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TEPEZZA (TEPROTUMUMAB-TRBW)
TEPEZZA (generic name: TEPROTUMUMAB-TRBW) is a Insulin-like Growth Factor-1 Receptor Inhibitor [EPC] drug developed by HORIZON THERAPEUTICS IRELAND. It is currently FDA-approved for Thyroid eye disease.
TEPEZZA is a monoclonal antibody that targets the insulin-like growth factor 1 receptor, classified as an antagonist. It is used to treat conditions such as Thyroid Eye Disease, Graves Ophthalmopathy, and Graves Disease, as well as to evaluate its bioavailability and bioequivalence.
At a glance
| Generic name | TEPROTUMUMAB-TRBW |
|---|---|
| Sponsor | HORIZON THERAPEUTICS IRELAND |
| Drug class | Insulin-like Growth Factor-1 Receptor Inhibitor [EPC] |
| Target | Insulin-like growth factor 1 receptor |
| Therapeutic area | Metabolic |
| Phase | FDA-approved |
Approved indications
- Thyroid eye disease
Common side effects
- Muscle spasm
- Nausea
- Alopecia
- Diarrhea
- Fatigue
- Hyperglycemia
- Hearing impairment
- Dysgeusia
- Headache
- Dry skin
- Weight decreased
- Nail disorder
Serious adverse events
- Bowel perforation
- Exacerbation of inflammatory bowel disease
- Diabetic ketoacidosis
- Hyperosmolar hyperglycemic state
- Severe hearing impairment including permanent hearing loss
- Infusion reactions
Key clinical trials
- A Phase 3, Randomized, Double-masked, Placebo-controlled, Parallel-group, Multicenter Trial to Evaluate the Efficacy, Safety and Tolerability of Subcutaneous Teprotumumab in Participants With Moderate (Phase 3)
- The Effect of Teprotumumab on Thyroid Eye Disease and Thyroid Dysfunction (N/A)
- A Phase 1, Open-Label, Single Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of TEPEZZA Subcutaneous Administration in Healthy Adult Subjects (Phase 1)
- A Phase 1, Randomized, Placebo-controlled, Double-blind, Single-dose Study to Evaluate Pharmacokinetics, Safety, and Tolerability of Teprotumumab (AMG 632) Administered Intravenously in Healthy Chines (Phase 1)
- A Randomized, Double-Blind, Placebo-Controlled, Repeat-Dose, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics, and Explore Efficacy of TEPEZZA in Patients (Phase 1)
- A Phase 1b, Open-label, Multicenter Trial to Evaluate the Pharmacokinetics, Safety, and Tolerability of Two Formulations of a Single Subcutaneous Dose of Teprotumumab Followed by Multiple Intravenous (Phase 1)
- A Phase 4, Randomized, Double-masked, Placebo-controlled, Multicenter Trial to Evaluate the Efficacy and Safety of TEPEZZA® in Treating Patients With Chronic (Inactive) Thyroid Eye Disease (Phase 4)
- Real World Use, Effectiveness and Safety of Teprotumumab Among Thyroid Eye Disease Patients Treated in China BOAO Pilot Zone: A Retrospective Cohort Study (N/A)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- TEPEZZA CI brief — competitive landscape report
- TEPEZZA updates RSS · CI watch RSS
- HORIZON THERAPEUTICS IRELAND portfolio CI
Frequently asked questions about TEPEZZA
What is TEPEZZA?
TEPEZZA (TEPROTUMUMAB-TRBW) is a Insulin-like Growth Factor-1 Receptor Inhibitor [EPC] drug developed by HORIZON THERAPEUTICS IRELAND, indicated for Thyroid eye disease.
What is TEPEZZA used for?
TEPEZZA is indicated for Thyroid eye disease.
Who makes TEPEZZA?
TEPEZZA is developed and marketed by HORIZON THERAPEUTICS IRELAND (see full HORIZON THERAPEUTICS IRELAND pipeline at /company/horizon-therapeutics-ireland).
What is the generic name of TEPEZZA?
TEPROTUMUMAB-TRBW is the generic (nonproprietary) name of TEPEZZA.
What drug class is TEPEZZA in?
TEPEZZA belongs to the Insulin-like Growth Factor-1 Receptor Inhibitor [EPC] class. See all Insulin-like Growth Factor-1 Receptor Inhibitor [EPC] drugs at /class/insulin-like-growth-factor-1-receptor-inhibitor-epc.
What development phase is TEPEZZA in?
TEPEZZA is FDA-approved (marketed).
What are the side effects of TEPEZZA?
Common side effects of TEPEZZA include Muscle spasm, Nausea, Alopecia, Diarrhea, Fatigue, Hyperglycemia. Serious adverse events: Bowel perforation, Exacerbation of inflammatory bowel disease, Diabetic ketoacidosis, Hyperosmolar hyperglycemic state.
What does TEPEZZA target?
TEPEZZA targets Insulin-like growth factor 1 receptor and is a Insulin-like Growth Factor-1 Receptor Inhibitor [EPC].
Related
- Drug class: All Insulin-like Growth Factor-1 Receptor Inhibitor [EPC] drugs
- Target: All drugs targeting Insulin-like growth factor 1 receptor
- Manufacturer: HORIZON THERAPEUTICS IRELAND — full pipeline
- Therapeutic area: All drugs in Metabolic
- Indication: Drugs for Thyroid eye disease
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing