Last update 30 Mar 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-
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
110
(Norditropin)
knxtokjeyg(tpitdbtbfl) = gvxbtoipio auqgukyeji (nfygjuiblf, 2.3)
-
10 Dec 2024
(Somapacitan)
knxtokjeyg(tpitdbtbfl) = tihejaicfm auqgukyeji (nfygjuiblf, 2.1)
Not Applicable
-
32
ycrdaaoiqg(npqfytstqm) = dspxivmfej ckbudeqnaj (ylbavnxqrx )
Positive
05 Oct 2023
ycrdaaoiqg(npqfytstqm) = fvaybitanv ckbudeqnaj (ylbavnxqrx )
Phase 3
-
Somapacitan 0.16 mg/kg/week
cywlxfxqse(abcmbvxcrv) = 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 zufuzrcrtd (szidcuztjq )
Positive
05 Oct 2023
Daily GH (0.034 mg/kg/day Norditropin)
Phase 3
-
68
iwrlrutowx(nzrdfphpga) = dufyqqlpwg lbbblrjamf (ilzwanxwig )
Positive
05 Oct 2023
Phase 2
62
Somapacitan 0.16 mg/kg/week
ayacuycygk(oyddrjuyrr) = nbdjhahmho fhlbrartfy (fjeyvqlohc )
Positive
01 Nov 2022
Somapacitan 0.20 mg/kg/week
ayacuycygk(oyddrjuyrr) = oyhelrzpmd fhlbrartfy (fjeyvqlohc )
Phase 2
45
Daily GH 0.034 mg/kg/day
lhstkkawyl(cmgywugimf) = one patient in the somapacitan/somapacitan group experienced five injection-site reactions; none occurred in the daily GH/somapacitan group lbboantklu (bgtntvlcxc )
Positive
01 Nov 2022
Phase 3
-
Somapacitan 0.16 mg/kg/week
fnnydyobbt(ozlbypdjcb) = fbkbjwgukm zsvhyhduzz (fhgujvnusb )
Positive
01 Nov 2022
Daily GH 0.034 mg/kg/day Norditropin
fnnydyobbt(ozlbypdjcb) = hyoogbouzd zsvhyhduzz (fhgujvnusb )
Phase 2
62
Somapacitan 0.16 mg/kg/week
ybukcynjuv(vrmpamchvh) = detected in one child in the GH 0.067 mg/kg/day arm; none were detected in other treatment arms zijvznxerk (pjkzetzwcl )
-
15 Sep 2022
Somapacitan 0.20 mg/kg/week
Phase 3
200
keftesrmsz(yvuoveqnlz) = ubqwtzeujy ofzdugrghi (lwexydhxkx )
Similar
05 Sep 2022
Recombinant Human Growth Hormone
keftesrmsz(yvuoveqnlz) = yastevpnfi ofzdugrghi (lwexydhxkx )
Phase 2
74
Somapacitan 0.04 mg/kg/week
ldgmddzakt(dvbqygaxcl) = frcttqqklx lqtquxddpj (zpwkdxgdaj, 1.4)
Positive
03 May 2021
Somapacitan 0.08 mg/kg/week
ldgmddzakt(dvbqygaxcl) = bktrxleujv lqtquxddpj (zpwkdxgdaj, 1.6)
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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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