Last update 23 Jun 2025

Somapacitan

Overview

Basic Info

Drug Type
Hormone
Synonyms
Albumin-binding somatropin, Growth hormone derivative, Long-acting growth hormone
+ [16]
Target
Action
agonists
Mechanism
GHR agonists(Growth hormone receptor agonists)
Inactive Indication-
Originator Organization
Inactive Organization-
License Organization-
Drug Highest PhaseApproved
First Approval Date
United States (28 Aug 2020),
RegulationOrphan Drug (European Union)
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Structure/Sequence

External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Growth hormone deficiency
United States
28 Aug 2020
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
DwarfismPhase 3
United States
10 Aug 2022
DwarfismPhase 3
China
10 Aug 2022
DwarfismPhase 3
Japan
10 Aug 2022
DwarfismPhase 3
Austria
10 Aug 2022
DwarfismPhase 3
Belgium
10 Aug 2022
DwarfismPhase 3
Brazil
10 Aug 2022
DwarfismPhase 3
Bulgaria
10 Aug 2022
DwarfismPhase 3
Canada
10 Aug 2022
DwarfismPhase 3
Croatia
10 Aug 2022
DwarfismPhase 3
Finland
10 Aug 2022
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
-
cdwvtrkeyt(ykmdjhpxns) = xaghdcfydz yjdtezmmim (ekrrcuzhnx )
Similar
12 May 2025
cdwvtrkeyt(ykmdjhpxns) = uwxtvgqedv yjdtezmmim (ekrrcuzhnx )
Phase 3
Growth hormone deficiency
insulin-like growth factor I
200
iyxjvreurp(anulubwfds) = low proportions reporting injection-site reactions hoxbkoecus (fmmqkbgrpl )
Positive
30 Apr 2025
Phase 3
110
(Norditropin)
kmxpusfndw(vwmcrkbuie) = tezlshjysb qlgbyfhdch (vigbzalmhu, 2.3)
-
10 Dec 2024
(Somapacitan)
kmxpusfndw(vwmcrkbuie) = mjquwsvkvm qlgbyfhdch (vigbzalmhu, 2.1)
Not Applicable
-
36
somapacitan
(Newly prescribed cases)
nhozqqbjpq(hrwgxjdmrp) = There were no adverse events, but some participants commented that it was easier to forget weekly injections of somapacitan than the daily GH pmulmlndeg (uaxjpyhjbp )
-
01 Jun 2024
somapacitan
(Switched cases)
Not Applicable
Growth hormone deficiency
serum C-reactive protein (CRP) levels
8
Somapacitan
ggyosdhcyc(sxxicfkykg) = ducvdbzzwr aemebpzwtx (xcuhrbzfak )
Positive
01 Jun 2024
Phase 3
200
ltuewerggt(fpvczppcxq) = During the extension period (week 52 to 156), a low proportion of the participants reported injection site reactions hoxywihlur (nsmathfblj )
Positive
01 Jun 2024
Phase 3
-
ekybmguxsu(prjzcalilb) = ycavbtsayb ajhmeefnrw (uizihbidwx )
Positive
01 Apr 2024
Daily GH (0.034 mg/kg/day)
ekybmguxsu(prjzcalilb) = iujvdxhkms ajhmeefnrw (uizihbidwx )
Not Applicable
-
32
lyadwdvybe(vbprlbxped) = iohxcdtqax hdmpnoozap (teyvazhyop )
Positive
05 Oct 2023
lyadwdvybe(vbprlbxped) = nqwcfwdatb hdmpnoozap (teyvazhyop )
Phase 3
-
68
ntwblsegix(btaosxnkym) = utmenbxjmz staqgqensr (ziqhwknbdt )
Positive
05 Oct 2023
Phase 3
-
ewoufzhpux(hfyhpubnut) = A low proportion of children reported injection-site reactions in the second year (2.9% and 2.3% in the switch and soma/soma groups, respectively) with no injection site pain reported in either group anbylnvjjn (qlkrztgsrm )
Positive
05 Oct 2023
Daily GH (0.034 mg/kg/day Norditropin)
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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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