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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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6M
YTD
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2Y
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FDA approval date
EMA approval date
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Study first post date
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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
107 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Thyroid neoplasmsD013964EFO_0003841411721033
InfertilityD007246EFO_000054526511931
Thyroid diseasesD013959E00-E072752722
Ovulation inductionD01006232117
Fertilization in vitroD005307235
SyndromeD0135772125
Female infertilityD007247EFO_0008560N971124
Polycystic ovary syndromeD011085EFO_0000660E28.2213
HypogonadismD007006E23.0123
AnovulationD000858112
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Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Papillary thyroid cancerD000077273314
Follicular adenocarcinomaD018263314
Head and neck neoplasmsD006258112
Pituitary diseasesD010900E23.711
Male infertilityD007248EFO_0004248N46111
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
EpilepsyD004827EFO_0000474G40.944
GoiterD006042EFO_0004283E04.9314
CarcinomaD002277C80.0213
Multiple sclerosisD009103EFO_0003885G3522
Brain diseasesD001927G93.4022
SeizuresD012640G40.422
ThyroidectomyD013965111
Peripheral arterial diseaseD058729EFO_000426511
AtherosclerosisD050197EFO_0003914I25.111
Intermittent claudicationD007383EFO_0003876I73.911
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Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Chronic obstructive pulmonary diseaseD029424EFO_0000341J44.911
Lung diseasesD008171EFO_0003818J98.411
AsthmaD001249EFO_0000270J4511
Obstructive lung diseasesD00817311
Area under curveD01954011
PharmacokineticsD01059911
AbsorptionD00004211
Heterotaxy syndromeD05944611
Primary ovarian insufficiencyD016649EFO_0004266E28.311
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
PregnancyD011247EFO_0002950Z33.122
SinusitisD012852EFO_0007486J3211
Nasal polypsD009298J3311
RhinosinusitisD00009682511
TinnitusD014012H93.111
Precocious pubertyD011629E22.811
Renal insufficiencyD051437N1911
Septic shockD012772A48.311
ShockD012769R57.111
Uterine cervical neoplasmsD00258311
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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 544 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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1,020 adverse events reported
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