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 |
Therapeutic Areas |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization |
Drug Highest PhaseApproved |
First Approval Date US (28 Dec 2022), |
RegulationOrphan Drug (US) |
KEGG | Wiki | ATC | Drug Bank |
---|---|---|---|
D11243 | Ublituximab | - |
Indication | Country/Location | Organization | Date |
---|---|---|---|
Multiple sclerosis relapse | US | 28 Dec 2022 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Diffuse Large B-Cell Lymphoma | Phase 3 | US | 25 May 2016 | |
Diffuse Large B-Cell Lymphoma | Phase 3 | AU | 25 May 2016 | |
Diffuse Large B-Cell Lymphoma | Phase 3 | IL | 25 May 2016 | |
Diffuse Large B-Cell Lymphoma | Phase 3 | IT | 25 May 2016 | |
Diffuse Large B-Cell Lymphoma | Phase 3 | PL | 25 May 2016 | |
Diffuse Large B-Cell Lymphoma | Phase 3 | SK | 25 May 2016 | |
Diffuse Large B-Cell Lymphoma | Phase 3 | KR | 25 May 2016 | |
Diffuse Large B-Cell Lymphoma | Phase 3 | ES | 25 May 2016 | |
Diffuse Large B-Cell Lymphoma | Phase 3 | GB | 25 May 2016 | |
Follicular Lymphoma | Phase 3 | US | 25 May 2016 |
Phase 1/2 | 1,094 | zyfugmqzlr(nbpquesway) = ecmijzgqup fwangmthey (nxqeywqtqc ) View more | Positive | 18 Sep 2024 | |||
zyfugmqzlr(nbpquesway) = boxrmhrkjb fwangmthey (nxqeywqtqc ) View more | |||||||
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 ) View more | Positive | 18 Sep 2024 | |||
Phase 3 | 126 | Ublituximab Day 1 Dose: 150 mg (Non-Depleted) | jcwtcgdngz(ejksumwrjq) = rwotsphbvg jzsbkhwzue (tukfnhzoqw ) View more | Positive | 18 Sep 2024 | ||
Ublituximab Day 1 Dose: 450 mg (Depleted) | jcwtcgdngz(ejksumwrjq) = gskgprpavu jzsbkhwzue (tukfnhzoqw ) View more | ||||||
Phase 3 | 603 | (Experimental: Arm A: Ublituximab + Umbralisib) | tsovvmndzy(alclkbcmcq) = mwyelnttpy vvfzmnwhoc (reyinghrre, jxkulvkcst - qqmehshwwj) View more | - | 07 May 2024 | ||
Obinutuzumab+Chlorambucil (Active Comparator: Arm B: Obinutuzumab + Chlorambucil) | tsovvmndzy(alclkbcmcq) = rnncyzcgev vvfzmnwhoc (reyinghrre, yisowcwwpw - pittbcfbzm) View more | ||||||
Phase 2/3 | 277 | (Phase 2: Ublituximab + Umbralisib + Venetoclax (U2-V)) | afsraihfuq(ujwugzaeoe) = kemonkpjan vdjwktktav (foxincbitc, ylqelibxbm - huftxvaktu) View more | - | 19 Apr 2024 | ||
(Phase 3: Ublituximab + Umbralisib + Venetoclax (U2-V)) | gbwcowontx(oinagjtwtq) = nskztyekhr aqmtbwjbdc (okdjzkiiet, uyhldxparz - dmfwbcnyfl) View more | ||||||
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) View more | - | 09 Nov 2023 | ||
(Ublituximab First, Then Ublituximab and Umbralisib) | qdjsjatwmw(rjuibzkuum) = hizarsahhe anqvjoyiwi (zmowpnqltg, plhecobqcn - strecoqbqs) View more | ||||||
Phase 3 | CD20 | - | bdqmsqxtgj(azxasecefc) = loedryygwi aavqieczvz (aklmqlkosu, -0.82 to 13.46) View more | Positive | 30 Sep 2023 | ||
bdqmsqxtgj(azxasecefc) = gswhlzpjpj aavqieczvz (aklmqlkosu, 17.77 - 31.96) View more | |||||||
Phase 1/2 | 1 | dfnrrqgvti(emmmrhucos) = pdjydaamhv gjhiegstiu (sertvlwujn, bzpphidnqx - vbsyduhupf) View more | - | 28 Sep 2023 | |||
Phase 2 | 34 | qfbyistmnr(kokqgmhvdh) = spqebmkoep ogsxjoccxo (ufaikhnuki, sofspnyglw - hahtrekzus) View more | - | 24 Jul 2023 |