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TEPEZZA
TEPEZZA is a monoclonal antibody that blocks the insulin-like growth factor-1 receptor (IGF-1R) to reduce inflammation and tissue remodeling in thyroid eye disease.
TEPEZZA is a monoclonal antibody that blocks the insulin-like growth factor-1 receptor (IGF-1R) to reduce inflammation and tissue remodeling in thyroid eye disease. Used for Moderate-to-severe thyroid eye disease (TED).
At a glance
| Generic name | TEPEZZA |
|---|---|
| Also known as | teprotumumab-trbw, HZN-001 |
| Sponsor | Amgen |
| Drug class | IGF-1R inhibitor monoclonal antibody |
| Target | IGF-1R (Insulin-like Growth Factor-1 Receptor) |
| Modality | Biologic |
| Therapeutic area | Immunology / Ophthalmology |
| Phase | FDA-approved |
Mechanism of action
TEPEZZA binds to and inhibits IGF-1R, a key mediator of orbital fibroblast activation and expansion in thyroid eye disease (TED). By blocking this pathway, it reduces the inflammatory cascade and prevents the pathological expansion of orbital tissues that causes eye protrusion, inflammation, and vision complications. This mechanism addresses the underlying pathophysiology of moderate-to-severe TED.
Approved indications
- Moderate-to-severe thyroid eye disease (TED)
Common side effects
- Infusion reactions
- Hyperglycemia
- Upper respiratory tract infection
- Fatigue
- Nausea
Key clinical trials
- A Study to Evaluate Pharmacokinetics, Safety, and Tolerability of Teprotumumab (AMG 632) Administered Intravenously in Healthy Chinese Participants (PHASE1)
- 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)
- Real World Study to Describe the Effectiveness and Safety of Teprotumumab Among Thyroid Eye Disease Patients
- A Trial to Investigate Teprotumumab (High-concentration Formulation) Subcutaneous Administration in Healthy Adult Non-Japanese and Japanese Participants (PHASE1)
- A Study of TEPEZZA Subcutaneous Administration in Healthy Adults (PHASE1)
- A Study Evaluating TEPEZZA® Treatment in Patients With Chronic (Inactive) Thyroid Eye Disease (PHASE4)
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
- Amgen portfolio CI