Drug

Obinutuzumab

Established medicine

ClassB-lymphocyte antigen CD20 binding agentResearchActive indication expansion

Also known as Gazyva, Afutuzumab.

RxNorm974779 ChEMBLCHEMBL1743048 ATCL01FA03UNIIO43472U9X8

Research papers

Active clinical trials

B-lymphocyte antigen CD20

Primary target

Regulatory events

Latest activity

beta

Recent clinical, regulatory, research and industry developments relating to this drug.

A Phase 3 Randomized, Open-Label, Multicenter Study of Sonrotoclax Plus Anti-CD20 Antibody Therapies Versus Venetoclax Plus Rituximab in Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Clinical trial2026-10-23Results expected Q3 2029 · ClinicalTrials.gov

A Phase II Study of Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, and Revlimid (ViPOR) in Relapsed or Refractory CD10-Negative Diffuse Large B-Cell Lymphoma (DLBCL) and High-Grade B-Cell Lymphoma With MYC and BCL2 Rearrangements (HGBCL-DH-BCL2)

Clinical trial2026-10-21Results expected Q3 2028 · ClinicalTrials.gov

A Phase 2 Study of Glofitamab With Acalabrutinib in Patients With Relapsed/Refractory Mantle Cell Lymphoma

Clinical trial2026-10-16Primary completion · ClinicalTrials.gov

An Open-Label, Multi-Center, Phase IB/II Study of Glofitamab and Atezolizumab or Polatuzumab Vedotin (Plus a Single Pre-Treatment Dose of Obinutuzumab) in Adult Patients With Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma

Clinical trial2026-10-16Primary completion · ClinicalTrials.gov

A Phase 3, Open-Label, Randomized Study of Sonrotoclax (BGB-11417) Plus Zanubrutinib (BGB-3111) Compared With Venetoclax Plus Obinutuzumab in Patients With Previously Untreated Chronic Lymphocytic Leukemia

Clinical trial2026-10-14Results expected Q1 2032 · ClinicalTrials.gov

FDA approves Gazyva for idiopathic nephrotic syndrome

Regulatory2026-09-25Regulatory news · Healio Nephrology

Indication expansion: OBINUTUZUMAB (BLA125486)

Regulatory2026-09-25FDA

Mosunetuzumab With Response-Adapted Polatuzumab Vedotin and Obinutuzumab in Untreated Indolent B-Cell Non-Hodgkin Lymphoma

Industry2026-08-14Journal of Clinical Oncology

Label change: OBINUTUZUMAB (BLA125486)

Regulatory2025-12-17FDA

Indication expansion: OBINUTUZUMAB (BLA125486)

Regulatory2025-10-17FDA

Indication expansion: OBINUTUZUMAB (BLA125486)

Regulatory2025-10-17FDA

Effects of different B-cell-depleting strategies on the lymphatic tissue.

Research2025-07-11Annals of the rheumatic diseases

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name

Obinutuzumab

Aliases & brands

GazyvaAfutuzumab

RxNorm CUI

974779

ChEMBL ID

CHEMBL1743048

ATC codes

L01FA03

UNII

O43472U9X8

Primary mechanism

B-lymphocyte antigen CD20 binding agent

Regulatory jurisdictions

fdaema

Pharmacology & targets

1 target

Known molecular targets and mechanisms supported by curated pharmacology databases.

B-lymphocyte antigen CD20

MS4A1 · P11836

BINDING AGENTB-lymphocyte antigen CD20 binding agent

Regulatory timeline

16 events

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Approval / market entry confirmed across FDA and EMA (2013-11-01 → 2014-12-24)

Earliest approval

2013-11-01

Latest approval

2026-09-25

Authorities

FDA · EMA

Total events

fdaU.S. Food and Drug Administration· 15 events

2026-09-25Indication expansion

Indication expansion: OBINUTUZUMAB (BLA125486)

Evidence ↗

2025-12-17Label change

Label change: OBINUTUZUMAB (BLA125486)

Evidence ↗

2025-10-17Indication expansion

Indication expansion: OBINUTUZUMAB (BLA125486)

Evidence ↗

emaEuropean Medicines Agency· 1 event

2014-07-22Original application approvalMulti-authority

Marketing authorisation: Gazyvaro (EMA)

Indication: Chronic lymphocytic leukaemia (CLL) Gazyvaro in combination with chlorambucil is indicated for the treatment of adult patients with previously untreated chronic lymphocytic… Show full indication

Chronic lymphocytic leukaemia (CLL) Gazyvaro in combination with chlorambucil is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL) and with comorbidities making them unsuitable for full-dose fludarabine based therapy.  Follicular Lymphoma (FL)  Gazyvaro in combination with chemotherapy, followed by Gazyvaro maintenance therapy in patients achieving a response, is indicated for the treatment of patients with previously untreated advanced follicular lymphoma.   Gazyvaro in combination with bendamustine followed by Gazyvaro maintenance is indicated for the treatment of patients with follicular lymphoma (FL) who did not respond or who progressed during or up to 6 months after treatment with rituximab or a rituximab-containing regimen.  Lupus nephritis (LN) Gazyvaro in combination with mycophenolate mofetil (MMF) is indicated for the treatment of adult patients with active Class III or IV, with or without concomitant Class V, lupus nephritis (LN). 

