Drugs / Ublituximab
last change Jul 2026 re-read 2 minutes ago

Ublituximab

Monoclonal antibody targets MS4A1

Developed for
chronic lymphocytic leukemia/small lymphocytic lymphoma · multiple sclerosis · B-cell chronic lymphocytic leukemia · follicular lymphoma · mantle cell lymphoma · relapsing-remitting multiple sclerosis · marginal zone lymphoma · Richter transformation
+13 more · Waldenstrom macroglobulinemia · autoimmune disease · B-cell non-Hodgkin lymphoma · diffuse large B-cell lymphoma · lymphoma · MALT lymphoma · myasthenia gravis · neuromyelitis optica · nodal marginal zone B-cell lymphoma · primary central nervous system lymphoma · primary mediastinal large B-cell lymphoma · schizophrenia · splenic marginal zone lymphoma
Investigated by
TG Therapeutics, Inc. · City of Hope Medical Center · Johns Hopkins University · National Cancer Institute (NCI) · AstraZeneca · Atlanta Neuroscience Institute
+14 more · Autoimmunity Centers of Excellence · Georgia State University · Jennifer R. Brown, MD, PhD · LFB · Memorial Sloan Kettering Cancer Center · National Institute of Allergy and Infectious Diseases (NIAID) · Northwestern University · Rho Federal Systems Division, Inc. · The Cleveland Clinic · University of Alabama at Birmingham · University of Colorado, Denver · University of Nottingham · Weill Medical College of Cornell University · Yazeed Sawalha

Regulatory milestones approvals, filings & regulatory actions · 1 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Approved EU (EMA) Briumvi 2023-05-31 europa.eu

