TEPEZZA

(Teprotumumab)

ApprovedMonoclonal antibody

TEPEZZA is a monoclonal antibody that works as a IGF-1R Inhibitor.[2] It is being used across 1 indication, with its most advanced program in Approved.[1]

TEPEZZA is one of 18 monoclonal antibody programs targeting Thyroid Eye Disease. It is currently in Approved.

Indications

Total Trials

Active Trials

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

Thyroid Eye DiseaseNot yet recruiting

Thyroid Eye DiseaseApproved

Not yet recruiting

Competition

Competitive Landscape

21 competitors in Thyroid Eye Disease

#DrugCompanyPhaseTrials

Medrol

Pfizer

Approved

4 2

Zolymbus

AbbVie

Approved

1 3

Timolol Maleate

CCidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Approved

1 4

TEPEZZA

HHorizon Therapeutics Ireland DAC

Approved

9 5

AMG 333

Amgen

Phase 2

2 6

Lipitor

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Phase 1

1 7

IBI311

Innovent Biologics (Suzhou) Co. Ltd.

Phase 3

4 8

VRDN-003

VViridian Therapeutics, Inc.

Phase 3

4 9

MHB018A

MMinghui Pharmaceutical (Hangzhou) Ltd

Phase 3

3 10

Batoclimab

IImmunovant Sciences GmbH

Phase 3

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 3Active, not recruiting

Thyroid Eye Disease

NCT06248619

Q4 2027

Recruiting

Thyroid Eye Disease

NCT06275373

Q2 2028

Post-ApprovalNot yet recruiting

Thyroid Eye Disease

NCT07308964

Clinical

Trials by Indication[1]

Thyroid Eye Disease9 trials

Expanded Access Protocol of Teprotumumab (HZN-001) for Patients With Active Thyroid Eye Disease

Approved for marketing· Amgen logo

Amgen··NCT04040894

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

Completed· Amgen logo

Amgen·Phase 2·NCT01868997·88 enrolled

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

Completed· Amgen logo

Amgen·Phase 1·NCT06389578·16 enrolled

Show 6 more trials

Comparison of the Efficacy and Safety of 4 vs. 8 Treatments With Tepezza (Teprotumumab) for Thyroid Eye Disease

Not yet recruiting·SSheba Medical Center·Phase 4·NCT07308964·40 enrolled

The Effect of Teprotumumab on Thyroid Eye Disease and Thyroid Dysfunction

Recruiting·WWalter Reed National Military Medical Center··NCT06275373·100 enrolled

Real World Study to Describe the Effectiveness and Safety of Teprotumumab Among Thyroid Eye Disease Patients

Completed· Amgen logo

Amgen··NCT07085117·5 enrolled

Treatment of Graves' Orbitopathy (Thyroid Eye Disease) to Reduce Proptosis With Teprotumumab Infusions in a Randomized, Placebo-Controlled, Clinical Study

Completed· Amgen logo

Amgen·Phase 3·NCT03298867·83 enrolled

A Phase 3b/4, Double-masked, Randomized, International, Parallel-assignment, Multicenter Trial in Patients With Thyroid Eye Disease to Evaluate the Safety and Tolerability of Different Dosing Durations of Teprotumumab

Completed· Amgen logo

Amgen·Approved·NCT05002998·313 enrolled

A Phase 3, Randomized, Double-masked, Placebo-controlled, Parallel-group, Multicenter Trial to Evaluate the Efficacy, Safety and Tolerability of Subcutaneous Teprotumumab in Participants With Moderate-to-Severe Active Thyroid Eye Disease

Active, not recruiting· Amgen logo

Amgen·Phase 3·NCT06248619·89 enrolled

Intravenous1 trial

A Study to Evaluate Pharmacokinetics, Safety, and Tolerability of Teprotumumab (AMG 632) Administered Intravenously in Healthy Chinese Participants

Completed· Amgen logo

Amgen·Phase 1·NCT07142642·20 enrolled

Concentration1 trial

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

Completed· Amgen logo

Amgen·Phase 1·NCT06674941·44 enrolled

Ptosis1 trial

Treatment of Graves' Orbitopathy to Reduce Proptosis With Teprotumumab Infusions in an Open-Label Clinical Extension Study

Completed· Amgen logo

Amgen·Phase 3·NCT03461211·51 enrolled

Diabetic Macular Edema1 trial

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

Completed· Amgen logo

Amgen·Phase 1·NCT02103283·5 enrolled

Regulatory

FDA Approval Timeline[4]

Jan 21, 2020

TEPEZZA

NDA BLA761143

Jan 21, 2020

TEPEZZA

BLA BLA761143

Oct 26, 2021

TEPEZZA

NDA BLA761143

Dec 6, 2022

TEPEZZA

NDA BLA761143

Apr 13, 2023

TEPEZZA

NDA BLA761143

Jul 17, 2023

TEPEZZA

NDA BLA761143

Aug 26, 2025

TEPEZZA

NDA BLA761143

Sep 9, 2025

TEPEZZA

NDA BLA761143

Nov 24, 2025

TEPEZZA

NDA BLA761143

Sources

References

[1]
ClinicalTrials.gov — 13 trial records for Teprotumumab. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Teprotumumab compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Teprotumumab. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA BLA761143). U.S. Food & Drug Administration.
[5]
PubMed — 1 publication indexed for Teprotumumab. U.S. National Library of Medicine.
[6]
SEC EDGAR — Horizon Therapeutics Ireland DAC company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: IGF-1R Inhibitor[2]
Modality: Monoclonal antibody[2]
Highest Phase: Approved[1]
Company: HHorizon Therapeutics Ireland DAC

Key Publications[5]

Teprotumumab in Active Thyroid Eye Disease: Long-Term Outcomes

N Engl J MedMay 11, 2023DOI: 10.1056/NEJMoa2302856

TEPEZZA

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q4 2027

Q2 2028

Trials by Indication[1]

Thyroid Eye Disease9 trials

Intravenous1 trial

Concentration1 trial

Ptosis1 trial

Diabetic Macular Edema1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Key Publications[5]

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