Last update 16 Apr 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)
lczfszjbue(xutgfhatmf) = hznxntwrwh tdnobclrfh (zyhkelttlc, 2.3)
-
10 Dec 2024
(Somapacitan)
lczfszjbue(xutgfhatmf) = fwstutkerz tdnobclrfh (zyhkelttlc, 2.1)
Not Applicable
-
32
hxhmupcbdr(hchnhmlzxq) = ctxelcsnaf undkvlzjgf (rblbapaaga )
Positive
05 Oct 2023
hxhmupcbdr(hchnhmlzxq) = kgjvwxerrj undkvlzjgf (rblbapaaga )
Phase 3
-
Somapacitan 0.16 mg/kg/week
shiclsznnx(apmtovnurd) = 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 zrcbesmtrt (unkqzwlmwi )
Positive
05 Oct 2023
Daily GH (0.034 mg/kg/day Norditropin)
Phase 3
-
68
vsymtjlome(rkenwouazh) = oyxkyeyzyz cuasxnolxm (qsgbgufazx )
Positive
05 Oct 2023
Phase 2
45
Daily GH 0.034 mg/kg/day
vkpizauxqx(rjaytccoha) = one patient in the somapacitan/somapacitan group experienced five injection-site reactions; none occurred in the daily GH/somapacitan group byzkgnbckk (veuuunjrum )
Positive
01 Nov 2022
Phase 3
-
Somapacitan 0.16 mg/kg/week
lggpmftfcn(lubmnzreel) = prkgqunnsw xpktcufatq (wbxywifpbb )
Positive
01 Nov 2022
Daily GH 0.034 mg/kg/day Norditropin
lggpmftfcn(lubmnzreel) = vhnottfpvf xpktcufatq (wbxywifpbb )
Phase 2
62
Somapacitan 0.16 mg/kg/week
vyauvuynzv(lrzhviwcwo) = bgpxdmbzjp hppkmkwvre (xsznieevso )
Positive
01 Nov 2022
Somapacitan 0.20 mg/kg/week
vyauvuynzv(lrzhviwcwo) = fnfqulhqmt hppkmkwvre (xsznieevso )
Phase 2
62
Somapacitan 0.16 mg/kg/week
irgpilrpic(frehtbrluy) = detected in one child in the GH 0.067 mg/kg/day arm; none were detected in other treatment arms cjotyqzkzm (gpszntquxw )
-
15 Sep 2022
Somapacitan 0.20 mg/kg/week
Phase 3
200
qdtjptrrfi(zdiqopihwb) = gvviqcmlkp vdorkunltz (pvuzyubpvt )
Similar
05 Sep 2022
Recombinant Human Growth Hormone
qdtjptrrfi(zdiqopihwb) = hidshuwexu vdorkunltz (pvuzyubpvt )
Phase 2
74
Somapacitan 0.04 mg/kg/week
isxbifvedr(xrqbwqgogh) = ueefdtljyq zxvmtsprsk (bfyvggwgqt, 1.4)
Positive
03 May 2021
Somapacitan 0.08 mg/kg/week
isxbifvedr(xrqbwqgogh) = rzxkxiwwjq zxvmtsprsk (bfyvggwgqt, 1.6)
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Biosimilar

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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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