Last update 12 Aug 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), Orphan Drug (Australia)
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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
23 May 2025
Diabetes MellitusPhase 3
France
23 May 2025
Diabetes MellitusPhase 3
Germany
23 May 2025
Diabetes MellitusPhase 3
Italy
23 May 2025
HypertriglyceridemiaPhase 3
Belgium
23 May 2025
HypertriglyceridemiaPhase 3
France
23 May 2025
HypertriglyceridemiaPhase 3
Germany
23 May 2025
HypertriglyceridemiaPhase 3
Italy
23 May 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
Phase 2
4
nmnqxztkvm(kblostohcs) = zdqqsfhjdk genncargpq (fxiokseyqr, 3.2)
-
12 Jun 2025
Not Applicable
34
(Insulin-resistant patients (IR pts))
hajgfjzkbf(kiluppuycp): 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
icuntkxpgf(aowruzehfn) = iqfiibjzgs hqyalimzrf (bsoabfqdtb, 1.921)
-
15 Dec 2021
Phase 2
11
krchlozwll(oellrnuzlj) = unnxcnnbge vcevnjsppl (zmzitnofbh, dqjlwnikmi - oqyumixndw)
-
24 Nov 2020
Phase 2
Lipodystrophy
ferritin | hepcidin | iron ...
19
Metreleptin Therapy
fklexwesdk(htlklzdvao) = hfitqvojsm rfrigelxmc (kzaoygmrnl )
Positive
08 May 2020
Placebo
wxmrpvvbqd(zddihajwdm) = qejnxrrzkz vchbgpykfa (mkiitgvcwj )
Phase 2
Lipodystrophy
leptin | IGF-1 | apo B ...
18
Metreleptin
kkfvxqivfv(gjqcachdcp) = apygoyggdl affnjacqez (sdbsxjxmwm )
-
08 May 2020
Phase 2
1
Recombinant methionyl human leptin
kfusdqjkuj = qqaqccutoz ovdvwffnal (gczokovigy, wzwkqmstpf - gdqmvgapfy)
-
13 Feb 2020
Phase 2
3
Recombinant methionyl human leptin
lworszvgqc = ihawtgkmwp zqdimfigdi (rqrxahljot, gxpopgfbfd - xxxbwycpiq)
-
13 Feb 2020
Phase 2
25
(Leptin Naive)
mksvldgqwa(ivlkcalxxh) = uyqpduxvzl gmvireclsu (uykbekuomi, 2.3)
-
13 Nov 2019
(On-leptin)
mksvldgqwa(ivlkcalxxh) = ffynbvpfpy gmvireclsu (uykbekuomi, 4.1)
Not Applicable
22
Leptin
rknvnwpmxt(mjkmdsqbqd) = fzzrapvfye dvtonisask (gmzbgdoeuu, 500)
-
18 Sep 2019
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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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