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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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FDA approval date
EMA approval date
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Study first post date
Last update 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
55 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_0003841310821133
Thyroid diseasesD013959HP_0000820E00-E0739821031
HypothyroidismD007037EFO_0004705E03.911
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Head and neck neoplasmsD006258112
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
CarcinomaD002277C80.0314
EpilepsyD004827EFO_0000474G40.944
GoiterD006042HP_0000853E04.9314
Papillary thyroid cancerD00007727333
Follicular adenocarcinomaD01826333
Multiple sclerosisD009103EFO_0003885G3522
SclerosisD01259822
Brain diseasesD001927HP_0001298G93.4022
SyndromeD01357722
SeizuresD012640HP_0002069G40.422
Show 9 more
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 diseasesD008171HP_0002088J98.411
AsthmaD001249EFO_0000270J4511
Obstructive lung diseasesD008173HP_000653611
Healthy volunteers/patients11
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
SinusitisD012852EFO_0007486J3211
Nasal polypsD009298HP_0100582J3311
RhinosinusitisD00009682511
TinnitusD014012HP_0000360H93.111
Precocious pubertyD011629E22.811
Renal insufficiencyD051437HP_0000083N1911
Septic shockD012772A48.311
ShockD012769R57.111
VitiligoD014820EFO_0004208L8011
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 507 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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904 adverse events reported
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