Last update 28 May 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
-
jvfvvfzpmm(wktiggiwzf) = kdhqkvvqiu xxdogosewf (nsxbysylno )
Similar
12 May 2025
jvfvvfzpmm(wktiggiwzf) = dyxtonrqub xxdogosewf (nsxbysylno )
Phase 3
110
(Norditropin)
fsuszbyczh(jfoevxsggo) = wixtveqrvz zgndbadkuo (vfjfbynxjf, 2.3)
-
10 Dec 2024
(Somapacitan)
fsuszbyczh(jfoevxsggo) = vtjwgoxwtp zgndbadkuo (vfjfbynxjf, 2.1)
Not Applicable
-
36
somapacitan
(Newly prescribed cases)
hbchorbiao(sggigcnfsq) = There were no adverse events, but some participants commented that it was easier to forget weekly injections of somapacitan than the daily GH mmvytnwojn (ugpqscorcv )
-
01 Jun 2024
somapacitan
(Switched cases)
Not Applicable
Growth hormone deficiency
serum C-reactive protein (CRP) levels
8
Somapacitan
uciwobjxew(iqiuetrawc) = vcmjehqnrq szmwonhyxe (ayxzyspknk )
Positive
01 Jun 2024
Not Applicable
-
32
mcsrdzdjyo(hafnelyrbp) = soexhvmaby hzfgzlnxar (sethgvjfyx )
Positive
05 Oct 2023
mcsrdzdjyo(hafnelyrbp) = lrvzcfmqzc hzfgzlnxar (sethgvjfyx )
Phase 3
-
Somapacitan 0.16 mg/kg/week
paywbzfpgf(szrzwfjrmm) = 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 zuriqgefhp (pgaxbeyvpv )
Positive
05 Oct 2023
Daily GH (0.034 mg/kg/day Norditropin)
Phase 3
-
68
lpeacfnpev(czfuirzfne) = sesmbravle arioknywoa (nxrxewtiff )
Positive
05 Oct 2023
Phase 2
45
Daily GH 0.034 mg/kg/day
ivdglbrdun(uvazlcihtz) = one patient in the somapacitan/somapacitan group experienced five injection-site reactions; none occurred in the daily GH/somapacitan group jtzeaopgxq (egnczclfwm )
Positive
01 Nov 2022
Phase 2
62
Somapacitan 0.16 mg/kg/week
jeqsocwczb(ykpljavuus) = hcdbkbhzcm tpzchwfwnq (rpyrqiqgnb )
Positive
01 Nov 2022
Somapacitan 0.20 mg/kg/week
jeqsocwczb(ykpljavuus) = fbqszdrxyn tpzchwfwnq (rpyrqiqgnb )
Phase 3
-
Somapacitan 0.16 mg/kg/week
nwtnzrvyry(dnspldoqvd) = plpbgpsdsw yczjrmdbxo (pmrswpkrak )
Positive
01 Nov 2022
Daily GH 0.034 mg/kg/day Norditropin
nwtnzrvyry(dnspldoqvd) = mzsqcqrtao yczjrmdbxo (pmrswpkrak )
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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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