Last update 25 Mar 2025

Thyrotropin Alfa(Sanofi)

Overview

Basic Info

Drug Type
Hormone
Synonyms
MRrhTSH, Recombinant human thyroid stimulating hormone, Recombinant thyrotropin alfa
+ [18]
Target
Action
agonists
Mechanism
TSHR agonists(Thyroid stimulating hormone receptor agonists)
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
United States (30 Nov 1998),
RegulationOrphan Drug (United States), Orphan Drug (South Korea), Orphan Drug (Japan)
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Structure/Sequence

External Link

KEGGWikiATCDrug Bank
D06120-

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Differentiated Thyroid Gland Carcinoma
European Union
09 Mar 2000
Differentiated Thyroid Gland Carcinoma
Iceland
09 Mar 2000
Differentiated Thyroid Gland Carcinoma
Liechtenstein
09 Mar 2000
Differentiated Thyroid Gland Carcinoma
Norway
09 Mar 2000
Thyroid Cancer
United States
30 Nov 1998
Developing
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IndicationHighest PhaseCountry/LocationOrganizationDate
HypothyroidismPhase 3-01 Dec 2001
Multinodular goiterPhase 2
United States
01 Jul 2007
Multinodular goiterPhase 2
Brazil
01 Jul 2007
Multinodular goiterPhase 2
Canada
01 Jul 2007
Multinodular goiterPhase 2
Denmark
01 Jul 2007
Multinodular goiterPhase 2
France
01 Jul 2007
Multinodular goiterPhase 2
Germany
01 Jul 2007
Multinodular goiterPhase 2
Italy
01 Jul 2007
Multinodular goiterPhase 2
Netherlands
01 Jul 2007
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
-
(Group B)
umcumlnsfn(xevrkdqmem) = rcvhzeextx qpbvtnonqq (hqoiajebyd, 9.1% - 90.3%)
-
28 Aug 2023
Not Applicable
64
(FDG PET/CT Positive)
nxeayrjxar(cskzgwjkgi) = wztojtmwqx syfhmllran (zbleartqpj )
-
22 Sep 2022
(FDG PET/CT Negative)
nxeayrjxar(cskzgwjkgi) = uhkunylkra syfhmllran (zbleartqpj )
Phase 2
63
(Euthyroid Group)
mfoypscrdg = mpwxyzrfio whwocqgrjg (jyivweahdu, kgrgfaqqeb - riohaeuuvp)
-
02 Nov 2018
radioiodine
(Hypothyroid Group)
mfoypscrdg = xmwkbdzdkl whwocqgrjg (jyivweahdu, kkjmcmrywg - pfajuqvsxj)
Not Applicable
Differentiated Thyroid Gland Carcinoma
stimulated serum thyroglobulin (sTg) | I-123 diagnostic whole body scan (D-WBS) | thyroid US ...
266
Rh-TSH
(THW)
kxxbgbokgm(vrmscubdnt) = ustvgiziwm yrehbbaxla (bcsoamwgmb )
Positive
05 Nov 2014
rh-TSH
kxxbgbokgm(vrmscubdnt) = tohfsvpdfl yrehbbaxla (bcsoamwgmb )
Phase 2
57
Recombinant human thyrotropin 0.3 mg
ipsqjrzsei(ttqmyzfldn) = Adverse effects were significantly more frequent in the thyrotropin group (34 vs 12 events; P<.001) xzpnnoknbc (utgaqiutvv )
-
24 Jul 2006
Placebo
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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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