Calcifediol

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

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
Opti Active D	414401	Factors Group Australia Pty Ltd	Medicine	A	7/24/2023
Ampli-D Capsules	370837	DSM Nutritional Products Australia Pty Ltd	Medicine	A	7/9/2021
Eagle Clinical BIO-D	361971	Integria Healthcare Australia Pty Ltd	Medicine	A	4/14/2021
Opti Active D & K2	413792	Factors Group Australia Pty Ltd	Medicine	A	7/20/2023
Ampli-D Generic Bulk Tablets	353551	DSM Nutritional Products Australia Pty Ltd	Medicine	A	1/25/2021
Alkalising Mineral Complex	482006	Designs For Health Pty Ltd	Medicine	A	3/7/2025
FORTARO Capsules	370835	DSM Nutritional Products Australia Pty Ltd	Medicine	A	7/9/2021
Swisse Ultiboost Fast Acting Vitamin D3	393359	Swisse Wellness Pty Ltd	Medicine	A	8/3/2022
d.velop	370833	DSM Nutritional Products Australia Pty Ltd	Medicine	A	7/9/2021
Eagle Clinical BIO-D + K2	441410	Integria Healthcare Australia Pty Ltd	Medicine	A	2/19/2024

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
RAYALDEE	eirgen pharma limited	02478498	Capsule - Oral	30 MCG	N/A

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
HIDROFEROL 0,266 mg SOLUCION ORAL	Faes Farma S.A.	53683	SOLUCIÓN ORAL	Medicamento Sujeto A Prescripción Médica	Commercialized
CALCIFEDIOL FAES 0,266 MG CAPSULAS BLANDAS EFG	Faes Farma S.A.	82268	CÁPSULA BLANDA	Medicamento Sujeto A Prescripción Médica	Not Commercialized
HIDROFEROL 0,1 mg/ml GOTAS ORALES EN SOLUCION	Faes Farma S.A.	55315	GOTAS ORALES EN SOLUCIÓN	Medicamento Sujeto A Prescripción Médica	Commercialized
HIDROFEROL CHOQUE 3 mg SOLUCION ORAL	Faes Farma S.A.	53684	SOLUCIÓN ORAL	Medicamento Sujeto A Prescripción Médica	Commercialized
RAYALDEE 30 MICROGRAMOS CAPSULAS BLANDAS DE LIBERACION PROLONGADA	Vifor Fresenius Medical Care Renal Pharma France	85519	CÁPSULA BLANDA DE LIBERACIÓN PROLONGADA	Medicamento Sujeto A Prescripción Médica	Not Commercialized

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

AI-Powered Research

Premium Access