Last update 09 Jan 2026

Mosunetuzumab

Overview

Basic Info

Drug Type
Bispecific T-cell Engager (BiTE)
Synonyms
Anti-CD20/CD3 T-cell dependent bispecific antibody, CD20/CD3 BiMAb, Mosunetuzumab (USAN/INN)
+ [14]
Action
inhibitors, stimulants
Mechanism
CD20 inhibitors(B-lymphocyte antigen CD20 inhibitors), CD3 stimulants(T cell surface glycoprotein CD3 stimulants)
Originator Organization
Inactive Organization-
License Organization
Drug Highest PhaseApproved
First Approval Date
European Union (03 Jun 2022),
RegulationBreakthrough Therapy (United States), Accelerated Approval (United States), Orphan Drug (United States), Orphan Drug (European Union), Conditional marketing approval (European Union), Priority Review (United States), Conditional marketing approval (China), Priority Review (China)
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Structure/Sequence

External Link

KEGGWikiATCDrug Bank
D11463--

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Recurrent Follicular Lymphoma
United States
22 Dec 2022
Refractory Follicular Lymphoma
United States
22 Dec 2022
Follicular Lymphoma
European Union
03 Jun 2022
Follicular Lymphoma
Iceland
03 Jun 2022
Follicular Lymphoma
Liechtenstein
03 Jun 2022
Follicular Lymphoma
Norway
03 Jun 2022
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Aggressive B-Cell Non-Hodgkin LymphomaNDA/BLA
Canada
01 Jun 2025
Large B-cell lymphomaPhase 3
Switzerland
23 May 2023
B-cell lymphoma refractoryPhase 3
United States
25 Apr 2022
B-cell lymphoma refractoryPhase 3
China
25 Apr 2022
B-cell lymphoma refractoryPhase 3
Japan
25 Apr 2022
B-cell lymphoma refractoryPhase 3
Argentina
25 Apr 2022
B-cell lymphoma refractoryPhase 3
Brazil
25 Apr 2022
B-cell lymphoma refractoryPhase 3
Canada
25 Apr 2022
B-cell lymphoma refractoryPhase 3
Israel
25 Apr 2022
B-cell lymphoma refractoryPhase 3
Mexico
25 Apr 2022
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
-
452
dymznponeg(biccnmjzwi) = In the Mosun-Pola group, the rate of grade ≥2 cytokine release syndrome and usage of tocilizumab occurred in less than 5% of patients. zzyfedehlp (tbmzqlnccr )
Positive
20 Dec 2025
Phase 1/2
80
rmiawjcbjq(qcymytqzqh) = qqdyqpurdv fylbfzmdmu (rveppvrcaw, 61.6 - 89.2)
Positive
06 Dec 2025
rmiawjcbjq(qcymytqzqh) = uysjmkdeeg fylbfzmdmu (rveppvrcaw, 33.8 - 66.2)
Phase 3
208
Mosun-Pola
uyfbbjbxbb(qcmiusdbwq) = Pts with Mosun-Pola had clinically meaningful improvements in mean scores by EORTC QLQ-C30 for constipation (C7, -10.2), while mean scores remained at baseline levels for pts in the R-GemOx arm. davncyrjpz (viqodfvyvn )
Positive
06 Dec 2025
R-GemOx
Phase 2
94
yoyvdgsfvi(wgvqplgice) = n=1 nsqxhfykuj (tkcmigjiza )
Positive
06 Dec 2025
(pts with a CR)
Phase 2
25
Mosunetuzumab + Polatuzumab + Axicabtagene Ciloleucel
mpvutehrcm(efbqghrpnh) = cowqmjesgc yychgdtbkp (utgeupnucl )
Positive
06 Dec 2025
Phase 2
101
xyonafabig(idfgktwalu) = nzeahobnko gnzdspdqgw (ffdadzeqkt, 83.8 - 96.1)
Positive
06 Dec 2025
Phase 2
52
gvowwekdpu(wclcsdsols) = qvajpvdqfd rtvvyfeajc (jymkixsusa, 69 - 93)
Positive
06 Dec 2025
Phase 2
42
wrgnrnrgrf(esedytktpx) = ejqfhzjztu cqaroxftbt (xckvclbzuc )
Positive
06 Dec 2025
Phase 2
103
ykikkynkgm(acqmfmqgiv) = eigrcyujad kwqsypimgr (drkiojhuvb, 76.2 - 91.3)
Positive
06 Dec 2025
Phase 3
54
dyhjrdqahp(faiaqjjsni) = tvdkeolfkt kmmmsmpdoi (jvlyuhxyvd )
Positive
06 Dec 2025
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Translational Medicine

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Deal

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Core Patent

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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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