Teprotumumab
Tepezza (teprotumumab) is an antibody pharmaceutical. Teprotumumab was first approved as Tepezza on 2020-01-21. It is used to treat graves ophthalmopathy in the USA. The pharmaceutical is active against insulin-like growth factor 1 receptor.
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Commercial
Trade Name
FDA
EMA
Tepezza
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)
Teprotumumab
Tradename | Proper name | Company | Number | Date | Products |
---|---|---|---|---|---|
Tepezza | teprotumumab-trbw | Horizon Therapeutics Public | N-761143 RX | 2020-01-21 | 1 products |
Labels
FDA
EMA
Brand Name | Status | Last Update |
---|---|---|
tepezza | Biologic Licensing Application | 2020-01-29 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
---|---|---|---|
graves ophthalmopathy | EFO_1001466 | D049970 | — |
Agency Specific
FDA
EMA
Expiration | Code | ||
---|---|---|---|
teprotumumab, Tepezza, Horizon Therapeutics Ireland DAC | |||
2027-01-21 | Orphan excl. |
Patent Expiration
No data
HCPCS
Code | Description |
---|---|
J3241 | Injection, teprotumumab-trbw, 10 mg |
Clinical
Clinical Trials
19 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 |
---|---|---|---|---|---|---|---|---|---|
Graves ophthalmopathy | D049970 | EFO_1001466 | — | 1 | 1 | — | 1 | 3 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Neoplasms | D009369 | C80 | 4 | — | — | — | — | 4 | |
Diffuse scleroderma | D045743 | EFO_0000404 | 1 | — | — | — | — | 1 | |
Macular edema | D008269 | 1 | — | — | — | — | 1 |
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common name | TEPROTUMUMAB |
INN | teprotumumab |
Description | Teprotumumab, sold under the brand name Tepezza, is a medication used to treat adults with thyroid eye disease, a rare condition where the muscles and fatty tissues behind the eye become inflamed, causing the eyes to bulge outwards.
|
Classification | Antibody |
Drug class | monoclonal antibodies |
Image (chem structure or protein) | |
Structure (InChI/SMILES or Protein Sequence) | — |
Identifiers
PDB | — |
CAS-ID | — |
RxCUI | — |
ChEMBL ID | CHEMBL1743079 |
ChEBI ID | — |
PubChem CID | — |
DrugBank | DB06343 |
UNII ID | Y64GQ0KC0A (ChemIDplus, GSRS) |
Target
Agency Approved
Alternate
No data
Variants
Clinical Variant
No data
Financial
Tepezza - Horizon Therapeutics Public
$
€
£
₣
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 462 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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54 adverse events reported
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