041501 NCI-2016-01981, U10CA180821 | Ph 3 | recruiting | Inotuzumab Ozogamicin and Frontline Chemotherapy in Treating Young Adults With Newly Diagnosed B Acute Lymphoblastic Leukemia |
| NCT05139017 | 2140-003 VLS-101, MK-2140-003 | Ph 2, Ph 3 | recruiting | A Study of Zilovertamab Vedotin (MK-2140) in Combination With Standard of Care in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (rrDLBCL) (MK-2140-003) |
| NCT06890884 | 2140-011 2024-515526-89-00, U1111-1309-2852 | Ph 2 | recruiting | 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) |
| NCT03274492 POLARIX | GO39942 2017-002023-21 | Ph 3 | completed | A Study Comparing the Efficacy and Safety of Polatuzumab Vedotin With Rituximab-Cyclophosphamide, Doxorubicin, and Prednisone (R-CHP) Versus Rituximab-Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in Participants With Diffuse Large B-Cell Lymphoma |
| NCT05976763 | A052101 NCI-2023-03577 | Ph 3 | recruiting | Testing Continuous Versus Intermittent Treatment With the Study Drug Zanubrutinib for Older Patients With Previously Untreated Mantle Cell Lymphoma |
| NCT05171647 SUNMO results posted | GO43643 | Ph 3 | active not recruiting | A Study Evaluating Efficacy and Safety of Mosunetuzumab in Combination With Polatuzumab Vedotin Compared to Rituximab in Combination With Gemcitabine Plus Oxaliplatin in Participants With Relapsed or Refractory Aggressive B-Cell Non-Hodgkin's Lymphoma |
| NCT04609046 | NCI-2020-08331 NCI-2020-08331, A051901 | Ph 1 | recruiting | Testing the Addition of Lenalidomide and Nivolumab to the Usual Treatment for Primary CNS Lymphoma |
| NCT03474744 | COUP-1 | Ph 2 | active not recruiting | Copanlisib and Rituximab in Marginal Zone Lymphoma Patients |
| NCT05376319 results posted | 21-012197 | Ph 2 | terminated | PR3-AAV Resilient Remission or PRRR |
| NCT06191744 EPCORE™FL-2 | M22-003 2023-506906-38-00 | Ph 3 | recruiting | Study of Subcutaneous Epcoritamab in Combination With Intravenous Rituximab and Oral Lenalidomide (R2) to Assess Adverse Events and Change in Disease Activity in Adult Participants With Previously Untreated Follicular Lymphoma |
| NCT04872790 | STUDY00022691 NCI-2021-01791, STUDY00022691 | Ph 1 | active not recruiting | Venetoclax, Dasatinib, Prednisone, Rituximab and Blinatumomab for the Treatment of Newly Diagnosed or Relapsed Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia or Mixed Phenotype Acute Leukemia |
| NCT05283720 | M22-132 2023-505347-38, 2023-505347-38-00 | Ph 2 | recruiting | A Study to Evaluate Adverse Events and Change in Disease Activity of Subcutaneous (SC) Epcoritamab in Combination With Oral and Intravenous Anti-Neoplastic Agents in Adult Participants With Non-Hodgkin Lymphoma |
| NCT06717347 | 2140-010 MK-2140-010, 2024-515566-13-00 | Ph 3 | recruiting | A Study to Evaluate Zilovertamab Vedotin (MK-2140) Combination With Rituximab Plus Cyclophosphamide, Doxorubicin, and Prednisone (R-CHP) Versus Rituximab Plus Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in Participants With Previously Untreated DLBCL (MK-2140-010) |
