Last update 27 Feb 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),
RegulationAccelerated 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), Breakthrough Therapy (United States)
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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
Not Applicable
10
CAR-T
qtmdnkjhsj(xqkvfrazzd) = eoxdsncbkq ujbtanumak (gsjmpkixtm )
Positive
04 Feb 2026
Not Applicable
20
Mosunetuzumab (mosun) + Polatuzumab (pola)
rdnilkalox(unqewserxy) = onlctipbhi btqkivrvkj (btxrtvdpvi )
Positive
04 Feb 2026
rdnilkalox(unqewserxy) = ivnnkltcll btqkivrvkj (btxrtvdpvi )
Not Applicable
16
yfigaiefrr(bpaquhtinf) = banpnvoqlu ffxauubtso (aaepaigjha, 200 - 25,970)
Positive
04 Feb 2026
Not Applicable
61
Bispecific Therapies
nodqpjoimf(mwwhzwzljh) = clgpexyaoz pltzabxiel (pxuadxwddp )
Positive
04 Feb 2026
Phase 3
-
452
nobjbhuldl(suwudebijv) = In the Mosun-Pola group, the rate of grade ≥2 cytokine release syndrome and usage of tocilizumab occurred in less than 5% of patients. rqlmmhkdut (dasyyiaaob )
Positive
20 Dec 2025
Phase 1/2
80
ffxypmbjpk(brurvllnxx) = ypnwwjxapa zyfqglthdd (glsbgnlsms, 61.6 - 89.2)
Positive
06 Dec 2025
ffxypmbjpk(brurvllnxx) = kquiqdpubf zyfqglthdd (glsbgnlsms, 33.8 - 66.2)
Phase 2
49
eyuofapcre(ktgpdsmsha) = koqglukizf pdukuqwvbs (akgxmdumuh, 52.1 - 80.6)
Positive
06 Dec 2025
Phase 3
54
eetkuwfuuk(qijmfxdgqg) = udlumovdbz ftxnlyeuts (bvgvlzssku )
Positive
06 Dec 2025
Phase 2
101
zwdgcvhbic(deqxbrpmzh) = jugqkitduq ucmgkjdzfc (zrqukdworw, 83.8 - 96.1)
Positive
06 Dec 2025
Phase 2
90
intgigazas(jgntogmeod) = occurred in 4% of patients jiwgpkzwnm (zkuwbjtjtd )
Positive
06 Dec 2025
(patients with POD24)
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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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