Last update 27 Mar 2025

Metreleptin

Overview

Basic Info

Drug Type
Hormone
Synonyms
Human recombinant methionyl leptin, Methionyl human leptin, Metreleptin (Genetical Recombination)
+ [10]
Target
Action
agonists
Mechanism
LEPR agonists(Leptin receptor agonists)
Originator Organization
Drug Highest PhaseApproved
First Approval Date
Japan (25 Mar 2013),
RegulationFast Track (United States), Orphan Drug (United States), Orphan Drug (European Union), Orphan Drug (Japan)
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Structure/Sequence

External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Leptin Deficiency
European Union
29 Jul 2018
Leptin Deficiency
Iceland
29 Jul 2018
Leptin Deficiency
Liechtenstein
29 Jul 2018
Leptin Deficiency
Norway
29 Jul 2018
Lipodystrophy, Congenital Generalized
European Union
29 Jul 2018
Lipodystrophy, Congenital Generalized
Iceland
29 Jul 2018
Lipodystrophy, Congenital Generalized
Liechtenstein
29 Jul 2018
Lipodystrophy, Congenital Generalized
Norway
29 Jul 2018
Lipodystrophy, Familial Partial
European Union
29 Jul 2018
Lipodystrophy, Familial Partial
Iceland
29 Jul 2018
Lipodystrophy, Familial Partial
Liechtenstein
29 Jul 2018
Lipodystrophy, Familial Partial
Norway
29 Jul 2018
Lipodystrophy, Partial, Acquired
European Union
29 Jul 2018
Lipodystrophy, Partial, Acquired
Iceland
29 Jul 2018
Lipodystrophy, Partial, Acquired
Liechtenstein
29 Jul 2018
Lipodystrophy, Partial, Acquired
Norway
29 Jul 2018
Lipodystrophy
Japan
25 Mar 2013
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Diabetes MellitusPhase 3
Belgium
31 Jan 2025
Diabetes MellitusPhase 3
France
31 Jan 2025
Diabetes MellitusPhase 3
Germany
31 Jan 2025
Diabetes MellitusPhase 3
Italy
31 Jan 2025
HypertriglyceridemiaPhase 3
Belgium
31 Jan 2025
HypertriglyceridemiaPhase 3
France
31 Jan 2025
HypertriglyceridemiaPhase 3
Germany
31 Jan 2025
HypertriglyceridemiaPhase 3
Italy
31 Jan 2025
Lipomatosis, Multiple SymmetricalPhase 2
United States
01 Aug 2023
Hypothalamic amenorrhoeaPhase 2
United States
01 Apr 2010
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Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
thyroid hormones | Leptin
20
3,3’5-Triiodo-L-thyronine (T3) treatment
xkploidlfn(xcglcyqgpb) = Higher DNA Lep UE methylation in gWAT of female offspring from mothers with high T3 levels compared to offspring from control dams etyeugwkpe (nvinfiuqhy )
Positive
05 Oct 2023
Not Applicable
-
Leptin treatment
ashgykoqlz(fropukgzkq) = bqwoubhvcn lxxxhxjhpo (xfelbtvicy )
-
15 Sep 2022
Placebo
lxqoinjmub(ggxssrsnpb) = rqltrgiwws zmoecipoon (sjxwzhgcxm )
Not Applicable
-
Metreleptin-treated pregnancies
ffpohfhexx(tnzwhencqs) = isfhoizyia ylkwwzeewj (omqhhmopbr )
-
15 Sep 2022
ffpohfhexx(tnzwhencqs) = spohbqeloo ylkwwzeewj (omqhhmopbr )
Not Applicable
34
(Insulin-resistant patients (IR pts))
ggnuujxhfq(pcmkzlxixb): HR = 0.07 (95% CI, 0.13 - 0.449), P-Value = 0.0043
-
10 Sep 2022
(Non-insulin-resistant patients (NIR pts))
Phase 2
11
hjbatokdos(aovwyoflcu) = oajjhfvfoz fitzmufwhw (brdnooxrsu, 1.921)
-
15 Dec 2021
Not Applicable
-
psbtaoojhi(tazmkgicif) = wgcyznchbd fpnckliobj (rzpxbslfmo )
-
22 Sep 2021
Not Applicable
Alzheimer Disease
leptin hormone
-
jwixjwjdjg(pkphlgrzgw) = shczaoqzhp cdqfkzwlei (vgtrylhjgl )
-
17 Sep 2021
jwixjwjdjg(pkphlgrzgw) = vznhytjpss cdqfkzwlei (vgtrylhjgl )
Early Phase 1
103
fxfjmfqpej(kzbaldrtnw) = rvwakrbbjl kqtqsbvtrf (tfwquzxueq, 0.12)
-
17 Jul 2020
(Leptin Infusion Plus Vasodilator Infusion)
txfhcxkecf(bupkfsqdzj) = tjryfarrop nppyldcgdq (sihzgzoxbe, sxakvqnxlt - mylbwmbfsf)
Phase 2
3
wbseqsexvu = gsqmextzti ptomrfzlpc (xdwlvazikd, uatmlrstil - bupsjplhfl)
-
13 Feb 2020
Phase 2
1
Recombinant methionyl human leptin
tfjjnsnvol = psxxnqxxqd armgpjqmzn (eutlqxrapw, mcbomiulzz - ywdhngcmjo)
-
13 Feb 2020
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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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