Trials 42 · a red edge is where a trial was stopped

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 01 trial
Phase 0 NCT06629428 Nov 2025 → Jun 2026 overdue relapsing-remitting multiple sclerosis Georgia State University Recruiting No outcome recorded
Phase 110 trials
Phase 1 NCT04635683 Sep 2022 → Dec 2023 MALT lymphoma, Waldenstrom macroglobulinemia, follicular lymphoma, mantle cell lymphoma +2 Yazeed Sawalha Withdrawn No outcome recorded
Phase 1 NCT04806035 Apr 2021 → Jun 2024 Richter transformation, chronic lymphocytic leukemia/small lymphocytic lymphoma, follicular lymphoma, marginal zone lymphoma +1 TG Therapeutics, Inc. Terminated No outcome recorded
Phase 1 NCT03778073 Apr 2019 → May 2022 B-cell non-Hodgkin lymphoma, Richter transformation TG Therapeutics, Inc. Terminated No outcome recorded
Phase 1 NCT03804996 Mar 2019 → Feb 2024 lymphoma TG Therapeutics, Inc. Completed No outcome recorded
Phase 1 NCT03671590 Sep 2018 → May 2024 chronic lymphocytic leukemia/small lymphocytic lymphoma TG Therapeutics, Inc. Terminated No outcome recorded
Phase 1 NCT02276963 Jan 2016 → Jul 2017 neuromyelitis optica Johns Hopkins University Completed No outcome recorded
Phase 1 NCT02535286 Sep 2015 → Nov 2021 Richter transformation, chronic lymphocytic leukemia/small lymphocytic lymphoma TG Therapeutics, Inc. Completed No outcome recorded
Phase 1 NCT02006485 Dec 2013 → Oct 2019 B-cell chronic lymphocytic leukemia TG Therapeutics, Inc. Completed No outcome recorded
Phase 1 NCT01744912 Nov 2012 → Feb 2014 Waldenstrom macroglobulinemia, chronic lymphocytic leukemia/small lymphocytic lymphoma, mantle cell lymphoma, marginal zone lymphoma TG Therapeutics, Inc. Terminated No outcome recorded
Phase 1 NCT01098188 Nov 2008 → Aug 2011 B-cell chronic lymphocytic leukemia LFB Completed No outcome recorded
Phase 1/24 trials
Phase 1/2 NCT05152459 May 2023 → Dec 2024 follicular lymphoma City of Hope Medical Center Withdrawn No outcome recorded
Phase 1/2 NCT04692155 Aug 2021 → Jun 2022 mantle cell lymphoma University of Alabama at Birmingham Terminated No outcome recorded
Phase 1/2 NCT02013128 Jan 2014 → Dec 2015 B-cell chronic lymphocytic leukemia, mantle cell lymphoma TG Therapeutics, Inc. Completed No outcome recorded
Phase 1/2 NCT01647971 Jul 2012 → May 2015 Waldenstrom macroglobulinemia, chronic lymphocytic leukemia/small lymphocytic lymphoma, marginal zone lymphoma, primary central nervous system lymphoma TG Therapeutics, Inc. Completed No outcome recorded
Phase 214 trials
Phase 2 NCT07673744 Jul 2026 → Jul 2028 expected myasthenia gravis TG Therapeutics, Inc. Recruiting No outcome recorded
Phase 2 NCT07680946 Jul 2026 → Dec 2028 expected schizophrenia TG Therapeutics, Inc. Not yet recruiting No outcome recorded
Phase 2 NCT07503873 Apr 2026 → May 2027 expected multiple sclerosis TG Therapeutics, Inc. Recruiting No outcome recorded
Phase 2 NCT07103746 Feb 2026 → Aug 2028 expected autoimmune disease National Institute of Allergy and Infectious Diseases (NIAID) Recruiting No outcome recorded
Phase 2 NCT04783415 Mar 2021 → Jul 2022 overdue mantle cell lymphoma City of Hope Medical Center Active not recruiting No outcome recorded
Phase 2 NCT04149821 Feb 2021 → Jan 2022 chronic lymphocytic leukemia/small lymphocytic lymphoma Weill Medical College of Cornell University Terminated No outcome recorded
Phase 2 NCT04624633 Dec 2020 → Dec 2023 overdue chronic lymphocytic leukemia/small lymphocytic lymphoma Jennifer R. Brown, MD, PhD Active not recruiting No outcome recorded
Phase 2 NCT04508647 Nov 2020 → Jul 2022 follicular lymphoma, marginal zone lymphoma University of Colorado, Denver Completed No outcome recorded
Phase 2 NCT04016805 Aug 2019 → May 2022 chronic lymphocytic leukemia/small lymphocytic lymphoma TG Therapeutics, Inc. Terminated No outcome recorded
Phase 2 NCT03828448 Jul 2019 → May 2022 chronic lymphocytic leukemia/small lymphocytic lymphoma, follicular lymphoma TG Therapeutics, Inc. Terminated No outcome recorded
Phase 2/33 trials
Phase 2/3 NCT07220252 Jul 2026 → Jan 2030 expected multiple sclerosis TG Therapeutics, Inc. Recruiting No outcome recorded
Phase 2/3 NCT03801525 May 2019 → Dec 2022 chronic lymphocytic leukemia/small lymphocytic lymphoma TG Therapeutics, Inc. Terminated No outcome recorded
Phase 2/3 NCT02793583 May 2016 → May 2022 chronic lymphocytic leukemia/small lymphocytic lymphoma, diffuse large B-cell lymphoma, follicular lymphoma, mantle cell lymphoma +1 TG Therapeutics, Inc. Terminated No outcome recorded
Phase 37 trials
Phase 3 NCT07211633 Jul 2025 → Oct 2026 expected multiple sclerosis TG Therapeutics, Inc. Active not recruiting No outcome recorded
Phase 3 NCT05877963 Jun 2023 → Dec 2027 expected multiple sclerosis TG Therapeutics, Inc. Recruiting No outcome recorded
Phase 3 NCT04130997 Nov 2019 → May 2032 expected multiple sclerosis TG Therapeutics, Inc. Active not recruiting No outcome recorded
Phase 3 NCT03277261 Sep 2017 → Jul 2020 relapsing-remitting multiple sclerosis TG Therapeutics, Inc. Completed No outcome recorded
Phase 3 NCT03277248 Aug 2017 → Aug 2020 relapsing-remitting multiple sclerosis TG Therapeutics, Inc. Completed No outcome recorded
Phase 3 NCT02612311 Nov 2015 → Feb 2023 B-cell chronic lymphocytic leukemia TG Therapeutics, Inc. Terminated No outcome recorded
Phase 3 NCT02301156 Jan 2015 → Apr 2020 B-cell chronic lymphocytic leukemia TG Therapeutics, Inc. Completed No outcome recorded
Phase 43 trials
Phase 4 NCT07389590 Feb 2026 → Oct 2028 expected multiple sclerosis Johns Hopkins University Recruiting No outcome recorded
Phase 4 NCT07225361 Nov 2025 → Mar 2029 expected relapsing-remitting multiple sclerosis Northwestern University Recruiting No outcome recorded
Phase 4 NCT03535298 Jan 2019 → Jul 2027 expected relapsing-remitting multiple sclerosis The Cleveland Clinic Active not recruiting No outcome recorded
Also used as a comparator or background therapy in 3 trials
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 1/21 trial
Phase 1/2 NCT03379051 Background Mar 2018 → May 2022 B-cell chronic lymphocytic leukemia TG Therapeutics, Inc. Terminated No outcome recorded
Phase 31 trial
Phase 3 NCT04047628 Background Dec 2019 → Oct 2026 expected relapsing-remitting multiple sclerosis, secondary progressive multiple sclerosis National Institute of Allergy and Infectious Diseases (NIAID) Recruiting No outcome recorded
Phase not applicable1 trial
NCT06864936 Comparator May 2026 → Dec 2027 expected relapsing-remitting multiple sclerosis University of Maryland, Baltimore Recruiting No outcome recorded

