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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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 |
---|---|---|---|---|---|
Thyrogen | thyrotropin alfa | Genzyme Corporation | N-20898 RX | 1998-11-30 | 1 products |
Labels
FDA
EMA
Brand Name | Status | Last Update |
---|---|---|
thyrogen | Biologic Licensing Application | 2020-03-23 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
---|---|---|---|
thyroid neoplasms | EFO_0003841 | D013964 | — |
Agency Specific
FDA
EMA
Expiration | Code | ||
---|---|---|---|
thyrotropin alfa, Thyrogen, Genzyme Corporation | |||
2114-12-14 | Orphan excl. |
Patent Expiration
No data
HCPCS
No data
Clinical
Clinical Trials
13 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 neoplasms | D013964 | EFO_0003841 | 1 | 4 | 3 | 1 | 2 | 10 | |
Hypothyroidism | D007037 | EFO_0004705 | E03.9 | — | — | — | 1 | — | 1 |
Indications Phases 3
No data
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Papillary thyroid cancer | D000077273 | — | 1 | — | — | — | 1 | ||
Follicular adenocarcinoma | D018263 | — | 1 | — | — | — | 1 | ||
Nodular goiter | D006044 | EFO_1001062 | — | 1 | — | — | — | 1 | |
Graves disease | D006111 | EFO_0004237 | E05.0 | — | 1 | — | — | — | 1 |
Indications Phases 1
No data
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common name | THYROTROPIN ALFA |
INN | thyrotropin 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 class | tricyclic compounds; atropine derivatives |
Image (chem structure or protein) | |
Structure (InChI/SMILES or Protein Sequence) | — |
Identifiers
PDB | — |
CAS-ID | — |
RxCUI | — |
ChEMBL ID | CHEMBL1201533 |
ChEBI ID | — |
PubChem CID | — |
DrugBank | — |
UNII ID | AVX3D5A4LM (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
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 386 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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4,623 adverse events reported
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