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 ...
- 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 (High-concentration Formulation) Subcutaneous Administration in Healthy Adult Non-Japanese and Japanese Participants
- 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® Treatment in Participants With Thyroid Eye Disease
- 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
A Trial to Investigate Teprotumumab Subcutaneous Administration Compared With Placebo in Male and Female Adult Participants With Moderate-to-severe Active Thyroid Eye Disease
- First Posted Date
- 2024-02-08
- Last Posted Date
- 2024-12-13
- Lead Sponsor
- Amgen
- Target Recruit Count
- 80
- Registration Number
- NCT06248619
- Locations
- 🇺🇸
Scheie Eye Institute, Philadelphia, Pennsylvania, United States
🇦🇺Sydney Eye Hospital, Sydney, New South Wales, Australia
🇺🇸Catalina Eye Care, Tucson, Arizona, United States
TEPEZZA® (Teprotumumab-trbw) Post-Marketing Requirement Study
- Conditions
- Interventions
- 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
A Phase 1, Open-Label Study of Teprotumumab in Patients With Diabetic Macular Edema (DME)
- 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
- Conditions
- Interventions
- 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
Drug Development Updates
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