NDAORALCAPSULE, EXTENDED RELEASE
Approved
Jun 2016
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
5
Data completeness
5/8 — Partial
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 ). First approved in 2016.
Drug data last refreshed 6h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
RAYALDEE is an oral extended-release capsule containing calcifediol, a vitamin D prohormone (25-hydroxyvitamin D3) approved by FDA in 2016. It is converted in the kidney to calcitriol (active vitamin D3), which regulates calcium and phosphorus absorption and suppresses parathyroid hormone synthesis. The drug is indicated for secondary hyperparathyroidism in patients with stage 3 or 4 chronic kidney disease.
$41MPart D
Peak7.7 years to LOEProduct is at peak commercial stage with stable Medicare Part D spending, suggesting mature market presence and established field team infrastructure.
Mechanism 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
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (5)
Efficacy and Safety of Calcifediol vs Placebo in Subjects With Vitamin D Deficiency
Started Dec 2020
674 enrolled
Vitamin D DeficiencyVitamin D Insufficiency
Safety and Efficacy of Rayaldee for Treating Mild to Moderate COVID-19
Started Nov 2020
171 enrolled
COVID-19CoronavirusSARS-CoV2 Infection
Prevention and Treatment With Calcifediol of COVID-19 Induced Acute Respiratory Syndrome
Started May 2020
517 enrolled
SARS-CoV 2COVID19SARS (Severe Acute Respiratory Syndrome)+2 more
Safety, Efficacy, PK and PD of CTAP101 (Calcifediol) ER Capsules for SHPT in HD Patients VDI
Started Jul 2018
44 enrolled
Secondary Hyperparathyroidism Due to Renal CausesChronic Kidney DiseasesVitamin D Deficiency+1 more
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
Started Jun 2018
69 enrolled
Secondary Hyperparathyroidism Due to Renal CausesVitamin D InsufficiencyCKD Stage 3+1 more
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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.