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Drug ReportsIbalizumab
Trogarzo(ibalizumab)
Trogarzo (ibalizumab) is an antibody pharmaceutical. Ibalizumab was first approved as Trogarzo on 2018-03-06. It is used to treat HIV infections in the USA. It has been approved in Europe to treat HIV infections. The pharmaceutical is active against T-cell surface glycoprotein CD4.
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YTD
1Y
2Y
5Y
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Events
FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
Start date
Primary completion date
Completion date
Results first post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
infectionsD007239
urogenital diseasesD000091642
immune system diseasesD007154
Trade Name
FDA
EMA
Trogarzo
Drug Products
FDA
EMA
Reference product - 351(a)
Reference product - 351(a)
Interchangeable product - 351(k)
Interchangeable product - 351(k)
Biosimilar product - 351(k)
Biosimilar product - 351(k)
Ibalizumab
Tradename
Proper name
Company
Number
Date
Products
Trogarzoibalizumab-uiykTheratechnologiesN-761065 RX2018-03-06
1 products
Labels
FDA
EMA
Brand Name
Status
Last Update
trogarzoBiologic Licensing Application2024-12-30
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
hiv infectionsEFO_0000764D015658B20
Agency Specific
FDA
EMA
Expiration
Code
ibalizumab, Trogarzo, Theratechnologies Inc.
2025-03-06Orphan excl.
Patent Expiration
No data
ATC Codes
J: Antiinfectives for systemic use
— J05: Antivirals for systemic use
— J05A: Direct acting antivirals
— J05AX: Other antivirals in atc
— J05AX23: Ibalizumab
HCPCS
Code
Description
J1746
Injection, ibalizumab-uiyk, 10 mg
Clinical
Clinical Trials
15 clinical trials
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Indications Phases 4
No data
Indications Phases 3
No data
Indications Phases 2
No data
Indications Phases 1
No data
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Hiv infectionsD015658EFO_0000764B20————22
Viral drug resistanceD024882——————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameIbalizumab
INNibalizumab
Description
Ibalizumab (humanized mab)
Classification
Antibody
Drug classmonoclonal antibodies
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
>3O2D:H|ibalizumab heavy chain QVQLQQSGPEVVKPGASVKMSCKASGYTFTSYVIHWVRQKPGQGLDWIGYINPYNDGTDYDEKFKGKATLTSDTSTSTAY MELSSLRSEDTAVYYCAREKDNYATGAWFAYWGQGTLVTVSSASTKGPSVFPLAPCSRSTSESTAALGCLVKDYFPEPVT VSWNSGALTSGVHTFPAVLQSSGLYSLSSVVTVPSSSLGTKTYTCNVDHKPSNTKVDKRVESKYG >3O2D:L|ibalizumab light chain DIVMTQSPDSLAVSLGERVTMNCKSSQSLLYSTNQKNYLAWYQQKPGQSPKLLIYWASTRESGVPDRFSGSGSGTDFTLT ISSVQAEDVAVYYCQQYYSYRTFGGGTKLEIKRTVAAPSVFIFPPSDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQ SGNSQESVTEQDSKDSTYSLSSTLTLSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC
Identifiers
PDB3O2D, 7T0R
CAS-ID—
RxCUI—
ChEMBL IDCHEMBL1743029
ChEBI ID—
PubChem CID—
DrugBankDB12698
UNII IDLT369U66CE (ChemIDplus, GSRS)
Target
Agency Approved
CD4
CD4
Organism
Homo sapiens
Gene name
CD4
Gene synonyms
NCBI Gene ID
920
Protein name
T-cell surface glycoprotein CD4
Protein synonyms
CD4, CD4 antigen (p55), CD4 receptor, T-cell surface antigen T4/Leu-3
Uniprot ID
Q9UDE5
Mouse ortholog
Cd4 (12504)
T-cell surface glycoprotein CD4 (P06332)
Alternate
No data
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
Trogarzo – Theratechnologies
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Tabular view
Estimated US medical usage
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 542 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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402 adverse events reported
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