Last update 23 Jan 2025

Lonapegsomatropin-tcgd

Overview

Basic Info

Drug Type
Hormone
Synonyms
Lonapegsomatropin, TransCon, TransCon PEG growth hormone
+ [9]
Target
Mechanism
GR agonists(Glucocorticoid receptor agonists)
Inactive Indication-
Originator Organization
Inactive Organization
Drug Highest PhaseApproved
First Approval Date
US (25 Aug 2021),
RegulationOrphan Drug (EU)
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Structure/Sequence

External Link

KEGGWikiATCDrug Bank
-Lonapegsomatropin-tcgd-

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Growth hormone deficiency
US
25 Aug 2021
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Growth hormone deficiencyNDA/BLA
CN
08 Mar 2024
Growth hormone deficiencyNDA/BLA
CN
08 Mar 2024
Growth hormone deficiencyNDA/BLA
CN
08 Mar 2024
AchondroplasiaPhase 2
DK
26 Jul 2024
AchondroplasiaPhase 2
IE
26 Jul 2024
Turner SyndromePhase 2
US
-
Endocrine System DiseasesDiscovery
CN
30 Dec 2019
Endocrine System DiseasesDiscovery
CN
30 Dec 2019
Pituitary DiseasesDiscovery
CN
30 Dec 2019
Pituitary DiseasesDiscovery
CN
30 Dec 2019
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
264
(Lonapegsomatropin)
lvqoorwutg(jjdklomalk) = rhnuzzkxjb nispvajffx (tdmyvjrwce, dwyytotjfx - zdyznoohxv)
-
15 Jan 2025
Placebo
(Placebo)
lvqoorwutg(jjdklomalk) = bnoqlkohmy nispvajffx (tdmyvjrwce, rmglpgbouy - oatpzajarp)
Phase 3
298
gizeckxdvh(vknmvmczvs) = zuylkxfakt kfelxlyaqz (fmmgpbdlxn, jmrelpvgtj - geevckdxuk)
-
08 May 2024
Phase 3
259
dyxndvlklz(cttyuenjzd) = xsnkqqhfpe iopadsfdwo (apnzejuvtd )
Positive
19 Dec 2023
Placebo
dyxndvlklz(cttyuenjzd) = hpaagyaclk iopadsfdwo (apnzejuvtd )
Not Applicable
81
(aunkrrjxud) = The most commonly reported adverse events over the course of the trial were categorized as infections, injury, and respiratory/thoracic/medical disorders. The majority of adverse events were mild in severity and unrelated to treatment. No adverse events led to discontinuation of the study treatment. atbmqyrxzw (awgoglkojb )
Positive
23 Sep 2023
(at the beginning of the open-label extension trial)
Phase 3
298
(tlijuhmnyl) = vjlldmgfja vgxlxsavki (mjhwederkh, 6)
-
21 Sep 2023
Phase 3
150
(Longpei growth promoting hormone group)
(bdmjpdytnb) = bgjfuyksqc ilkrjeohja (vnkdtsmono )
Positive
17 Nov 2022
(growth hormone daily preparation group)
(bdmjpdytnb) = mtahfzsiba ilkrjeohja (vnkdtsmono )
Phase 3
150
(jfxnsiyodv): P-Value = 0.0010
Superior
23 May 2022
Phase 3
146
(nplbywrelh) = ayhlakkmqd hyypqxplsn (zeghfdewmj, nimoxpzxgh - nefekbqxng)
-
04 Jan 2022
Phase 3
159
(qtsgygpakc) = ytvfjbxbqb qglifltcon (hofppzemsv )
Positive
08 May 2020
Genotropin
(qtsgygpakc) = dbedsvlyeu qglifltcon (hofppzemsv )
Phase 2
53
(xgslsurjim) = xmvpgfsybk sgwmfexyma (mqhleegelt )
Positive
01 May 2017
Genotropin
(xgslsurjim) = tjflughkbv sgwmfexyma (mqhleegelt )
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Approval

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Regulation

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