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Etelcalcetide is a novel, synthetic calcimimetic peptide approved for the treatment of secondary hyperparathyroidism (SHPT) in adult patients with chronic kidney disease (CKD) receiving hemodialysis. SHPT is a common and serious complication of end-stage renal disease, caused by disruptions in calcium, phosphorus, and vitamin D metabolism. Persistent elevation of parathyroid hormone (PTH) can lead to renal osteodystrophy, vascular calcification, cardiovascular disease, and increased mortality.
Etelcalcetide offers a targeted, non-surgical option to control PTH levels in dialysis patients, representing a second-generation calcimimetic with distinct advantages over oral therapies like cinacalcet.
Etelcalcetide is a synthetic peptide agonist of the calcium-sensing receptor (CaSR), located on the surface of parathyroid gland cells. It mimics the action of extracellular calcium by allosterically activating the CaSR, thereby:
Unlike oral calcimimetics, Etelcalcetide is administered intravenously after hemodialysis, which improves treatment adherence and minimizes gastrointestinal side effects.
Etelcalcetide has been evaluated in multiple Phase 3 clinical trials, including two pivotal randomized controlled studies published in The Lancet and New England Journal of Medicine. These studies involved over 1000 hemodialysis patients with uncontrolled SHPT.
Key clinical outcomes include:
These benefits support Etelcalcetide as a first-line injectable calcimimetic for managing SHPT in dialysis patients.
Etelcalcetide API is manufactured via solid-phase peptide synthesis (SPPS), ensuring high yield, purity, and molecular stability. The API:
Etelcalcetide API is used as an active pharmaceutical ingredient to formulate medications for treating secondary hyperparathyroidism (SHPT) in adult patients with chronic kidney disease (CKD) undergoing hemodialysis.
Etelcalcetide is a second-generation calcimimetic peptide administered intravenously post-hemodialysis, which significantly improves patient adherence and minimizes common gastrointestinal side effects associated with oral calcimimetics.
It acts as a synthetic peptide agonist of the calcium-sensing receptor (CaSR) on parathyroid gland cells, allosterically activating the receptor to suppress parathyroid hormone (PTH) secretion and lower serum calcium and phosphorus levels.
Etelcalcetide API is produced using solid-phase peptide synthesis (SPPS), ensuring high chemical purity, consistent yield, and compliance with stringent GMP and ICH Q7 quality standards.
The API undergoes rigorous analytical testing including HPLC, residual solvent analysis, heavy metals testing, and endotoxin evaluation to ensure suitability for injectable pharmaceutical formulations.
