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Drug ReportsThyrotropin alfa
Thyrogen(thyrotropin alfa)
Thyrogen (thyrotropin alfa) is a protein pharmaceutical. Thyrotropin alfa was first approved as Thyrogen on 1998-11-30. It is used to treat thyroid neoplasms in the USA. It has been approved in Europe to treat thyroid neoplasms. The pharmaceutical is active against thyrotropin receptor.
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YTD
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2Y
5Y
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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
neoplasmsD009369
endocrine system diseasesD004700
Trade Name
FDA
EMA
Thyrogen
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)
Thyrotropin alfa
Tradename
Proper name
Company
Number
Date
Products
Thyrogenthyrotropin alfaSanofiN-20898 RX1998-11-30
1 products
Labels
FDA
EMA
Brand Name
Status
Last Update
thyrogenBiologic Licensing Application2023-02-24
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
thyroid neoplasmsEFO_0003841D013964—
Agency Specific
FDA
EMA
Expiration
Code
thyrotropin alfa, Thyrogen, Genzyme Corporation
2114-12-14Orphan excl.
Patent Expiration
No data
ATC Codes
H: Systemic hormonal preparations, excl. sex hormones and insulins
— H01: Pituitary and hypothalamic hormones and analogues
— H01A: Anterior pituitary lobe hormones and analogues
— H01AB: Thyrotropin class in atc
— H01AB01: Thyrotropin alfa
HCPCS
No data
Clinical
Clinical Trials
55 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
Thyroid neoplasmsD013964EFO_0003841——12—25
Thyroid diseasesD013959—E00-E07—12—25
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
GoiterD006042EFO_0004283E04.9—1———1
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients———1————1
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameThyrotropin alfa
INNthyrotropin alfa
Description
Thyrogen (thyrotropin alfa) is a protein pharmaceutical. Thyrotropin alfa was first approved as Thyrogen on 2000-03-09. It is used to treat thyroid neoplasms in the USA. It has been approved in Europe to treat thyroid neoplasms. The pharmaceutical is active against thyrotropin receptor.
Classification
Protein
Drug classtricyclic compounds; atropine derivatives
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)—
Identifiers
PDB—
CAS-ID—
RxCUI—
ChEMBL IDCHEMBL1201533
ChEBI ID—
PubChem CID—
DrugBank—
UNII IDAVX3D5A4LM (ChemIDplus, GSRS)
Target
Agency Approved
TSHR
TSHR
Organism
Homo sapiens
Gene name
TSHR
Gene synonyms
LGR3
NCBI Gene ID
Protein name
thyrotropin receptor
Protein synonyms
seven transmembrane helix receptor, Thyroid-stimulating hormone receptor, thyrotropin receptor-I, hTSHR-I, TSH receptor, TSH-R
Uniprot ID
Mouse ortholog
Tshr (22095)
thyrotropin receptor (Q9D697)
Alternate
No data
Variants
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 526 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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982 adverse events reported
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