NDAORALCAPSULE, EXTENDED RELEASE
Approved
Jun 2016
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
5
Data completeness
7/8 — Comprehensive
RAYALDEE (calcifediol) by Merck & Co. is (25-hydroxyvitamin d 3 ) is a prohormone of the active form of vitamin d 3 , calcitriol (1,25‑dihydroxyvitamin d 3 ). Approved for secondary hyperparathyroidism, vitamin d insufficiency. First approved in 2016.
Drug data last refreshed 21h ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
RAYALDEE (calcifediol) is an oral extended-release capsule containing 25-hydroxyvitamin D3, a prohormone that is converted to the active form of vitamin D (calcitriol) primarily in the kidney. It is indicated for secondary hyperparathyroidism in adult patients with stage 3-4 chronic kidney disease and serum total 25-hydroxyvitamin D levels less than 30 ng/mL, as well as in patients with stage 5 chronic kidney disease and end-stage renal disease on dialysis. Calcifediol works by binding to vitamin D receptors to increase intestinal calcium and phosphorus absorption while reducing parathyroid hormone synthesis. The product addresses an important management gap in chronic kidney disease-mineral bone disorder (CKD-MBD) therapy.
$0.0BPart D
7.9 years to LOEMechanism of Action
(25-hydroxyvitamin D 3 ) is a prohormone of the active form of vitamin D 3 , calcitriol (1,25‑dihydroxyvitamin D 3 ). Calcifediol is converted to calcitriol by cytochrome P450 27B1 (CYP27B1), also called 1-alpha hydroxylase, primarily in the kidney. Calcitriol binds to the vitamin D receptor in…
Indications (2)
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.