GAZYVA (obinutuzumab)
GAZYVA is indicated for the treatment of Chronic Lymphocytic Leukemia; Follicular Lymphoma; Lupus Nephritis.
How GAZYVA Works
Obinutuzumab is a monoclonal antibody that targets the CD20 antigen expressed on the surface of pre-B and mature B lymphocytes. Upon binding to CD20, the drug mediates B-cell lysis by engaging immune effector cells, activating the complement cascade, and directly triggering intracellular death signaling pathways. The antibody is engineered with reduced fucose content, which enhances its affinity for immune receptors and increases its ability to induce cell death compared to rituximab. These combined mechanisms lead to the depletion of targeted B cells.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2013-11-01
- Patent Cliff
- 2024
- Revenue
- $304M (Q4-2025)
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
GAZYVA Approval History
What GAZYVA Treats
3 indicationsGAZYVA is approved for 3 conditions since its original approval in 2013. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Chronic Lymphocytic Leukemia
- Follicular Lymphoma
- Lupus Nephritis
GAZYVA Boxed Warning
HEPATITIS B VIRUS REACTIVATION and PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY Hepatitis B Virus (HBV) reactivation, in some cases resulting in fulminant hepatitis, hepatic failure, and death, can occur in patients receiving CD20-directed cytolytic antibodies, including GAZYVA. Screen all patients for HBV infection before treatment initiation. Monitor HBV-positive patients during and after treatment with GAZYVA. Discontinue GAZYVA and concomitant medications in the event of HBV reactivation [see ...
WARNING: HEPATITIS B VIRUS REACTIVATION and PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY Hepatitis B Virus (HBV) reactivation, in some cases resulting in fulminant hepatitis, hepatic failure, and death, can occur in patients receiving CD20-directed cytolytic antibodies, including GAZYVA. Screen all patients for HBV infection before treatment initiation. Monitor HBV-positive patients during and after treatment with GAZYVA. Discontinue GAZYVA and concomitant medications in the event of HBV reactivation [see Warnings and Precautions (5.1) ] . Progressive Multifocal Leukoencephalopathy (PML) including fatal PML, can occur in patients receiving GAZYVA [see Warnings and Precautions (5.2) ] . WARNING: HEPATITIS B VIRUS REACTIVATION and PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY See full prescribing information for complete boxed warning. Hepatitis B Virus (HBV) reactivation, in some cases resulting in fulminant hepatitis, hepatic failure, and death. ( 5.1 ) Progressive Multifocal Leukoencephalopathy (PML) resulting in death. ( 5.2 )
GAZYVA 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.
GAZYVA 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 GAZYVA's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications GAZYVA treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to GAZYVA
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
234 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT04269902 | NCI-2020-00752 NCI-2020-00752, S1925 | Ph 3 | recruiting | Testing Early Treatment for Patients With High-Risk Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Leukemia (SLL), EVOLVE CLL/SLL Study |
| NCT06649812 | NCI-2024-08642 NCI-2024-08642, EA4231 | Ph 2 | recruiting | Testing the Effectiveness of a Combination Targeted Therapy (ViPOR) for Patients With Relapsed and/or Refractory Aggressive B-cell Lymphoma |
