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doxercalciferol capsules, Hectorol®
Doxercalciferol is a vitamin D analog that activates the vitamin D receptor to regulate calcium and phosphate metabolism and suppress parathyroid hormone (PTH) secretion.
Doxercalciferol is a vitamin D analog that activates the vitamin D receptor to regulate calcium and phosphate metabolism and suppress parathyroid hormone (PTH) 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® |
|---|---|
| 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 liver to its active metabolite, 1,25-dihydroxyvitamin D2, which binds to the vitamin D receptor in target tissues. This activation increases intestinal calcium and phosphate absorption and suppresses PTH production, thereby normalizing serum calcium and phosphate levels in patients with secondary hyperparathyroidism.
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
- Headache
- Malaise
- Nausea
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 |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- doxercalciferol capsules, Hectorol® CI brief — competitive landscape report
- doxercalciferol capsules, Hectorol® updates RSS · CI watch RSS
- Genzyme, a Sanofi Company portfolio CI