Ublituximab: Difference between revisions

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{{Short description|Chemical compound}}
{{Short description|Chemical compound}}
{{Use dmy dates|date=December 2022}}
{{Drugbox
{{Infobox drug
| Verifiedfields = changed
| Verifiedfields = changed
| verifiedrevid = 470619391
| verifiedrevid = 470619391
| type = mab
| type = mab
| image =
| image =
| width =
| alt =
| alt =
| caption =

<!-- Monoclonal antibody data -->
| mab_type = mab
| mab_type = mab
| source = xi/o
| source = xi/o
| target = [[CD20]]
| target = [[CD20]]

<!--Clinical data -->
<!-- Clinical data -->
| tradename = Briumvi
| pronounce =
| tradename = Briumvi
| Drugs.com =
| Drugs.com =
| MedlinePlus =
| MedlinePlus =
| DailyMedID = Ublituximab
| pregnancy_AU = <!-- A / B1 / B2 / B3 / C / D / X -->
| pregnancy_AU = <!-- A / B1 / B2 / B3 / C / D / X -->
| pregnancy_AU_comment =
| pregnancy_US = <!-- A / B / C / D / X -->
| pregnancy_category=
| pregnancy_category =
| routes_of_administration = [[Intravenous]]
| legal_AU = <!-- S2, S3, S4, S5, S6, S7, S8, S9 or Unscheduled -->
| legal_CA = <!-- OTC, Rx-only, Schedule I, II, III, IV, V, VI, VII, VIII -->
| class =
| ATCvet =
| legal_UK = <!-- GSL, P, POM, CD, CD Lic, CD POM, CD No Reg POM, CD (Benz) POM, CD (Anab) POM or CD Inv POM -->
| legal_US = <!-- OTC / Rx-only / Schedule I, II, III, IV, V -->
| ATC_prefix = None <!-- scheduled to be L04AA57 in 2023 -->
| legal_status =
| ATC_suffix =
| ATC_supplemental =
| routes_of_administration =
| biosimilars =

<!-- Legal status -->
| legal_AU = <!-- S2, S3, S4, S5, S6, S7, S8, S9 or Unscheduled -->
| legal_AU_comment =
| legal_BR = <!-- OTC, A1, A2, A3, B1, B2, C1, C2, C3, C4, C5, D1, D2, E, F -->
| legal_BR_comment =
| legal_CA = <!-- OTC, Rx-only, Schedule I, II, III, IV, V, VI, VII, VIII -->
| legal_CA_comment =
| legal_DE = <!-- Anlage I, II, III or Unscheduled -->
| legal_DE_comment =
| legal_NZ = <!-- Class A, B, C -->
| legal_NZ_comment =
| legal_UK = <!-- GSL, P, POM, CD, CD Lic, CD POM, CD No Reg POM, CD (Benz) POM, CD (Anab) POM or CD Inv POM / Class A, B, C -->
| legal_UK_comment =
| legal_US = Rx-only
| legal_US_comment = <ref name="Briumvi FDA label">https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761238s000lbl.pdf</ref>
| legal_EU =
| legal_EU_comment =
| legal_UN = <!-- N I, II, III, IV / P I, II, III, IV -->
| legal_UN_comment =
| legal_status = <!-- For countries not listed above -->

<!-- Pharmacokinetic data -->
<!-- Pharmacokinetic data -->
| bioavailability =
| bioavailability =
| protein_bound =
| protein_bound =
| metabolism =
| metabolism =
| metabolites =
| onset =
| elimination_half-life =
| elimination_half-life =
| duration_of_action =
| excretion =
| excretion =
<!-- Identifiers -->
| ChemSpiderID_Ref = {{chemspidercite|changed|chemspider}}
| ChemSpiderID = none


