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Myalept, Myalepta(metreleptin)
Myalept, Myalepta (metreleptin) is a protein pharmaceutical. Metreleptin was first approved as Myalept on 2014-02-24. It is used to treat lipodystrophy in the USA. It has been approved in Europe to treat familial partial lipodystrophy.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
hereditary congenital and neonatal diseases and abnormalitiesD009358
skin and connective tissue diseasesD017437
nutritional and metabolic diseasesD009750
Trade Name
FDA
EMA
Myalept
Drug Products
FDA
EMA
Reference product - 351(a)
Reference product - 351(a)
Interchangeable product - 351(k)
Interchangeable product - 351(k)
Biosimilar product - 351(k)
Biosimilar product - 351(k)
Metreleptin
Tradename
Proper name
Company
Number
Date
Products
MyaleptmetreleptinAmryt Pharmaceuticals DACN-125390 RX2014-02-24
1 products
Labels
FDA
EMA
Brand Name
Status
Last Update
myaleptBiologic Licensing Application2020-09-28
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
lipodystrophy—D008060E88.1
Agency Specific
FDA
EMA
Expiration
Code
metreleptin, Myalept, Amryt Pharmaceuticals DAC
2121-02-24Orphan excl.
Patent Expiration
No data
ATC Codes
A: Alimentary tract and metabolism drugs
— A16: Other alimentary tract and metabolism products in atc
— A16A: Other alimentary tract and metabolism products in atc
— A16AA: Amino acids and derivatives
— A16AA07: Metreleptin
HCPCS
No data
Clinical
Clinical Trials
26 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Congenital generalized lipodystrophyD052497———1—1
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
LipodystrophyD008060E88.1—41—16
HyperlipidemiasD006949EFO_0003774E78.5—11——2
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
ObesityD009765EFO_0001073E66.9—6——17
Non-alcoholic fatty liver diseaseD065626EFO_0003095K75.81—3———3
Metabolic syndromeD024821EFO_0000195E88.81—3———3
Familial partial lipodystrophyD052496—1——12
OverweightD050177E66.3—2———2
FastingD005215EFO_000275611———1
AmenorrheaD000568N91.2—1———1
Insulin resistanceD007333EFO_0002614—1———1
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Multiple symmetrical lipomatosisD0080691————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Hiv-associated lipodystrophy syndromeD039682EFO_1001348————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameMETRELEPTIN
INNmetreleptin
Description
Metreleptin, sold under the brand name Myalept among others, is a synthetic analog of the hormone leptin used to treat various forms of dyslipidemia. It has been approved in Japan for metabolic disorders including lipodystrophy and in the United States as replacement therapy to treat the complications of leptin deficiency, in addition to diet, in patients with congenital generalized or acquired generalized lipodystrophy.
Classification
Protein
Drug classleptin derivatives
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)—
Identifiers
PDB—
CAS-ID186018-45-1
RxCUI1491625
ChEMBL IDCHEMBL2107857
ChEBI ID—
PubChem CID—
DrugBankDB09046
UNII IDTL60C27RLH (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
Metreleptin - Amryt Pharma
$
€
£
₣
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Metreleptin - NOVELION THERAPEUTICS INC.
$
€
£
₣
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 691 documents
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Safety
Black-box Warning
Black-box warning for: Myalept
Adverse Events
Top Adverse Reactions
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950 adverse events reported
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