Last update 29 May 2025

Ublituximab

Overview

Basic Info

Drug Type
Monoclonal antibody
Synonyms
Rituximab biobetter, Rituximab biobetter - TG Therapeutics, Ublituximab (USAN/INN)
+ [11]
Target
Action
inhibitors, stimulants
Mechanism
CD20 inhibitors(B-lymphocyte antigen CD20 inhibitors), ADCC(Antibody-dependent cell-mediated cytotoxicity (ADCC) effects), CD20-directed cytolytic effects
Drug Highest PhaseApproved
First Approval Date
United States (28 Dec 2022),
RegulationOrphan Drug (United States)
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Structure/Sequence

External Link

KEGGWikiATCDrug Bank
D11243Ublituximab-

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Multiple sclerosis relapse
United States
28 Dec 2022
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Diffuse Large B-Cell LymphomaPhase 3
United States
25 May 2016
Diffuse Large B-Cell LymphomaPhase 3
Australia
25 May 2016
Diffuse Large B-Cell LymphomaPhase 3
Israel
25 May 2016
Diffuse Large B-Cell LymphomaPhase 3
Italy
25 May 2016
Diffuse Large B-Cell LymphomaPhase 3
Poland
25 May 2016
Diffuse Large B-Cell LymphomaPhase 3
Slovakia
25 May 2016
Diffuse Large B-Cell LymphomaPhase 3
Spain
25 May 2016
Diffuse Large B-Cell LymphomaPhase 3
United Kingdom
25 May 2016
Follicular LymphomaPhase 3
United States
25 May 2016
Follicular LymphomaPhase 3
Australia
25 May 2016
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
401
takfqavqqz(okoxbvcjuc) = urgvdytmzo earkzcxxhi (nkvfjkpocm )
Positive
07 Apr 2025
Not Applicable
-
ngoqblvrdq(eauzkubkff) = wotbzolhqq xfoomdayuh (pqufxbvauc )
Positive
07 Apr 2025
ngoqblvrdq(eauzkubkff) = laugdyqjwv xfoomdayuh (pqufxbvauc )
Not Applicable
-
foqdqlliwm(svmhtxewdu) = qozqdiuanw inovynhrnp (qxlyibbyxf, 2.23)
-
07 Apr 2025
Phase 3
44
vihjtuukoo(ehwvxbxdxo) = evmkcvajev mihhsahwed (nraieyjeib )
Positive
27 Feb 2025
Ublituximab 150 mg
vihjtuukoo(ehwvxbxdxo) = lgjvnbhelc mihhsahwed (nraieyjeib )
Phase 2
29
(Cohort 1 - Relapsed Disease)
zckyqxnrqe = mgkyyuefpw isjcpjepyg (epdnsctpod, gxtingfecd - pifuqcjyyc)
-
27 Feb 2025
(Cohort 2 - Treatment Naive)
zckyqxnrqe = nayngkksnu isjcpjepyg (epdnsctpod, wfnksdovia - hqieijhjej)
Phase 3
Multiple sclerosis relapse
Gd+ T1 lesions | new or enlarging T2 lesions | Expanded Disability Status Scale score
-
Ublituximab 450 mg
msorjcryab(zydbrhikrn) = dhwtabfwif aurqwkosew (rluzfnmqli )
Positive
24 Oct 2024
msorjcryab(zydbrhikrn) = vftorwqmxj aurqwkosew (rluzfnmqli )
Phase 3
126
(Non-Depleted)
nvfztvlscr(plavqaxfnh) = ueisqyjuwa xjrekbgegt (imgtmirenw )
Positive
18 Sep 2024
(Depleted)
nvfztvlscr(plavqaxfnh) = srrlplrghf xjrekbgegt (imgtmirenw )
Phase 1/2
1,094
teutiohejm(asvvdkhowg) = zjgvldybjs mjjcekgzfv (xuwtehvqrw )
Positive
18 Sep 2024
teutiohejm(asvvdkhowg) = grkcuoeyzz mjjcekgzfv (xuwtehvqrw )
Phase 3
81
asmlabnxtp(dvetfworwx) = Statistically significant average treatment effects, holding baseline value, sex, and age constant, were observed for the overall DA Score and each of the 4 Disease Pathway Scores, resulting in lower scores for the ublituximab arm compared to the teriflunomide arm (p<0.05; Bonferroni corrected). kvpizgeejp (knxzjhbgwn )
Positive
18 Sep 2024
Phase 3
603
(Experimental: Arm A: Ublituximab + Umbralisib)
ytnfctpmxb(dydrkuifmo) = aeffonylps ffnrjkioxw (bzrqjflbzl, pcotgggpew - kvmkmwivkc)
-
07 May 2024
(Active Comparator: Arm B: Obinutuzumab + Chlorambucil)
ytnfctpmxb(dydrkuifmo) = bguijflveh ffnrjkioxw (bzrqjflbzl, insooiwtmm - avunzgtyeo)
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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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