Ublituximab
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Also known as BriumviEMAB-6EMAB6LFB-R 603LFBR-603LFBR603R-603R603TG-1101TG1101TGT-1101TGT1101TGTX-1101TGTX1101Ublituximab xiiyUblituximab-xiiy
Summary
Ublituximab (CHEMBL2108354) is an approved antibody (ATC L04AG14) targeting MS4A1; indicated across 11 conditions including relapsing-remitting multiple sclerosis and chronic progressive multiple sclerosis.
At a glance
- Status: Approved (max clinical phase 4)
- Modality: Antibody
- ATC class: L04AG14
- Targets: 1 (MS4A1)
- Indications: 11 conditions
- Clinical trials: 41
Identifiers
Drug identity and classification
| Field | Value |
|---|---|
| ChEMBL ID | CHEMBL2108354 |
| Name | Ublituximab |
| Type | Antibody |
| Max phase | 4 |
| ATC | L04AG14 |
Also known as: Briumvi, EMAB-6, EMAB6, LFB-R 603, LFBR-603, LFBR603, R-603, R603, TG-1101, TG1101, TGT-1101, TGT1101
Targets
Targets
Primary targets (GtoPdb curated mechanism): the Cancer dependency column is the DepMap CRISPR fitness signal (% of screened cell lines dependent on the target).
| Gene | Target | Action | pAffinity | Cancer dependency | UniProt |
|---|---|---|---|---|---|
| MS4A1 | CD20 (membrane-spanning 4-domains, subfamily A, member 1) | Binding | 0% | P11836 |
Bioactivity
No ChEMBL bioactivity rows at pChembl ≥ 5 (expected for biologics / antibodies).
Target pathways
Aggregated over 1 target gene(s): MS4A1.
Dominant GO biological processes
| GO term | Targets |
|---|---|
| store-operated calcium entry | 1 |
| humoral immune response | 1 |
| cell surface receptor signaling pathway | 1 |
| response to bacterium | 1 |
| B cell differentiation | 1 |
| B cell proliferation | 1 |
| B cell activation | 1 |
| B cell receptor signaling pathway | 1 |
| protein tetramerization | 1 |
| calcium ion import into cytosol | 1 |
| positive regulation of calcium ion import across plasma membrane | 1 |
Indications & clinical
Indications
11 indications (2 at ChEMBL trial phase 4). Phase below is the highest clinical-trial phase recorded for this drug against each disease — not the molecule’s overall approval status (that is in the Summary).
| Indication | Trial phase | MONDO | EFO |
|---|---|---|---|
| relapsing-remitting multiple sclerosis | 4 | MONDO:0005314 | EFO:0003929 |
| chronic progressive multiple sclerosis | 4 | MONDO:0005284 | EFO:0003840 |
| B-cell chronic lymphocytic leukemia | 3 | MONDO:0004948 | EFO:0000095 |
| multiple sclerosis | 3 | MONDO:0005301 | MONDO:0005301 |
| diffuse large B-cell lymphoma | 2 | MONDO:0018905 | EFO:0000403 |
| mantle cell lymphoma | 2 | MONDO:0018876 | EFO:1001469 |
| follicular lymphoma | 2 | MONDO:0018906 | MONDO:0018906 |
| neoplasm of mature B-cells | 2 | MONDO:0004949 | EFO:0000096 |
| neuromyelitis optica | 1 | MONDO:0019100 | EFO:0004256 |
| Waldenstrom macroglobulinemia | 1 | MONDO:0100280 | EFO:0009441 |
| non-Hodgkin lymphoma | 1 | MONDO:0018908 | EFO:0005952 |
Clinical trials
Total trials: 41.
