RAYALDEE (calcifediol)
Rayaldee helps adults with stage 3 or 4 chronic kidney disease manage secondary hyperparathyroidism. It is specifically used for patients whose serum total 25-hydroxyvitamin D levels have fallen below 30 ng/mL. This medication is not intended for patients with end-stage renal disease or those currently receiving dialysis.
How RAYALDEE Works
This medication works by providing a prohormone that the kidneys convert into calcitriol, the active form of vitamin D3. Once activated, it binds to vitamin D receptors to increase the absorption of calcium and phosphorus while simultaneously reducing the production of parathyroid hormone.
Details
- Status
- Prescription
- First Approved
- 2016-06-17
- Patent Cliff
- 2034
- Routes
- ORAL
- Dosage Forms
- CAPSULE, EXTENDED RELEASE
RAYALDEE Approval History
What RAYALDEE Treats
2 indicationsRAYALDEE is approved for 2 conditions since its original approval in 2016. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Secondary Hyperparathyroidism
- Chronic Kidney Disease
RAYALDEE Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to RAYALDEE
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
5 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT02962102 ACTIVATE-AKI results posted | 2016P002527 5K23DK106448 | Ph 2 | completed | Activated Vitamin D for the Prevention and Treatment of Acute Kidney Injury |
| NCT04551911 results posted | CTAP101-CL-2014 | Ph 2 | completed | Safety and Efficacy of Rayaldee for Treating Mild to Moderate COVID-19 |
| NCT02548364 VITDAMI | FJD-VITDAMI-14-01 | Ph 3 | completed | Effect of Vitamin D on Ventricular Remodeling in Patients With Acute Myocardial Infarction (VITDAMI) |
| NCT01939977 PARIDOINAL results posted | ACA-SPAI-11-24 2013-001326-25 | Ph 4 | completed | Efficacy and Safety of Paricalcitol in the Reduction of Secondary Hyperparathyroidism After Kidney Transplantation. |
| NCT02805907 ACViD results posted | 300681 | Ph 4 | completed | Efficacy of Calcifediol Supplementation in Asthma Control in Asthmatic Patients With Vitamin D Deficiency (ACViD) |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
RAYALDEE FDA Label Details
Indications & Usage
FDA Label (PDF)RAYALDEE is indicated for the treatment of Secondary Hyperparathyroidism; Chronic Kidney Disease.
RAYALDEE Patents & Exclusivity
Patents (16 active)
Pro Intelligence Preview
Deep insights for RAYALDEE
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2034
- • 22 active patents
Trial Analysis
- • Clinical trial tracking
- • Development stage analysis
Competitive Landscape
- • 20 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.