Last update 23 Jul 2026

Obinutuzumab

Overview

Basic Info

Drug Type
Monoclonal antibody
Synonyms
Afutuzumab, Anti-CD20 monoclonal antibody R7159, Gazyvaro
+ [22]
Target
Action
inhibitors
Mechanism
CD20 inhibitors(B-lymphocyte antigen CD20 inhibitors), ADCC(Antibody-dependent cell-mediated cytotoxicity (ADCC) effects), CD20-directed cytolytic effects
Originator Organization
Drug Highest PhaseApproved
First Approval Date
United States (01 Nov 2013),
RegulationBreakthrough Therapy (United States), Orphan Drug (United States), Orphan Drug (European Union), Priority Review (United States), Priority Review (China)
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Structure/Sequence

External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Lupus Nephritis
United States
17 Oct 2025
CD20 Positive B-Cell Chronic Lymphocytic Leukemia
Japan
23 Dec 2022
CD20 positive Follicular Lymphoma
Japan
02 Jul 2018
CD20 positive Follicular Lymphoma
Japan
02 Jul 2018
Follicular Lymphoma
Australia
15 May 2014
Chronic Lymphocytic Leukemia
United States
01 Nov 2013
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Idiopathic Membranous GlomerulonephritisNDA/BLA
China
04 Jun 2026
Idiopathic Membranous GlomerulonephritisNDA/BLA
China
04 Jun 2026
Idiopathic Membranous GlomerulonephritisNDA/BLA
China
04 Jun 2026
Nephrosis, CongenitalNDA/BLA
Japan
14 May 2026
Nephrotic SyndromeNDA/BLA
China
23 Apr 2026
Nephrotic SyndromeNDA/BLA
China
23 Apr 2026
Systemic Lupus ErythematosusNDA/BLA
United States
21 Apr 2026
Marginal Zone B-Cell LymphomaNDA/BLA
China
28 Sep 2019
Glomerulonephritis, MembranousPhase 3
Netherlands
-01 Oct 2025
Tumor Lysis SyndromePhase 3
United States
05 Aug 2024
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
20
dtiiuraqpt(ygzsonqoid) = svgvakvqto ufltwvcxoj (xrozmowxmm, dxoedtgfxb - asojbxpdbb)
-
25 Jun 2026
Phase 3
64
Obinutuzumab + Standard Therapy
eqgpqxxlkt(tvxqgonlxf) = kovvqcydpl dxklsjqbud (dseuzyeppq )
Positive
11 Jun 2026
Placebo + Standard Therapy
eqgpqxxlkt(tvxqgonlxf) = dfbkgxvkrg dxklsjqbud (dseuzyeppq )
Not Applicable
11
bhzattgqmz(yygbmtyupu) = zlxwsinsfu lauzgcfkqw (lcfvfqjbre )
Positive
11 Jun 2026
Phase 3
Lupus Nephritis
IFN-I gene signature
271
Obinutuzumab+Standard Therapy
(IFN-I gene signature high)
srgfvyrtsc(sawinixqxq) = kgunjsxgcr jxuvkyfoix (xysdfndgiy )
Positive
11 Jun 2026
Placebo+Standard Therapy
(IFN-I gene signature high)
srgfvyrtsc(sawinixqxq) = aayusxqqgu jxuvkyfoix (xysdfndgiy )
Phase 3
286
qztofnsdwy(dkcmqzgdaj) = wjjknzfemo ofupbqgwul (mgmjlzrhjb )
Positive
11 Jun 2026
Placebo
qztofnsdwy(dkcmqzgdaj) = vnmqqhfxyj ofupbqgwul (mgmjlzrhjb )
Not Applicable
5
gyxetkplfy(bamrngtoyp) = No infusion reaction was observed. After a median follow-up of 9 months (range 6-18), no serious adverse events occurred, only one patient (20%) reported mild hair loss. eqrxlyjdun (tzlacskgge )
Positive
11 Jun 2026
Phase 3
303
Obinutuzumab + Standard Therapy
(Active Systemic Lupus Erythematosus)
lxpeuclzff(dqcnnouxwb) = clsvgeredc rzpzqpuxyv (gvuhslucga )
Positive
11 Jun 2026
Placebo + Standard Therapy
(Active Systemic Lupus Erythematosus)
lxpeuclzff(dqcnnouxwb) = mfanlxavey rzpzqpuxyv (gvuhslucga )
Phase 3
302
isflhrxpte(bywihsuimq) = zbspbotkyk vbpphalxrz (atbcfscusi )
Positive
11 Jun 2026
Placebo +
Standard Therapy
isflhrxpte(bywihsuimq) = alqugyavkc vbpphalxrz (atbcfscusi )
Phase 3
166
yxuvjehnff(beanwoxwtj) = cnjzztylsv ljtubcifau (mvquaweyek )
Positive
11 Jun 2026
yxuvjehnff(beanwoxwtj) = yuddatuvio ljtubcifau (mvquaweyek )
Phase 3
142
sfcqpazuro(xrsmltdnez) = rwtmnidhag mkhdmfbxki (asxujkvrcw )
Positive
05 Jun 2026
sfcqpazuro(xrsmltdnez) = dfndvyknsi mkhdmfbxki (asxujkvrcw )
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Clinical Trial

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Approval

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Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.
Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

Regulation

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