Drugs / Ublituximab
Ublituximab
also known as
Briumvi · Briumvi (ublituximab) · EMAB-6 · LFB-R603 · R-603 · TG-1101 · TGT-1101 · TGTX-1101 · +2 more
Monoclonal antibody targets MS4A1
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Briumvi | — | 2023-05-31 | europa.eu ↗ |
Trials 43
News releases announcing trial results or a regulatory action · 9
| Date | Issuer | Release |
|---|---|---|
| 2026-06-09 | TG Therapeutics, Inc. | Results TG Therapeutics Announces Positive Topline Phase 1 Data for Subcutaneous BRIUMVI in Patients with Myasthenia Gravis and Initiation of Potential Registration Directed Randomized Phase 2 Trial tgtherapeutics.com ↗
We are pleased to report positive data from 11 patients with myasthenia gravis treated with subcutaneous BRIUMVI in our Phase 1 study. |
| 2026-06-03 | TG Therapeutics, Inc. | Results TG Therapeutics Announces Positive Results from Phase 1 Trial Evaluating Subcutaneous BRIUMVI® (ublituximab-xiiy) tgtherapeutics.com ↗
today announced positive pharmacokinetic (PK), pharmacodynamic (PD), safety, and tolerability data from its Phase 1 clinical trial evaluating subcutaneous formulation of ublituximab (the active agent in BRIUMVI ® ) as compared to IV BRIUMVI. |
| 2026-06-01 | TG Therapeutics, Inc. | Results TG Therapeutics Announces Publication of Post-Hoc Data from the Phase 3 ULTIMATE I & II Trials in Treatment Naive Patients with Relapsing Forms of MS Published in Frontiers in Immunology tgtherapeutics.com ↗
These post-hoc analyses demonstrate that BRIUMVI provided significant and consistent improvements across multiple clinical and MRI endpoints compared to teriflunomide in patients who had not received a prior disease-modifying therapy, including those treated early in their disease course. |
| 2026-05-27 | TG Therapeutics, Inc. | Results TG Therapeutics Announces Positive Topline Results from Phase 3 ENHANCE Trial tgtherapeutics.com ↗ |
| 2026-05-26 | TG Therapeutics, Inc. | Results TG Therapeutics Announces Data Presentations for BRIUMVI® at the 2026 Consortium of Multiple Sclerosis Centers Annual Meeting tgtherapeutics.com ↗
We are pleased to present four data presentations at CMSC 2026 that continue to reinforce the differentiated clinical profile of BRIUMVI in relapsing multiple sclerosis. |
| 2026-03-09 | TG Therapeutics, Inc. | Results Data Published in Neurology and Therapy Demonstrate Significant Reductions in Relapse and MRI Activity with BRIUMVI® in People with Highly Active Relapsing Multiple Sclerosis tgtherapeutics.com ↗
Results demonstrated statistically significant reductions in relapse rates and MRI activity, as well as significantly higher rates of no evidence of disease activity (NEDA-3), with BRIUMVI compared to teriflunomide. |
| 2026-02-17 | TG Therapeutics, Inc. | Results Long Term Data Published in JAMA Neurology Demonstrate Sustained Efficacy and Consistent Safety of BRIUMVI in Relapsing Multiple Sclerosis tgtherapeutics.com ↗
Patients who continued BRIUMVI treatment exhibited low and decreasing annualized relapse rate (ARR) throughout the observation period, ARR: 0.053, 0.032, and 0.020 for Years 3, 4, and 5, respectively. |
| 2017-03-09 | IlDong Pharmaceutical Co Ltd | Results 만성림프구성 백혈병치료제 유블리툭시맙 3상 결과 발표 ildong.com ↗
TG테라퓨틱스에 따르면, 유블리툭시맙(TG-1101) 및 이브루티닙 병용요법 환자 59명과, 이브루티닙 단독요법 환자 58명의 객관적 반응률(ORR, overall response rate)을 비교했는데, 병용군의 경우 반응률이 80%로, 단독군의 경우 47%로 나타났다. |
| 2017-01-20 | IlDong Pharmaceutical Co Ltd | Results 일동제약 개발제휴 바이오베터 ‘유블리툭시맙’ 2상 파트1 완료 ildong.com ↗
24명의 피험자를 대상으로 24주간 실시한 임상2상 파트1 시험에서 유블리툭시맙(TG-1101)을 투여한 재발성다발성경화증 환자의 B세포가 평균 99%의 감소율을 보였다. |
All press releases naming this drug 18 releases
Evidence & citations 15 cited values
Every value below carries the sentence it was read from. 47 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Ublituximab | “ublituximab (BRIUMVI™)” NCT04047628 ↗ |
| 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 ↗ |