Teprotumumab
Tepezza (teprotumumab) is an antibody pharmaceutical. Teprotumumab was first approved as Tepezza on 2020-01-21. It is used to treat graves ophthalmopathy in the USA. The pharmaceutical is active against insulin-like growth factor 1 receptor.
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Commercial
Therapeutic Areas
Trade Name
FDA
EMA
Tepezza
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)
Teprotumumab
Tradename | Proper name | Company | Number | Date | Products |
|---|---|---|---|---|---|
| Tepezza | teprotumumab-trbw | Horizon Therapeutics Public | N-761143 RX | 2020-01-21 | 1 products |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| tepezza | Biologic Licensing Application | 2024-06-24 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| graves ophthalmopathy | EFO_1001466 | D049970 | — |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
teprotumumab, Tepezza, Horizon Therapeutics Ireland DAC | |||
| 2027-01-21 | Orphan excl. | ||
Patent Expiration
No data
HCPCS
Code | Description |
|---|---|
| J3241 | Injection, teprotumumab-trbw, 10 mg |
Clinical
Clinical Trials
27 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Graves ophthalmopathy | D049970 | EFO_1001466 | — | 1 | 2 | 3 | 2 | 2 | 10 |
| Eye diseases | D005128 | EFO_0003966 | H44 | 1 | 2 | 3 | 2 | 2 | 10 |
| Thyroid diseases | D013959 | HP_0000820 | E00-E07 | 1 | 2 | 2 | 1 | 2 | 8 |
Indications Phases 3
No data
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Non-small-cell lung carcinoma | D002289 | — | — | — | 2 | — | — | — | 2 |
| Lung neoplasms | D008175 | HP_0100526 | C34.90 | — | 2 | — | — | — | 2 |
| Sarcoma | D012509 | — | — | — | 1 | — | — | 1 | 2 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 1 | 1 | — | — | — | 2 |
| Prostatic neoplasms | D011471 | — | C61 | 1 | 2 | — | — | — | 2 |
| Neoplasm metastasis | D009362 | EFO_0009708 | — | 1 | 1 | — | — | — | 1 |
| Endocrine system diseases | D004700 | EFO_0001379 | E34.9 | — | 1 | — | — | — | 1 |
| Exophthalmos | D005094 | HP_0000520 | H05.20 | — | 1 | — | — | — | 1 |
| Orbital diseases | D009916 | — | H05 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Neoplasms | D009369 | — | C80 | 4 | — | — | — | — | 4 |
| Systemic scleroderma | D012595 | EFO_0000717 | M34.0 | 1 | — | — | — | — | 1 |
| Diffuse scleroderma | D045743 | EFO_0000404 | — | 1 | — | — | — | — | 1 |
| Sclerosis | D012598 | — | — | 1 | — | — | — | — | 1 |
| Macular edema | D008269 | — | — | 1 | — | — | — | — | 1 |
| Edema | D004487 | HP_0000969 | R60.9 | 1 | — | — | — | — | 1 |
| Therapeutic equivalency | D013810 | — | — | 1 | — | — | — | — | 1 |
| Biological availability | D001682 | — | — | 1 | — | — | — | — | 1 |
| Healthy volunteers/patients | — | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Graves disease | D006111 | EFO_0004237 | E05.0 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Teprotumumab |
| INN | teprotumumab |
| Description | Teprotumumab, sold under the brand name Tepezza, is a medication used to treat adults with thyroid eye disease, a rare condition where the muscles and fatty tissues behind the eye become inflamed, causing the eyes to bulge outwards.
|
| Classification | Antibody |
| Drug class | monoclonal antibodies |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | — |
Identifiers
| PDB | — |
| CAS-ID | — |
| RxCUI | — |
| ChEMBL ID | CHEMBL1743079 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | DB06343 |
| UNII ID | Y64GQ0KC0A (ChemIDplus, GSRS) |
Target
Agency Approved
Alternate
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Tepezza – Horizon Therapeutics Public
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Tepezza – Amgen
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Tabular view
Estimated US medical usage
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 1,228 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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3,290 adverse events reported
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