<!-- Identifiers -->
| CAS_number = 1174014-05-1
| CAS_number = 1174014-05-1
| CAS_number_Ref = {{cascite|correct|CAS}}
| CAS_number_Ref = {{cascite|correct|CAS}}
| CAS_supplemental =
| UNII_Ref = {{fdacite|correct|FDA}}
| UNII = U59UGK3IPC
| ATC_prefix = None <!-- scheduled to be L04AA57 in 2023 -->
| ATC_suffix =
| PubChem =
| PubChem =
| IUPHAR_ligand =
| DrugBank_Ref = {{drugbankcite|correct|drugbank}}
| DrugBank_Ref = {{drugbankcite|correct|drugbank}}
| DrugBank =
| DrugBank =
| ChemSpiderID_Ref = {{chemspidercite|changed|chemspider}}
| ChemSpiderID = none
| UNII_Ref = {{fdacite|correct|FDA}}
| UNII = U59UGK3IPC
| KEGG = D11243
| KEGG = D11243
| ChEBI =
<!-- Chemical data -->
| ChEMBL =
| NIAID_ChemDB =
| PDB_ligand =
| synonyms = ublituximab-xiiy

<!-- Chemical and physical data -->
| IUPAC_name =
| chemical_formula_ref =
| chemical_formula =
| chemical_formula =
| C= | H= | Ag= | Al= | As= | Au= | B= | Bi= | Br= | Ca= | Cl= | Co= | F= | Fe= | Gd= | I=
| K= | Li= | Mg= | Mn= | N= | Na= | O= | P= | Pt= | S= | Sb= | Se= | Sr= | Tc= | Zn= | charge=
| molecular_weight =
| molecular_weight =
| molecular_weight_comment =

| SMILES =
| StdInChI =
| StdInChI_comment =
| StdInChIKey =
| density =
| density_notes =
| melting_point =
| melting_high =
| melting_notes =
| boiling_point =
| boiling_notes =
| solubility =
| sol_units =
| specific_rotation =
}}
}}


'''Ublituximab''' (brand name '''Briumvi''') is an [[Immunotherapy#Immunomodulators|immunomodulator]]. It binds to [[CD20]].<ref>{{cite journal | author = [[World Health Organization]] | title = International Nonproprietary Names for Pharmaceutical Substances (INN). Proposed INN: List 104 | journal = WHO Drug Information | volume = 24 | issue = 4 | year = 2010 | url =https://www.who.int/medicines/publications/druginformation/innlists/Final_PL104.pdf }}</ref>
'''Ublituximab''', sold under the brand name '''Briumvi''', is an [[Immunotherapy#Immunomodulators|immunomodulator]] used for the treatment of [[multiple sclerosis]].<ref name="Briumvi FDA label" /> It is a [[CD20]]-directed cytolytic [[monoclonal antibody]].<ref name="Briumvi FDA label" />


It was approved for medical use in the United States in December 2022.<ref name="Briumvi FDA label" /><ref>{{cite web | title=Briumvi: FDA-Approved Drugs | publisher=U.S. [[Food and Drug Administration]] (FDA) | url=https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761238 | access-date=29 December 2022}}</ref>

== Medical uses ==
Ublituximab is [[indicated]] for the treatment of relapsing forms of multiple sclerosis.<ref name="Briumvi FDA label" />

== Society and culture ==
=== Names ===
Ublituximab is the [[international nonproprietary name]] (INN).<ref>{{cite journal | vauthors = ((World Health Organization)) | title = International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 66 | journal = WHO Drug Information | volume = 25 | issue = 3 | year = 2011 | hdl = 10665/74683 | hdl-access = free | author-link = World Health Organization }}</ref>

== Research ==
It is in [[phases of clinical research|phase III clinical trials]] for [[multiple sclerosis]].<ref>{{ClinicalTrialsGov|NCT03277261|A Phase 3, Randomized, Multi-center, Double-blinded, Active-controlled Study to Assess the Efficacy and Safety/Tolerability of Ublituximab (TG-1101; UTX) as Compared to Teriflunomide in Subjects With Relapsing Multiple Sclerosis (RMS) (ULTIMATE 1)}}</ref>
It is in [[phases of clinical research|phase III clinical trials]] for [[multiple sclerosis]].<ref>{{ClinicalTrialsGov|NCT03277261|A Phase 3, Randomized, Multi-center, Double-blinded, Active-controlled Study to Assess the Efficacy and Safety/Tolerability of Ublituximab (TG-1101; UTX) as Compared to Teriflunomide in Subjects With Relapsing Multiple Sclerosis (RMS) (ULTIMATE 1)}}</ref>


