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Drug

Obinutuzumab

Approved · EMA
ClassB-lymphocyte antigen CD20 binding agentEmerging researchLate-stage development

Also known as Gazyva, Afutuzumab.

RxNorm974779ChEMBLCHEMBL1743048ATCL01FA03UNIIO43472U9X8
1
Research papers
98
Active clinical trials
B-lymphocyte antigen CD20
Primary target
1
Regulatory events
Latest activity
beta

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

A Phase 2 Study of Glofitamab and Obinutuzumab for First-line Treatment of Follicular Lymphoma and Marginal Zone Lymphoma

Clinical trial2026-08-01Primary 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 trial2026-07-22Results expected Q1 2032 · ClinicalTrials.gov

A Phase 1b Open-Label Study to Evaluate the Safety and Anti-cancer Activity of Loncastuximab Tesirine in Combination With Other Anti-cancer Agents in Patients With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma (LOTIS-7)

Clinical trial2026-07-17Status changed to Active, not recruiting · ClinicalTrials.gov

A Randomized Phase II Study of Acalabrutinib (ACA) + Venetoclax (VEN) +/- Early Obinutuzumab (OBIN) for Patients With Chronic Lymphocytic Leukemia (CLL)

Clinical trial2026-07-16Results expected Q3 2028 · 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 trial2026-07-10Results expected Q3 2027 · ClinicalTrials.gov

A Phase II, Multicenter, Open-label Study Evaluating Glofitamab in Combination With Venetoclax Plus Zanubrutinib or Venetoclax Alone in Subjects With Untreated or Relapsed/Refractory High-risk Mantle-cell Lymphoma

Clinical trial2026-07-10Results expected Q2 2028 · ClinicalTrials.gov

Randomized, Phase III Study of Early Intervention With Venetoclax and Obinutuzumab Versus Delayed Therapy With Venetoclax and Obinutuzumab in Newly Diagnosed Asymptomatic High-Risk Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL): EVOLVE CLL/SLL Study

Clinical trial2026-07-09Results expected Q4 2028 · ClinicalTrials.gov

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 trial2026-07-08Results expected Q3 2029 · ClinicalTrials.gov

Phase II Study of Nemtabrutinib With Venetoclax and Obinutuzumab in Patients With Chronic Lymphocytic Leukemia

Clinical trial2026-07-08Results expected Q4 2029 · ClinicalTrials.gov

A Phase II Study of Glofitamab for Relapsed/Refractory Mantle Cell Lymphoma in Patients Previously Treated With CD19-Directed CAR T-Cell Therapy

Clinical trial2026-07-07Results expected Q3 2027 · ClinicalTrials.gov

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

Research2025-07-11Annals of the rheumatic diseases

Approval: Gazyvaro (EMA)

Regulatory2014-07-22EMA

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
ema

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

1 event

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.

Earliest approval
2014-07-22
Latest approval
2014-07-22
Authorities
EMA
Total events
1
emaEuropean Medicines Agency· 1 event
2014-07-22Approval
Approval: 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 ↗

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

Clinical trials

199 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
199
registered trials across all phases
LATEST COMPLETION 2025
98
Active studies
57
Recruiting
33
Late-stage (III+)
60
Completed
41
Discontinued
PHASE DISTRIBUTIONn = 199
Phase 144Phase 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

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

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

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

RecruitingPH IIIBeOne Medicinesn=6302031

Recent completions

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

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

A Phase II Trial Evaluating Glofitamab, a Bispecific CD3xCD20 Antibody for Relapse/Refractory Lymphomas After CAR T-cells Therapy

CompletedPH IIThe Lymphoma Academic Research Organisationn=672025

Research activity

1 papers

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
Recent papers

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

Annals of the rheumatic diseases · 2025 · 7 cites
Major research themes5
Antibodies, Bispecific1Antibodies, Monoclonal, Humanized1B-Lymphocytes1Lymph Nodes1Lymphocyte Depletion1
Journals, researchers & institutions
Top journals
  • Annals of the rheumatic diseases1
Leading researchers
  • Auth J1
  • Bergmann C1
  • Böltz S1
  • Bozec A1
  • Bucci L1
  • Corte G1
  • D Agostino MA1
  • Eckstein M1
Leading institutions
free-text, unnormalised
  • Division of Rheumatology-Fondazione Policlinico Universitario A. Gemelli IRCCS - Università Cattolica del Sacro Cuore1
  • Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU) and Universitätsklinikum Erlangen1
  • Friedrich-Alexander-Universität Erlangen-Nürnberg and Uniklinikum Erlangen1
  • Institute of Pathology and Comprehensive Cancer Center EMN1
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.