NDAORALCAPSULE
Approved
Aug 1980
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
4
Data completeness
4/8 — Partial
CALDEROL (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, vitamin d deficiency and 1 more indications. First approved in 1980.
Drug data last refreshed 1w ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
CALDEROL (calcifediol) is an oral vitamin D prohormone approved in 1980 for treating secondary hyperparathyroidism, vitamin D insufficiency and deficiency in chronic kidney disease patients. It is converted by kidney enzymes to the active form calcitriol, which binds vitamin D receptors to increase calcium absorption and reduce parathyroid hormone synthesis.
LOE Approaching
Product approaching loss of exclusivity signals potential team restructuring and transition to generic-focused or lifecycle extension strategies.
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 (4)
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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.