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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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FDA Novel Drug Approvals 2020
Commercial
Therapeutic Areas
Therapeutic Area
MeSH
eye diseasesD005128
hereditary congenital and neonatal diseases and abnormalitiesD009358
endocrine system diseasesD004700
immune system diseasesD007154
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
Tepezzateprotumumab-trbwHorizon Therapeutics PublicN-761143 RX2020-01-21
1 products
Labels
FDA
EMA
Brand Name
Status
Last Update
tepezzaBiologic Licensing Application2020-01-29
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
graves ophthalmopathyEFO_1001466D049970—
Agency Specific
FDA
EMA
Expiration
Code
teprotumumab, Tepezza, Horizon Therapeutics Ireland DAC
2027-01-21Orphan excl.
Patent Expiration
No data
ATC Codes
L: Antineoplastic and immunomodulating agents
— L04: Immunosuppressants
— L04A: Immunosuppressants
— L04AA: Selective immunosuppressants
— L04AA53: Teprotumumab
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 ophthalmopathyD049970EFO_1001466—11—13
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Non-small-cell lung carcinomaD002289—2———2
Breast neoplasmsD001943EFO_0003869C5011———2
Prostatic neoplasmsD011471C6112———2
SarcomaD012509—1———1
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
NeoplasmsD009369C804————4
Diffuse sclerodermaD045743EFO_00004041————1
Macular edemaD0082691————1
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameTEPROTUMUMAB
INNteprotumumab
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 classmonoclonal antibodies
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)—
Identifiers
PDB—
CAS-ID—
RxCUI—
ChEMBL IDCHEMBL1743079
ChEBI ID—
PubChem CID—
DrugBankDB06343
UNII IDY64GQ0KC0A (ChemIDplus, GSRS)
Target
Agency Approved
IGF1R
IGF1R
Organism
Homo sapiens
Gene name
IGF1R
Gene synonyms
NCBI Gene ID
3480
Protein name
insulin-like growth factor 1 receptor
Protein synonyms
CD221, IGF-I receptor, Insulin-like growth factor I receptor
Uniprot ID
Q9UCC0
Mouse ortholog
Igf1r (16001)
insulin-like growth factor 1 receptor (Q60751)
Alternate
No data
Variants
Clinical Variant
No data
Financial
Tepezza - Horizon Therapeutics Public
$
€
£
₣
Mock data
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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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