Obinutuzumab

Summary

Obinutuzumab (CHEMBL1743048) is an approved antibody (ATC L01FA03) targeting MS4A1; indicated across 33 conditions including b-cell chronic lymphocytic leukemia and neoplasm.

At a glance

• Status: Approved (max clinical phase 4)
• Modality: Antibody
• ATC class: L01FA03
• Targets: 1 (MS4A1)
• Indications: 33 conditions
• Clinical trials: 286

Identifiers

Drug identity and classification

Field	Value
ChEMBL ID	CHEMBL1743048
Name	Obinutuzumab
Type	Antibody
Max phase	4
ATC	L01FA03

Also known as: AFUTUZUMAB, GA-101, GA101, Gazyva, Gazyvaro, HUMAB CD20, HUMAB, HUMABCD20, Obinutuzumab, R-7159, RG-7159, RO 5072759

Targets

Targets

Primary targets (GtoPdb curated mechanism): the Cancer dependency column is the DepMap CRISPR fitness signal (% of screened cell lines dependent on the target).

Gene	Target	Action	pAffinity	Cancer dependency	UniProt
MS4A1	CD20 (membrane-spanning 4-domains, subfamily A, member 1)	Binding		0%	P11836

Bioactivity

No ChEMBL bioactivity rows at pChembl ≥ 5 (expected for biologics / antibodies).

Target pathways

Aggregated over 1 target gene(s): MS4A1.

Dominant GO biological processes

GO term	Targets
store-operated calcium entry	1
humoral immune response	1
cell surface receptor signaling pathway	1
response to bacterium	1
B cell differentiation	1
B cell proliferation	1
B cell activation	1
B cell receptor signaling pathway	1
protein tetramerization	1
calcium ion import into cytosol	1
positive regulation of calcium ion import across plasma membrane	1

Indications & clinical

Indications

33 indications (5 at ChEMBL trial phase 4). Phase below is the highest clinical-trial phase recorded for this drug against each disease — not the molecule’s overall approval status (that is in the Summary).

Indication	Trial phase	MONDO	EFO
B-cell chronic lymphocytic leukemia	4	MONDO:0004948	EFO:0000095
neoplasm	4	MONDO:0005070	EFO:0000616
neoplasm of mature B-cells	4	MONDO:0004949	EFO:0000096
follicular lymphoma	4	MONDO:0018906	MONDO:0018906
non-Hodgkin lymphoma	3	MONDO:0018908	EFO:0005952
lymphoma	3	MONDO:0005062	EFO:0000574
diffuse large B-cell lymphoma	3	MONDO:0018905	EFO:0000403
lupus nephritis	3	MONDO:0005556	EFO:0005761
kidney disorder	3	MONDO:0005240	EFO:0003086
systemic lupus erythematosus	3	MONDO:0007915	MONDO:0007915
leukemia	2	MONDO:0005059	EFO:0000565
mantle cell lymphoma	2	MONDO:0018876	EFO:1001469
Waldenstrom macroglobulinemia	2	MONDO:0100280	EFO:0009441
hairy cell leukemia	2	MONDO:0018935	EFO:1000956
graft versus host disease	2	MONDO:0013730	MONDO:0013730
acute lymphoblastic leukemia	2	MONDO:0004967	EFO:0000220
non-small cell lung carcinoma	2	MONDO:0005233	EFO:0003060
focal segmental glomerulosclerosis	2	MONDO:0100313	EFO:0004236
nephrotic syndrome	2	MONDO:0005377	EFO:0004255
MALT lymphoma	2	MONDO:0007650	EFO:0000191
lymphoid leukemia	2	MONDO:0005402	EFO:0004289
autoimmune thrombocytopenic purpura	2	MONDO:0008558	EFO:0007160
marginal zone lymphoma	2	MONDO:0017604	EFO:1000630
glomerulonephritis	2	MONDO:0002462	MONDO:0002462
Burkitt lymphoma	1	MONDO:0007243	EFO:0000309
Hodgkins lymphoma	1	MONDO:0004952	EFO:0000183
mycosis fungoides	1	MONDO:0009691	EFO:1001051
prolymphocytic leukemia	1	MONDO:0001023	MONDO:0001023
urothelial carcinoma	1	MONDO:0040679	EFO:0008528
primary cutaneous T-cell non-Hodgkin lymphoma	1	MONDO:0000607	EFO:0002913
colorectal neoplasm	1	MONDO:0005335	MONDO:0005575
chronic kidney disease	1	MONDO:0005300	MONDO:0024327

1 further indication record had no mapped disease name (EFO/MeSH-only) or were duplicates, and are omitted.