Evidence & citations 15 cited values

Every value below carries the sentence it was read from. 46 sources stand behind the page.

FieldValueCited text
Known as ublituximab ublituximab (BRIUMVI™)” NCT04047628
43

“Briumvi (ublituximab)” NCT03535298

NCT02535286

NCT04806035

NCT04508647

NCT02656303

NCT03277248

NCT04016805

NCT02301156

NCT03671590

NCT02006485

NCT06629428

NCT05877963

NCT07680946

NCT04149821

NCT03828448

NCT03381170

NCT03277261

NCT06864936

NCT04130997

NCT02612311

NCT03801525

NCT03379051

NCT03778073

NCT02793583

NCT07673744

NCT02276963

NCT02013128

NCT04624633

NCT07211633

NCT01647971

NCT04635683

NCT07220252

NCT07503873

NCT07389590

NCT05152459

NCT07225361

NCT04692155

NCT03804996

NCT04783415

NCT01744912

NCT02738775

NCT07103746

NCT03207256

Known as Briumvi “ublituximab (Briumvi)” NCT06864936
Known as Briumvi (ublituximab) Briumvi (ublituximab)NCT03535298
Known as EMAB-6 ChEMBL registry synonym — accepted as the source's own label CHEMBL2108354
Known as LFB-R603 ClinicalTrials.gov intervention name — accepted as the source's own label NCT01098188
Known as R-603 ChEMBL registry synonym — accepted as the source's own label CHEMBL2108354
Known as TG-1101 “receive ublituximab (TG-1101) treatment in combination with umbralisib (TGR-1202)” NCT02656303
Known as TGT-1101 ChEMBL registry synonym — accepted as the source's own label CHEMBL2108354
Known as TGTX-1101 ChEMBL registry synonym — accepted as the source's own label CHEMBL2108354
Known as ublituximab (BRIUMVI) “ublituximab (BRIUMVI™)” NCT04047628
Known as Ublituximab xiiy ChEMBL registry synonym — accepted as the source's own label CHEMBL2108354
Action Deplete “The binding induces immune response that causes lysis of B cells.” NCT02276963
Modality Monoclonal antibody “anti-CD20 monoclonal antibody LFB-R603” NCT01098188
Route Intravenous intravenous administration, dose-escalation study” NCT01098188
Target CD20 “recombinant chimeric anti-CD20 monoclonal antibody” NCT04806035