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Tepezza (TEPROTUMUMAB)
Tepezza (generic name: TEPROTUMUMAB) is a Insulin-like Growth Factor-1 Receptor Inhibitor [EPC] Monoclonal antibody drug developed by Horizon Therapeutics Ireland. It is currently FDA-approved (first approved 2020) for Thyroid Eye Disease.
Teprotumumab-trbw binds to IGF-1R and blocks its activation and signaling.
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 and Chronic (Inactive) Thyroid Eye Disease, among others.
At a glance
| Generic name | TEPROTUMUMAB |
|---|---|
| Sponsor | Horizon Therapeutics Ireland |
| Drug class | Insulin-like Growth Factor-1 Receptor Inhibitor [EPC] |
| Target | IGF-1R |
| Modality | Monoclonal antibody |
| Therapeutic area | Metabolic |
| Phase | FDA-approved |
| First approval | 2020 |
| Annual revenue | 2000 |
Mechanism of action
Teprotumumab-trbw works by binding to the insulin-like growth factor 1 receptor (IGF-1R). By blocking the activation and signaling of IGF-1R, it may help reduce the symptoms of Thyroid Eye Disease.
Approved indications
- Thyroid Eye Disease
Common side effects
- Muscle spasms
- Nausea
- Alopecia
- Diarrhea
- Fatigue
- Hyperglycemia
- Hearing impairment
- Dysgeusia
- Headache
- Dry skin
- Weight decreased
- Nail disorder
Key clinical trials
- A Study to Evaluate the Efficacy and Safety of LASN01 in Patients With Thyroid Eye Disease (PHASE2)
- A Study to Evaluate Pharmacokinetics, Safety, and Tolerability of Teprotumumab (AMG 632) Administered Intravenously in Healthy Chinese Participants (PHASE1)
- Evaluating the Efficacy and Safety of Teprotumumab N01 in Patients With Thyroid Eye Disease. (NA)
- A Trial to Investigate Teprotumumab Subcutaneous Administration Compared With Placebo in Male and Female Adult Participants With Moderate-to-severe Active Thyroid Eye Disease (PHASE3)
- TEPEZZA® (Teprotumumab-trbw) Post-Marketing Requirement Study (PHASE4)
- Comparison of the Efficacy and Safety of 4 vs. 8 Treatments With Tepezza (Teprotumumab) for Thyroid Eye Disease (PHASE4)
- A Study of Teprotumumab N01 in Subjects With Active Thyroid Eye Disease (PHASE4)
- Safety and Efficacy Evaluation of Anti IGF-1R Monoclonal Antibody Combined With Anti-PD-1 Monoclonal Antibody in Treatment in Patients With Metastatic Castration-Resistant Prostate Cancer (EARLY_PHASE1)
Patents
| Patent | Expiry | Type |
|---|---|---|
| Biologic Exclusivity |
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 |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
| SEC EDGAR | Revenue + earnings |
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
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Related
- Drug class: All Insulin-like Growth Factor-1 Receptor Inhibitor [EPC] drugs
- Target: All drugs targeting IGF-1R
- 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