| NCT06149286 OLYMPIA-5 | R1979-ONC-22102 2022-503092-28-00 | Ph 3 | recruiting | A Trial to Find Out if Odronextamab Combined With Lenalidomide is Safe and Works Better Than Rituximab Combined With Lenalidomide in Adult Participants With Follicular Lymphoma and Marginal Zone Lymphoma |
| NCT06045247 | 2023-0031 NCI-2023-07174 | Ph 2 | recruiting | Phase 2 Trial of Epcoritamab in Combination With Rituximab-mini CVP for Older Unfit/Frail Patients or Anthracycline-Ineligible Adult Patients With Newly Diagnosed Diffuse Large B-cell Lymphoma |
| NCT03920722 RITUXGOPRO | P170909J 2018-000637-12 | Ph 3 | completed | Efficacy and Safety of Rituximab in the Treatment of Good Prognosis Microscopic Polyangiitis |
| NCT06564038 Soundtrack-E | D7407C00001 2024-515034-33-00 | Ph 1, Ph 2 | recruiting | A Study of AZD0486 Monotherapy or in Combination With Other Anti-Cancer Agents for Mature B-Cell Malignancies |
| NCT03267433 | EA4151 NCI-2016-01403, EA4151 | Ph 3 | active not recruiting | Rituximab With or Without Stem Cell Transplant in Treating Patients With Minimal Residual Disease-Negative Mantle Cell Lymphoma in First Complete Remission |
| NCT04115631 | EA4181 NCI-2019-05536, EA4181 | Ph 2 | active not recruiting | A Comparison of Three Chemotherapy Regimens for the Treatment of Patients With Newly Diagnosed Mantle Cell Lymphoma |
| NCT04712097 Celestimo | GO42909 2020-005239-53 | Ph 3 | active not recruiting | A Study Evaluating the Efficacy and Safety of Mosunetuzumab in Combination With Lenalidomide in Comparison to Rituximab in Combination With Lenalidomide With a US Extension of Mosunetuzumab in Combination With Lenalidomide in Participants With Follicular Lymphoma |
| NCT02727803 | 2015-0313 NCI-2016-00584, 2015-0313 | Ph 2 | recruiting | Personalized NK Cell Therapy in CBT |
| NCT05952024 ACRUE | D8227C00002 | Ph 2 | recruiting | Study of Acalabrutinib and Rituximab in Untreated Elderly and/or Frail Patients With DLBCL |
| NCT05848765 REFRACT | RG_22-020 | Ph 2 | recruiting | Relapsed Follicular Lymphoma Randomised Trial Against Standard ChemoTherapy |
| NCT04978584 | 2021-0046 NCI-2021-04298, 2021-0046 | Ph 2 | active not recruiting | Rituximab, Lenalidomide, Acalabrutinib, Tafasitamab Alone and With Combination Chemotherapy for the Treatment of Newly Diagnosed Non-germinal Center Diffuse Large B-Cell Lymphoma, Smart Stop Study |
Showing 50 of 986 trials
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
RITUXAN FDA Label Details
Indications & Usage
FDA Label (PDF)RITUXAN is indicated for the treatment of Non-Hodgkin's Lymphoma; Diffuse Large B-Cell Lymphoma; Burkitt Lymphoma; Mature B-Cell Acute Leukemia; Chronic Lymphocytic Leukemia; Rheumatoid Arthritis.
WARNING: FATAL INFUSION-RELATED REACTIONS, SEVERE MUCOCUTANEOUS REACTIONS, HEPATITIS B VIRUS REACTIVATION and PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY WARNING: FATAL INFUSION-RELATED REACTIONS, SEVERE MUCOCUTANEOUS REACTIONS, HEPATITIS B VIRUS REACTIVATION and PROGRESSIVE MULTIFOCAL LEUKOENCEPHALO...
Pro Intelligence Preview
Deep insights for RITUXAN
Revenue Insights
- • Q4-2025: $375M
- • Historical trend analysis
Patent Timeline
- • Cliff: 2018
- • Generic/biosimilar risk
Trial Analysis
- • 16 total trials
- • Stage: Declining
Competitive Landscape
- • 20 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment