HECTOROL (doxercalciferol) · Sanofi
HECTOROL is FDA-approved to treat 2 conditions (same as DOXERCALCIFEROL).
Development Insights
Details
- Status
- Discontinued
- First Approved
- 1999-06-09
- Patent Cliff
- 2028
- Routes
- ORAL, INJECTION
- Dosage Forms
- CAPSULE, INJECTABLE
HECTOROL Approval History
What HECTOROL Treats
2 indicationsHECTOROL is approved for 2 conditions since its original approval in 1999. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Secondary Hyperparathyroidism
- Chronic Kidney Disease
Same approved indications as DOXERCALCIFEROL (same active ingredient).
Sanofi's other novel FDA approvals
Other CDER-designated drugs from the same sponsor (2016–2025).
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.
HECTOROL FDA Label Details
Indications & Usage
FDA Label (PDF)HECTOROL is FDA-approved to treat 2 conditions — same approved indications as DOXERCALCIFEROL.
HECTOROL Patents & Exclusivity
Exclusivity
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment