Etelcalcetide

Drug Profile

Etelcalcetide

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

Latest Information Update: 15 Nov 2016

Price : $50

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.

    No
  • On Fast track

    Fast track status is assigned by the US FDA so therapies with the potential to address unmet needs can move faster through development.

    No
  • New Molecular Entity Yes

Highest Development Phases

  • Registered Secondary hyperparathyroidism

Most Recent Events

  • 11 Nov 2016 Registered for Secondary hyperparathyroidism in European Union, Norway, Iceland, Liechtenstein (IV)
  • 21 Sep 2016 Chemical structure information added
  • 16 Sep 2016 The Committee for Medicinal Products for Human Use of the EMA recommends approval of etelcalcetide for Secondary hyperparathyroidism in European Union
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