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
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 |
|---|---|---|---|---|---|
| Myalept | metreleptin | Chiesi Farmaceutici | N-125390 RX | 2014-02-24 | 1 products |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| myalept | Biologic Licensing Application | 2024-03-25 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| lipodystrophy | HP_0009125 | D008060 | E88.1 |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
metreleptin, Myalept, Amryt Pharmaceuticals DAC | |||
| 2121-02-24 | Orphan excl. | ||
Patent Expiration
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HCPCS
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Clinical
Clinical Trials
40 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Lipodystrophy | D008060 | HP_0009125 | E88.1 | — | 8 | 6 | 2 | 5 | 20 |
| Congenital generalized lipodystrophy | D052497 | HP_0009064 | — | — | 1 | 4 | 1 | 1 | 6 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Diabetes mellitus | D003920 | HP_0000819 | E08-E13 | 1 | 3 | 1 | — | 1 | 6 |
| Familial partial lipodystrophy | D052496 | — | — | — | 1 | 1 | — | 1 | 3 |
| Hyperlipidemias | D006949 | HP_0003077 | E78.5 | — | 1 | 1 | — | — | 2 |
| Insulin resistance | D007333 | HP_0000855 | — | — | 2 | 1 | — | — | 2 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Obesity | D009765 | EFO_0001073 | E66.9 | — | 8 | — | — | 2 | 10 |
| Body weight | D001835 | EFO_0004338 | — | — | 4 | — | — | — | 4 |
| Non-alcoholic fatty liver disease | D065626 | EFO_0003095 | K75.81 | — | 3 | — | — | — | 3 |
| Fatty liver | D005234 | EFO_0003934 | — | — | 3 | — | — | — | 3 |
| Overweight | D050177 | — | E66.3 | 1 | 3 | — | — | — | 3 |
| Metabolic syndrome | D024821 | EFO_0000195 | E88.810 | — | 3 | — | — | — | 3 |
| Liver diseases | D008107 | HP_0002910 | K70-K77 | — | 2 | — | — | — | 2 |
| Hiv infections | D015658 | EFO_0000764 | B20 | — | 1 | — | — | — | 1 |
| Syndrome | D013577 | — | — | — | 1 | — | — | — | 1 |
| Fasting | D005215 | EFO_0002756 | — | 1 | 1 | — | — | — | 1 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Type 1 diabetes mellitus | D003922 | EFO_0001359 | E10 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Morbid obesity | D009767 | EFO_0001074 | — | — | — | — | — | 1 | 1 |
| Hiv-associated lipodystrophy syndrome | D039682 | EFO_1001348 | — | — | — | — | — | 1 | 1 |
| Hypertriglyceridemia | D015228 | EFO_0004211 | — | — | — | — | — | 1 | 1 |
| Weight loss | D015431 | HP_0001824 | — | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Metreleptin |
| INN | metreleptin |
| 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 class | leptin derivatives |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | — |
Identifiers
| PDB | — |
| CAS-ID | — |
| RxCUI | — |
| ChEMBL ID | CHEMBL2107857 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | DB09046 |
| UNII ID | TL60C27RLH (ChemIDplus, GSRS) |
Target
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Metreleptin – Amryt Pharma
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Metreleptin – Novelion Therapeutics
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Estimated US medical usage
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Trends
PubMed Central
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Additional graphs summarizing 870 documents
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Safety
Black-box Warning
Black-box warning for: Myalept
Adverse Events
Top Adverse Reactions
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1,017 adverse events reported
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