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Drug

Ublituximab

Approved · EMA
Late-stage development

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.

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

Clinical trial2026-07-08Results expected Q1 2030 · ClinicalTrials.gov

Evaluating Safety and Efficacy of Ublituximab in Participants With Schizophrenia

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

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

Clinical trial2026-06-18Results expected Q2 2032 · ClinicalTrials.gov

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

Clinical trial2026-06-18Results expected Q4 2027 · ClinicalTrials.gov

Approval: 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
2023-05-31Approval
Approval: 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.

Recent completions

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

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.