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doxercalciferol capsules, Hectorol® capsules
Doxercalciferol is a vitamin D analog that activates the vitamin D receptor to regulate calcium and phosphate metabolism and suppress parathyroid hormone secretion.
Doxercalciferol is a vitamin D analog that activates the vitamin D receptor to regulate calcium and phosphate metabolism and suppress parathyroid hormone secretion. Used for Secondary hyperparathyroidism in patients with chronic kidney disease on dialysis, Secondary hyperparathyroidism in patients with stage 3 or 4 chronic kidney disease not on dialysis.
At a glance
| Generic name | doxercalciferol capsules, Hectorol® capsules |
|---|---|
| Sponsor | Genzyme, a Sanofi Company |
| Drug class | Vitamin D analog |
| Target | Vitamin D receptor (VDR) |
| Modality | Small molecule |
| Therapeutic area | Endocrinology / Nephrology |
| Phase | FDA-approved |
Mechanism of action
Doxercalciferol is a prodrug that is converted in the body to the active metabolite 1,25-dihydroxyvitamin D2, which binds to and activates the vitamin D receptor (VDR) in target tissues. This activation regulates intestinal calcium and phosphate absorption, bone mineralization, and suppresses parathyroid hormone (PTH) production, making it effective for treating secondary hyperparathyroidism in patients with chronic kidney disease.
Approved indications
- Secondary hyperparathyroidism in patients with chronic kidney disease on dialysis
- Secondary hyperparathyroidism in patients with stage 3 or 4 chronic kidney disease not on dialysis
Common side effects
- Hypercalcemia
- Hyperphosphatemia
- Elevated calcium-phosphate product
- Nausea
- Headache
Key clinical trials
- Safety and Efficacy of Hectorol in Pediatric Patients With Chronic Kidney Disease Stage 3 and 4 With Secondary Hyperparathyroidism Not Yet on Dialysis (PHASE3)
- A Phase 4 Study to Determine Dosing of Hectorol® Capsules When Converting From Zemplar® Injection (PHASE4)
- A Phase 4, Conversion Study of Hectorol® Injection to Hectorol® Capsules in Stage 5 CKD Patients on Dialysis (PHASE4)
- A Study to Evaluate the Safety and Effectiveness of Doxercalciferol Capsules in Participants With Moderate to Severe Psoriasis (PHASE2)
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 |
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