RAYALDEE

Peak

calcifediol

NDAORALCAPSULE, EXTENDED RELEASE
Approved
Jun 2016
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
5

Clinical Trials (5)

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
NCT04551911Phase 2Completed

Safety and Efficacy of Rayaldee for Treating Mild to Moderate COVID-19

Started Nov 2020
171 enrolled
COVID-19CoronavirusSARS-CoV2 Infection
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

Loss of Exclusivity

LOE Date
Mar 14, 2034
97 months away
Patent Expiry
Mar 14, 2034

Patent Records (5)

Patent #ExpiryTypeUse Code
10213442
Feb 2, 2027
Product
8906410
Feb 2, 2027
Product
9943530
Feb 2, 2027
U-2274
11154509
Apr 25, 2028
U-3815
8207149
Apr 25, 2028
U-1871