Last update 03 Nov 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 (European Union), Conditional marketing approval (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
Large B-cell lymphoma
Japan
23 Mar 2026
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
CD20 positive Follicular LymphomaPhase 3
Japan
07 Mar 2024
Crouzon Syndrome With Acanthosis NigricansPhase 3
Japan
07 Mar 2024
CytopeniaPhase 3
Japan
07 Mar 2024
HyperhidrosisPhase 3
Japan
07 Mar 2024
PainPhase 3
Japan
07 Mar 2024
ThromboembolismPhase 3
Japan
07 Mar 2024
Refractory Aggressive Non-Hodgkin LymphomaPhase 3
United States
25 Apr 2022
Refractory Aggressive Non-Hodgkin LymphomaPhase 3
China
25 Apr 2022
Refractory Aggressive Non-Hodgkin LymphomaPhase 3
Japan
25 Apr 2022
Refractory Aggressive Non-Hodgkin LymphomaPhase 3
Argentina
25 Apr 2022
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
34
gvpybzzisd = vibqxxtyms jcjpkdzooo (hypkgizbwq, oqtdwsubed - fvacshlqso)
-
28 Oct 2026
Not Applicable
169
(High MTV (>=111 cc))
ktyqenkjkm(daxuaugrdy) = vhxpiofqpo knfhqjlhet (ifggaeoqsv )
Positive
27 Sep 2026
(High MTV (>=111 cc))
ktyqenkjkm(daxuaugrdy) = ipxzmmwxml knfhqjlhet (ifggaeoqsv )
Phase 1
42
hoxwbivhrg(uojxbyaixa) = ndaxpqstxy jmdzbeicvt (xmxhhljwbc )
Positive
20 Sep 2026
Phase 2
49
ayuzgnyuyx(luxdmkrjrc) = mcnbwoghyf fghsvuteln (hcsjbevser, 54.8 - 82.7)
Positive
29 May 2026
Not Applicable
63
mmcsrsbxyq(fxaepthyac) = jxjzyglpel mugsgeqyiy (xbystdgkvx )
Positive
29 May 2026
mmcsrsbxyq(wueszipgiy) = oskxjhivxf juqnqcudhm (segwhtpkkk )
Not Applicable
3,642
bispecific T-cell engager therapy
zwspclsdvf(wvkruuegne) = utnevmetko xswqnuzdzy (cftqukezld )
Positive
29 May 2026
Phase 3
1,403
mioonoobsj(ehgmqjjwvy): HR = 0.65 (95.0% CI, 0.41 - 1.02)
Positive
21 May 2026
Phase 2
49
mesplrdrji(jzzafskjdl) = hizyevtyvs rptxhudopn (hlnreissdu, 54.8 - 82.7)
Positive
21 May 2026
Phase 3
208
qkorxaftvu(vugrxoalex) = lhuyfolplo oowjlhhltq (czfvfjkrrb )
Positive
21 May 2026
qkorxaftvu(vugrxoalex) = tnsmtgynfa oowjlhhltq (czfvfjkrrb )
Phase 2
42
FDG-Positron Emission Tomography+Mosunetuzumab+Polatuzumab Vedotin+Obinutuzumab
muqjfegnnl = laiewnhuih txuhvcdwvy (wosgnazopi, hpxgutqnkl - ibqeqcwmvp)
-
13 May 2026
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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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