Teprotumumab

Teprotumumab
Monoclonal antibody
TypeWhole antibody
SourceHuman
TargetIGF-1R
Clinical data
Trade namesTepezza
Other namesTeprotumumab-trbw, RG-1507
AHFS/Drugs.comMonograph
MedlinePlusa620025
License data
Routes of
administration		Intravenous
ATC code
Legal status
Legal status
Identifiers
CAS Number
DrugBank
ChemSpider
  • none
UNII
KEGG
ChEMBL
ECHA InfoCard100.081.384
Chemical and physical data
FormulaC6476H10012N1748O2000S40
Molar mass145639.97 g·mol−1
 NY (what is this?)  (verify)

Teprotumumab, sold under the brand name Tepezza, is a medication used to treat thyroid eye disease (Graves' eye disease), a rare condition where the muscles and fatty tissues behind the eye become inflamed, causing the eyes to bulge outwards.[6][7] It is a human monoclonal antibody developed by Genmab and Roche[8] for tumor treatment but was later developed by River Vision Development Corporation and Horizon Therapeutics to be used for ophthalmic uses.[9] It binds to IGF-1R.[3]

The most common side effects are muscle spasm, nausea, hair loss, diarrhea, fatigue, high blood sugar, hearing loss, dry skin, altered sense of taste, and headache.[7] Teprotumumab should not be used if pregnant.[7]

Teprotumumab was approved for medical use in the United States in January 2020.[7][10][11][12] The US Food and Drug Administration (FDA) considers it to be a first-in-class medication.[13]

  1. ^ "Tepezza (Amgen Australia Pty Ltd)". Therapeutic Goods Administration (TGA). 16 April 2025. Retrieved 3 May 2025.
  2. ^ "Register of Innovative Drugs". Health Canada. Retrieved 23 May 2025.
  3. ^ a b "Tepezza- teprotumumab injection, powder, lyophilized, for solution". DailyMed. 24 July 2023. Retrieved 20 December 2023.
  4. ^ Cite error: The named reference Tepezza EPAR was invoked but never defined (see the help page).
  5. ^ Cite error: The named reference Tepezza PI was invoked but never defined (see the help page).
  6. ^ Shah K, Charitou M (1 July 2022). "A Novel Case of Hyperglycemic Hyperosmolar State After the Use of Teprotumumab in a Patient With Thyroid Eye Disease". AACE Clinical Case Reports. 8 (4): 148–149. doi:10.1016/j.aace.2022.01.004. PMC 9363510. PMID 35959086.
  7. ^ a b c d "FDA approves first treatment for thyroid eye disease" (Press release). U.S. Food and Drug Administration (FDA). 21 January 2020. Retrieved 21 January 2020. This article incorporates text from this source, which is in the public domain.
  8. ^ Ali F, Chorsiya A, Anjum V, Ali A (April 2021). "Teprotumumab (Tepezza): from the discovery and development of medicines to USFDA approval for active thyroid eye disease (TED) treatment". International Ophthalmology. 41 (4): 1549–1561. doi:10.1007/s10792-021-01706-3. PMID 33481154. S2CID 231670915.
  9. ^ "Horizon Pharma plc Announces Agreement to Acquire River Vision Development Corp. and Teprotumumab (RV001), a Biologic in Late-Stage Development for Rare Eye Disease" (Press release). Horizon Pharma. 8 May 2017. Retrieved 22 August 2022 – via GlobeNewswire.
  10. ^ "Teprotumumab-trbw: FDA-Approved Drugs". U.S. Food and Drug Administration (FDA). Retrieved 28 January 2020.
  11. ^ "Drug Trial Snapshot: Tepezza". U.S. Food and Drug Administration (FDA). 29 January 2020. Retrieved 29 January 2020. This article incorporates text from this source, which is in the public domain.
  12. ^ "Drug Approval Package: Tepezza". U.S. Food and Drug Administration (FDA). 4 June 2021. Retrieved 20 December 2023.
  13. ^ "New Drug Therapy Approvals 2020". U.S. Food and Drug Administration (FDA). 31 December 2020. Archived from the original on 18 January 2021. Retrieved 17 January 2021. This article incorporates text from this source, which is in the public domain.
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