Clinical trials

Total trials: 286.

Phase distribution

Phase	Trials
PHASE2	133
PHASE1	60
PHASE3	40
PHASE1/PHASE2	39
Not specified	12
PHASE4	1
PHASE2/PHASE3	1

Top trials by phase / activity

NCT	Phase	Status	Title
NCT03817853	PHASE4	COMPLETED	An Open-Label, Single Arm Study of Obinutuzumab Short Duration Infusion in Patients With Previously Untreated Advanced Follicular Lymphoma
NCT02475681	PHASE3	ACTIVE_NOT_RECRUITING	Acalabrutinib, Obinutuzumab and Chlorambucil in Treatment naïve CLL
NCT03462719	PHASE3	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)
NCT03701282	PHASE3	ACTIVE_NOT_RECRUITING	Assessing the Ability of Combination Treatment With Venetoclax to Permit Time Limited Therapy in Chronic Lymphocytic Leukemia
NCT03737981	PHASE3	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
NCT03836261	PHASE3	ACTIVE_NOT_RECRUITING	Study of Acalabrutinib (ACP-196) in Combination With Venetoclax (ABT-199), With and Without Obinutuzumab (GA101) Versus Chemoimmunotherapy for Previously Untreated CLL
NCT04221477	PHASE3	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
NCT04269902	PHASE3	RECRUITING	Testing Early Treatment for Patients With High-Risk Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Leukemia (SLL), EVOLVE CLL/SLL Study
NCT04408638	PHASE3	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
NCT04608318	PHASE3	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)
NCT04629248	PHASE3	ACTIVE_NOT_RECRUITING	A Study Evaluating the Efficacy and Safety of Obinutuzumab in Participants With Primary Membranous Nephropathy
NCT04702256	PHASE3	RECRUITING	Induction Therapy for Lupus Nephritis With no Added Oral Steroids: A Trial Comparing Oral Corticosteroids Plus Mycophenolate Mofetil (MMF) Versus Obinutuzumab and MMF
NCT04963296	PHASE3	ACTIVE_NOT_RECRUITING	A Study to Evaluate the Efficacy and Safety of Obinutuzumab in Participants With Systemic Lupus Erythematosus
NCT05057494	PHASE3	ACTIVE_NOT_RECRUITING	A Study of Acalabrutinib Plus Venetoclax Versus Venetoclax Plus Obinutuzumab in Previously Untreated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
NCT05100862	PHASE3	RECRUITING	A Study of Zanubrutinib Plus Anti-CD20 Versus Lenalidomide Plus Rituximab in Participants With Relapsed/Refractory Follicular or Marginal Zone Lymphoma
NCT05197192	PHASE3	RECRUITING	A Phase-3-trial of Acalabrutinib, Obinutuzumab & Venetoclax Compared to Obinutuzumab and Venetoclax in Previously Untreated Patients With High Risk CLL
NCT05627557	PHASE3	ACTIVE_NOT_RECRUITING	A Study to Evaluate the Efficacy and Safety of Obinutuzumab Versus MMF in Participants With Childhood Onset Idiopathic Nephrotic Syndrome
NCT06073821	PHASE3	ACTIVE_NOT_RECRUITING	Study of Sonrotoclax (BGB-11417) Plus Zanubrutinib (BGB-3111) Compared With Venetoclax Plus Obinutuzumab in Participants With Chronic Lymphocytic Leukemia (CLL)
NCT06084936	PHASE3	RECRUITING	A Study to Evaluate Glofitamab as a Single Agent vs. Investigator’s Choice in Participants With Relapsed/Refractory Mantle Cell Lymphoma
NCT06191744	PHASE3	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
NCT06284122	PHASE3	RECRUITING	Study of Mosunetuzumab Plus Lenalidomide Compared to Anti-CD20 Anti-body + Chemotherapy in Follicular Lymphoma FLIPI2-5
NCT06428019	PHASE3	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)
NCT06781944	PHASE3	RECRUITING	OBINOTUZUMAB Versus Cyclophosphamide + Glucocorticoids in Primary Membranous Nephropathy(Blossom Study)
NCT06943872	PHASE3	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)
