Teprotumumab

Overview

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

Title	Posted	Study ID	Phase	Status	Sponsor
A Study to Evaluate Pharmacokinetics, Safety, and Tolerability of Teprotumumab (AMG 632) Administered Intravenously in Healthy Chinese Participants	2025/08/27	NCT07142642	Not Applicable	Not yet recruiting	Amgen
Real World Study to Describe the Effectiveness and Safety of Teprotumumab Among Thyroid Eye Disease Patients	2025/07/25	NCT07085117	N/A	Recruiting	Amgen
A Trial to Investigate Teprotumumab (High-concentration Formulation) Subcutaneous Administration in Healthy Adult Non-Japanese and Japanese Participants	2024/11/05	NCT06674941	Phase 1	Completed	Amgen
A Study of TEPEZZA Subcutaneous Administration in Healthy Adults	2024/08/21	NCT06563856	Phase 1	Completed	Amgen
A Study of TEPEZZA® Treatment in Participants With Thyroid Eye Disease	2024/04/29	NCT06389578	Phase 1	Completed	Amgen
The Effect of Teprotumumab on Thyroid Eye Disease and Thyroid Dysfunction	2024/02/23	NCT06275373	N/A	Recruiting	Walter Reed National Military Medical Center
A Trial to Investigate Teprotumumab Subcutaneous Administration Compared With Placebo in Male and Female Adult Participants With Moderate-to-severe Active Thyroid Eye Disease	2024/02/08	NCT06248619	Phase 3	Active, not recruiting	Amgen
TEPEZZA® (Teprotumumab-trbw) Post-Marketing Requirement Study	2021/08/12	NCT05002998	Phase 4	Active, not recruiting	Amgen
A Phase 1, Open-Label Study of Teprotumumab in Patients With Diabetic Macular Edema (DME)	2014/04/03	NCT02103283	Phase 1	Completed	Amgen
Teprotumumab (RV 001) Treatment in Patients With Active Thyroid Eye Disease	2013/06/05	NCT01868997	Phase 2	Completed	Amgen

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
TEPEZZA	Horizon Therapeutics USA, Inc.	75987-130	INTRAVENOUS	500 mg in 1 1	7/24/2023

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
TEPEZZA teprotumumab 500 mg injection powder vial	444610	Amgen Australia Pty Ltd	Medicine	A	3/27/2025

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
TEPEZZA	Amgen Canada Inc	02557061	Powder For Solution - Intravenous	500 MG / VIAL	N/A

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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