| NCT03701282 | NCI-2018-02127 NCI-2018-02127, EA9161 | Ph 3 | active not recruiting | Assessing the Ability of Combination Treatment With Venetoclax to Permit Time Limited Therapy in Chronic Lymphocytic Leukemia |
| NCT06504199 ZGR | IIT2024010 | Ph 2 | active not recruiting | Obinutuzumab, Zanubrutinib, and Lenalidomide Followed Short-Cycle of Obinutuzumab and Cytarabine in Newly Diagnosed Mantle Cell Lymphoma |
| NCT05169658 results posted | RG1121407 NCI-2021-12489, 10823 | Ph 2 | completed | Mosunetuzumab With or Without Polatuzumab Vedotin and Obinutuzumab for the Treatment of Untreated Indolent B-Cell Non-Hodgkin Lymphoma |
| NCT07003295 | NCI-2025-03915 NCI-2025-03915, 10702 | Ph 2 | recruiting | Testing the Anti-cancer Drug, Glofitamab, in Patients With Mantle Cell Lymphoma (A Type of Blood Cancer) Whose Disease Returned After CAR-T Cell Therapy |
| NCT03269669 | NCI-2017-00009 NCI-2017-00009, S1608 | Ph 2 | active not recruiting | Obinutuzumab With or Without Umbralisib, Lenalidomide, or Combination Chemotherapy in Treating Patients With Relapsed or Refractory Grade I-IIIa Follicular Lymphoma |
| NCT07261163 | IIT2025103 | Ph 2 | recruiting | Obinutuzumab, Zanubrutinib, and Lenalidomide in First-line Treatment of Mantle Cell Lymphoma |
| 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) |
| 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 |
| NCT04221477 REGENCY results posted | CA41705 2019-004034-42, 2023-503628-22-00 | Ph 3 | active not recruiting | A Study to Evaluate the Efficacy and Safety of Obinutuzumab in Participants With ISN/RPS 2003 Class III or IV Lupus Nephritis |
| NCT06634589 | BGB-16673-104 2024-516234-35-00, CTR20244676 | Ph 1, Ph 2 | recruiting | A Study to Investigate Safety and Effectiveness of BGB-16673 in Combination With Other Agents in Participants With Relapsed or Refractory B-Cell Malignancies |
| NCT06073821 | BGB-11417-301 CTR20241195 | Ph 3 | active not recruiting | Study of Sonrotoclax (BGB-11417) Plus Zanubrutinib (BGB-3111) Compared With Venetoclax Plus Obinutuzumab in Participants With Chronic Lymphocytic Leukemia (CLL) |
| NCT03462719 GLOW results posted | CR108428 2017-004699-77, 54179060CLL3011 | Ph 3 | active not recruiting | A Study of the Combination of Ibrutinib Plus Venetoclax Versus Chlorambucil Plus Obinutuzumab for the First-line Treatment of Participants With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) |
| NCT03824483 | 18-427 | Ph 2 | recruiting | Study of Zanubrutinib, Obinutuzumab, and Venetoclax in Patients With Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Leukemia (SLL) |
| NCT03322865 | OLYMP-1 2017-003149-56 | Ph 2 | active not recruiting | Obinutuzumab in Marginal Zone Lymphoma |
| NCT05376319 results posted | 21-012197 | Ph 2 | terminated | PR3-AAV Resilient Remission or PRRR |
| NCT05896163 MAPtivate-6 | C4971006 2022-502822-41-00 | Ph 1, Ph 2 | terminated | A Study to Learn About the Effects of Two Study Medicines (Maplirpacept [PF-07901801] And Glofitamab) When Given Together In People With Relapsed Or Refractory Diffuse Large B Cell Lymphoma. |
| 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 |
| NCT05848765 REFRACT | RG_22-020 | Ph 2 | recruiting | Relapsed Follicular Lymphoma Randomised Trial Against Standard ChemoTherapy |
| NCT05533775 iMATRIX GLO | CO43810 | Ph 1, Ph 2 | recruiting | A Study to Evaluate Glofitamab Monotherapy and Glofitamab + Chemoimmunotherapy in Pediatric and Young Adult Participants With Relapsed/Refractory Mature B-Cell Non-Hodgkin Lymphoma |
