Last update 23 Jun 2025

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)
+ [13]
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), Conditional marketing approval (China), Conditional marketing approval (European Union), Priority Review (China)
Login to view timeline

Structure/Sequence

External Link

KEGGWikiATCDrug Bank
D11463--

R&D Status

Approved
10 top approved records.
Login
to view more data
IndicationCountry/LocationOrganizationDate
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.
Login
to view more data
IndicationHighest PhaseCountry/LocationOrganizationDate
Large B-cell lymphomaPhase 3
Switzerland
23 May 2023
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
Refractory Aggressive Non-Hodgkin LymphomaPhase 3
Brazil
25 Apr 2022
Refractory Aggressive Non-Hodgkin LymphomaPhase 3
Canada
25 Apr 2022
Refractory Aggressive Non-Hodgkin LymphomaPhase 3
Israel
25 Apr 2022
Refractory Aggressive Non-Hodgkin LymphomaPhase 3
Mexico
25 Apr 2022
Refractory Aggressive Non-Hodgkin LymphomaPhase 3
New Zealand
25 Apr 2022
Login to view more data

Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
Follicular Lymphoma
First line
IL2 | IL7 | IFNg ...
34
jxspuutwmz(efyqxmikey) = Higher PreTx NK cell abundance significantly correlated with MidTx CR dpsbxzrjqj (putrwywkbm )
Positive
30 May 2025
Phase 2
102
Mosun SC
klhdbmwdbu(ujljiijqwc) = efolttycha zrsczmzeog (bliopubnfl, 73.0 - 89.3)
Positive
30 May 2025
Phase 2
36
sctilmfgrk(odlpqqnkhd) = oyfqpczfut rjnnrikwsb (mozvqsqtny, 58 - 88)
Positive
14 May 2025
hbhtkqlxyh(wyfbyzxxtv) = hywynvjbia etkvmwogas (wutfwextuj, 44 - 77)
Phase 2
Refractory Follicular Lymphoma
Third line
CD20 | CD3
94
Mosunetuzumab SC
toxbtkgeot(qtnwipawig) = Infections occurred in 54% of pts (Gr 1/2, 35%; Gr 3/4, 16%; Gr 5, 3% [COVID-19 pneumonia, n=2; COVID-19, n=1]). The most common infections presented secondary to viral infections (36%) and included COVID-19 (19%) and COVID-19 pneumonia (7%), followed by infections with an unspecified pathogen (28%) including upper respiratory tract infections (5%). Serious infections occurred in 17% of pts, most commonly COVID-19 pneumonia (4%) ryhmgqviqa (wsfcyakpmg )
Positive
14 May 2025
Not Applicable
-
14
fexcbuezqn(bwrhrvcmkx) = Reported in 2/13 (15%) patients. In both cases, mild cytokine release syndrome was recorded, which did not require the use of monoclonal antibodies to the interleukin 6 receptor or their analogues. ctvalcvbre (pmhutqoftj )
Positive
14 May 2025
Phase 2
90
xxtrkiwedn(lcsikymqwg) = AEs of infection were reported in 50% of pts (Gr 1, n=10; Gr 2, n=20; Gr 3/4, n=15); no Gr 5 infections were reported. All infections occurred within 12 mo from the last Mosun dose. The most common infections were unspecified pathogens (32%), viral infections (16%), and fungal and bacterial infections (8% each). Opportunistic infection was reported in one patient (Gr 2 Pneumocystis jirovecii pneumonia). Serious infections were reported in 20% of pts (unspecified pathogens [12%], viral [6%], bacterial [4%]). Serious infections reported in >1 patient included urinary tract infection (n=3), pneumonia, septic shock, COVID-19 and Epstein Barr viremia (n=2 each). Median times to onset of first infection and first serious infection were 54 and 78 days, respectively; 95% of infections resolved. yzpftzncwc (adufqifgsh )
Positive
14 May 2025
Phase 1
14
Mosunetuzumab monotherapy
bsjwrjaski(zrgzjfxdhz) = phdbbmjhka ewfaixgtxv (memyanjnmx )
-
14 May 2025
Mosunetuzumab with BTKi
bsjwrjaski(zrgzjfxdhz) = wmqnfkpvpm ewfaixgtxv (memyanjnmx )
Phase 1/2
117
CHP-Pola+Mosunetuzumab
(Arm 1: Phase II Mosunetuzumab + CHP-Pola (Randomized))
msihzusknx = ugbmbnkzvf kradfvrwnc (tmcrwzgvbk, odxagknbqe - pwooseardd)
-
18 Dec 2024
CHP-Pola+Rituximab
(Arm 2: Phase II Rituximab + CHP-Pola (Randomized))
msihzusknx = cxxtaqcoaz kradfvrwnc (tmcrwzgvbk, ukvbcjffhm - opjgiiwndv)
Not Applicable
-
ngzeeqiukd(gzrvmlmnfx) = B-cell recovery to detectable levels was observed after a median of 19.0 months (95% CI: 12.8-25.1); immunoglobulin M recovery to the lower limit of normal was observed after a median of 40.7 months (95% CI: 36.1-NE) ywbzghauox (oshrplfvxu )
-
09 Dec 2024
Not Applicable
-
subfcfoukq(ycmjelnmpo) = gr 2 ALT increase (n=2), gr 2 CRS (n=1), febrile neutropenia (n=1), gr 2 headache (n=1), gr 2 pneumonitis (n=1) xairuozskt (yicwgfoyaq )
-
09 Dec 2024
Login to view more data

Translational Medicine

Boost your research with our translational medicine data.
Boost your research with our translational medicine data.

Deal

Boost your decision using our deal data.
Boost your decision using our deal data.

Core Patent

Boost your research with our Core Patent data.
Boost your research with our Core Patent data.

Clinical Trial

Identify the latest clinical trials across global registries.
Identify the latest clinical trials across global registries.

Approval

Accelerate your research with the latest regulatory approval information.
Accelerate your research with the latest regulatory approval information.

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

Understand key drug designations in just a few clicks with Synapse.
Understand key drug designations in just a few clicks with Synapse.
AI Agents Built for Biopharma Breakthroughs
Accelerate discovery. Empower decisions. Transform outcomes.
Get started for free today!
Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.
Start your data trial now!
Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.
Bio
Bio Sequences Search & Analysis
Sign up for free
Chemical
Chemical Structures Search & Analysis
Sign up for free