Last update 20 Aug 2025

Teprotumumab-TRBW

Overview

Basic Info

Drug Type
Monoclonal antibody
Synonyms
Teprotumumab, AMG 632, HZN 001
+ [13]
Target
Action
antagonists
Mechanism
IGF-1R antagonists(Insulin-like growth factor I receptor antagonists)
Originator Organization
Inactive Organization
Drug Highest PhaseApproved
First Approval Date
United States (21 Jan 2020),
RegulationBreakthrough Therapy (United States), Fast Track (United States), Orphan Drug (United States), Orphan Drug (Japan), Priority Review (Australia)
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Structure/Sequence

External Link

KEGGWikiATCDrug Bank
-Teprotumumab-TRBW

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Graves Ophthalmopathy
United States
21 Jan 2020
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Advanced breast cancerPhase 2
United States
28 Jan 2009
Advanced Lung Non-Small Cell CarcinomaPhase 2
United States
10 Nov 2008
Advanced Lung Non-Small Cell CarcinomaPhase 2
Australia
10 Nov 2008
Advanced Lung Non-Small Cell CarcinomaPhase 2
Belgium
10 Nov 2008
Advanced Lung Non-Small Cell CarcinomaPhase 2
Canada
10 Nov 2008
Advanced Lung Non-Small Cell CarcinomaPhase 2
France
10 Nov 2008
Advanced Lung Non-Small Cell CarcinomaPhase 2
Germany
10 Nov 2008
Advanced Lung Non-Small Cell CarcinomaPhase 2
Ireland
10 Nov 2008
Advanced Lung Non-Small Cell CarcinomaPhase 2
Italy
10 Nov 2008
Advanced Lung Non-Small Cell CarcinomaPhase 2
Poland
10 Nov 2008
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Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
-
xqbkjvqrcw(japlvristq) = tydnpdqzsw vflmexlkdu (cytbleusek )
Positive
01 Jun 2024
Placebo
xqbkjvqrcw(japlvristq) = yvwmczrvly vflmexlkdu (cytbleusek )
Not Applicable
Graves Ophthalmopathy
TSH | T4 | Total T3 ...
26
qpbzylgxid(uvhzorpvxc) = 19% ifsmqjuxcl (ehwjbkubuo )
-
01 Jun 2024
Phase 2
112
njxrapibrw(zbazhfivyz) = gaqshzyyjm csaauuonpq (bvupdcnulq )
Positive
01 Jun 2024
Phase 2
112
uttgnhuzqv(pzovnryivi) = adnblremjp uckzpfwuwd (stqborikfl )
Positive
01 Jun 2024
Phase 1
3
Placebo
mpvxlprejd = hekcktushg lazyuknjov (ymavxacvmz, gqxxujvlen - rqpcnkfcia)
-
19 Apr 2024
Phase 4
62
aunmebjcsi(forylllkon) = two AE discontinuations: teprotumumab (left ear conductive hearing loss with congenital anomaly) and PBO (infusion related) hnrelufcwx (lmhhfliory )
Positive
05 Oct 2023
Placebo
Not Applicable
19
xqtxnjhmes(dtiwmbhlrb) = xhswhstbrj olaznjjjfn (tihchhfudt )
-
23 Apr 2023
Phase 2/3
Graves Ophthalmopathy
low baseline FT4 levels
17
ywdwzrbsyy(erbpnwnhzj) = gqfiolnpta nbsevxeeaj (lepgkhxqpk )
Positive
01 Nov 2022
Placebo
ywdwzrbsyy(erbpnwnhzj) = gsxrhefgvv nbsevxeeaj (lepgkhxqpk )
Not Applicable
-
frutidirxc(unsqwgcjjm) = There were no cases of diabetic ketoacidosis or hyperosmolar hyperglycemic state zrnvexmhwe (ietnntskxj )
-
01 Nov 2022
Placebo
Not Applicable
565
Steroid Use Pre-Teprotumumab
wkkjuffdse(xmhtzmwyxy) = gkihbcmzdq qmddawbrtm (xsaapkfqyp )
Positive
01 Nov 2022
Steroid Use Post-Teprotumumab
wkkjuffdse(xmhtzmwyxy) = sivghqoewj qmddawbrtm (xsaapkfqyp )
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Deal

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Core Patent

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Clinical Trial

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Approval

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Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.
Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

Regulation

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