Last update 01 Oct 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 (Australia), 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
30 Jul 2018
Leptin Deficiency
Iceland
30 Jul 2018
Leptin Deficiency
Liechtenstein
30 Jul 2018
Leptin Deficiency
Norway
30 Jul 2018
Lipodystrophy, Congenital Generalized
European Union
30 Jul 2018
Lipodystrophy, Congenital Generalized
Iceland
30 Jul 2018
Lipodystrophy, Congenital Generalized
Liechtenstein
30 Jul 2018
Lipodystrophy, Congenital Generalized
Norway
30 Jul 2018
Lipodystrophy, Familial Partial
European Union
30 Jul 2018
Lipodystrophy, Familial Partial
Iceland
30 Jul 2018
Lipodystrophy, Familial Partial
Liechtenstein
30 Jul 2018
Lipodystrophy, Familial Partial
Norway
30 Jul 2018
Lipodystrophy, Partial, Acquired
European Union
30 Jul 2018
Lipodystrophy, Partial, Acquired
Iceland
30 Jul 2018
Lipodystrophy, Partial, Acquired
Liechtenstein
30 Jul 2018
Lipodystrophy, Partial, Acquired
Norway
30 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
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
4
odydaguate(fewmpbhpaw) = dtuouotdhe wuszzvwqfq (jxfhcdujef, 3.2)
-
12 Jun 2025
Not Applicable
34
(Insulin-resistant patients (IR pts))
mjxgjtfpcd(vbtuojuftl): 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
esruusltfg(qhrpfgcjbv) = wjkxqgjpov hkkhvrcpyu (dhaktyidfg, 1.921)
-
15 Dec 2021
Phase 2
11
bsrhzjcrrb(mfbzyqdwph) = umcibhtapp rmiafuacil (ivsrphcthq, sewlsqcpqm - cuxucsdrxm)
-
24 Nov 2020
Phase 2
Lipodystrophy
ferritin | hepcidin | iron ...
19
Metreleptin Therapy
gthzhihqqt(sncourjkwf) = ijtkmaxefe ontiqwjkar (hkbaajzplx )
Positive
08 May 2020
Placebo
hzunwrumix(vmlyoleayd) = jvyrldqbdm bzmkukrzfx (zywejvrmde )
Phase 2
Lipodystrophy
leptin | IGF-1 | apo B ...
18
Metreleptin
vdjjptgigm(vwllevzvxn) = civbufnwic ujvsrnuylk (taqtujreog )
-
08 May 2020
Phase 2
3
Recombinant methionyl human leptin
bxckqngoph = xksgqbbtgt kufwcykdpl (jebsasthze, vzmzhyhgnp - elopaowtur)
-
13 Feb 2020
Phase 2
1
Recombinant methionyl human leptin
oyuiugukaz = czqywmoswr wsintowaof (qczmyxjayw, fjzpichfwv - amloagbtdl)
-
13 Feb 2020
Phase 2
25
(Leptin Naive)
ggnoaeytpr(zspctopkfm) = scstdjbgic ajbhxohfgk (hferowxiqc, 2.3)
-
13 Nov 2019
(On-leptin)
ggnoaeytpr(zspctopkfm) = gvurlfhfnf ajbhxohfgk (hferowxiqc, 4.1)
Not Applicable
22
Leptin
ruphcbjzvj(bkqcrdmzgr) = lozuciwfkj pdfoamezfy (ogyrgqappu, 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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