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Drug

Teprotumumab

Approved · EMA
Emerging researchLate-stage development

Also known as Tepezza.

RxNorm2274803UNIIY64GQ0KC0A
2
Research papers
2
Active clinical trials
1
Regulatory events
Latest activity
beta

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

Approval: Tepezza (EMA)

Regulatory2025-06-19EMA

Teprotumumab for the Treatment of Active Thyroid Eye Disease.

Research2020-01-01The New England journal of medicine

Teprotumumab for Thyroid-Associated Ophthalmopathy.

Research2017-05-01The New England journal of medicine

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
UNII
Y64GQ0KC0A
Regulatory jurisdictions
ema

Regulatory timeline

1 event

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
2025-06-19
Latest approval
2025-06-19
Authorities
EMA
Total events
1
emaEuropean Medicines Agency· 1 event
2025-06-19Approval
Approval: Tepezza (EMA)

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

Evidence ↗

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.

Recent completions

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

Research activity

2 papers

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

Publications over time
20172020
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
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.