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
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
No data
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| tepezza | Biologic Licensing Application | 2024-06-24 |
Indications
FDA
EMA
No data
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
26 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 |
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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Variants
No data
Financial
Revenue by drug
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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 1,204 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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