| NCT06084936 GLOBRYTE | GO43878 | Ph 3 | recruiting | A Study to Evaluate Glofitamab as a Single Agent vs. Investigator's Choice in Participants With Relapsed/Refractory Mantle Cell Lymphoma |
| NCT06624085 | GO44900 | Ph 1 | recruiting | A Study Evaluating the Safety and Efficacy of Glofitamab + Gemcitabine + Oxaliplatin in U.S. Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma |
| NCT05039619 POSTERITY | WA42985 2021-000097-29, 2023-505825-15-00 | Ph 2 | recruiting | A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Obinutuzumab in Adolescents With Active Class III or IV Lupus Nephritis and the Safety and PK of Obinutuzumab in Pediatric Participants |
| NCT03737981 results posted | NCI-2018-02485 NCI-2018-02485, A041702 | Ph 3 | active not recruiting | Testing the Addition of a New Anti-cancer Drug, Venetoclax, to the Usual Treatment (Ibrutinib and Obinutuzumab) in Untreated, Older Patients With Chronic Lymphocytic Leukemia |
| NCT04608318 CLL17 | CLL17 2022-500439-35-00, 2019-003854-99 | Ph 3 | active not recruiting | Ibrutinib Monotherapy Versus Fixed-duration Venetoclax Plus Obinutuzumab Versus Fixed-duration Ibrutinib Plus Venetoclax in Patients With Previously Untreated Chronic Lymphocytic Leukaemia (CLL) |
| NCT05536349 | 2021-0578 NCI-2022-07625 | Ph 2 | recruiting | Time-limited Triplet Combination of Pirtobrutinib, Venetoclax, and Obinutuzumab for Patients With Treatment-naïve Chronic Lymphocytic Leukemia (CLL) or Richter Transformation (RT) |
| NCT03075696 | NP30179 2016-001185-28, 2023-505625-14-00 | Ph 1, Ph 2 | active not recruiting | A Dose Escalation Study of Glofitamab (RO7082859) as a Single Agent and in Combination With Obinutuzumab, Administered After a Fixed, Single Pre-treatment Dose of Obinutuzumab in Participants With Relapsed/Refractory B-cell Non-hodgkin's Lymphoma |
| NCT04739813 | 210014 21-C-0014 | Ph 1 | recruiting | Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, and Revlimid in Combination With Polatuzumab (ViPOR-P) in Relapsed/Refractory B-cell Lymphoma |
| NCT03863184 results posted | 1807019439 | Ph 2 | active not recruiting | Acalabrutinib-Lenalidomide-Rituximab in Patients With Untreated MCL |
| NCT06806033 | GO45434 | Ph 2 | recruiting | A Study to Evaluate the Optimization of the Cytokine Release Syndrome Profile for Glofitamab in Combination With Gemcitabine Plus Oxaliplatin in Participants With Relapsed/Refractory Aggressive B-Cell Non-Hodgkin's Lymphoma |
| NCT05169515 | CO43805 | Ph 1 | recruiting | A Study Evaluating the Safety, Pharmacokinetics, and Efficacy of Mosunetuzumab or Glofitamab in Combination With CC-220 and/or CC-99282 in Participants With B-Cell Non-Hodgkin Lymphoma |
| NCT03223610 | 170127 17-C-0127 | Ph 1, Ph 2 | recruiting | Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, and Revlimid (ViPOR) in Relapsed/Refractory B-cell Lymphoma |
| NCT06252675 | 232516 NCI-2024-00054 | Ph 2 | recruiting | Glofitamab With Pirtobrutinib for Relapsed or Refractory Mantle Cell Lymphoma |
| NCT06561360 | 24-160 | Ph 2 | recruiting | A Study of Vemurafenib and Obinutuzumab Compared to Cladribine and Rituximab in People With Hairy Cell Leukemia (HCL) |
| NCT04169737 | 2019-0565 NCI-2019-06675, 2019-0565 | Ph 2 | recruiting | Acalabrutinib and Venetoclax With or Without Early Obinutuzumab for the Treatment of High Risk, Recurrent, or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma |
