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Etelcalcetide Hydrochloride API is a novel synthetic peptide calcimimetic developed for the treatment of secondary hyperparathyroidism (SHPT) in patients with chronic kidney disease (CKD) undergoing hemodialysis. SHPT is a common and serious complication in CKD patients, characterized by elevated parathyroid hormone (PTH) levels, disrupted calcium-phosphate metabolism, and increased risk of bone and cardiovascular disease. Etelcalcetide represents a second-generation calcimimetic, administered intravenously, and offers advantages over earlier oral therapies like cinacalcet by improving compliance and reducing gastrointestinal side effects.
Etelcalcetide works by binding to and activating the calcium-sensing receptor (CaSR) located on parathyroid gland cells. This mimics the physiological effect of extracellular calcium, leading to:
As a peptide-based allosteric activator of CaSR, Etelcalcetide shows high specificity and sustained activity following intravenous administration post-dialysis.
Etelcalcetide has been extensively evaluated in phase 3 clinical trials, including EVOLVE, AMPLIFY, and EQUIP studies. Key findings include:
Significant and sustained reduction in PTH levels in CKD patients on hemodialysis.
Effective control of serum calcium and phosphorus, contributing to improved bone-mineral homeostasis.
Better tolerability compared to oral calcimimetics, exhibiting less nausea and vomiting.
Improved patient adherence due to thrice-weekly IV administration during dialysis sessions.
These benefits make Etelcalcetide an important therapeutic option for nephrologists managing SHPT in dialysis populations.
Our Etelcalcetide Hydrochloride API characteristics include:
