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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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| neoplasms | D009369 |
| endocrine system diseases | D004700 |
Trade Name
FDA
EMA
Thyrogen
Drug Products
FDA
EMA
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| thyrogen | Biologic Licensing Application | 2023-02-24 |
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
108 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 | — | 4 | 9 | 7 | 2 | 10 | 31 |
| Infertility | D007246 | EFO_0000545 | — | 2 | 6 | 5 | 11 | 9 | 31 |
| Thyroid diseases | D013959 | — | E00-E07 | 2 | 4 | 5 | 2 | 7 | 19 |
| Ovulation induction | D010062 | — | — | — | 3 | 2 | 1 | 1 | 7 |
| Fertilization in vitro | D005307 | — | — | — | — | 2 | 3 | — | 5 |
| Female infertility | D007247 | EFO_0008560 | N97 | 1 | — | — | 1 | 2 | 4 |
| Polycystic ovary syndrome | D011085 | EFO_0000660 | E28.2 | — | — | 2 | 1 | — | 3 |
| Hypogonadism | D007006 | — | E23.0 | — | — | 1 | 2 | — | 3 |
| Syndrome | D013577 | — | — | — | — | 1 | 2 | — | 3 |
| Anovulation | D000858 | — | — | — | — | 1 | 1 | — | 2 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Papillary thyroid cancer | D000077273 | — | — | — | 3 | 1 | — | — | 4 |
| Follicular adenocarcinoma | D018263 | — | — | — | 3 | 1 | — | — | 4 |
| Head and neck neoplasms | D006258 | — | — | — | 1 | 1 | — | — | 2 |
| Pituitary diseases | D010900 | — | E23.7 | — | — | 1 | — | — | 1 |
| Male infertility | D007248 | EFO_0004248 | N46 | — | 1 | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Epilepsy | D004827 | EFO_0000474 | G40.9 | — | 4 | — | — | — | 4 |
| Goiter | D006042 | EFO_0004283 | E04.9 | — | 3 | — | — | 1 | 4 |
| Carcinoma | D002277 | — | C80.0 | — | 1 | — | — | 1 | 2 |
| Multiple sclerosis | D009103 | EFO_0003885 | G35 | — | 2 | — | — | — | 2 |
| Seizures | D012640 | — | G40.4 | — | 2 | — | — | — | 2 |
| Thyroidectomy | D013965 | — | — | 1 | 1 | — | — | — | 1 |
| Peripheral arterial disease | D058729 | EFO_0004265 | — | — | 1 | — | — | — | 1 |
| Atherosclerosis | D050197 | EFO_0003914 | I25.1 | — | 1 | — | — | — | 1 |
| Intermittent claudication | D007383 | EFO_0003876 | I73.9 | — | 1 | — | — | — | 1 |
| Peripheral vascular diseases | D016491 | EFO_0003875 | I73.9 | — | 1 | — | — | — | 1 |
Show 9 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Chronic obstructive pulmonary disease | D029424 | EFO_0000341 | J44.9 | 1 | — | — | — | — | 1 |
| Lung diseases | D008171 | EFO_0003818 | J98.4 | 1 | — | — | — | — | 1 |
| Asthma | D001249 | EFO_0000270 | J45 | 1 | — | — | — | — | 1 |
| Obstructive lung diseases | D008173 | — | — | 1 | — | — | — | — | 1 |
| Area under curve | D019540 | — | — | 1 | — | — | — | — | 1 |
| Pharmacokinetics | D010599 | — | — | 1 | — | — | — | — | 1 |
| Absorption | D000042 | — | — | 1 | — | — | — | — | 1 |
| Heterotaxy syndrome | D059446 | — | — | 1 | — | — | — | — | 1 |
| Primary ovarian insufficiency | D016649 | EFO_0004266 | E28.3 | 1 | — | — | — | — | 1 |
| Leukemia | D007938 | — | C95 | 1 | — | — | — | — | 1 |
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Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pregnancy | D011247 | EFO_0002950 | Z33.1 | — | — | — | — | 2 | 2 |
| Sinusitis | D012852 | EFO_0007486 | J32 | — | — | — | — | 1 | 1 |
| Nasal polyps | D009298 | — | J33 | — | — | — | — | 1 | 1 |
| Rhinosinusitis | D000096825 | — | — | — | — | — | — | 1 | 1 |
| Tinnitus | D014012 | — | H93.1 | — | — | — | — | 1 | 1 |
| Precocious puberty | D011629 | — | E22.8 | — | — | — | — | 1 | 1 |
| Renal insufficiency | D051437 | — | N19 | — | — | — | — | 1 | 1 |
| Septic shock | D012772 | — | A48.3 | — | — | — | — | 1 | 1 |
| Shock | D012769 | — | R57.1 | — | — | — | — | 1 | 1 |
| Uterine cervical neoplasms | D002583 | — | — | — | — | — | — | 1 | 1 |
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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
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 602 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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1,071 adverse events reported
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