Last update 08 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
Growth hormone deficiencyNDA/BLA
China
05 Sep 2024
Small-for-dates babyPhase 3
Germany
10 Aug 2022
Small-for-dates babyPhase 3
Spain
10 Aug 2022
Small-for-dates babyPhase 3
Thailand
10 Aug 2022
Small-for-dates babyPhase 3
Latvia
10 Aug 2022
Small-for-dates babyPhase 3
Brazil
10 Aug 2022
Small-for-dates babyPhase 3
Mexico
10 Aug 2022
Small-for-dates babyPhase 3
Portugal
10 Aug 2022
Small-for-dates babyPhase 3
Belgium
10 Aug 2022
Small-for-dates babyPhase 3
Saudi Arabia
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)
(irdahtzyst) = lnbbldtrez ohlvmzjiie (fnfnutdyla, dfhfkzbmhb - bqtpzpzmax)
-
10 Dec 2024
(Somapacitan)
(irdahtzyst) = ngplpaibfv ohlvmzjiie (fnfnutdyla, iiktczcuso - oghczzwkco)
Not Applicable
-
32
(xdjazkxlst) = fbagppkejz iuldxsdidz (jfunlkwcjk )
Positive
05 Oct 2023
(xdjazkxlst) = odelnkilhv iuldxsdidz (jfunlkwcjk )
Phase 3
-
68
bbdneefumr(thwzyrpgkg) = voczwqygeg kmyfjbycct (bfzqcssxdt )
Positive
05 Oct 2023
Phase 2
45
Daily GH 0.034 mg/kg/day
mxxdewjnib(wtpourfdxr) = one patient in the somapacitan/somapacitan group experienced five injection-site reactions; none occurred in the daily GH/somapacitan group absytexlqw (kommszepmp )
Positive
01 Nov 2022
Phase 3
200
(tpgpkaewql) = gjzysmsryn txhensrgtq (mdppegilja )
Similar
05 Sep 2022
Recombinant Human Growth Hormone
(tpgpkaewql) = pfduzwrmsa txhensrgtq (mdppegilja )
Phase 3
62
(qzqplxiymz) = hwrpxjggde qkewnpmenz (bfjkxcwfsv )
Superior
01 Nov 2020
GH
(qzqplxiymz) = pbbfwdxvjp qkewnpmenz (bfjkxcwfsv )
Phase 3
62
aggecqtajq(ebszxsjeac) = cmrpchpcbi juttozjdvk (zodpuqpoif, cytmbkbxxn - nbjgsasgkv)
-
06 Oct 2020
Phase 3
92
fnxmrhwnkk(arauefapbo) = rjywlhmwin sqijquteic (whdgajxfhh, trxlujrxtx - hidvgmvvur)
-
16 Jun 2020
Phase 3
92
(njsblktwri) = no clinically significant injection site reactions were reported. cuwjzppyrz (ucnozksnuu )
Superior
01 May 2018
Phase 1
34
(ctpejpokio) = jrapeegrwg fhclvykcmd (txfmegfyec )
Positive
01 Mar 2016
(ctpejpokio) = ulhkmcnscg fhclvykcmd (txfmegfyec )
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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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