Ublituximab
Highest phase reached
Approved
Drug type
Antibody
First approval year
2022
- First approval year
- 2022
- Listing at source
- Listed
- Highest phase reached
- Approved
- Drug type
- Antibody
- Drug name
- Ublituximab
- briumvi
- Briumvi
- briumvi
- Briumvi
- briumvi 150 mg concentrate for solution for infusion
- emab 6
- EMAB-6
- emab6
- EMAB6
- immunoglobulin g1 anti human cd20 antigen human mouse monoclonal gamma 1 chain disulfide with human mouse monoclonal kappa chain dimer
- IMMUNOGLOBULIN G1, ANTI-(HUMAN CD20 (ANTIGEN)) (HUMAN-MOUSE MONOCLONAL .GAMMA.1-CHAIN), DISULFIDE WITH HUMAN-MOUSE MONOCLONAL .KAPPA.-CHAIN, DIMER
- lfb r 603
- LFB-R 603
- lfbr 603
- LFBR-603
- lfbr603
- LFBR603
- r 603
- R-603
- r603
- R603
- tg 1101
- TG-1101
- tg1101
- TG1101
- tgt 1101
- TGT-1101
And 21 more, listed on the interactive page.
- CAS registry numbers
- 1174014-05-1
- ChEMBL ID
- CHEMBL2108354
- FDA ingredient codes (UNII)
- U59UGK3IPC
- L04
- L04AG14
Sources for recorded values
- 2626348
- 2626349
- Applicant
- TG THERAPEUTICS, INC
- Approval date
- 28 Dec 2022
- Application number
- BLA761238
- Status
- Authorised
- Status date
- 31 May 2023
- Authorisation date
- 31 May 2023
- Approved indications
- 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.
- Product number
- EMEA/H/C/005914
- Authorisation holder
- Neuraxpharm Pharmaceuticals S.L.
- Priority medicines scheme
- No
- Generic
- No
- Biosimilar
- No
- Generic medicines
- 0
- Biosimilar medicines
- 0
- Advanced therapy
- No
- Conditional approval
- No
- Additional monitoring
- Yes
- Accelerated assessment
- No
- Exceptional circumstances
- No
Therapeutic areas
- Multiple Sclerosis
- Multiple Sclerosis, Relapsing-Remitting
European medicines record
- Patents
- 0
- Designations
- 1
- First in class
- No
- Fast track
- No
- Breakthrough designation
- No
- Orphan designation
- No
- Priority review
- No
- Orphan exclusivity
- No
- Accelerated approval
- No
- Availability
- Prescription only
- Pharmacology name
- ublituximab
- Type
- Antibody
- Drug name stem
- -mab
- Approval recorded by Guide to Pharmacology
- Yes
Administration routes
- Parenteral
- Mechanism
- B-lymphocyte antigen CD20 binding agent
- Action type
- BINDING_AGENT
- Target
- B-lymphocyte antigen CD20
- Protein identifier
- P11836
- Action
- Binding
- Action type
- Binding
- Target
- CD20 (membrane-spanning 4-domains, subfamily A, member 1)
- Gene symbol
- MS4A1
- Protein identifier
- P11836
- Primary target
- Yes
Open Targets mechanisms
- Mechanism
- B-lymphocyte antigen CD20 binding agent
- Action type
- BINDING AGENT
- Target
- B-lymphocyte antigen CD20
- Condition
- Leukemia, Lymphocytic, Chronic, B-Cell
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000095
- Subject identifier
- D015451
- Condition
- Lymphoma, Follicular
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000096
- Subject identifier
- D008224
- Condition
- Lymphoma, Large B-Cell, Diffuse
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000403
- Subject identifier
- D016403
- Condition
- Multiple Sclerosis, Chronic Progressive
- Highest recorded phase
- 4
- Condition identifier
- EFO:0003840
- Subject identifier
- D020528
- Condition
- Multiple Sclerosis, Relapsing-Remitting
- Highest recorded phase
- 4
- Condition identifier
- EFO:0003929
- Subject identifier
- D020529
- Condition
- Neuromyelitis Optica
