Zinplava(bezlotoxumab)
Zinplava (bezlotoxumab) is an antibody pharmaceutical. Bezlotoxumab was first approved as Zinplava on 2016-10-21. It is used to treat clostridium infections in the USA. It has been approved in Europe to treat pseudomembranous enterocolitis. It is known to target Toxin B.
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FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
Start date
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Completion date
Results first post date
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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| infections | D007239 |
| digestive system diseases | D004066 |
Trade Name
FDA
EMA
Zinplava
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)
Bezlotoxumab
Tradename | Proper name | Company | Number | Date | Products |
|---|---|---|---|---|---|
| Zinplava | bezlotoxumab | Merck & Co | N-761046 RX | 2016-10-21 | 1 products |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| zinplava | Biologic Licensing Application | 2023-05-26 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| clostridium infections | EFO_1000874 | D003015 | A05.2 |
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
HCPCS
Code | Description |
|---|---|
| J0565 | Injection, bezlotoxumab, 10 mg |
Clinical
Clinical Trials
16 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Clostridium infections | D003015 | EFO_1000874 | A05.2 | — | 3 | 3 | 5 | 3 | 14 |
| Infections | D007239 | EFO_0000544 | — | — | 2 | 3 | 4 | 4 | 13 |
| Communicable diseases | D003141 | — | — | — | 1 | 3 | 2 | 3 | 9 |
| Recurrence | D012008 | — | — | — | 1 | — | 2 | 2 | 5 |
| Inflammatory bowel diseases | D015212 | EFO_0003767 | — | — | 1 | — | 1 | — | 2 |
| Intestinal diseases | D007410 | HP_0002242 | K63.9 | — | 1 | — | 1 | — | 2 |
| Clostridioides difficile | D016360 | NCBITaxon_1496 | — | — | — | — | 2 | — | 2 |
| Ulcerative colitis | D003093 | EFO_0000729 | K51 | — | — | — | 1 | — | 1 |
| Crohn disease | D003424 | EFO_0000384 | K50 | — | — | — | 1 | — | 1 |
| Sepsis | D018805 | HP_0100806 | A41.9 | — | — | — | 1 | — | 1 |
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Indications Phases 3
No data
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Multiple organ failure | D009102 | EFO_1001373 | — | — | 1 | — | — | — | 1 |
| Mortality | D009026 | EFO_0004352 | — | — | 1 | — | — | — | 1 |
| Gastrointestinal microbiome | D000069196 | — | — | — | 1 | — | — | — | 1 |
Indications Phases 1
No data
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Bezlotoxumab |
| INN | bezlotoxumab |
| Description | Bezlotoxumab (human mab) |
| Classification | Antibody |
| Drug class | monoclonal antibodies |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | >4NP4:H,I|bezlotoxumab heavy chain
EVQLVQSGAEVKKSGESLKISCKGSGYSFTSYWIGWVRQMPGKGLEWMGIFYPGDSSTRYSPSFQGQVTISADKSVNTAY
LQWSSLKASDTAMYYCARRRNWGNAFDIWGQGTMVTVSSASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSW
NSGALTSGVHTFPAVLQSSGLYSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKRVEPKSC
>4NP4:L,M|bezlotoxumab light chain
EIVLTQSPGTLSLSPGERATLSCRASQSVSSSYLAWYQQKPGQAPRLLIYGASSRATGIPDRFSGSGSGTDFTLTISRLE
PEDFAVYYCQQYGSSTWTFGQGTKVEIKRTVAAPSVFIFPPSDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNS
QESVTEQDSKDSTYSLSSTLTLSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC |
Identifiers
| PDB | 4NP4 |
| CAS-ID | — |
| RxCUI | — |
| ChEMBL ID | CHEMBL2108670 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | DB13140 |
| UNII ID | 4H5YMK1H2E (ChemIDplus, GSRS) |
Target
Agency Approved
No data
Alternate
tcdB
tcdB
Organism
Clostridioides difficile
Gene name
tcdB
Gene synonyms
toxB
NCBI Gene ID
—
Protein name
Toxin B
Protein synonyms
Uniprot ID
Mouse ortholog
—
—
Variants
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 815 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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291 adverse events reported
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