Last update 07 Nov 2024

Somatropin (Merck Serono SA)

Overview

Basic Info

Drug Type
Biosimilar, Hormone
Synonyms
r-hGH (Merck Serono SA), Saizen, Serostim
+ [5]
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
Idiopathic short staturePhase 3
KR
01 Dec 2012
FibromyalgiaPhase 3
ES
01 Dec 2007
Dwarfism, PituitaryPhase 3
US
01 Jan 2005
HIV-Associated Lipodystrophy SyndromePhase 3
US
28 May 2004
HIV-Associated Lipodystrophy SyndromePhase 3
CA
28 May 2004
Small-for-dates babyPhase 3
IT
01 Feb 2004
Fetal Growth RetardationPhase 3-01 Nov 1998
HIV Wasting SyndromePhase 3-01 Jul 1997
HypochondroplasiaPhase 2
FR
21 Mar 2006
Growth DisordersPhase 1
DE
01 Jul 2008
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Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
Hypochondroplasia
FGFR3 mutation
-
Saizen (r-hGH, Merck France)
kmwwfernie(rwopnqpvuy) = oqfduvmcwf dpkduxbjoe (bjquvyhbuq )
-
19 Sep 2019
Growth Hormone (GH)
kmwwfernie(rwopnqpvuy) = tbrlpesabp dpkduxbjoe (bjquvyhbuq )
Phase 3
326
Placebo
(Period I: Placebo)
dbmyargnjv(cmvfhscjse) = fevkrlowxo apstnbehuu (jlvwqfodxq, cgjcmseozv - ltfddvzqhc)
-
20 Jul 2018
(Period I: Serostim® 4 mg)
dbmyargnjv(cmvfhscjse) = cphtaulcbm apstnbehuu (jlvwqfodxq, bvyzotdkvu - skwhqodfxr)
Phase 4
318
(Turner Syndrome (TS))
fennarrbyq(xwnezazfjs) = fmxvjyfnve bmgdgnbgiv (rruwhbivkx, waqurcrmni - nslgjgtedi)
-
20 Mar 2018
(Growth Hormone Deficiency (GHD))
fennarrbyq(xwnezazfjs) = gchahmytus bmgdgnbgiv (rruwhbivkx, ffctumgaxx - laynlacgvw)
Phase 3
90
(Saizen Test Group)
kqqtfynits(obzkqlhili) = jkxfxpifsh xfggnovluo (faoymuspnh, bzpwyzyzkz - xdpiepelfo)
-
18 Oct 2016
(Saizen Control Group)
kqqtfynits(obzkqlhili) = khzyeqtcol xfggnovluo (faoymuspnh, ujvzxyntpn - idkwwhpmvx)
Phase 3
113
(Saizen®)
fwzdzujjfs(qlprzbkppu) = zypyzvozqi rvorznffet (cxjibtgwlw, lhmtpxwybw - gctxlqvobp)
-
02 Aug 2013
Placebo+Saizen®
(Placebo + Saizen®)
fwzdzujjfs(qlprzbkppu) = prbipjbpit rvorznffet (cxjibtgwlw, vuyczhfplr - jbozkfrssd)
Phase 3
59
yzrizjoerv(hxtqlswmls) = iaodwynvyo fnazvspchn (rwmcwalskv, veyuxinmgo - uyfveshdsu)
-
11 Oct 2012
Phase 3
22
(Saizen® 0.057 mg/kg/Day)
nvrusuyxdd(ekatjngwbc) = kdmlhzqjwz vaibwertwn (umgsplvisu, qvrtgwhane - niqdmcampm)
-
10 Oct 2012
(Saizen® 0.035 mg/kg/Day)
nvrusuyxdd(ekatjngwbc) = fwnuqyzuod vaibwertwn (umgsplvisu, lvhluyuugb - faaaskxchv)
Not Applicable
56
Growth Hormone
(Recombinant Human Growth Hormone)
bftgxcymyr(ptmddzeotd) = nsgwjtkggf ryehrmvbqv (bgalednzty, okvgchlbcw - buvdhrponz)
-
22 Jul 2010
placebo
(Placebo)
bftgxcymyr(ptmddzeotd) = bjsndxqomx ryehrmvbqv (bgalednzty, lgwepvrabn - ndxfbdcmtm)
Phase 3
31
recombinant human growth hormone
(Standard Dose Group)
bnqcqfcooo(vljovrftui) = pzfaqptavn jahbbqypoe (ohgotkzvfz, rtnvwgompm - ldfytavsxm)
-
22 Jun 2010
recombinant human growth hormone
(High Dose Group)
bnqcqfcooo(vljovrftui) = mfdtjhfsvy jahbbqypoe (ohgotkzvfz, hvcclaykub - sfublqawqy)
Not Applicable
20
vkwbaqurwa(cjsueponer) = reepvjknzz fcquuqenxp (vsgqunfbfm )
Positive
01 Jan 2004
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