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Teprotumumab

Generic Name
Teprotumumab
Brand Names
Tepezza
Drug Type
Biotech
Chemical Formula
-
CAS Number
1036734-93-6
Unique Ingredient Identifier
Y64GQ0KC0A
Background

Teprotumumab is a fully human IgG1 monoclonal antibody directed against the human insulin-like growth factor-1 receptor. Following a clinical trial in which its efficacy in the treatment of thyroid eye disease (TED) was assessed, it received "breakthrough therapy" designation from the FDA in 2016 and was approved by the FDA in January 2020 for the treatment of TED. Thyroid eye disease is a potentially debilitating complication of Graves' Disease involving inflammation and tissue remodeling behind the eye, and previous treatment options typically involved multiple invasive surgeries - teprotumumab is the first drug ever approved for the treatment of TED and therefore represents a significant step forward in the treatment this disease.

Indication

Teprotumumab is indicated for the treatment of thyroid eye disease regardless of disease activity or duration.

Associated Conditions
Thyroid Eye Disease
Associated Therapies
-

A Trial to Investigate Teprotumumab Subcutaneous Administration Compared With Placebo in Male and Female Adult Participants With Moderate-to-severe Active Thyroid Eye Disease

Phase 3
Recruiting
Conditions
Thyroid Eye Disease
Interventions
First Posted Date
2024-02-08
Last Posted Date
2025-01-03
Lead Sponsor
Amgen
Target Recruit Count
80
Registration Number
NCT06248619
Locations
🇺🇸

Advanced Quality Medical Research, Orland Park, Illinois, United States

🇺🇸

The Center for Eye and Facial Plastic Surgery, Somerset, New Jersey, United States

🇺🇸

Catalina Eye Care, Tucson, Arizona, United States

and more 19 locations
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