Evidence ↗

Data from the U.S. Food and Drug Administration (U.S. Food and Drug Administration), public domain (CC0).

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

200 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme

CLINICALTRIALS.GOV · LIVE REGISTRY

200

registered trials across all phases

LATEST COMPLETION 2026

Active studies

Recruiting

Late-stage (III+)

Completed

Discontinued

PHASE DISTRIBUTIONn = 200

Phase 145Phase 1 / 224Phase 298Phase 331Phase 41Phase N / A1

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

A Multicentric, Open-Label, Single Arm Study of Obinutuzumab Short Duration Infusion (SDI) in Patients With Previously Untreated Advanced Follicular Lymphoma

CompletedPH IVHoffmann-La Rochen=1142023

A Phase III Randomized, Open-label, International, Multicenter Study Evaluating the Efficacy and Safety of Mosunetuzumab Plus Lenalidomide in Comparison to Anti-CD20 Monoclonal Antibody Plus Chemotherapy in Subjects With Previously Untreated FLIPI 2-5 Follicular Lymphoma

RecruitingPH IIIThe Lymphoma Academic Research Organisationn=7902034

Active, not recruitingPH IIIBeOne Medicinesn=6522032

A Phase 3, Double-Blind, Randomized, Placebo-Controlled Study of Parsaclisib Plus Investigator's Choice of Either Rituximab or Obinutuzumab in Participants With Relapsed or Refractory Follicular Lymphoma and Marginal Zone Lymphoma

WithdrawnPH IIIIncyte Corporation2032

RecruitingPH IIIBeOne Medicinesn=6302031

Recent completions

Trials that read out recently, adding to the completed evidence base.

Obinutuzumab for Primary Membranous Nephropathy: a Pilot Study in Patients With Rituximab-resistant or Rituximab-dependent Nephrotic Syndrome and in Patients Intolerant to Rituximab (the ORION Study)

CompletedPH IIMario Negri Institute for Pharmacological Researchn=202026

A Phase IB, Open-Label, Multicenter, Single Arm Study Evaluating the Preliminary Efficacy, Safety, and Pharmacokinetics of Glofitamab in Combination With Rituximab Plus Ifosfamide, Carboplatin Etoposide Phosphate in Patients With Relapsed/Refractory Transplant or CAR-T Therapy Eligible Diffuse B-Cell Lymphoma

CompletedPH IHoffmann-La Rochen=432025

A Phase 2 Study of the Safety and Efficacy of Venetoclax in Combination With Obinutuzumab or Ibrutinib in Japanese Subjects With Previously Untreated Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)

CompletedPH IIAbbVien=202025

A Phase 1 Study to Assess the Safety, Tolerability, Pharmacokinetics and Anti-tumour Activity of Acalabrutinib, a Selective and Irreversible Bruton's Tyrosine Kinase Inhibitor, in Japanese Adult Patients With Advanced B-cell Malignancies

CompletedPH IAstraZenecan=352025

A Prospective, Open-Label, Multicenter Randomized Phase III Trial to Compare The Efficacy and Safety of A Combined Regimen of Obinutuzumab and Venetoclax Versus Obinutuzumab and Chlorambucil in Previously Untreated Patients With CLL and Coexisting Medical Conditions

CompletedPH IIIHoffmann-La Rochen=4452025

A Single-center, Phase 2 Open-label Trial Evaluating the Efficacy and Safety of OBINUTUZUMAB in Treatment of Immunosuppression-dependent or Immunosuppression/Treatment-resistant Primary FSGS, or Contraindication/Patient Refusal to Take High Dose Corticosteroids

CompletedPH IIMayo Clinicn=202025

Research activity

1 paper

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Most influential

Effects of different B-cell-depleting strategies on the lymphatic tissue.

Annals of the rheumatic diseases · 2025 · 7 cites

Related drugs

1 matches

Drugs sharing diseases, protein targets and literature with this one. Ranked by graph evidence (shared targets + diseases weighted above co-mentions).

Rituximab

Frequently co-studied with Obinutuzumab in the research literature.

1 shared paper

References & data sources

RxNorm (U.S. National Library of Medicine) — drug identity
ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
Europe PMC — research literature
ClinicalTrials.gov — clinical trials
Regulatory event sources are credited in the Regulatory Timeline above.