Etelcalcetide Hydrochloride
Etelcalcetide Hydrochloride API
Etelcalcetide Hydrochloride 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.
Mechanism of Action
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:
Suppression of PTH secretion
Reduction in serum calcium and phosphate levels
Improved mineral balance and bone metabolism
As a peptide-based allosteric activator of CaSR, Etelcalcetide shows high specificity and sustained activity following intravenous administration post-dialysis.
Clinical Research and Therapeutic Effect
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 (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.
Quality and Manufacturing
Our Etelcalcetide Hydrochloride API:
Is synthesized through solid-phase peptide synthesis (SPPS) with high purity
Conforms to pharmaceutical-grade specifications, suitable for injectable formulations
Shows low levels of residual solvents, impurities, and endotoxins
Is scalable for GMP-compliant large-batch production