NCT07163611	PHASE2/PHASE3	RECRUITING	Obinutuzumab Induced Decreases of PLA2R Antibodies in Membranous Nephropathy: a Pilot Study
NCT01010061	PHASE3	COMPLETED	CLL11: A Study of Obinutuzumab (RO5072759 [GA101]) With Chlorambucil in Patients With Previously Untreated Chronic Lymphocytic Leukemia (Stage 1a)
NCT01059630	PHASE3	COMPLETED	A Study to Investigate the Efficacy and Safety of Bendamustine Compared With Bendamustine+Obinutuzumab (GA101) in Participants With Rituximab-Refractory, Indolent Non-Hodgkin’s Lymphoma (GADOLIN)
NCT01287741	PHASE3	TERMINATED	A Study of Obinutuzumab in Combination With CHOP Chemotherapy Versus Rituximab With CHOP in Participants With CD20-Positive Diffuse Large B-Cell Lymphoma (GOYA)
NCT01332968	PHASE3	COMPLETED	A Study of Obinutuzumab (RO5072759) Plus Chemotherapy in Comparison With Rituximab Plus Chemotherapy Followed by Obinutuzumab or Rituximab Maintenance in Patients With Untreated Advanced Indolent Non-Hodgkin’s Lymphoma (GALLIUM)
NCT01659099	PHASE3	TERMINATED	GA In NEwly Diagnosed Diffuse Large B Cell Lymphoma
NCT01905943	PHASE3	COMPLETED	A Safety and Efficacy Study of Obinutuzumab Alone or in Combination With Chemotherapy in Participants With Chronic Lymphocytic Leukemia
NCT01980875	PHASE3	TERMINATED	Efficacy and Safety of Idelalisib in Combination With Obinutuzumab Compared to Chlorambucil in Combination With Obinutuzumab for Previously Untreated Chronic Lymphocytic Leukemia
NCT01998880	PHASE3	COMPLETED	CLL11: A Study of Rituximab With Chlorambucil or Chlorambucil Alone in Patients With Previously Untreated Chronic Lymphocytic Leukemia (Stage 1b)
NCT02053610	PHASE3	COMPLETED	CLL11: A Study of Obinutuzumab (RO5072759 [GA101]) With Chlorambucil in Patients With Previously Untreated Chronic Lymphocytic Leukemia (Stage 2)
NCT02242942	PHASE3	COMPLETED	Comparison of the Treatments of Obinutuzumab + Venetoclax Versus Obinutuzumab + Chlorambucil in Patients With Chronic Lymphocytic Leukemia
NCT02264574	PHASE3	COMPLETED	A Multi-Center Study of Ibrutinib in Combination With Obinutuzumab Versus Chlorambucil in Combination With Obinutuzumab in Patients With Treatment naïve Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL)
NCT02612311	PHASE3	TERMINATED	Ublituximab + TGR-1202 Compared to Obinutuzumab + Chlorambucil in Participants With Untreated and Previously Treated Chronic Lymphocytic Leukemia
NCT02950051	PHASE3	COMPLETED	Standard Chemoimmunotherapy (FCR/BR) Versus Rituximab + Venetoclax (RVe) Versus Obinutuzumab (GA101) + Venetoclax (GVe) Versus Obinutuzumab + Ibrutinib + Venetoclax (GIVe) in Fit Patients With Previously Untreated Chronic Lymphocytic Leukemia (CLL) Without Del(17p) or TP53 Mutation
NCT03406156	PHASE3	COMPLETED	A Study in Previously Untreated Chronic Lymphocytic Leukemia (CLL) Subjects, Excluding Those With the 17p Deletion, to Evaluate Debulking Regimens Prior to Initiating Venetoclax Combination Therapy
NCT04285567	PHASE3	COMPLETED	A Study to Compare the Efficacy and Safety of a Combined Regimen of Venetoclax and Obinutuzumab Versus Fludarabine, Cyclophosphamide, and Rituximab (FCR)/ Bendamustine And Rituximab (BR) in FIT Patients With Previously Untreated Chronic Lymphocytic Leukemia (CLL) Without DEL (17P) or TP53 Mutation

Clinical evidence (CIViC)

No CIViC predictive evidence (expected for non-precision-medicine drugs).

Pharmacology

Pharmacogenomics

No PharmGKB pharmacogenomic data curated for this drug.

Related molecules

Related molecules

No competitor molecules sharing a primary target (ChEMBL phase ≥2 or PubChem drug-class).