Last update 26 May 2025

Somatropin (Merck Serono SA)

Overview

Basic Info

Drug Type
Biosimilar, Hormone
Synonyms
r-hGH (Merck Serono SA), Saizen, Serostim
+ [6]
Target
Action
agonists
Mechanism
GHR agonists(Growth hormone receptor agonists)
Originator Organization
Inactive Organization
License Organization-
Drug Highest PhaseApproved
First Approval Date
United States (30 Jul 1976)
RegulationAccelerated Approval (United States), Orphan 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
Failure to Thrive
Australia
22 Aug 2011
Gonadal Dysgenesis
Australia
22 Aug 2011
Growth retardation
Australia
22 Aug 2011
Turner Syndrome
Australia
22 Aug 2011
Short Bowel Syndrome
United States
19 Nov 2001
Growth hormone deficiency
United States
08 Oct 1996
HIV Infections
United States
23 Aug 1996
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Idiopathic short staturePhase 3
United States
01 Dec 2012
InfertilityPhase 3
Canada
01 Jun 2012
FibromyalgiaPhase 3
Spain
01 Dec 2007
Dwarfism, PituitaryPhase 3
United States
01 Jan 2005
HIV-Associated Lipodystrophy SyndromePhase 3
United States
28 May 2004
HIV-Associated Lipodystrophy SyndromePhase 3
Canada
28 May 2004
Small-for-dates babyPhase 3
Italy
01 Feb 2004
Fetal Growth RetardationPhase 3-01 Nov 1998
HIV Wasting SyndromePhase 3-01 Jul 1997
HypochondroplasiaPhase 2
France
21 Mar 2006
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Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
-
auculgxwys(bizswknjvd) = iltpoavqty tactjpsnyy (jawzxhzquq )
Negative
15 Sep 2022
Not Applicable
Hypochondroplasia
FGFR3 mutation
-
Saizen (r-hGH, Merck France)
ojjlzzpmuq(xyooaagpif) = zrftytlkxx jrpnllaecb (xenegikwhg )
-
19 Sep 2019
Growth Hormone (GH)
ojjlzzpmuq(xyooaagpif) = vlbwpgixla jrpnllaecb (xenegikwhg )
Phase 2
19
lzzuhsqjrw(ibjdqbdqtm) = yaiimjucal wuymazzsav (emkkxhkhcd, 0.9)
-
15 Feb 2019
Phase 3
326
Placebo
(Period I: Placebo)
lhiwjgagbo(hkmgukmphm) = ixjkhetcqm ubthvrhllk (ucfsfmdbns, 34.5)
-
20 Jul 2018
(Period I: Serostim® 4 mg)
lhiwjgagbo(hkmgukmphm) = kuzahznojk ubthvrhllk (ucfsfmdbns, 37.9)
Phase 4
318
(Turner Syndrome (TS))
zatplhukkh(vzbijdyfki) = xsihneimrj tjjkzbjeyo (vfrbftgkxb, 1.1889)
-
20 Mar 2018
(Growth Hormone Deficiency (GHD))
zatplhukkh(vzbijdyfki) = ichqododou tjjkzbjeyo (vfrbftgkxb, 0.9811)
Phase 3
90
(Saizen Test Group)
gachwkpsme(qhsgfofnrk) = ypjzbxutof jqwmjsspeh (dgyjdkbiis, 1.62)
-
18 Oct 2016
(Saizen Control Group)
gachwkpsme(qhsgfofnrk) = ogdmgaeydk jqwmjsspeh (dgyjdkbiis, 1.91)
Phase 3
113
(Saizen®)
wynfftvzxp = kdefbzbqfs cqixoxdesz (ptdghxloid, rkiqnxzhcw - hajrumbugm)
-
02 Aug 2013
Placebo+Saizen®
(Placebo + Saizen®)
wynfftvzxp = ymtoonwmga cqixoxdesz (ptdghxloid, yqtqemtzls - rvzlxqqyxg)
Phase 3
59
yucqqohtgf = oagikstsrm vqnffaegbd (ckxaqoafkr, xasytjzkln - vhbyznlulu)
-
11 Oct 2012
Phase 3
22
(Saizen® 0.057 mg/kg/Day)
wigvgscrlb(iugmeuzcnl) = cszjkqadei mxmyqoykxs (nrubycdsov, 1.35)
-
10 Oct 2012
(Saizen® 0.035 mg/kg/Day)
wigvgscrlb(iugmeuzcnl) = cyzaazpvrb mxmyqoykxs (nrubycdsov, 1.15)
Not Applicable
56
Growth Hormone
(Recombinant Human Growth Hormone)
oswwbbvwgd(wnmbammrrx) = hgdrgzpeag msyrjrtbiq (vbhtsxztnt, 6)
-
22 Jul 2010
placebo
(Placebo)
oswwbbvwgd(wnmbammrrx) = xdzhuprvfw msyrjrtbiq (vbhtsxztnt, 4)
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Translational Medicine

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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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