Literature DB >> 27900648

Etelcalcetide: First Global Approval.

Hannah A Blair1.   

Abstract

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. This article summarizes the milestones in the development of etelcalcetide leading to this first global approval for the treatment of SHPT.

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Year:  2016        PMID： 27900648     DOI： 10.1007/s40265-016-0671-3

Source DB:  PubMed          Journal:  Drugs        ISSN： 0012-6667            Impact factor:   9.546


  13 in total

1.  A pharmacokinetic/pharmacodynamic model for AMG 416, a novel calcimimetic peptide, following a single intravenous dose in healthy subjects.

Authors:  Jun Shen; Jim Xiao; Karen Pickthorn; Saling Huang; Gregory Bell; Andrew Vick; Ping Chen
Journal:  J Clin Pharmacol       Date:  2014-05-02       Impact factor: 3.126

2.  Population pharmacokinetics analysis of AMG 416, an allosteric activator of the calcium-sensing receptor, in subjects with secondary hyperparathyroidism receiving hemodialysis.

Authors:  Ping Chen; Murad Melhem; Jim Xiao; Mita Kuchimanchi; Juan Jose Perez Ruixo
Journal:  J Clin Pharmacol       Date:  2015-02-18       Impact factor: 3.126

3.  A randomized, double-blind, phase 2 study evaluating the safety and efficacy of AMG 416 for the treatment of secondary hyperparathyroidism in hemodialysis patients.

Authors:  Gregory Bell; Saling Huang; Kevin J Martin; Geoffrey A Block
Journal:  Curr Med Res Opin       Date:  2015-05       Impact factor: 2.580

4.  Critical Cysteine Residues in Both the Calcium-Sensing Receptor and the Allosteric Activator AMG 416 Underlie the Mechanism of Action.

Authors:  Shawn T Alexander; Thomas Hunter; Sarah Walter; Jin Dong; Derek Maclean; Amos Baruch; Raju Subramanian; James E Tomlinson
Journal:  Mol Pharmacol       Date:  2015-08-19       Impact factor: 4.436

Review 5.  The Use of Calcimimetics for the Treatment of Secondary Hyperparathyroidism: A 10 Year Evidence Review.

Authors:  Mariano Rodríguez; William G Goodman; Vassilios Liakopoulos; Piergiorgio Messa; Andrzej Wiecek; John Cunningham
Journal:  Semin Dial       Date:  2015-03-08       Impact factor: 3.455

Review 6.  Emerging drugs for secondary hyperparathyroidism.

Authors:  Mario Cozzolino; James Tomlinson; Liron Walsh; Antonio Bellasi
Journal:  Expert Opin Emerg Drugs       Date:  2015-02-23       Impact factor: 4.191

7.  Pharmacology of AMG 416 (Velcalcetide), a novel peptide agonist of the calcium-sensing receptor, for the treatment of secondary hyperparathyroidism in hemodialysis patients.

Authors:  Sarah Walter; Amos Baruch; Jin Dong; James E Tomlinson; Shawn T Alexander; Julie Janes; Tom Hunter; Qun Yin; Derek Maclean; Gregory Bell; Dirk B Mendel; Randolph M Johnson; Felix Karim
Journal:  J Pharmacol Exp Ther       Date:  2013-05-14       Impact factor: 4.030

8.  Pharmacokinetics, Biotransformation, and Excretion of [14C]Etelcalcetide (AMG 416) Following a Single Microtracer Intravenous Dose in Patients with Chronic Kidney Disease on Hemodialysis.

Authors:  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
Journal:  Clin Pharmacokinet       Date:  2017-02       Impact factor: 6.447

9.  Comparison of AMG 416 and cinacalcet in rodent models of uremia.

Authors:  Sarah Walter; Amos Baruch; Shawn T Alexander; Julie Janes; Eiketsu Sho; Jin Dong; Qun Yin; Derek Maclean; Dirk B Mendel; Felix Karim; Randolph M Johnson
Journal:  BMC Nephrol       Date:  2014-05-19       Impact factor: 2.388

10.  Velcalcetide (AMG 416), a novel peptide agonist of the calcium-sensing receptor, reduces serum parathyroid hormone and FGF23 levels in healthy male subjects.

Authors:  Kevin J Martin; Gregory Bell; Karen Pickthorn; Saling Huang; Andrew Vick; Peter Hodsman; Munro Peacock
Journal:  Nephrol Dial Transplant       Date:  2013-11-13       Impact factor: 5.992
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  6 in total

Review 1.  Vitamin D and Calcimimetics in Cardiovascular Disease.

Authors:  Kenneth Lim; Takayuki Hamano; Ravi Thadhani
Journal:  Semin Nephrol       Date:  2018-05       Impact factor: 5.299

2.  Old and new calcimimetics for treatment of secondary hyperparathyroidism: impact on biochemical and relevant clinical outcomes.

Authors:  Luciano Pereira; Catarina Meng; Daniela Marques; João M Frazão
Journal:  Clin Kidney J       Date:  2017-12-08

Review 3.  Treatment of secondary hyperparathyroidism: the clinical utility of etelcalcetide.

Authors:  Mario Cozzolino; Andrea Galassi; Ferruccio Conte; Michela Mangano; Luca Di Lullo; Antonio Bellasi
Journal:  Ther Clin Risk Manag       Date:  2017-06-01       Impact factor: 2.423

4.  New scenarios in secondary hyperparathyroidism: etelcalcetide. Position paper of working group on CKD-MBD of the Italian Society of Nephrology.

Authors:  Antonio Bellasi; Mario Cozzolino; Fabio Malberti; Giovanni Cancarini; Ciro Esposito; Carlo Maria Guastoni; Patrizia Ondei; Giuseppe Pontoriero; Ugo Teatini; Giuseppe Vezzoli; Marzia Pasquali; Piergiorgio Messa; Francesco Locatelli
Journal:  J Nephrol       Date:  2019-12-18       Impact factor: 3.902

5.  Thymodepressin-Unforeseen Immunosuppressor.

Authors:  Vladislav I Deigin; Julia E Vinogradova; Dmitry L Vinogradov; Marina S Krasilshchikova; Vadim T Ivanov
Journal:  Molecules       Date:  2021-10-29       Impact factor: 4.411

6.  2-(Fluoromethoxy)-4'-(S-methanesulfonimidoyl)-1,1'-biphenyl (UCM-1306), an Orally Bioavailable Positive Allosteric Modulator of the Human Dopamine D1 Receptor for Parkinson's Disease.

Authors:  Javier García-Cárceles; Henar Vázquez-Villa; José Brea; David Ladron de Guevara-Miranda; Giovanni Cincilla; Melchor Sánchez-Martínez; Anabel Sánchez-Merino; Sergio Algar; María Teresa de Los Frailes; Richard S Roberts; Juan A Ballesteros; Fernando Rodríguez de Fonseca; Bellinda Benhamú; María I Loza; María L López-Rodríguez
Journal:  J Med Chem       Date:  2022-08-31       Impact factor: 8.039
  6 in total

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