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== References ==
== References ==
{{reflist}}
{{reflist}}

== External links ==
* {{ClinicalTrialsGov|NCT03277261|Study to Assess the Efficacy and Safety of Ublituximab in Participants With Relapsing Forms of Multiple Sclerosis (RMS) (ULTIMATE 1)}}
* {{ClinicalTrialsGov|NCT03277248|Study to Assess the Efficacy and Safety of Ublituximab in Participants With Relapsing Forms of Multiple Sclerosis (RMS) (ULTIMATE II)}}


{{Immunosuppressants}}
{{Immunosuppressants}}
{{Monoclonals for tumors}}
{{Monoclonals for tumors}}
{{Portal bar | Medicine}}


[[Category:Monoclonal antibodies]]
[[Category:Monoclonal antibodies]]

Revision as of 06:18, 30 December 2022

Ublituximab
Monoclonal antibody
TypeWhole antibody
SourceChimeric (mouse/human)
TargetCD20
Clinical data
Trade namesBriumvi
Other namesublituximab-xiiy
License data
Routes of
administration		Intravenous
ATC code
  • None
Legal status
Legal status
Identifiers
CAS Number
ChemSpider
  • none
UNII
KEGG
 ☒NcheckY (what is this?)  (verify)

Ublituximab, sold under the brand name Briumvi, is an immunomodulator used for the treatment of multiple sclerosis.[1] It is a CD20-directed cytolytic monoclonal antibody.[1]

It was approved for medical use in the United States in December 2022.[1][2]

Medical uses

Ublituximab is indicated for the treatment of relapsing forms of multiple sclerosis.[1]

Society and culture

Names

Ublituximab is the international nonproprietary name (INN).[3]

Research

It is in phase III clinical trials for multiple sclerosis.[4]

It is also in "U2" phase III clinical trials for chronic lymphocytic leukemia in combination with umbralisib.[5][6]

References

  1. ^ a b c d e https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761238s000lbl.pdf
  2. ^ "Briumvi: FDA-Approved Drugs". U.S. Food and Drug Administration (FDA). Retrieved 29 December 2022.
  3. ^ World Health Organization (2011). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 66". WHO Drug Information. 25 (3). hdl:10665/74683.
  4. ^ Clinical trial number NCT03277261 for "A Phase 3, Randomized, Multi-center, Double-blinded, Active-controlled Study to Assess the Efficacy and Safety/Tolerability of Ublituximab (TG-1101; UTX) as Compared to Teriflunomide in Subjects With Relapsing Multiple Sclerosis (RMS) (ULTIMATE 1)" at ClinicalTrials.gov
  5. ^ Lunning M, Vose J, Nastoupil L, Fowler N, Burger JA, Wierda WG, et al. (November 2019). "Ublituximab and umbralisib in relapsed/refractory B-cell non-Hodgkin lymphoma and chronic lymphocytic leukemia". Blood. 134 (21): 1811–1820. doi:10.1182/blood.2019002118. PMC 7042665. PMID 31558467.
  6. ^ Babiker HM, Glode AE, Cooke LS, Mahadevan D (April 2018). "Ublituximab for the treatment of CD20 positive B-cell malignancies". Expert Opinion on Investigational Drugs. 27 (4): 407–412. doi:10.1080/13543784.2018.1459560. PMID 29609506. S2CID 4775126.

External links

  • Clinical trial number NCT03277261 for "Study to Assess the Efficacy and Safety of Ublituximab in Participants With Relapsing Forms of Multiple Sclerosis (RMS) (ULTIMATE 1)" at ClinicalTrials.gov
  • Clinical trial number NCT03277248 for "Study to Assess the Efficacy and Safety of Ublituximab in Participants With Relapsing Forms of Multiple Sclerosis (RMS) (ULTIMATE II)" at ClinicalTrials.gov


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