BLAINJECTIONINJECTABLEPriority Review
Approved
Nov 2013
Lifecycle
Peak
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
7/8 — Comprehensive
Priority Review
GAZYVA (obinutuzumab) by Roche is cd20-directed antibody interactions [moa]. Approved for cd20-directed cytolytic antibody [epc]. First approved in 2013.
Drug data last refreshed 6h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
GAZYVA (obinutuzumab) is a CD20-directed cytolytic monoclonal antibody administered by injection for B-cell malignancies and autoimmune conditions. It works by binding to CD20 antigen on B cells, triggering direct cell death and immune-mediated cytotoxicity. The drug targets patients with conditions requiring B-cell depletion, including chronic lymphocytic leukemia and certain lymphomas.
$6MPart D
PeakStable
Product is in peak commercial phase with established market presence; commercial team size is likely stable with focus on market defense against competing CD20 agents.
Mechanism of Action
CD20-directed Antibody Interactions
Pharmacologic Class:
CD20-directed Cytolytic Antibody
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
A Phase 2 Trial Of The Combination Of Zanubrutinib, Sonrotoclax, And Obinutuzumab For Patients With Treatment-Naïve Chronic Lymphocytic Leukemia
Started Dec 2026
40 enrolled
Chronic Lymphocytic Leukemia
Obinutuzumab for Systemic Lupus Erythematosus Pure Membranous Nephropathy: a Phase II Trial
Started Sep 2026
65 enrolled
Lupus NephritisMembranous Nephropathy
A Study of Zanubrutinib, Obinutuzumab, and Sonrotoclax in People With Mantle Cell Lymphoma
Started Sep 2026
45 enrolled
Mantle Cell Lymphoma
A Trial to Assess the Efficacy and Safety of Obinutuzumab in Treating Adults With Minimal Change Disease (MCD)
Started Jul 2026
48 enrolled
Minimal Change Disease (MCD)
Phase 2 Study of Disease Risk Mutation-Guided Finite Acalabrutinib+Venetoclax for Relapsed CLL Post-1L Finite cBTKi+BCL2i ± Obinutuzumab
Started Jun 2026
80 enrolled
Chronic Lymphocytic Leukemia (CLL)Small Lymphocytic Lymphoma (SLL)
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.