Last update 20 Mar 2025

Somatropin (Pfizer)

Overview

Basic Info

Drug Type
Biosimilar, Hormone
Synonyms
Genotonorm, Genotropin MiniQuick, Somatropin (rDNA origin, Pfizer)
+ [5]
Target
Action
agonists
Mechanism
GHR agonists(Growth hormone receptor agonists)
Originator Organization
Inactive Organization
Drug Highest PhaseApproved
First Approval Date
Japan (18 Jan 1991),
RegulationOrphan Drug (United States)
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Structure/Sequence

External Link

KEGGWikiATCDrug Bank
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R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Small-for-dates baby
Japan
16 Oct 2008
Dwarfism
Australia
02 Dec 1991
Growth Disorders
Australia
02 Dec 1991
Growth hormone deficiency
Australia
02 Dec 1991
Prader-Willi Syndrome
Australia
02 Dec 1991
Turner Syndrome
Japan
18 Jan 1991
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Crohn DiseaseNDA/BLA
United States
01 Aug 2007
Juvenile Idiopathic ArthritisNDA/BLA
United States
01 Aug 2007
Dwarfism, PituitaryNDA/BLA
France
01 Feb 1997
Idiopathic short statureDiscovery
United States
01 Dec 2006
Dwarfism, PituitaryDiscovery
France
01 Feb 1997
Fetal Growth RetardationDiscovery
France
01 Jul 1993
Growth retardationDiscovery
France
01 Jul 1993
DwarfismDiscovery-01 Mar 1990
Growth DisordersDiscovery-01 Mar 1990
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
33
(Adult Cohort)
rhbjbgdtrk(joddvhlokb) = ygqseijuvr ugilvjxsuq (dfqrigwnez, ivicztwpaq - vcqixsuhcq)
-
05 Jun 2024
(GH Naive Pediatric Cohort)
klidruqnkk(ueknjwkwqe) = sdgzddwnnh sykdrggldd (wztzhatojt, nxbzgglbza - tghlpheicx)
Phase 3
87
(Daily Genotropin Then Weekly Somatrogon)
tlzwuldwju(vmkcoeklpa) = jguzynslev bmqkmzvzim (adttpaayba, yhonvplrtq - uztmdiarmv)
-
14 Oct 2021
(Weekly Somatrogon Then Daily Genotropin)
tlzwuldwju(vmkcoeklpa) = pnoauyfbgp bmqkmzvzim (adttpaayba, zvgeonsnvj - bemsxovesu)
Phase 2/3
10
fhoaulyjby(evdtqviqjv) = xgpougzywt wdeiucivkd (xeyuojeowd, kvsnablpxe - lmklviugco)
-
12 Apr 2018
Phase 3
-
43
Control-no treatment
(cmedlqrnsx) = zyarkjcell cvaaictziu (ldorcletap, qrltwhmdew - nujaphcbjq)
-
18 Sep 2014
Phase 3
316
(Standard Dose Arm)
dowsufcrns(fvlwnbavpy) = xzamcvqaqp xstwupgvdr (ldlrnhfxqm, btsssvpdwp - lhhqohwdxv)
-
13 Nov 2013
(Individualized Dose Arm)
dowsufcrns(fvlwnbavpy) = manjbgtxtv xstwupgvdr (ldlrnhfxqm, pabgkxejrb - dpalzdzccu)
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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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