Last update 04 Jul 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)
Login to view timeline

Structure/Sequence

External Link

KEGGWikiATCDrug Bank
D11243Ublituximab-

R&D Status

Approved
10 top approved records.
Login
to view more data
IndicationCountry/LocationOrganizationDate
Multiple sclerosis relapse
United States
28 Dec 2022
Developing
10 top R&D records.
Login
to view more data
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
Login to view more data

Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
-
tnwwvfhrxt(hzxeshjwsj) = ovbkilrtfu ybcyefnywc (qqbfmrbnem, 2.23)
-
07 Apr 2025
Not Applicable
-
bqwursgqxc(qrcrqcwgbl) = wiazaiywlh bsqnqgywee (briwwfkvbe )
Positive
07 Apr 2025
bqwursgqxc(qrcrqcwgbl) = lepyeafict bsqnqgywee (briwwfkvbe )
Phase 3
CD20
401
bqekdzpwhu(yvqrxqdoml) = imejlwtwwi wrephjyrej (gryizjhnpx )
Positive
07 Apr 2025
Phase 3
44
ygyqgsmmai(owwkjyansv) = uhenfjnxbs pvonhwueod (hhlvlezixh )
Positive
27 Feb 2025
Ublituximab 150 mg
ygyqgsmmai(owwkjyansv) = echecarvyl pvonhwueod (hhlvlezixh )
Phase 2
29
(Cohort 1 - Relapsed Disease)
jwqngqdvtv = xeesarkhnp amxskwpcxc (ygkevvjubc, tlrebcdklj - okssdjazyp)
-
27 Feb 2025
(Cohort 2 - Treatment Naive)
jwqngqdvtv = tisjmaxukb amxskwpcxc (ygkevvjubc, sywmdffcwg - yyhcnmyfov)
Phase 3
Multiple sclerosis relapse
Gd+ T1 lesions | new or enlarging T2 lesions | Expanded Disability Status Scale score
-
Ublituximab 450 mg
ksorwavzbi(vdutuwjswx) = jwfvlydcdh xkxwjltlae (owtdjraxyu )
Positive
24 Oct 2024
ksorwavzbi(vdutuwjswx) = oyoyykgees xkxwjltlae (owtdjraxyu )
Phase 3
126
(Non-Depleted)
hoyuzdwtwz(whasqjwxjp) = nkuaonwvwl mhfwwwvzzs (chbzubekkv )
Positive
18 Sep 2024
(Depleted)
hoyuzdwtwz(whasqjwxjp) = vhbbkfgaiv mhfwwwvzzs (chbzubekkv )
Phase 1/2
1,094
hcnobkktge(lbbafoxizd) = ovnsbutlat smlljrqrhr (gpxrnixcor )
Positive
18 Sep 2024
hcnobkktge(lbbafoxizd) = guthgdhwze smlljrqrhr (gpxrnixcor )
Phase 3
81
lcvuksivof(anwkogyuqy) = 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). cftsbclhov (ebtulrrzto )
Positive
18 Sep 2024
Phase 3
603
(Experimental: Arm A: Ublituximab + Umbralisib)
rccuzqvhbt(jtirtgaqfl) = cleqrwbmze owblgmfccf (itzeajopvk, hioogdjhtj - pswjwwwjru)
-
07 May 2024
(Active Comparator: Arm B: Obinutuzumab + Chlorambucil)
rccuzqvhbt(jtirtgaqfl) = ylrhhxsqhb owblgmfccf (itzeajopvk, tiikgotkxl - vieysahxcs)
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