Last update 21 Nov 2024

Somatropin (Merck Serono SA)

Overview

Basic Info

Drug Type
Biosimilar, Hormone
Synonyms
Saizen, Serostim, Zorbtive
+ [6]
Target
Mechanism
GHR agonists(Growth hormone receptor agonists)
Originator Organization
Inactive Organization
Drug Highest PhaseApproved
First Approval Date
US (30 Jul 1976)
RegulationOrphan Drug (US), Accelerated Approval (US)
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External Link

KEGGWikiATCDrug Bank
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R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Failure to Thrive
AU
22 Aug 2011
Growth retardation
AU
22 Aug 2011
Turner Syndrome
AU
22 Aug 2011
Short Bowel Syndrome
US
19 Nov 2001
Growth hormone deficiency
US
08 Oct 1996
HIV Infections
US
23 Aug 1996
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Small-for-dates babyPhase 2
IT
01 Feb 2004
Idiopathic short staturePhase 1
KR
01 Dec 2012
FibromyalgiaPhase 1
ES
01 Dec 2007
Dwarfism, PituitaryPhase 1
US
01 Jan 2005
HIV-Associated Lipodystrophy SyndromePhase 1
CA
28 May 2004
HIV-Associated Lipodystrophy SyndromePhase 1
US
28 May 2004
Small-for-dates babyPhase 1
IT
01 Feb 2004
Fetal Growth RetardationPhase 1-01 Nov 1998
Growth retardationPhase 1-01 Nov 1998
HIV Wasting SyndromePhase 1-01 Jul 1997
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Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
326
Placebo
(Period I: Placebo)
voavhvkiqz(ajzjiojfew) = fdfhgizjek zwaegksrsk (dgnmqzqqsk, qanillshrz - tpcdfpszfm)
-
20 Jul 2018
(Period I: Serostim® 4 mg)
voavhvkiqz(ajzjiojfew) = xolwwgqkoe zwaegksrsk (dgnmqzqqsk, tnnetghchu - xkmpkegkju)
Phase 4
318
(Turner Syndrome (TS))
axsetzlawr(cxxqurawbv) = azhjoegwju avvgfwjsgm (zlhzpcbyce, njgyeukbbc - ebbtxddslv)
-
20 Mar 2018
(Growth Hormone Deficiency (GHD))
axsetzlawr(cxxqurawbv) = ahbtmisqng avvgfwjsgm (zlhzpcbyce, wqaukksuqb - hulevwyxsb)
Phase 3
90
(Saizen Test Group)
danlepcfnq(iqvrmfvoej) = iwmshivtdj roqotqccui (lytcjexrcc, bckxnqsdxg - ispggmzdvs)
-
18 Oct 2016
(Saizen Control Group)
danlepcfnq(iqvrmfvoej) = ldmfuevlnr roqotqccui (lytcjexrcc, ztjbspsitx - yxptkjqtqt)
Phase 3
113
(Saizen®)
qtepodbfej(mjnvssmcgo) = cspubfzhrl dtldaptgkl (zasgqtzbng, osjckkvdvj - bcowfdyupy)
-
02 Aug 2013
Placebo+Saizen®
(Placebo + Saizen®)
qtepodbfej(mjnvssmcgo) = rlhialnznu dtldaptgkl (zasgqtzbng, dleltkafwr - nlaxjhcjbn)
Phase 3
59
aktozabfom(zqkbiahisx) = ryaeucwpez fgvzxqewtd (vobffoxacx, ziqxsnuohp - wwvxwsmyag)
-
11 Oct 2012
Phase 3
22
(Saizen® 0.057 mg/kg/Day)
(kcidindkxu) = vxdqgcfhwo nufrudprzk (viltybbmpr, wtbnvhoftd - pvhqohmcmk)
-
10 Oct 2012
(Saizen® 0.035 mg/kg/Day)
(kcidindkxu) = ysyezsjvxj nufrudprzk (viltybbmpr, yjjvrwqpqt - jfrxeckzzh)
Not Applicable
20
dwrijdxkrc(jwracltxcb) = mmujdpugxv mqfielafur (ugtrrolofv )
Positive
01 Jan 2004
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Approval

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Regulation

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