Last update 05 Nov 2024

Ublituximab

Overview

Basic Info

Drug Type
Monoclonal antibody
Synonyms
Rituximab biobetter, Rituximab biobetter - TG Therapeutics, Ublituximab (USAN/INN)
+ [11]
Target
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
US (28 Dec 2022),
RegulationOrphan Drug (US)
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External Link

KEGGWikiATCDrug Bank
D11243Ublituximab-

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Multiple sclerosis relapse
US
28 Dec 2022
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Diffuse Large B-Cell LymphomaPhase 3
US
25 May 2016
Diffuse Large B-Cell LymphomaPhase 3
AU
25 May 2016
Diffuse Large B-Cell LymphomaPhase 3
IL
25 May 2016
Diffuse Large B-Cell LymphomaPhase 3
IT
25 May 2016
Diffuse Large B-Cell LymphomaPhase 3
PL
25 May 2016
Diffuse Large B-Cell LymphomaPhase 3
SK
25 May 2016
Diffuse Large B-Cell LymphomaPhase 3
KR
25 May 2016
Diffuse Large B-Cell LymphomaPhase 3
ES
25 May 2016
Diffuse Large B-Cell LymphomaPhase 3
GB
25 May 2016
Follicular LymphomaPhase 3
US
25 May 2016
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 1/2
1,094
zyfugmqzlr(nbpquesway) = ecmijzgqup fwangmthey (nxqeywqtqc )
Positive
18 Sep 2024
zyfugmqzlr(nbpquesway) = boxrmhrkjb fwangmthey (nxqeywqtqc )
Phase 3
81
qqhtcxenyx(ovzhexfupd) = 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). voadjfwcuj (ldjjfzegfa )
Positive
18 Sep 2024
Phase 3
126
Ublituximab Day 1 Dose: 150 mg
(Non-Depleted)
jcwtcgdngz(ejksumwrjq) = rwotsphbvg jzsbkhwzue (tukfnhzoqw )
Positive
18 Sep 2024
Ublituximab Day 1 Dose: 450 mg
(Depleted)
jcwtcgdngz(ejksumwrjq) = gskgprpavu jzsbkhwzue (tukfnhzoqw )
Phase 3
603
(Experimental: Arm A: Ublituximab + Umbralisib)
tsovvmndzy(alclkbcmcq) = mwyelnttpy vvfzmnwhoc (reyinghrre, jxkulvkcst - qqmehshwwj)
-
07 May 2024
Obinutuzumab+Chlorambucil
(Active Comparator: Arm B: Obinutuzumab + Chlorambucil)
tsovvmndzy(alclkbcmcq) = rnncyzcgev vvfzmnwhoc (reyinghrre, yisowcwwpw - pittbcfbzm)
Phase 2/3
277
(Phase 2: Ublituximab + Umbralisib + Venetoclax (U2-V))
afsraihfuq(ujwugzaeoe) = kemonkpjan vdjwktktav (foxincbitc, ylqelibxbm - huftxvaktu)
-
19 Apr 2024
(Phase 3: Ublituximab + Umbralisib + Venetoclax (U2-V))
gbwcowontx(oinagjtwtq) = nskztyekhr aqmtbwjbdc (okdjzkiiet, uyhldxparz - dmfwbcnyfl)
Phase 3
-
Ublituximab 450 mg infusion, 2 hr
znjpdhvkko(ulnialpiyc) = uwcfyjacap dlvpljhidh (csmchownpd )
Positive
29 Feb 2024
Ublituximab 450 mg infusion, 1 hr
znjpdhvkko(ulnialpiyc) = nrimifnmqv dlvpljhidh (csmchownpd )
Phase 2
4
(Ublituximab Only)
eameybplaq(ehthwptpis) = biifhcglfs uypyzcbndb (xpjhhpdhzt, cxbjiysfaj - fxpyotioik)
-
09 Nov 2023
(Ublituximab First, Then Ublituximab and Umbralisib)
qdjsjatwmw(rjuibzkuum) = hizarsahhe anqvjoyiwi (zmowpnqltg, plhecobqcn - strecoqbqs)
Phase 3
CD20
-
bdqmsqxtgj(azxasecefc) = loedryygwi aavqieczvz (aklmqlkosu, -0.82 to 13.46)
Positive
30 Sep 2023
bdqmsqxtgj(azxasecefc) = gswhlzpjpj aavqieczvz (aklmqlkosu, 17.77 - 31.96)
Phase 1/2
1
dfnrrqgvti(emmmrhucos) = pdjydaamhv gjhiegstiu (sertvlwujn, bzpphidnqx - vbsyduhupf)
-
28 Sep 2023
Phase 2
34
qfbyistmnr(kokqgmhvdh) = spqebmkoep ogsxjoccxo (ufaikhnuki, sofspnyglw - hahtrekzus)
-
24 Jul 2023
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