Calcifediol extended release - OPKO Renal

Drug Profile

Calcifediol extended release - OPKO Renal

Alternative Names: CTAP-101; CTAP101 Capsules; Modified-release calcifediol - OPKO; Rayaldee; Rayaldy

Latest Information Update: 25 Nov 2016

Price : $50

At a glance

  • Originator Cytochroma
  • Developer OPKO Renal
  • Class Calcium regulators; Osteoporosis therapies; Vitamin D analogues
  • Mechanism of Action Calcitriol 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 No

Highest Development Phases

  • Marketed Secondary hyperparathyroidism
  • Phase I Bone disorders

Most Recent Events

  • 23 Nov 2016 Launched for Secondary hyperparathyroidism in USA (PO)
  • 21 Jun 2016 Registered for Secondary hyperparathyroidism in USA (PO)
  • 09 May 2016 Extended release calcifediol licensed to Vifor Fresenius Medical Care Renal Pharma in Europe (except Russia), Canada, Mexico, Australia and South Korea
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