DOXERCALCIFEROL
Doxercalciferol is a synthetic vitamin D2 analog that treats secondary hyperparathyroidism in adults. It helps patients with Stage 3 or 4 chronic kidney disease, as well as those who are currently on dialysis. This medication is used to help manage parathyroid hormone levels as kidney function declines.
How DOXERCALCIFEROL Works
This drug works by undergoing metabolic activation into an active metabolite that binds to vitamin D receptors. This binding triggers specific pathways that inhibit the synthesis and secretion of parathyroid hormone. By doing so, the medication effectively lowers PTH levels in the body.
Details
- Status
- Discontinued
- First Approved
- 2011-09-23
- Routes
- INJECTION, ORAL
- Dosage Forms
- INJECTABLE, CAPSULE
Companies
DOXERCALCIFEROL Approval History
What DOXERCALCIFEROL Treats
2 indicationsDOXERCALCIFEROL is approved for 2 conditions since its original approval in 2011. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Secondary Hyperparathyroidism
- Chronic Kidney Disease
DOXERCALCIFEROL Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to DOXERCALCIFEROL
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
5 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT00889629 | 08-080 | Ph 4 | completed | Pilot Study Evaluating Doxercalciferol Replacement Therapy in Kidney Transplant Recipients |
| NCT02282813 results posted | CTAP101-CL-3003 | Ph 3 | completed | Extension Study of CTAP101-CL-3001 or CTAP101-CL-3002 |
| NCT00646282 PAD results posted | IRB00006614 | Ph 4 | terminated | Mineral Metabolism and Vascular Effects of Vitamin D Therapy in Kidney Transplant Patients |
| NCT00792857 | CTAP201-CL-1007 | Ph 1 | completed | Comparison of I.V. CTAP201 and Doxercalciferol (Hectorol) in Subjects With Chronic Kidney Disease (CKD) and Secondary Hyperparathyroidism (SHPT) |
| NCT00601107 results posted | HECTPS02507 | Ph 2 | completed | A Study to Evaluate the Safety and Effectiveness of Doxercalciferol Capsules in Participants With Moderate to Severe Psoriasis |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
DOXERCALCIFEROL FDA Label Details
Indications & Usage
FDA Label (PDF)DOXERCALCIFEROL is indicated for the treatment of Secondary Hyperparathyroidism; Chronic Kidney Disease.
Looking for the branded version?
HECTOROL
Full clinical data, patents, trials, and competitive landscape for doxercalciferol.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.