CALDEROL

LOE Approaching

calcifediol

NDAORALCAPSULE
Approved
Aug 1980
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
4

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…

Clinical Trials (4)

NCT04735926Phase 2/3Completed

Efficacy and Safety of Calcifediol vs Placebo in Subjects With Vitamin D Deficiency

Started Dec 2020
674 enrolled
Vitamin D DeficiencyVitamin D Insufficiency
NCT04366908Phase 2Completed

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
NCT03602261Phase 2Terminated

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
NCT03588884Phase 4Completed

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