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Etelcalcetide

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https://www.readbyqxmd.com/read/27900648/etelcalcetide-first-global-approval
#1
Hannah A Blair
Etelcalcetide (Parsabiv™) is a novel second generation calcimimetic agent developed by Amgen for the treatment of secondary hyperparathyroidism (SHPT), a complication of chronic kidney disease (CKD). Etelcalcetide reduces circulating levels of parathyroid hormone and calcium by binding directly to the calcium-sensing receptor. Intravenous etelcalcetide has been approved in the EU for the treatment of SHPT in adult patients with CKD on haemodialysis therapy. Regulatory applications for etelcalcetide in SHPT are also under review in the USA and Japan...
November 29, 2016: Drugs
https://www.readbyqxmd.com/read/27639083/population-pharmacokinetics-and-pharmacodynamics-of-the-calcimimetic-etelcalcetide-in-chronic-kidney-disease-and-secondary-hyperparathyroidism-receiving-hemodialysis
#2
P Chen, P Olsson Gisleskog, J J Perez-Ruixo, J Xiao, J Wilkins, A Narayanan, J P Gibbs, M Melhem
Etelcalcetide is a novel calcimimetic in development for the treatment of secondary hyperparathyroidism (SHPT). A population pharmacokinetic/pharmacodynamic (PK/PD) model was developed relating etelcalcetide exposures to markers of efficacy (parathyroid hormone [PTH]) and safety (calcium) using data from three clinical studies. The semimechanistic model was developed that included allosteric activation pharmacology and understanding of calcium homeostasis. The temporal profiles for all biomarkers were well described by the model...
September 2016: CPT: Pharmacometrics & Systems Pharmacology
https://www.readbyqxmd.com/read/27517676/pharmacokinetics-biotransformation-and-excretion-of-14-c-etelcalcetide-amg-416-following-a-single-microtracer-intravenous-dose-in-patients-with-chronic-kidney-disease-on-hemodialysis
#3
Raju Subramanian, Xiaochun Zhu, M Benjamin Hock, Bethlyn J Sloey, Benjamin Wu, Sarah F Wilson, Ogo Egbuna, J Greg Slatter, Jim Xiao, Gary L Skiles
Etelcalcetide (AMG 416) is a novel synthetic peptide calcium-sensing receptor activator in clinical development as an intravenous calcimimetic for the treatment of secondary hyperparathyroidism in patients with chronic kidney disease (CKD) on hemodialysis. Etelcalcetide is composed of seven D-aminoacids with an L-cysteine linked to a D-cysteine by a disulfide bond. A single intravenous dose of [(14)C]etelcalcetide (10 mg; 26.3 kBq; 710 nCi) was administered to patients with CKD on hemodialysis to elucidate the pharmacokinetics, biotransformation, and excretion of etelcalcetide in this setting...
August 12, 2016: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/26941242/nonclinical-safety-profile-of-etelcalcetide-a-novel-peptide-calcimimetic-for-the-treatment-of-secondary-hyperparathyroidism
#4
Mark R Fielden, Charles Dean, Kurt Black, Satin G Sawant, Raju Subramanian, James E Tomlinson, Sarah Walter, Cameron Zimmermann, Mark W Griggs, Marie E McKeon, Elise M Lewis, Carol Beevers, Ian Pyrah
Etelcalcetide is a novel d-amino acid peptide that functions as an allosteric activator of the calcium-sensing receptor and is being developed as an intravenous calcimimetic for the treatment of secondary hyperparathyroidism in patients with chronic kidney disease on hemodialysis. To support clinical development and marketing authorization, a comprehensive nonclinical safety package was generated. Primary adverse effects included hypocalcemia, tremoring, and convulsions. Other adverse effects were considered sequelae of stress associated with hypocalcemia...
May 2016: International Journal of Toxicology
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