| NCT04450173 | UCDCC#275 NCI-2020-01372, UCDCC#275 | Ph 2 | active not recruiting | Obinutuzumab, Ibrutinib, and Venetoclax for the Treatment of Previously Untreated Stage II-IV Follicular Lymphoma |
| NCT07520006 | NX-5948-203 | Ph 1, Ph 2 | not yet recruiting | Study of NX-5948 in Combination With Other Agents in Adults With B-cell Malignancies |
| NCT04560322 | 19-743 | Ph 2 | recruiting | Venetoclax-Obinutuzumab +/- Acalabrutinib in R/R CLL |
| NCT06295770 | 23-006712 | Ph 2 | recruiting | Obinutuzumab in Treatment of Fibrillary Glomerulonephritis |
| NCT06428019 | M24-287 2024-512147-23-00 | Ph 3 | recruiting | A Study to Evaluate the Risk of Tumor Lysis Syndrome (TLS) in Adult Participants Receiving Oral Venetoclax in Combination With Intravenously Infused Obinutuzumab or Oral Acalabrutinib for Previously Untreated Chronic Lymphocytic Leukemia (CLL) |
| NCT05798156 R-Pola-Glo | R-Pola-Glo ML44400, 2022-003398-51 | Ph 2 | active not recruiting | Rituximab in Combination With Glofitamab and Polatuzumab Vedotin in Patients With Previously Untreated Aggressive B-cell Lymphoma Ineligible for R-CHOP |
| NCT04629248 MAJESTY | WA41937 2020-003233-38, 2023-506525-11-00 | Ph 3 | active not recruiting | A Study Evaluating the Efficacy and Safety of Obinutuzumab in Participants With Primary Membranous Nephropathy |
| NCT04408638 | GO41944 2020-001021-31 | Ph 3 | active not recruiting | A Phase III Study Evaluating Glofitamab in Combination With Gemcitabine + Oxaliplatin vs Rituximab in Combination With Gemcitabine + Oxaliplatin in Participants With Relapsed/Refractory Diffuse Large B-Cell Lymphoma |
| NCT06108232 | 2023-0063 NCI-2023-09268 | Ph 2 | active not recruiting | Phase 2 Trial of Obinutuzumab and CC-99282 for Patients With Previously Untreated High Tumor Burden Follicular Lymphoma |
| NCT04722172 | 20-503 | Ph 2 | active not recruiting | A Study on Limiting Treatment Time With Acalabrutinib Combined With Obinutuzumab in People With CLL or SLL |
| NCT04963296 ALLEGORY | CA42750 2020-005760-57, 2023-504774-38-00 | Ph 3 | active not recruiting | A Study to Evaluate the Efficacy and Safety of Obinutuzumab in Participants With Systemic Lupus Erythematosus |
| NCT06824701 TARZAN | HCI183680 | Ph 1 | suspended | Tazemetostat in Combination With Zanubrutinib and Anti-CD20 Monoclonal Antibody in Relapsed or Refractory B-cell Non-Hodgkin Lymphoma |
| NCT03533283 | NP39488 | Ph 1, Ph 2 | active not recruiting | An Open-Label Phase lB/II Study of Glofitamab and Atezolizumab or Polatuzumab Vedotin in Adult Patients With Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma |
| NCT02537613 | 15-283 | Ph 1 | active not recruiting | A Study of Ibrutinib + Obinutuzumab in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia |
Showing 50 of 234 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.
GAZYVA FDA Label Details
Indications & Usage
FDA Label (PDF)GAZYVA is indicated for the treatment of Chronic Lymphocytic Leukemia; Follicular Lymphoma; Lupus Nephritis.
WARNING: HEPATITIS B VIRUS REACTIVATION and PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY Hepatitis B Virus (HBV) reactivation, in some cases resulting in fulminant hepatitis, hepatic failure, and death, can occur in patients receiving CD20-directed cytolytic antibodies, including GAZYVA. Screen all pa...
Pro Intelligence Preview
Deep insights for GAZYVA
Revenue Insights
- • Q4-2025: $304M
- • Historical trend analysis
Patent Timeline
- • Cliff: 2024
- • Generic/biosimilar risk
Trial Analysis
- • 235 total trials
- • Stage: Growth
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