Phase distribution
| Phase | Trials |
|---|---|
| PHASE2 | 12 |
| PHASE1 | 9 |
| PHASE3 | 7 |
| PHASE1/PHASE2 | 5 |
| PHASE2/PHASE3 | 3 |
| PHASE4 | 2 |
| Not specified | 2 |
| EARLY_PHASE1 | 1 |
Top trials by phase / activity
| NCT | Phase | Status | Title |
|---|---|---|---|
| NCT07225361 | PHASE4 | RECRUITING | Ublituximab (Briumvi) for Early Forms of Relapsing Multiple Sclerosis |
| NCT07389590 | PHASE4 | RECRUITING | Study of Ublituximab for Ocrelizumab Wearing-Off in Multiple Sclerosis |
| NCT04130997 | PHASE3 | ACTIVE_NOT_RECRUITING | An Extension Study of Ublituximab in Participants With Relapsing Multiple Sclerosis |
| NCT05877963 | PHASE3 | RECRUITING | Study to Evaluate Safety, Efficacy and Pharmacokinetics (PK) of a Modified Regimen of Ublituximab |
| NCT07211633 | PHASE3 | ACTIVE_NOT_RECRUITING | A Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, Radiological and Clinical Effects of Subcutaneous Ublituximab in Participants With Relapsing Multiple Sclerosis (RMS) |
| NCT07220252 | PHASE2/PHASE3 | NOT_YET_RECRUITING | Study to Assess Effects of Ublituximab in Pediatric Participants With Relapsing Forms of Multiple Sclerosis |
| NCT02301156 | PHASE3 | COMPLETED | Ublituximab in Combination With Ibrutinib Versus Ibrutinib Alone in Participants With Previously Treated High-Risk Chronic Lymphocytic Leukemia (CLL) |
| NCT02612311 | PHASE3 | TERMINATED | Ublituximab + TGR-1202 Compared to Obinutuzumab + Chlorambucil in Participants With Untreated and Previously Treated Chronic Lymphocytic Leukemia |
| NCT02793583 | PHASE2/PHASE3 | TERMINATED | Study to Assess the Efficacy and Safety of Ublituximab + Umbralisib With or Without Bendamustine and Umbralisib Alone in Patients With Previously Treated Non-Hodgkins Lymphoma |
| NCT03277248 | PHASE3 | COMPLETED | Study to Assess the Efficacy and Safety of Ublituximab in Participants With Relapsing Forms of Multiple Sclerosis (RMS) |
| NCT03277261 | PHASE3 | COMPLETED | Study to Assess the Efficacy and Safety of Ublituximab in Participants With Relapsing Forms of Multiple Sclerosis (RMS) ( ULTIMATE 1 ) |
| NCT03801525 | PHASE2/PHASE3 | TERMINATED | Study to Assess the Efficacy and Safety of Ublituximab in Combination With Umbralisib and Venetoclax Compared to Ublituximab in Combination With Umbralisib in Subjects With CLL (ULTRA-V) |
| NCT04624633 | PHASE2 | ACTIVE_NOT_RECRUITING | Acalabrutinib, Umbralisib, and Ublituximab (AU2) In Relapsed and Untreated CLL |
| NCT04783415 | PHASE2 | ACTIVE_NOT_RECRUITING | Acalabrutinib, Umbralisib, and Ublituximab for the Treatment of Previously Untreated Mantle Cell Lymphoma |
| NCT07103746 | PHASE2 | RECRUITING | Ublituximab in Autoantibody Positive Immune Mediated Necrotizing Myopathy |
| NCT07503873 | PHASE2 | NOT_YET_RECRUITING | A Study to Evaluate Pharmacokinetics (PK) and Safety of Subcutaneous (SC) Ublituximab Administered at Various Injection Sites and Relative Bioavailability Via Autoinjector (AI) Versus Syringe Subcutaneously in Participants With Multiple Sclerosis (MS) |
| NCT01647971 | PHASE1/PHASE2 | COMPLETED | Study of the Efficacy and Safety of Ublituximab in Patients With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma |
| NCT02013128 | PHASE1/PHASE2 | COMPLETED | Ublituximab + Ibrutinib in Select B-cell Malignancies |
| NCT02656303 | PHASE2 | TERMINATED | A Study to Evaluate the Safety and Efficacy of Ublituximab in Combination With Umbralisib for Participants Previously Enrolled in Protocol UTX-TGR-304 |
