Learn the latest about our investigational medicine in development for thyroid eye disease.
Teprotumumab is a fully human monoclonal antibody, insulin-like growth factor-1 receptor (IGF-1R) inhibitor being evaluated for the treatment of active thyroid eye disease (TED).
The robust clinical development program for teprotumumab in the treatment of TED includes positive results from the Phase 3 OPTIC confirmatory clinical trial as well as positive Phase 2 results which were published in The New England Journal of Medicine. The FDA is currently reviewing Horizon’s Biologics License Application. Teprotumumab has received Breakthrough Therapy, Orphan Drug and Fast Track designations from the FDA.
Teprotumumab is an investigational medicine and its safety and efficacy have not been established.
- 10/31/19: Integrated Clinical Trial Analyses Further Substantiate that Teprotumumab Significantly Improves Debilitating Effects of Thyroid Eye Disease, Including Eye Bulging, Double Vision and Quality of Life
- 10/11/19: New Data from Teprotumumab Phase 3 OPTIC Study Shows Significantly Reduced Double Vision and Improved Quality of Life for People with Active Thyroid Eye Disease
- 09/09/19: Horizon Therapeutics plc Announces the FDA has Granted Priority Review of the Teprotumumab Biologics License Application (BLA) for the Treatment of Active Thyroid Eye Disease (TED)
- 08/01/19: Horizon Therapeutics plc Announces Teprotumumab Expanded Access Program
- 07/10/2019: Horizon Therapeutics plc Submits Teprotumumab Biologics License Application (BLA) for the Treatment of Active Thyroid Eye Disease (TED)
- 04/26/2019: New Data from Phase 3 Teprotumumab Trial (OPTIC) Shows Dramatic Reduction in Proptosis, or Eye Bulging, the Main Cause of Morbidity in Active Thyroid Eye Disease (TED)
- 02/28/2019: Horizon Pharma plc Announces Phase 3 Confirmatory Trial Evaluating Teprotumumab (OPTIC) for the Treatment of Active Thyroid Eye Disease (TED) Met Primary and All Secondary Endpoints
Presentations and Resources
More About Thyroid Eye Disease
For more information on teprotumumab, please visit clinicaltrials.gov.
- The 2016 European Thyroid Association/European Group on Graves' Orbitopathy Guidelines for the Management of Graves' Orbitopathy. European Thyroid Journal.2 March 2016. https://www.ncbi.nlm.nih.gov/pubmed/27099835. Accessed Feb 22, 2019.
- Update on thyroid eye disease and management. Clinical Ophthalmology. 19 October 2009. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2770865/. Accessed Feb 22, 2019.