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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EMA approval date
Patent expiration date
Study first post date
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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| infections | D007239 |
| urogenital diseases | D000091642 |
| immune system diseases | D007154 |
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 |
|---|---|---|---|---|---|
| Trogarzo | ibalizumab-uiyk | Theratechnologies | N-761065 RX | 2018-03-06 | 1 products |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| trogarzo | Biologic Licensing Application | 2023-12-20 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| hiv infections | EFO_0000764 | D015658 | B20 |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
ibalizumab, Trogarzo, Theratechnologies Inc. | |||
| 2025-03-06 | Orphan excl. | ||
Patent Expiration
No data
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
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hiv infections | D015658 | EFO_0000764 | B20 | 1 | 3 | 2 | — | 3 | 8 |
| Hiv | D006678 | — | — | — | 1 | 2 | — | — | 3 |
Indications Phases 2
No data
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Leukemia | D007938 | — | C95 | 3 | — | — | — | — | 3 |
| Lymphoma | D008223 | — | C85.9 | 1 | — | — | — | — | 1 |
| T-cell lymphoma | D016399 | — | — | 1 | — | — | — | — | 1 |
| T-cell leukemia | D015458 | — | — | 1 | — | — | — | — | 1 |
| Infections | D007239 | EFO_0000544 | — | 1 | — | — | — | — | 1 |
| Myelomonocytic leukemia chronic | D015477 | — | C93.1 | 1 | — | — | — | — | 1 |
| Myelomonocytic leukemia acute | D015479 | — | C92.5 | 1 | — | — | — | — | 1 |
| Myelomonocytic leukemia juvenile | D054429 | — | C93.3 | 1 | — | — | — | — | 1 |
| Myeloid leukemia acute | D015470 | — | C92.0 | 1 | — | — | — | — | 1 |
| Myeloid leukemia | D007951 | — | C92 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Acquired immunodeficiency syndrome | D000163 | EFO_0000765 | B20 | — | — | — | — | 1 | 1 |
| Hiv-2 | D015498 | — | — | — | — | — | — | 1 | 1 |
| Viral drug resistance | D024882 | — | — | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Ibalizumab |
| INN | ibalizumab |
| Description | Ibalizumab (humanized mab) |
| Classification | Antibody |
| Drug class | monoclonal antibodies |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | >3O2D:H|ibalizumab heavy chain
QVQLQQSGPEVVKPGASVKMSCKASGYTFTSYVIHWVRQKPGQGLDWIGYINPYNDGTDYDEKFKGKATLTSDTSTSTAY
MELSSLRSEDTAVYYCAREKDNYATGAWFAYWGQGTLVTVSSASTKGPSVFPLAPCSRSTSESTAALGCLVKDYFPEPVT
VSWNSGALTSGVHTFPAVLQSSGLYSLSSVVTVPSSSLGTKTYTCNVDHKPSNTKVDKRVESKYG
>3O2D:L|ibalizumab light chain
DIVMTQSPDSLAVSLGERVTMNCKSSQSLLYSTNQKNYLAWYQQKPGQSPKLLIYWASTRESGVPDRFSGSGSGTDFTLT
ISSVQAEDVAVYYCQQYYSYRTFGGGTKLEIKRTVAAPSVFIFPPSDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQ
SGNSQESVTEQDSKDSTYSLSSTLTLSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC |
Identifiers
| PDB | 3O2D, 7T0R |
| CAS-ID | — |
| RxCUI | — |
| ChEMBL ID | CHEMBL1743029 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | DB12698 |
| UNII ID | LT369U66CE (ChemIDplus, GSRS) |
Target
Alternate
No data
Variants
No data
Financial
Revenue by drug
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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 508 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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372 adverse events reported
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