- Highest recorded phase
- 1
- Condition identifier
- EFO:0004256
- Subject identifier
- D009471
- Condition
- Lymphoma, Non-Hodgkin
- Highest recorded phase
- 1
- Condition identifier
- EFO:0005952
- Subject identifier
- D008228
- Condition
- Waldenstrom Macroglobulinemia
- Highest recorded phase
- 1
- Condition identifier
- EFO:0009441
- Subject identifier
- D008258
- Condition
- Lymphoma, Mantle-Cell
- Highest recorded phase
- 2
- Condition identifier
- EFO:1001469
- Subject identifier
- D020522
- Condition
- Multiple Sclerosis
- Highest recorded phase
- 3
- Condition identifier
- MONDO:0005301
- Subject identifier
- D009103
- Condition
- Lymphoma, Follicular
- Highest recorded phase
- 2
- Condition identifier
- MONDO:0018906
- Subject identifier
- D008224
- Condition identifier
- EFO_0000095
- Highest recorded phase
- 3
- Condition identifier
- EFO_0000574
- Condition identifier
- EFO_0003840
- Condition identifier
- EFO_0003929
- Condition identifier
- EFO_0004256
- Highest recorded phase
- 1
- Condition identifier
- EFO_0005809
- Highest recorded phase
- 2
- Condition identifier
- EFO_0005952
- Condition identifier
- EFO_1001469
- Condition identifier
- HP_0002960
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0002083
- Highest recorded phase
- 1
- Condition identifier
- MONDO_0004948
- Highest recorded phase
- 3
- Condition identifier
- MONDO_0004949
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0005062
- Highest recorded phase
- 1
- Condition identifier
- MONDO_0005284
- Highest recorded phase
- 4
- Condition identifier
- MONDO_0005301
- Condition identifier
- MONDO_0005301
- Highest recorded phase
- 4
- Condition identifier
- MONDO_0005314
- Highest recorded phase
- 4
- Condition identifier
- MONDO_0005885
- Highest recorded phase
- 1
- Condition identifier
- MONDO_0015759
- Highest recorded phase
- 1
- Condition identifier
- MONDO_0017604
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0018876
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0018905
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0018906
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0018908
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0019100
- Highest recorded phase
- 1
And 4 more, listed on the interactive page.
- Event
- covid-19 pneumonia
- Reports
- 2
- Reporting signal score
- 8.90958
- Event
- cytomegalovirus colitis
- Reports
- 2
- Reporting signal score
- 10.1717
- Event
- fungal foot infection
- Reports
- 1
- Reporting signal score
- 9.1209
- Event
- fungal pharyngitis
- Reports
- 1
- Reporting signal score
- 7.43931
- Event
- haemophilus bacteraemia
- Reports
- 1
- Reporting signal score
- 8.49233
- Event
- intestinal adenocarcinoma
- Reports
- 1
- Reporting signal score
- 6.81867
- Event
- neutropenia
- Reports
- 4
- Reporting signal score
- 7.09874
- Event
- oral herpes
- Reports
- 2
- Reporting signal score
- 7.26718
- Event
- subperiosteal abscess
- Reports
- 1
- Reporting signal score
- 8.25596
- NCT01744912
- NCT02006485
- NCT02301156
- NCT02535286
- NCT02612311
- NCT02656303
- NCT03207256
- NCT03379051
- NCT03671590
- NCT03801525
- NCT03828448
- NCT04016805
- NCT04149821
- NCT04624633
- NCT02793583
- NCT03804996
- NCT04692155
- NCT04783415
- NCT02276963
- NCT02738775
- NCT03277248
- NCT03277261
- NCT04130997
- NCT05877963
- NCT04508647
And 2 more, listed on the interactive page.
