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Calcifediol Oral Product
Calcifediol is an active vitamin D metabolite that binds to the vitamin D receptor to regulate calcium and phosphate homeostasis and modulate immune function.
Calcifediol is an active vitamin D metabolite that binds to the vitamin D receptor to regulate calcium and phosphate homeostasis and modulate immune function. Used for Secondary hyperparathyroidism in patients with chronic kidney disease, Hypocalcemia in patients with hypoparathyroidism.
At a glance
| Generic name | Calcifediol Oral Product |
|---|---|
| Sponsor | OPKO Health, Inc. |
| Drug class | Vitamin D analog |
| Target | Vitamin D receptor (VDR) |
| Modality | Small molecule |
| Therapeutic area | Endocrinology / Nephrology |
| Phase | FDA-approved |
Mechanism of action
Calcifediol (1,25-dihydroxyvitamin D3) is a potent active form of vitamin D that acts as a ligand for the vitamin D receptor (VDR), a nuclear receptor that regulates gene expression involved in calcium absorption, phosphate metabolism, and immune cell differentiation. By activating VDR signaling, calcifediol increases intestinal calcium absorption and helps maintain mineral homeostasis, while also modulating T-cell and B-cell function through immune regulatory pathways.
Approved indications
- Secondary hyperparathyroidism in patients with chronic kidney disease
- Hypocalcemia in patients with hypoparathyroidism
Common side effects
- Hypercalcemia
- Hyperphosphatemia
- Nausea
- Vomiting
- Headache
Key clinical trials
- Oral Vitamin D3 Effect on Inflammatory Biomarkers in Ulcerative Colitis Patients (NA)
- Phase 3 Safety and Efficacy Study of CTAP101 Extended-release Capsules in Children With Secondary Hyperparathyroidism (PHASE3)
- Safety and Efficacy of Rayaldee for Treating Mild to Moderate COVID-19 (PHASE2)
- 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 (PHASE4)
- Pregnancy Outcome and Vitamin D Level Among Vitamin D Supplementation During Pregnancy (PHASE3)
- Effect of Vitamin D Supplement on Inflammation Markers in High-Risk Cardiovascular Patients With Chronic Kidney Disease (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Calcifediol Oral Product CI brief — competitive landscape report
- Calcifediol Oral Product updates RSS · CI watch RSS
- OPKO Health, Inc. portfolio CI