Drug Profile


Alternative Names: AMG-416; Etelcalcetide hydrochloride; KAI-4169; KAI-4169-HCl; ONO-5163; Parsabiv; Telcalcetide; Velcalcetide; Velcalcetide hydrochloride

Latest Information Update: 10 Sep 2017

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At a glance

  • Originator KAI Pharmaceuticals
  • Developer Amgen; Ono Pharmaceutical
  • Class Disulfides; Peptides
  • Mechanism of Action Calcium-sensing receptor agonists
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Secondary hyperparathyroidism

Most Recent Events

  • 03 Oct 2017 Amgen plans a phase III trial for Secondary hyperparathyroidism (in Asian haemodialysis patients) (NCT03299244)
  • 19 Sep 2017 Amgen plans a phase I trial of AMG 416 for Secondary hyperparathyroidism in China in November 2017 (NCT03283098)
  • 26 Jun 2017 Amgen completes a phase III extension trial for Secondary hyperparathyroidism (in patients with CKD on haemodialysis) in USA, Australia, Austria, Belgium, Canada, Czech Republic, Denmark, France, Germany, Greece, Hungary, Israel, Italy, Latvia, Lithuania, the Netherlands, New Zealand, Poland, Portugal, Russia, Spain, Sweden, Switzerland and Turkey (IV) (NCT02102204)
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