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CTAP101 Capsules
CTAP101 is a capsule formulation of calcitriol (active vitamin D) that enhances calcium absorption and regulates calcium-phosphate metabolism.
CTAP101 is a capsule formulation of calcitriol (active vitamin D) that enhances calcium absorption and regulates calcium-phosphate metabolism. Used for Secondary hyperparathyroidism in patients with chronic kidney disease, Vitamin D deficiency-related mineral metabolism disorders.
At a glance
| Generic name | CTAP101 Capsules |
|---|---|
| Also known as | Calcifediol, calcifediol |
| Sponsor | OPKO Health, Inc. |
| Drug class | Vitamin D analog |
| Target | Vitamin D receptor (VDR) |
| Modality | Small molecule |
| Therapeutic area | Nephrology / Endocrinology |
| Phase | Phase 3 |
Mechanism of action
Calcitriol is the active metabolite of vitamin D that binds to the vitamin D receptor (VDR) in intestinal epithelial cells and bone, promoting calcium and phosphate absorption and homeostasis. This formulation is designed to treat secondary hyperparathyroidism and related mineral metabolism disorders in patients with chronic kidney disease or other conditions causing vitamin D deficiency.
Approved indications
- Secondary hyperparathyroidism in patients with chronic kidney disease
- Vitamin D deficiency-related mineral metabolism disorders
Common side effects
- Hypercalcemia
- Hyperphosphatemia
- Nausea
- Headache
Key clinical trials
- Pharmacokinetics, Pharmacodynamics, Safety and Tolerability Evaluation of CTAP101 Extended-release Capsules in Pediatric Participants (PHASE2)
- 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 CTAP101 to Treat Secondary Hyperparathyroidism in Stage 3 or 4 CKD and Vitamin D Insufficiency (PHASE3)
- Safety and Efficacy of CTAP101 to Treat Secondary Hyperparathyroidism in Stage 3 or 4 CKD and Vitamin D Insufficiency (PHASE3)
- Safety and Efficacy of Rayaldee for Treating Mild to Moderate COVID-19 (PHASE2)
- 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)
- Pharmacokinetics and Safety Study of CTAP101 Capsules in Japanese and Non-Japanese Healthy Subjects and Non-Japanese Healthy Subjects (PHASE1)
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 |