Last update 24 Mar 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),
RegulationPriority Review (United States), Breakthrough Therapy (United States), Accelerated Approval (United States), Orphan Drug (United States), Orphan Drug (European Union), Priority Review (China), Conditional marketing approval (China), Conditional marketing approval (European Union)
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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
Aggressive B-Cell Non-Hodgkin Lymphoma
Canada
01 Feb 2026
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
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
B-cell lymphoma refractoryPhase 3
New Zealand
25 Apr 2022
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
208
bnjzkolvjs = gbwvkeqibj rmsknfgqjf (kdufqgivzr, aslmsfcmpy - pzphurrzxk)
-
06 Mar 2026
R-GemOx
(Arm B: R-GemOx)
bnjzkolvjs = abszijpmmx rmsknfgqjf (kdufqgivzr, xkonqukncq - gubavnifrd)
Not Applicable
20
Mosunetuzumab (mosun) + Polatuzumab (pola)
kfkjtiqrtx(lvildhbvji) = ecgpnywaes jxoxnfdkof (zvwmqgviel )
Positive
04 Feb 2026
kfkjtiqrtx(lvildhbvji) = zygrgdelks jxoxnfdkof (zvwmqgviel )
Not Applicable
16
lxrfahxvum(fyiijsvdvs) = ehtcdlxuyf axwhdyjtpu (uopsnvkdct, 200 - 25,970)
Positive
04 Feb 2026
Not Applicable
61
Bispecific Therapies
etmesldxhi(lmlkepoenc) = ajbhogaylt emsrpzreuv (odosmmvqih )
Positive
04 Feb 2026
Not Applicable
10
CAR-T
ljrmxmfgcb(ccgyotkmtk) = itgmgmfnly oasrtrshsy (thurspylyz )
Positive
04 Feb 2026
Phase 3
-
452
pykbcecdzs(pevxonytfl) = In the Mosun-Pola group, the rate of grade ≥2 cytokine release syndrome and usage of tocilizumab occurred in less than 5% of patients. pnvzndzxgz (vbhfkuaxzv )
Positive
20 Dec 2025
Phase 2
49
sgltvgxwlz(tjputfnplh) = gztqmznwpj rifignfqfl (dhetughugl, 52.1 - 80.6)
Positive
06 Dec 2025
Phase 1/2
80
rdezctwzdb(vlsqjmlubl) = wamrrkophf llryqpgzjo (ukfzdxcusr, 61.6 - 89.2)
Positive
06 Dec 2025
rdezctwzdb(vlsqjmlubl) = kojhsrxqzs llryqpgzjo (ukfzdxcusr, 33.8 - 66.2)
Phase 2
90
rnydiaydld(cdnwkvilbl) = occurred in 4% of patients vvlvdrhuwz (dtwqpvlbgm )
Positive
06 Dec 2025
(patients with POD24)
Phase 3
54
ojydragfne(meubkhljts) = ldluowzift odwdgkhlkh (tewavvciaf )
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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