Last reviewed · How we verify
Calcifediol Oral Capsule
At a glance
| Generic name | Calcifediol Oral Capsule |
|---|---|
| Also known as | CTAP101, Vitamin D |
| Sponsor | OPKO Health, Inc. |
| Modality | Small molecule |
| Phase | FDA-approved |
Approved indications
Common side effects
Key clinical trials
- Oral Vitamin D3 Effect on Inflammatory Biomarkers in Ulcerative Colitis Patients (NA)
- Effect of Vitamin D3 on Brain Waves in Male Parkinson's Patients With Low Vitamin D: A qEEG Study (NA)
- Phase 3 Safety and Efficacy Study of CTAP101 Extended-release Capsules in Children With Secondary Hyperparathyroidism (PHASE3)
- Safety, Efficacy, PK and PD of CTAP101 (Calcifediol) ER Capsules for SHPT in HD Patients VDI (PHASE2)
- Safety and Efficacy of Rayaldee for Treating Mild to Moderate COVID-19 (PHASE2)
- REstoration of VItamin D in Pulmonary Arterial Hypertension (PHASE4)
- Efficacy and Safety of Calcifediol vs Placebo in Subjects With Vitamin D Deficiency (PHASE2, PHASE3)
- 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 (PHASE4)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Calcifediol Oral Capsule CI brief — competitive landscape report
- Calcifediol Oral Capsule updates RSS · CI watch RSS
- OPKO Health, Inc. portfolio CI