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Drug

Teprotumumab

Approved medicine
ResearchOngoing clinical research

Also known as Tepezza.

RxNorm2274803ChEMBLCHEMBL1743079UNIIY64GQ0KC0A
2
Research papers
2
Active clinical trials
10
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Teprotumumab for Thyroid Eye Disease: A Systematic Review and Meta-Analysis of Randomized Controlled Trials and Real-World Studies

Clinical trial2026-09-29Trial news · American Journal of Ophthalmology

Label change: TEPROTUMUMAB (BLA761143)

Regulatory2026-09-23FDA

Sling reels in $123M series C to fund oral Tepezza rival through phase 3 trial

Clinical trial2026-09-15Trial news · Fierce Biotech

Ethyreal Bio manifests with $101M in pack of biotechs gunning for Amgen’s Tepezza

Industry2026-06-10Fierce Biotech

Under-the-skin Tepezza comparable to infused version in key study, Amgen says

Research2026-04-06Research news · BioPharma Dive

A Phase 1, Randomized, Placebo-controlled, Double-blind, Single-dose Study to Evaluate Pharmacokinetics, Safety, and Tolerability of Teprotumumab (AMG 632) Administered Intravenously in Healthy Chinese Participants

Clinical trial2026-01-15Completed · ClinicalTrials.gov

A Comparative Study of Shortened (4-Infusion) Versus Standard (8-Infusion) Teprotumumab Regimens in Patients With Thyroid Eye Disease (TED) Exhibiting an Early Optimal Clinical Response

Clinical trial2025-12-30Results expected Q1 2028 · ClinicalTrials.gov

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

Clinical trial2025-12-23Primary completion · ClinicalTrials.gov

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

Clinical trial2025-12-19Completed · ClinicalTrials.gov

Label change: TEPROTUMUMAB (BLA761143)

Regulatory2025-11-24FDA

Label change: TEPROTUMUMAB (BLA761143)

Regulatory2025-09-09FDA

Label change: TEPROTUMUMAB (BLA761143)

Regulatory2025-08-26FDA

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Teprotumumab
Aliases & brands
Tepezza
RxNorm CUI
2274803
ChEMBL ID
CHEMBL1743079
UNII
Y64GQ0KC0A
Regulatory jurisdictions
fdaema

Regulatory timeline

10 events

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2020-01-21
Latest approval
2025-06-19
Authorities
FDA · EMA
Total events
10
fdaU.S. Food and Drug Administration· 9 events
2026-09-23Label change
Label change: TEPROTUMUMAB (BLA761143)
Evidence ↗
2025-11-24Label change
Label change: TEPROTUMUMAB (BLA761143)
Evidence ↗
2025-09-09Label change
Label change: TEPROTUMUMAB (BLA761143)
Evidence ↗
emaEuropean Medicines Agency· 1 event
2025-06-19Original application approval
Marketing authorisation: Tepezza (EMA)

Indication: Treatment of moderate to severe thyroid eye disease (TED).

Evidence ↗

Data from the U.S. Food and Drug Administration (U.S. Food and Drug Administration), public domain (CC0).

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

10 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
10
registered trials across all phases
LATEST COMPLETION 2026
2
Active studies
1
Recruiting
5
Late-stage (III+)
8
Completed
PHASE DISTRIBUTIONn = 10
Phase 14Phase 21Phase 33Phase 42

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

A Comparative Study of Shortened (4-Infusion) Versus Standard (8-Infusion) Teprotumumab Regimens in Patients With Thyroid Eye Disease (TED) Exhibiting an Early Optimal Clinical Response

Not yet recruitingPH IVSheba Medical Centern=402028

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

CompletedPH IVAmgenn=3132025

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 recruitingPH IIIAmgenn=892026

Multicenter, Safety and Efficacy, Open-Label Extension Study Evaluating Teprotumumab (HZN-001) Treatment in Subjects With Thyroid Eye Disease

CompletedPH IIIAmgenn=512021

A Phase 3, Randomized, Double-Masked, Placebo-Controlled, Parallel-Group, Multicenter Study Evaluating Teprotumumab (HZN-001) Treatment in Subjects With Active Thyroid Eye Disease

CompletedPH IIIAmgenn=832020

Recent completions

Trials that read out recently, adding to the completed evidence base.

A Phase 1, Randomized, Placebo-controlled, Double-blind, Single-dose Study to Evaluate Pharmacokinetics, Safety, and Tolerability of Teprotumumab (AMG 632) Administered Intravenously in Healthy Chinese Participants

CompletedPH IAmgenn=202026

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

CompletedPH IVAmgenn=3132025

A Phase 1, Open-label, Single-dose Trial to Evaluate the Pharmacokinetics, Safety and Tolerability of Teprotumumab (High-concentration Formulation) Subcutaneous Administration in Healthy Adult Non-Japanese and Japanese Volunteers

CompletedPH IAmgenn=442023

A Phase 1b, Open-label, Multicenter Trial to Evaluate the Pharmacokinetics, Safety, and Tolerability of Two Formulations of a Single Subcutaneous Dose of Teprotumumab Followed by Multiple Intravenous Doses of TEPEZZA in Participants With Thyroid Eye Disease

CompletedPH IAmgenn=162023

Multicenter, Safety and Efficacy, Open-Label Extension Study Evaluating Teprotumumab (HZN-001) Treatment in Subjects With Thyroid Eye Disease

CompletedPH IIIAmgenn=512021

A Phase 3, Randomized, Double-Masked, Placebo-Controlled, Parallel-Group, Multicenter Study Evaluating Teprotumumab (HZN-001) Treatment in Subjects With Active Thyroid Eye Disease

CompletedPH IIIAmgenn=832020

Research activity

2 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Publications over time
2017–2020
Most influential

Teprotumumab for the Treatment of Active Thyroid Eye Disease.

The New England journal of medicine · 2020 · 523 cites

Teprotumumab for Thyroid-Associated Ophthalmopathy.

The New England journal of medicine · 2017 · 521 cites
Recent papers

Teprotumumab for the Treatment of Active Thyroid Eye Disease.

The New England journal of medicine · 2020 · 523 cites

Teprotumumab for Thyroid-Associated Ophthalmopathy.

The New England journal of medicine · 2017 · 521 cites
Journals, researchers & institutions
Top journals
  • The New England journal of medicine2
Leading researchers
  • Antonelli A2
  • Douglas RS2
  • Fleming JC2
  • Harris GJ2
  • Kahaly GJ2
  • Salvi M2
  • Smith TJ2
  • Couch SM1
Leading institutions
free-text, unnormalised
  • From Cedars-Sinai Medical Center1
  • Kellogg Eye Center (T.J.S.1
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.