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Calcifediol

Generic Name
Calcifediol
Brand Names
Rayaldee
Drug Type
Small Molecule
Chemical Formula
C27H44O2
CAS Number
19356-17-3
Unique Ingredient Identifier
T0WXW8F54E

Overview

The major circulating metabolite of vitamin D3 (cholecalciferol). It is produced in the liver and is the best indicator of the body's vitamin D stores. It is effective in the treatment of rickets and osteomalacia, both in azotemic and non-azotemic patients. Calcifediol also has mineralizing properties.

Indication

Used to treat vitamin D deficiency or insufficiency, refractory rickets (vitamin D resistant rickets), familial hypophosphatemia and hypoparathyroidism, and in the management of hypocalcemia and renal osteodystrophy in patients with chronic renal failure undergoing dialysis. Also used in conjunction with calcium in the management and prevention of primary or corticosteroid-induced osteoporosis.

Associated Conditions

  • Secondary Hyperparathyroidism (SHPT)

Clinical Trials

Title
Posted
Study ID
Phase
Status
Sponsor
Calcifediol in the Treatment of SARS-CoV-2 Disease (COVID-19).
2024/02/28
NCT06279910
N/A
Completed
Complejo Hospitalario Universitario de Albacete
REstoration of VItamin D in Pulmonary Arterial Hypertension
2024/02/14
NCT06258850
Phase 4
Not yet recruiting
Parc de Salut Mar
Calcifediol in the Treatment of COVID 19
2023/04/19
NCT05819918
N/A
Completed
Maimónides Biomedical Research Institute of Córdoba
Phase 3 Safety and Efficacy Study of CTAP101 Extended-release Capsules in Children With Secondary Hyperparathyroidism
2022/09/16
NCT05543928
Phase 3
Terminated
OPKO Health, Inc.
Efficacy and Safety of Calcifediol vs Placebo in Subjects With Vitamin D Deficiency
2021/02/03
NCT04735926
Phase 2
Completed
Faes Farma, S.A.
Safety and Efficacy of Rayaldee for Treating Mild to Moderate COVID-19
2020/09/16
NCT04551911
Phase 2
Completed
OPKO Health, Inc.
Safety, Efficacy, PK and PD of CTAP101 (Calcifediol) ER Capsules for SHPT in HD Patients VDI
2018/07/26
NCT03602261
Phase 2
Terminated
OPKO Health, Inc.
Repeated-dose Safety, Efficacy, Pharmacokinetic and Pharmacodynamic of CTAP101, Immediate-release Calcifediol, High-dose Cholecalciferol, and Paricalcitol Plus Low-dose Cholecalciferol in Patients With Secondary Hyperparathyroidism, Chronic Kidney Disease 3-4 and Vitamin D Insufficiency
2018/07/17
NCT03588884
Phase 4
Completed
OPKO Health, Inc.
25-Hydroxyvitamin D Pharmacokinetic Study
2018/01/17
NCT03401541
Early Phase 1
Completed
Boston University
The Effect of Supplementation of Vitamin D Deficiency in Older People With Acute Hip Fracture:
2017/07/11
NCT03213886
Phase 4
Completed
Leonor Cuadra Llopart

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
Rayaldee
OPKO Pharmaceuticals LLC
70301-1001
ORAL
30 ug in 1 1
1/19/2024
Rayaldee
OPKO Pharmaceuticals LLC
70301-1002
ORAL
30 ug in 1 1
1/19/2024

EMA Drug Approvals

Approved Product
Authorization Holder
Status
Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product
Manufacturer
Approval Number
Dosage Form
Strength
Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product
Registration No.
Company
Licence No.
Strength
Registration Date
HIDROFEROL CAPSULES 0.266MG
N/A
DCH Auriga (Hong Kong) Limited
N/A
N/A
7/10/2023
RAYALDEE EXTENDED-RELEASE SOFT CAPSULES 30MCG
N/A
nicoya therapeutics (hong kong) limited
N/A
N/A
6/18/2025

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