Product Description
Calcifediol is a vitamin D3 analog that is used to treat secondary hyperparathyroidism in adult patients with stage 3 or 4 chronic kidney disease and serum total 25-hydroxyvitamin D levels less than 30 ng/mL. Hyperparathyroidism is a condition that is caused when the parathyroid glands located in the neck make too much parathyroid hormone (PTH). This hormone helps to control the concentrations of calcium and phosphorus in your blood. (Sourced from: https://www.mayoclinic.org/drugs-supplements/calcifediol-oral-route/description/drg-20312274)
Mechanisms of Action: VDR Agonist
Novel Mechanism: No
Modality: Small Molecule
Route of Administration: Oral
FDA Designation: None *
Approval Status: Approved
Approved Countries: Algeria | Australia | Austria | Belgium | Bulgaria | Canada | Chile | Colombia | Croatia | Denmark | Dominican Republic | Ecuador | Estonia | France | Germany | Greece | Hungary | Ireland | Italy | Jordan | Korea | Latvia | Lebanon | Lithuania | Luxembourg | Mexico | Netherlands | Pakistan | Peru | Philippines | Poland | Portugal | Romania | Spain | Sweden | Switzerland | Tunisia | Turkey | United Arab Emirates | United States | Vietnam
Approved Indications: Hyperparathyroidism | Hyperparathyroidism, Secondary | Kidney Diseases
Known Adverse Events: Heart Failure | Nasopharyngitis | Pharyngitis | Anemia | Dyspnea | Constipation
Company: DSM Nutritional Products
Company Location:
Company CEO:
Additonal Commercial Interests: None
Clinical Description
Countries in Clinic: Bulgaria, Czech Republic, France, Italy, Serbia, Slovakia, Spain
Active Clinical Trial Count: 4
Highest Development Phases
Phase 3: Vitamin D Deficiency
Phase 2: COVID-19|Cytokine Release Syndrome|Severe Acute Respiratory Syndrome
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
|---|---|---|---|---|---|
| WORFEROL | P3 |
Completed |
Vitamin D Deficiency |
2022-07-21 |
72% |
| WORFEROL | P3 |
Active, not recruiting |
Vitamin D Deficiency |
2022-07-12 |
|
| COVIDIOL | P2 |
Completed |
COVID-19|Cytokine Release Syndrome|Severe Acute Respiratory Syndrome |
2022-04-19 |
|
| 2020-001717-20 | P2 |
Active, not recruiting |
COVID-19|Severe Acute Respiratory Syndrome |
2020-09-16 |