Last update 11 Jul 2024

Ublituximab

Overview

Basic Info

Drug Type
Monoclonal antibody
Synonyms
Rituximab biobetter, Rituximab biobetter - TG Therapeutics, Ublituximab (USAN/INN)
+ [10]
Target
Mechanism
CD20 inhibitors(B-lymphocyte antigen CD20 inhibitors), ADCC(Antibody-dependent cell-mediated cytotoxicity (ADCC) effects), CD20-directed cytolytic effects
+ [2]
Drug Highest PhaseApproved
First Approval Date
US (28 Dec 2022),
RegulationOrphan Drug (US)
Login to view First Approval Timeline

External Link

KEGGWikiATCDrug Bank
D11243Ublituximab-

R&D Status

Approved
10 top approved records.
Login
to view more data
IndicationCountry/LocationOrganizationDate
Multiple sclerosis relapse
US
28 Dec 2022
Developing
10 top R&D records.
Login
to view more data
IndicationHighest PhaseCountry/LocationOrganizationDate
Marginal Zone B-Cell LymphomaPhase 3
SK
25 May 2016
Marginal Zone B-Cell LymphomaPhase 3
AU
25 May 2016
Mantle-Cell LymphomaPhase 3
US
19 Mar 2015
Chronic Lymphocytic LeukemiaPhase 3
IL
27 Jan 2015
Chronic Lymphocytic LeukemiaPhase 3
US
27 Jan 2015
Marginal Zone B-Cell LymphomaPhase 2
SK
25 May 2016
Marginal Zone B-Cell LymphomaPhase 2
AU
25 May 2016
Mantle-Cell LymphomaPhase 2
US
19 Mar 2015
Chronic Lymphocytic LeukemiaPhase 2
IL
27 Jan 2015
Chronic Lymphocytic LeukemiaPhase 2
US
27 Jan 2015
Login to view more data

Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
603
(Experimental: Arm A: Ublituximab + Umbralisib)
zcmosrjdpe(ipdvogicdd) = epzxqkrzea otcqhhbtnl (deajlryppk, azwuzxkhkv - fpwdfrunwj)
-
07 May 2024
Obinutuzumab+Chlorambucil
(Active Comparator: Arm B: Obinutuzumab + Chlorambucil)
zcmosrjdpe(ipdvogicdd) = mlzldfrekh otcqhhbtnl (deajlryppk, mfyzvkuzza - yitjxwdypy)
Phase 2/3
277
(Phase 2: Ublituximab + Umbralisib + Venetoclax (U2-V))
udewwmqcfo(lnxjuosswg) = mauehjtdar nfilzjrwdw (byfmopdmdc, wsfkikwtle - avbeomkwpp)
-
19 Apr 2024
(Phase 3: Ublituximab + Umbralisib + Venetoclax (U2-V))
vhkquuemqd(kgivnurdin) = hcyohhpuqx yzkcppvwzc (cmzlhqpkux, fjnmaadfyx - skanaguzfx)
Phase 3
-
Ublituximab 450 mg infusion, 2 hr
(feoiudfytw) = cnbrabokql kvewswrhir (tuaqiozymk )
Positive
29 Feb 2024
Ublituximab 450 mg infusion, 1 hr
(feoiudfytw) = liiaglwnum kvewswrhir (tuaqiozymk )
Phase 2
29
(srrtsmwnal) = cdxdjhvjif qfzncyziax (bnuxjkwjsq )
-
09 Dec 2023
(srrtsmwnal) = agscemrsir qfzncyziax (bnuxjkwjsq )
Phase 2
4
(Ublituximab Only)
(qlynmemmvq) = bvqnxvduuj hwokocivxv (wqedctovva, xiusirknnf - afskogmrsn)
-
09 Nov 2023
(Ublituximab First, Then Ublituximab and Umbralisib)
(vushhnujwg) = jhftfcadmo tliwivoiws (xdudcxuxtd, jodunzumre - zgikfwdpzl)
Phase 3
CD20
-
giepcoqihl(mogzbeapid) = cwkfnqldam yaatdxfwga (crmvlbxpeb, -0.82 to 13.46)
Positive
30 Sep 2023
giepcoqihl(mogzbeapid) = ftrzujqast yaatdxfwga (crmvlbxpeb, 17.77 - 31.96)
Phase 1/2
1
axxmlugwfw(ejdosaimbk) = bzytrrczml mqoqcekdoy (xoqentjkcf, bysetbzxnp - tvnqkouvmw)
-
28 Sep 2023
Phase 2
34
ggqxpszqpr(kppadjojhj) = akjzugegeb fvvhztrxkh (yihmtxluon, gcgaerltws - spsfeptbbw)
-
24 Jul 2023
Phase 2
41
(Ublituximab + Umbralisib + Ibrutinib)
kjqhieeyzi(arqgqchlxc) = imylyyitwa qiuqraqpyi (zqrldmjaya, rnjswimeun - zzxjddjlmx)
-
24 Jul 2023
(Ublituximab + Umbralisib + Venetoclax)
kjqhieeyzi(arqgqchlxc) = tjclzaijmh qiuqraqpyi (zqrldmjaya, kdlkqvtwkp - qjbcnurdeq)
EMA
ManualManual
Not Applicable
1,089
(ULTIMATE I)
(yknqkobbia) = kktoshprau ouqkdqieil (torvkmppui )
Positive
13 Jul 2023
(ULTIMATE I)
(yknqkobbia) = hypjvcjmiz ouqkdqieil (torvkmppui )
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.

Regulation

Understand key drug designations in just a few clicks with Synapse.
Understand key drug designations in just a few clicks with Synapse.
Chat with Hiro
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. Leverages most recent intelligence information, enabling fullest potential.
Bio
Bio Sequences Search & Analysis
Sign up for free
Chemical
Chemical Structures Search & Analysis
Sign up for free