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Drug

Ublituximab

Approved medicine
ResearchOngoing clinical research

Also known as Briumvi.

RxNorm2626349UNIIU59UGK3IPC
14
Active clinical trials
1
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

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

Clinical trial2026-10-31Primary completion · ClinicalTrials.gov

A Phase II Study of BTK Inhibitor Acalabrutinib and PI3Kδ Inhibitor Umbralisib in Combination With Ublituximab (AU2) in Patients With Previously Untreated Mantle Cell Lymphoma (MCL)

Clinical trial2026-10-06Results posted · ClinicalTrials.gov

An Open Label Extension Study of Ublituximab in Subjects With Relapsing Multiple Sclerosis

Clinical trial2026-09-23Results expected Q2 2032 · ClinicalTrials.gov

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

Clinical trial2026-09-21Results expected Q3 2027 · ClinicalTrials.gov

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

Clinical trial2026-09-21Results expected Q1 2027 · ClinicalTrials.gov

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

Clinical trial2026-09-21Results expected Q1 2030 · ClinicalTrials.gov

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

Clinical trial2026-09-09Results expected Q3 2028 · ClinicalTrials.gov

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

Clinical trial2026-08-21Results expected Q3 2028 · ClinicalTrials.gov

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

Clinical trial2026-07-29Results expected Q4 2027 · ClinicalTrials.gov

Evaluating Safety and Efficacy of Ublituximab in Participants With Schizophrenia

Clinical trial2026-07-02Results expected Q4 2028 · ClinicalTrials.gov

Effects of Ublituximab on Unperturbed and Perturbed Ambulatory Functions in People With Relapsing Multiple Sclerosis

Clinical trial2026-06-30Primary completion · ClinicalTrials.gov

Marketing authorisation: Briumvi (EMA)

Regulatory2023-05-31EMA

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Ublituximab
Aliases & brands
Briumvi
RxNorm CUI
2626349
UNII
U59UGK3IPC
Regulatory jurisdictions
ema

Regulatory timeline

1 event

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2023-05-31
Latest approval
2023-05-31
Authorities
EMA
Total events
1
emaEuropean Medicines Agency· 1 event
2023-05-31Original application approval
Marketing authorisation: Briumvi (EMA)

Indication: Briumvi is indicated for the treatment of adult patients with relapsing forms of multiple sclerosis (RMS) with active disease defined by clinical or imaging features.

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

39 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
39
registered trials across all phases
LATEST COMPLETION 2024
14
Active studies
10
Recruiting
13
Late-stage (III+)
11
Completed
14
Discontinued
PHASE DISTRIBUTIONn = 39
Early Phase 11Phase 17Phase 1 / 25Phase 213Phase 2 / 33Phase 37Phase 42Phase N / A1

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Ublituximab (Briumvi) for Early Forms of Relapsing Multiple Sclerosis

RecruitingPH IVNorthwestern Universityn=402029

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

RecruitingPH IVJohns Hopkins Universityn=502029

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

RecruitingPH II/IIITG Therapeutics, Inc.n=2402033

An Open Label Extension Study of Ublituximab in Subjects With Relapsing Multiple Sclerosis

Active, not recruitingPH IIIKey trialTG Therapeutics, Inc.n=1,1002032

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

Active, not recruitingPH IIITG Therapeutics, Inc.n=3602028

Recent completions

Trials that read out recently, adding to the completed evidence base.

A Phase 1 First-in-Human Study of Bispecific Antibody TG-1801 in Subjects With B-Cell Lymphoma

CompletedPH ITG Therapeutics, Inc.n=502024

An Open Label Extension of the TG1101-RMS201 Trial, for Subjects Currently Enrolled in TG1101-RMS201Treated With Ublituximab for Relapsing Forms of Multiple Sclerosis

CompletedPH IITG Therapeutics, Inc.n=482022

Ublituximab as Initial Therapy for Treatment-naive Follicular or Marginal Zone Lymphoma With Response-driven Addition of Umbralisib for Suboptimal Response

CompletedPH IIUniversity of Colorado, Denvern=42022

Phase I Study of Ublituximab and Umbralisib in Combination With Targeted Immunotherapy in Patients With Relapsed-refractory Chronic Lymphocytic Leukemia (CLL) or Richter's Transformation (RT) of CLL

CompletedPH ITG Therapeutics, Inc.n=272021

Phase III: UbLiTuximab in Multiple Sclerosis Treatment Effects (ULTIMATE II STUDY)

CompletedPH IIITG Therapeutics, Inc.n=5452020

Phase III: UbLiTuximab In Multiple Sclerosis Treatment Effects (ULTIMATE I STUDY)

CompletedPH IIITG Therapeutics, Inc.n=5492020
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.