| NCT02738775 | PHASE2 | COMPLETED | Phase IIa Study of Ublituximab in Participants With Relapsing Forms of Multiple Sclerosis |
| NCT03207256 | PHASE2 | TERMINATED | Extension Trial of Ublituximab and TGR-1202 in Combination or as Single Agents in Subjects Currently Receiving Treatment on Ublituximab and/or TGR-1202 Trials |
| NCT03379051 | PHASE1/PHASE2 | TERMINATED | Phase I/II Study of Venetoclax or Lenalidomide in Combination With Ublituximab and Umbralisib in Subjects With Relapsed or Refractory CLL/SLL and NHL |
| NCT03381170 | PHASE2 | COMPLETED | An Extension of the TG1101-RMS201 Trial |
| NCT03828448 | PHASE2 | TERMINATED | Study to Assess Umbralisib Plus Ublituximab in Participants With Treatment Naïve Follicular Lymphoma |
| NCT04016805 | PHASE2 | TERMINATED | Study to Assess the Efficacy and Safety of Ublituximab and Umbralisib in Participants With Chronic Lymphocytic Leukemia (CLL) Currently Treated With Ibrutinib, Acalabrutinib or Venetoclax |
| NCT04149821 | PHASE2 | TERMINATED | Umbralisib Plus Ublituximab (U2) in Progressive CLL After Novel Therapy |
| NCT04508647 | PHASE2 | COMPLETED | Ublituximab Followed by Response-driven Addition of Umbralisib for Treatment-naive Follicular or Marginal Zone Lymphoma |
| NCT04692155 | PHASE1/PHASE2 | TERMINATED | Clinical Trial of Ublituximab and Umbralisib With CHOP (U2-CHOP) Followed by U2 Maintenance (U2-CHOP-U2) in Previously Untreated Mantle Cell Lymphoma (MCL) |
| NCT05152459 | PHASE1/PHASE2 | WITHDRAWN | Tazemetostat in Combination With Umbralisib and Ublituximab for the Treatment Relapsed or Refractory Follicular Lymphoma |
| NCT01744912 | PHASE1 | TERMINATED | Ublituximab in Combination With Lenalidomide in Patients With B-Cell Lymphoid Malignancies |
| NCT02006485 | PHASE1 | COMPLETED | Ublituximab in Combination With TGR-1202 +/- Ibrutinib or Bendamustine in Patients With B-cell Malignancies |
| NCT02276963 | PHASE1 | COMPLETED | Ublituximab for Acute Neuromyelitis Optica (NMO) Relapses |
| NCT02535286 | PHASE1 | COMPLETED | Study of Immunotherapy in Combination With Ublituximab and Umbralisib in Patients With Relapsed-refractory CLL or Richter’s Transformation |
| NCT03671590 | PHASE1 | TERMINATED | Study of TG-1701, an Irreversible Bruton’s Tyrosine Kinase Inhibitor, in Patients With B-Cell Malignancies |
| NCT03778073 | PHASE1 | TERMINATED | Study of Cosibelimab in Subjects With Relapsed or Refractory Lymphoma |
| NCT03804996 | PHASE1 | COMPLETED | Study of TG-1801 in Subjects With B-Cell Lymphoma |
| NCT04635683 | PHASE1 | WITHDRAWN | Lenalidomide, Umbralisib, and Ublituximab for the Treatment of Relapsed or Refractory Indolent Non-Hodgkin Lymphoma or Mantle Cell Lymphoma |
| NCT04806035 | PHASE1 | TERMINATED | Study of TG-1801 Alone or in Combination With Ublituximab in Subjects With B-Cell Lymphoma or Chronic Lymphocytic Leukemia |
| NCT06629428 | EARLY_PHASE1 | RECRUITING | Effects of Ublituximab on Motor Functions in Multiple Sclerosis |
| NCT06681623 | Not specified | RECRUITING | A Single-Center Study to Characterize the Safety and Efficacy of Ublituximab in Older Adults With Relapsing Forms of Multiple Sclerosis (RMS) |
Clinical evidence (CIViC)
No CIViC predictive evidence (expected for non-precision-medicine drugs).
Pharmacology
Pharmacogenomics
No PharmGKB pharmacogenomic data curated for this drug.
Related molecules
Related molecules
No competitor molecules sharing a primary target (ChEMBL phase ≥2 or PubChem drug-class).