- Dose
- 150mg for first infusion, 450mg for second and subsequent infusions
- Route
- Intravenous
- How often
- Every 24 weeks after initial infusions
Conditions of use
- Must be diluted in 0.9% Sodium Chloride Injection, USP prior to administration
- Prodrug
- No
- Chirality
- Single enantiomer
- Inorganic
- No
- Natural product
- No
- Component
- Heavy chain
- Type
- Protein
- Sequence
- QAYLQQSGAELVRPGASVKMSCKASGYTFTSYNMHWVKQTPRQGLEWIGGIYPGNGDTSYNQKFKGKATLTVGKSSSTAYMQLSSLTSEDSAVYFCARYDYNYAMDYWGQGTSVTVSSASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSSGLYSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKKVEPKSCDKTHTCPPCPAPELLGGPSVFLFPPKPKDTLMISRTPEVTCVVVDVSHEDPEVKFNWYVDGVEVHNAKTKPREEQYNSTYRVVSVLTVLHQDWLNGKEYKCKVSNKALPAPIEKTISKAKGQPREPQVYTLPPSRDELTKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSKLTVDKSRWQQGNVFSCSVMHEALHNHYTQKSLSLSPGK
- Component
- Light chain
- Type
- Protein
- Sequence
- QIVLSQSPAILSASPGEKVTMTCRASSSVSYMHWYQQKPGSSPKPWIYATSNLASGVPARFSGSGSGTSYSFTISRVEAEDAATYYCQQWTFNPPTFGGGTRLEIKRTVAAPSVFIFPPSDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQESVTEQDSKDSTYSLSSTLTLSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC
- Component
- Disulfide bridges location
- Sequence
- 22-96 | 22''-96'' | 23'-87' | 23'''-87''' | 133'-193' | 133'''-193''' | 145-201 | 145''-201'' | 213'-221 | 213'''-221'' | 227-227'' | 230-230'' | 262-322 | 262''-322'' | 368-426 | 368''-426''
- 73150-150
Related records
Trials (43)
- A Single-Center Study to Characterize the Safety and Efficacy of Ublituximab in Older Adults With Relapsing Forms of Multiple Sclerosis (RMS)
- 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)
- A Study to Evaluate the Efficacy and Safety of Maintenance Ublituximab Following Induction With Efgartigimod Administration in Participants With Myasthenia Gravis (MG)
- A Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, Radiological and Clinical Effects of Subcutaneous Ublituximab in Participants With Relapsing Multiple Sclerosis (RMS)
- A Study to Evaluate the Safety and Efficacy of Ublituximab in Combination With Umbralisib for Participants Previously Enrolled in Protocol UTX-TGR-304
- Acalabrutinib, Umbralisib, and Ublituximab (AU2) In Relapsed and Untreated CLL
- Acalabrutinib, Umbralisib, and Ublituximab for the Treatment of Previously Untreated Mantle Cell Lymphoma
- An Extension of the TG1101-RMS201 Trial
- An Extension Study of Ublituximab in Participants With Relapsing Multiple Sclerosis
- Clinical Trial of Ublituximab and Umbralisib With CHOP (U2-CHOP) Followed by U2 Maintenance (U2-CHOP-U2) in Previously Untreated Mantle Cell Lymphoma (MCL)
- Effects of Ublituximab on Motor Functions in Multiple Sclerosis
- Exploration of Novel Imaging Biomarkers on OCT for Ublituximab Treatment Response in Multiple Sclerosis
- 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
- Lenalidomide, Umbralisib, and Ublituximab for the Treatment of Relapsed or Refractory Indolent Non-Hodgkin Lymphoma or Mantle Cell Lymphoma
- Phase I/II Study of Venetoclax or Lenalidomide in Combination With Ublituximab and Umbralisib in Subjects With Relapsed or Refractory CLL/SLL and NHL
- Phase IIa Study of Ublituximab in Participants With Relapsing Forms of Multiple Sclerosis
- Study of Cosibelimab in Subjects With Relapsed or Refractory Lymphoma
- Study of Immunotherapy in Combination With Ublituximab and Umbralisib in Patients With Relapsed-refractory CLL or Richter's Transformation
- Study of TG-1701, an Irreversible Bruton's Tyrosine Kinase Inhibitor, in Patients With B-Cell Malignancies
- Study of TG-1801 Alone or in Combination With Ublituximab in Subjects With B-Cell Lymphoma or Chronic Lymphocytic Leukemia
Approved for (2)
In development for (10)
- Autoimmune disease Phase 2
- B-cell chronic lymphocytic leukemia Phase 3
- Diffuse large B-cell lymphoma Phase 2
- Follicular lymphoma Phase 2
- Mantle cell lymphoma Phase 2
- Multiple sclerosis Phase 3
- Neoplasm of mature B-cells Phase 2
- Neuromyelitis optica Phase 1
- Non-Hodgkin lymphoma Phase 1
- Waldenstrom macroglobulinemia Phase 1
Other linked conditions (2)
- Lymphoma
- Nodal marginal zone B-cell lymphoma
Targets (1)
- MS4A1 B-lymphocyte antigen CD20 binding agent