Teprotumumab

Generic Name: Teprotumumab

Brand Names: Tepezza

Drug Type: Biotech

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

Clinical Trials

A Trial to Investigate Teprotumumab (High-concentration Formulation) Subcutaneous Administration in Healthy Adult Non-Japanese and Japanese Participants

Phase 1

Completed

Conditions: Healthy Volunteers

Interventions: Drug: Teprotumumab

First Posted Date: 2024-11-05

Last Posted Date: 2024-11-05

Lead Sponsor: Amgen

Target Recruit Count: 44

Registration Number: NCT06674941

Locations: 🇺🇸
PPD Development, LP, Las Vegas, Nevada, United States

A Study of TEPEZZA Subcutaneous Administration in Healthy Adults

Phase 1

Completed

Conditions: Bioavailability
Bioequivalence

Interventions: Drug: TEPEZZA
Drug: EDP

First Posted Date: 2024-08-21

Last Posted Date: 2024-08-21

Lead Sponsor: Amgen

Target Recruit Count: 37

Registration Number: NCT06563856

Locations: 🇺🇸
PPD Development, Las Vegas, Nevada, United States

A Study of TEPEZZA® Treatment in Participants With Thyroid Eye Disease

Phase 1

Completed

Conditions: Thyroid Eye Disease

Interventions: Drug: Teprotumumab

First Posted Date: 2024-04-29

Last Posted Date: 2024-06-21

Lead Sponsor: Amgen

Target Recruit Count: 16

Registration Number: NCT06389578

Locations: 🇺🇸
Bascom Palmer Eye Institute - University of Miami, Miami, Florida, United States
🇺🇸
Barnes Jewish Hospital Washington University, Saint Louis, Missouri, United States
🇺🇸
Neuro-Eye Clinical Trials, Bellaire, Texas, United States

The Effect of Teprotumumab on Thyroid Eye Disease and Thyroid Dysfunction

Recruiting

Conditions: Thyroid Eye Disease
Graves Disease
Graves Ophthalmopathy

First Posted Date: 2024-02-23

Last Posted Date: 2024-02-23

Lead Sponsor: Walter Reed National Military Medical Center

Target Recruit Count: 100

Registration Number: NCT06275373

Locations: 🇺🇸
Walter Reed National Military Medical Center, Bethesda, Maryland, United States

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: Other: Placebo
Biological: Teprotumumab

First Posted Date: 2024-02-08

Last Posted Date: 2025-05-22

Lead Sponsor: Amgen

Target Recruit Count: 80

Registration Number: NCT06248619

Locations: 🇺🇸
Catalina Eye Care - NVISION - PPDS, Tucson, Arizona, United States
🇺🇸
Shiley Eye Center University of California at San Diego, La Jolla, California, United States
🇺🇸
Amy Patel Jain MD Inc., Newport Beach, California, United States

and more 51 locations

TEPEZZA® (Teprotumumab-trbw) Post-Marketing Requirement Study

Phase 4

Active, not recruiting

Conditions: Thyroid Eye Disease

Interventions: Drug: Teprotumumab
Drug: Placebo

First Posted Date: 2021-08-12

Last Posted Date: 2024-10-18

Lead Sponsor: Amgen

Target Recruit Count: 313

Registration Number: NCT05002998

Locations: 🇺🇸
The Private Practice of Raymond Douglas, MD - Beverly Hills, Beverly Hills, California, United States
🇺🇸
University of Colorado - Eye Center - PPDS, Aurora, Colorado, United States
🇺🇸
Mayo Clinic - PPDS, Rochester, Minnesota, United States

and more 26 locations

A Phase 1, Open-Label Study of Teprotumumab in Patients With Diabetic Macular Edema (DME)

Phase 1

Completed

Conditions: Diabetic Macular Edema

Interventions: Drug: Teprotumumab

First Posted Date: 2014-04-03

Last Posted Date: 2016-08-19

Lead Sponsor: River Vision Development Corporation

Target Recruit Count: 5

Registration Number: NCT02103283

Locations: 🇺🇸
David A Eichenbaum, MD, St. Petersburg, Florida, United States
🇺🇸
Diana Do, MD, Omaha, Nebraska, United States
🇺🇸
David S Boyer, Beverley Hills, California, United States

Teprotumumab (RV 001) Treatment in Patients With Active Thyroid Eye Disease

Phase 2

Completed

Conditions: Thyroid Associated Ophthalmopathies
Thyroid-Associated Ophthalmopathy

Interventions: Drug: normal saline
Drug: teprotumumab

First Posted Date: 2013-06-05

Last Posted Date: 2024-12-17

Lead Sponsor: Amgen

Target Recruit Count: 88

Registration Number: NCT01868997

Locations: 🇺🇸
Jules Stein Eye Institute at UCLA, Los Angeles, California, United States
🇮🇹
Fondazione Ca' Granda Ospedale Policlinico Graves GO Center, Milan, Italy
🇮🇹
University of Pisa, Azienda Ospedaliera, Pisa, Italy

and more 12 locations

Drug Development Updates

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