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ublituximab

Generic: ublituximab·Brand: Briumvi

ublituximab: developed by 1 company · 13 clinical trials tracked.

ublituximab evidence translation

What we can confirm

What it means

Source-backed records connect ublituximab to TGTX; that link alone does not prove the drug works.

What to watch

Watch trial status, endpoints, and the next source-backed update.
BioSniper AIPage evidence connected

Prepared research question

How could ublituximab → TGTX affect its developer, and what evidence supports the link?

Run cited research

Traceable citations · Unknowns marked

See linked entities and source evidence7 indications · 0 study sponsors

Study sponsors

No additional listed-company sponsor is linked.

Development Pipeline (2)
CompanyPhase
TG THERAPEUTICS, INC. (TGTX)
Schizophrenia; Multiple Sclerosis; Relapsing Multiple Sclero…
Phase 3
TG THERAPEUTICS, INC. (TGTX)
Schizophrenia; Multiple Sclerosis; Relapsing Multiple Sclero…
Phase 3
Clinical Trials (13)showing 10 most recent

A Phase 2, Randomized, Double-blind, Multicenter, Placebo-controlled Study to Evaluate the Efficacy and Safety of Maintenance Ublituximab Treatment Following Induction With Efgartigimod Administration in Adults With Myasthenia Gravis

NCT07673744·Phase 2·TGTX
Recruiting

Primary endpoint: Time to Onset of a Clinical Worsening Event

InterventionalRandomizeddouble120 targetStarted 2026-07Completion 2030-015 sites · United StatesTG Therapeutics, Inc.

Evaluating Safety and Efficacy of Ublituximab in Participants With Schizophrenia

NCT07680946·Phase 2·TGTX
Recruiting

Primary endpoint: Percentage of Participants with at Least 20% Reduction From Baseline in PANSS Total Score

Interventionalopen60 targetStarted 2026-07Completion 2029-032 sites · United StatesTG Therapeutics, Inc.

Ublituximab in Pediatric Participants With Relapsing Forms of Multiple Sclerosis (RMS)

NCT07220252·Phase 2/Phase 3·TGTX
Recruiting

Primary endpoint: Part A: Area Under the Curve From Week 0 to 24 (AUC0-W24) of Ublituximab

InterventionalRandomizedquadruple240 targetStarted 2026-07Completion 2033-062 sites · PolandTG Therapeutics, Inc.

Exploration of Novel Imaging Biomarkers on OCT for Ublituximab Treatment Response in Multiple Sclerosis

Recruiting

Primary endpoint: Evaluation of the effect of ublituximab on macular hyperreflective foci (HRF) in MS.

Interventionalopen30 targetStarted 2026-05Completion 2028-011 site · United StatesUniversity of Maryland, Baltimore

Study of Ublituximab in Early, Active, Autoantibody-Positive, IMMune-MedIated NecroTizing Myopathy (AIM01)

NCT07103746·Phase 2
Recruiting

Primary endpoint: The primary endpoint is the Total Improvement Score (TIS) at Week 24 reflecting the change from baseline

InterventionalRandomizedtriple30 targetStarted 2026-04Completion 2029-088 sites · United StatesNational Institute of Allergy and Infectious Diseases (NIAID)

A Phase 2, Multicenter, Study to Evaluate the Pharmacokinetics and Safety of Subcutaneous Ublituximab Administered at Various Injection Sites and Relative Bioavailability Via Autoinjector Device Versus Syringe in Patients With Multiple Sclerosis

NCT07503873·Phase 2·TGTX
Recruiting

Primary endpoint: Part 2: Area under the curve (AUC) at Steady State [AUCss] of Ublituximab

InterventionalRandomizedopen350 targetStarted 2026-04Completion 2029-0539 sites · Bosnia and Herzegovina, Georgia, North Macedonia, Poland…TG Therapeutics, Inc.

A Pilot Study of Ublituximab in People With MS Experiencing Wearing Off Phenomena While Receiving Treatment With Ocrelizumab

NCT07389590·Phase 4
Not yet recruiting

Primary endpoint: Proportion of Patients with Wearing-Off

InterventionalRandomizedsingle50 targetStarted 2026-02Completion 2029-031 site · United StatesJohns Hopkins University

Ublituximab (Briumvi) for Early Forms of Relapsing Multiple Sclerosis

NCT07225361·Phase 4
Recruiting

Primary endpoint: Change in plasma neurofilament light chain

Interventionalopen40 targetStarted 2025-11Completion 2029-081 site · United StatesNorthwestern University

A Phase 3, Non-Inferiority, Randomized, Open-Label, Parallel Group, Multicenter Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, Radiological and Clinical Effects of Subcutaneous Ublituximab Versus Intravenous Ublituximab in Patients With Multiple Sclerosis

NCT07211633·Phase 3·TGTX
Active, not recruiting

Primary endpoint: Area Under the Curve From Week 0 to Week 24 (AUC0-W24) of Ublituximab

InterventionalRandomizedopen360 targetStarted 2025-07Completion 2028-1248 sites · Bosnia and Herzegovina, Bulgaria, Croatia, Czechia…TG Therapeutics, Inc.

Evaluating Safety, Efficacy and Pharmacokinetics of a Modified Regimen of Ublituximab (ENHANCE )

NCT05877963·Phase 3·TGTX
Recruiting

Primary endpoint: Part A and Part C: Percentage of Participants With no Change or Reduction in Number of T1 Gd-Enhancing Lesions From Baseline to Week 48

InterventionalRandomizeddouble800 targetStarted 2023-06Completion 2027-0150 sites · Poland, United StatesTG Therapeutics, Inc.

Frequently asked questions

Who is developing ublituximab?

ublituximab is being developed by TG THERAPEUTICS, INC..

How many clinical trials involve ublituximab?

BioSniper tracks 13 clinical trials involving ublituximab.