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Calcifediol - OPKO Renal/Vifor Fresenius Medical Care Renal Pharma

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Drug Profile

Calcifediol - OPKO Renal/Vifor Fresenius Medical Care Renal Pharma

Alternative Names: Calcifediol extended release - OPKO Renal/Vifor Fresenius Medical Care Renal Pharma; CTAP-101; CTAP101 Capsules; JTT-762; Modified-release calcifediol - OPKO Renal/Vifor Fresenius Medical Care Renal Pharma; RAYALDEE; Rayaldee; Rayaldy

Latest Information Update: 15 Apr 2025

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At a glance

  • Originator Cytochroma
  • Developer OPKO Health; OPKO Renal; Vifor Fresenius Medical Care Renal Pharma
  • Class Antivirals; 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
  • New Molecular Entity No

Highest Development Phases

  • Marketed Secondary hyperparathyroidism
  • Phase II COVID 2019 infections; Cystic fibrosis
  • No development reported Bone disorders

Most Recent Events

  • 30 Mar 2025 OPKO terminates a phase II trial for Secondary hyperparathyroidism (Late-stage disease, In adults) in USA (PO) (NCT03602261)
  • 19 Jun 2024 OPKO Health terminates a phase-III clinical trial in Secondary hyperparathyroidism (In adolescents, In children) in USA (PO), as FDA changed the post-marketing requirement necessitating a new study design and protocol (NCT05543928)
  • 11 Dec 2023 Phase-II clinical trials in Cystic fibrosis in USA (unspecified route) (OPKO Renal pipeline, December 2023)

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