Metreleptin API is a recombinant human leptin analog used as leptin replacement therapy for the treatment of complications associated with leptin deficiency in patients with generalized lipodystrophy. Metreleptin is a recombinant protein produced using biotechnology and is structurally related to naturally occurring human leptin.
Metreleptin is a 147-amino-acid, nonglycosylated recombinant polypeptide containing one disulfide bond between Cys-97 and Cys-147. It differs from native human leptin by the addition of a methionine residue at the amino terminus. The reported molecular weight is approximately 16.15 kDa.
As a leptin analog, Metreleptin binds to and activates the human leptin receptor (LEPR/Ob-R). Leptin receptor signaling plays an important role in energy homeostasis and metabolic regulation. Metreleptin replacement can improve metabolic abnormalities associated with severe leptin deficiency, including improvements in insulin sensitivity, glycemic parameters and triglyceride levels in appropriate patients.
Metreleptin API is relevant to pharmaceutical and biologic development programs requiring a characterized recombinant protein active ingredient, with quality assessment focused on identity, protein content, purity, potency, aggregation, charge variants and other product-specific critical quality attributes.
Metreleptin is a recombinant analog of the human hormone leptin. Leptin is predominantly produced by adipose tissue and participates in the regulation of appetite, energy balance and metabolic homeostasis.
Metreleptin is designed to provide leptin activity in patients with severe leptin deficiency associated with certain forms of lipodystrophy. It binds to the human leptin receptor and activates downstream leptin signaling.
The molecule is produced as a recombinant protein in E. coli and differs from native human leptin by an additional methionine at its amino terminus.
| Parameter | Specification |
|---|---|
| Appearance | White crystalline powder or crystals |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |
| Loss on Drying | NMT 1.0% |
| Residue on Ignition | NMT 0.5% |
| Individual Impurity | NMT 0.5% |
| Total Impurities | NMT 1.0% |
| Water Content | NMT 1.0% |