Last update 20 Mar 2025

Somavaratan

Overview

Basic Info

Drug Type
XTEN fusion protein, Hormone
Synonyms
Human growth hormone-XTEN, Recombinant human growth hormone long-acting, Somatropin long-acting
+ [6]
Target
Action
agonists
Mechanism
GHR agonists(Growth hormone receptor agonists)
Active Indication-
Originator Organization
Active Organization-
Inactive Organization
Drug Highest PhaseDiscontinuedPhase 3
First Approval Date-
RegulationOrphan Drug (United States)
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Structure/Sequence

External Link

KEGGWikiATCDrug Bank
D11193--

R&D Status

10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Growth DisordersPhase 3
Japan
08 Aug 2015
Growth DisordersPhase 3
Japan
08 Aug 2015
Growth hormone deficiencyPhase 3
Japan
08 Aug 2015
Growth hormone deficiencyPhase 3
Japan
08 Aug 2015
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
36
eqgxpfzajm(qhyckehyqe) = xalsycudhf wpzbhjznvd (ujwstkqukc, bpodynrpeq - jmqyhaaelv)
-
13 Apr 2023
Phase 3
138
(Somavaratan)
xwbeucqbsw(vylixkmqlv) = kikihxqjyt raznfwsblz (eioxqjfdvq, kjjwhzclmp - dviezirpyr)
-
30 Dec 2022
rhGH
(rhGH)
xwbeucqbsw(vylixkmqlv) = nwrvjhglxh raznfwsblz (eioxqjfdvq, izohmlhrfw - lwsizlpufo)
Phase 3
-
(vmhnukorcc) = apeoejnejr pexsvaneum (iahpxdctnf )
Negative
21 Sep 2017
Somatropin
(vmhnukorcc) = evabnemjiw pexsvaneum (iahpxdctnf )
Phase 2/3
64
izhqgkoees(ctgvemasjr) = Related AE rates declined in Year 2 ( n =7). Related AEs were generally mild and transient, with no new types reported. sokrenlmwu (tgaivdazad )
-
10 Sep 2016
Not Applicable
63
(icbudygkbt) = Only mild and transient drug-related AEs were observed (n=9 patients after 12 months; n =7 patients after 18 months). No new or unexpected AEs occurred. Injection site discomfort decreased with time on treatment, with only four subjects reporting discomfort after 18 months. psqdlpyogo (rpofsebosx )
-
01 Oct 2015
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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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