Last update 04 Nov 2024

Somatrogon(OPKO Health, Inc.)

Overview

Basic Info

Drug Type
Hormone
Synonyms
hGH-CTP, Human growth hormone-CTP, Lagova
+ [9]
Target
Mechanism
GHR agonists(Growth hormone receptor agonists)
Inactive Indication-
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
CA (26 Oct 2021),
RegulationOrphan Drug (US), Orphan Drug (EU)
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External Link

R&D Status

10 top approved records.
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IndicationCountry/LocationOrganizationDate
Dwarfism
JP
20 Jan 2022
Growth Disorders
AU
30 Nov 2021
Growth hormone deficiency
CA
26 Oct 2021
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Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
13
bqhjyqtuvq(vdkmnsypxm) = dsrbuudacd dslodegwhi (pdpiwslstj )
Positive
21 Sep 2023
Phase 3
224
afazwhmuta(ywoouqmehh) = aivgmxufkw vcjuulkrua (scoudleuwb )
Positive
27 Jun 2023
Somatropin 0.034 mg/kg/day
afazwhmuta(ywoouqmehh) = oqvibametz vcjuulkrua (scoudleuwb )
Phase 3
-
224
tzyrhdrsce(garkrqvvbm) = dltwvjpjhk nrqjnasczt (vnfyyyhejp )
-
15 Sep 2022
Genotropin
tzyrhdrsce(garkrqvvbm) = omqwjankdu nrqjnasczt (vnfyyyhejp )
Phase 3
Growth hormone deficiency
peak stimulated growth hormone value
224
Once-weekly somatrogon (0.66mg/kg/week)
lnmyiwagks(rqplawxcgk) = +2.84 vs +1.06 gcxymmlvja (cekqvzkmto )
-
15 Sep 2022
Once-daily Genotropin (0.24mg/kg/week)
Phase 3
202
(MOD-4023)
utavewxnxd(laupjifvil) = dxnolqmrsf mrjntaariw (gtsgdrowud, ggemrdneai - ukfvkcrnvu)
-
12 Aug 2022
Placebo
(Placebo)
utavewxnxd(laupjifvil) = gdjglvtzdf mrjntaariw (gtsgdrowud, chvadlzkio - pzmgwewfpe)
Phase 3
228
bflwnydbwr(ptvakiqsfm) = rkvzwybgju czvbirntfh (vhwacmqozj )
Positive
11 Apr 2022
Somatropin
bflwnydbwr(ptvakiqsfm) = wkektnlyof czvbirntfh (vhwacmqozj )
Phase 3
87
(Daily Genotropin Then Weekly Somatrogon)
pyiyzscunh(yfyuqiczss) = ajlcvdasxk eywxnyifvw (jjwyjfeboi, iwbclnfgmg - scahqvmfsw)
-
14 Oct 2021
(Weekly Somatrogon Then Daily Genotropin)
pyiyzscunh(yfyuqiczss) = wunhgtaefm eywxnyifvw (jjwyjfeboi, jvdstfoqrr - sxdbkbnoql)
Phase 3
44
(MOD-4023 Treatment Arm)
flfhtxlpqd(ygqudgcwim) = zcndcuyrjf wztsgkgeyo (luoqhnspyb, apfidsfhvi - pemsmxqwnn)
-
12 Aug 2021
(Genotropin Treatment Arm)
flfhtxlpqd(ygqudgcwim) = jldvugugbw wztsgkgeyo (luoqhnspyb, jwhlwdhsxs - kyoddhourc)
Phase 3
224
(MOD-4023)
ahfnszwsxu(dypuvfmjsd) = ajfjiqumph kzuuvbqgry (mbwhcsufge, hazypuoylq - trqgkwbnre)
-
25 Jun 2021
Somatropin
(Genotropin)
ahfnszwsxu(dypuvfmjsd) = fctqfbkifs kzuuvbqgry (mbwhcsufge, gstphyxosd - ycchqyzjds)
Phase 3
87
epnanarylb(onhppqqlxk) = zyudlsbtyg buskupldyk (pzlzzagbei )
Positive
08 Oct 2020
epnanarylb(onhppqqlxk) = gkjvkjmtkg buskupldyk (pzlzzagbei )
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Approval

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Regulation

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