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← All drugs Report issue

ublituximab

Trade name: Briumvi

mAbapproved

Approved

Dec 28, 2022

Ublituximab, sold under the brand name Briumvi, is an immunomodulator used for the treatment of multiple sclerosis. It is a CD20-directed cytolytic monoclonal antibody. — Wikipedia

Clinical trial activity

36 trials · 24 clinical orgs · 1 marketing orgs

Phase 1
13
Phase 2
26
Phase 3
9
Phase 4
1

Earliest trial started Aug 1, 2012 (NCT01647971)

Timeline

2010s

  1. Jan 1, 2012

    TG Therapeutics, Inc. — Earliest Phase 1 Sponsor(trial)

  2. Jan 1, 2015

    TG Therapeutics, Inc. — Earliest Phase 3 Sponsor(trial)

  3. Jan 1, 2016

    TG Therapeutics, Inc. — Earliest Phase 2 Sponsor(trial)

2020s

  1. Dec 28, 2022

    TG Therapeutics, Inc. — Earliest FDA Approval

  2. Dec 28, 2022

    TG Therapeutics, Inc. — Marketing Organization

  3. Dec 28, 2022

    TG Therapeutics, Inc. — NDA Secondary Org

  4. Dec 28, 2022

    TG Therapeutics, Inc. — NDA Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedDec 28, 2022

Chemistry & pharmacology

Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Parenteral
Availability
Prescription Only
Multi-specific
No

Oral

No

Parenteral

Yes

Topical

No

Sources

Also known as

  • tg-1101
  • ublitixiumab
  • ublituximab
  • ublituximab
  • ublituximab

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT06864936N/AJan 1, 2026TG Therapeutics, Inc., University of Maryland
NCT07220252Phase 2/Phase 3 (Phase 3)Dec 1, 2025TG Therapeutics, Inc.
NCT07103746Phase 2Nov 30, 2025National Institute of Allergy and Infectious Diseases (NIAID), Rho, Inc., TG Therapeutics, Inc.
NCT07225361Phase 4Nov 25, 2025Northwestern University, TG Therapeutics, Inc.
NCT07211633Phase 3Jul 9, 2025TG Therapeutics, Inc.
NCT06629428Early Phase 1 (Phase 1)Oct 1, 2024Georgia State University
NCT05877963Phase 3Jun 13, 2023TG Therapeutics, Inc.
NCT05152459Phase 1/Phase 2 (Phase 2)Dec 30, 2021City of Hope National Medical Center, National Cancer Institute (NCI)
NCT04692155Phase 1/Phase 2 (Phase 2)Jun 30, 2021University of Alabama, Birmingham
NCT04624633Phase 2Apr 30, 2021AstraZeneca, Harvard University, TG Therapeutics, Inc.
NCT04806035Phase 1Apr 23, 2021TG Therapeutics, Inc.
NCT04783415Phase 2Mar 26, 2021City of Hope National Medical Center, National Cancer Institute (NCI)
NCT04635683Phase 1Jan 1, 2021Ohio State University
NCT04508647Phase 2Dec 31, 2020University of Colorado, Denver
NCT04130997Phase 3Dec 31, 2019TG Therapeutics, Inc.
NCT04149821Phase 2Nov 30, 2019Cornell University, TG Therapeutics, Inc.
NCT04016805Phase 2Jul 31, 2019TG Therapeutics, Inc.
NCT03828448Phase 2Jun 30, 2019TG Therapeutics, Inc.
NCT03801525Phase 2May 31, 2019TG Therapeutics, Inc.
NCT03671590Phase 1Sep 10, 2018St. Vincents Hospital, TG Therapeutics, Inc.
Showing 20 of 36 trials
Page 1 / 2

Organizations

Research & Development (24)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
TG Therapeutics, Inc.For profit292452012
City of Hope National Medical CenterAcademic/Hospital2212021
National Cancer Institute (NCI)Government2012021
Willamette Valley Cancer InstituteAcademic/Hospital2022013
AstraZenecaFor profit1012021
Central Texas Neurology ConsultantsAcademic/Hospital1012016
Columbia UniversityAcademic/Hospital1012016
Cornell UniversityAcademic/Hospital1112019
Georgia State UniversityAcademic/Hospital1112024
Harvard UniversityAcademic/Hospital1112021
Johns Hopkins UniversityAcademic/Hospital1112015
National Institute of Allergy and Infectious Diseases (NIAID)Government1112025
New York UniversityAcademic/Hospital1012018
Northwestern UniversityAcademic/Hospital1112025
Ohio State UniversityAcademic/Hospital1112021
Rho, Inc.For profit1012025
St. Vincents HospitalAcademic/Hospital1012018
University of Alabama, BirminghamAcademic/Hospital1112021
University of California, IrvineAcademic/Hospital1012013
University of Colorado, DenverAcademic/Hospital1112020
24 organizations
Page 1 / 2

Marketing (3)

OrganizationOrg typeRelationshipDate
TG Therapeutics, Inc.For profitMKTGDec 28, 2022
TG Therapeutics, Inc.For profitNDA2Dec 28, 2022
TG Therapeutics, Inc.For profitNDADec 28, 2022