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Hectorol (DOXERCALCIFEROL)
Hectorol works by activating the Vitamin D receptor, which helps regulate calcium levels in the body.
Hectorol (Doxercalciferol) is a Vitamin D2 analog that targets the Vitamin D3 receptor. It is a small molecule modality that was originally developed by Genzyme Corp and is now owned by Sanofi. Hectorol is FDA-approved for the treatment of secondary hyperparathyroidism in patients with chronic renal failure undergoing dialysis. The drug is off-patent and has multiple generic manufacturers. As an off-patent medication, Hectorol's commercial status is primarily driven by generic competition.
At a glance
| Generic name | DOXERCALCIFEROL |
|---|---|
| Sponsor | Sanofi |
| Drug class | Vitamin D2 Analog [EPC] |
| Target | Vitamin D3 receptor |
| Modality | Small molecule |
| Therapeutic area | Metabolic |
| Phase | FDA-approved |
| First approval | 1999 |
Mechanism of action
Mechanism of Action. Calcitriol (1,25-(OH)2D3) and 1,25-(OH)2D2 regulate blood calcium at levels required for essential body functions. Specifically, the biologically active vitamin metabolites control the intestinal absorption of dietary calcium, the tubular reabsorption of calcium by the kidney and, in conjunction with parathyroid hormone (PTH), the mobilization of calcium from the skeleton. They act directly on bone cells (osteoblasts) to stimulate skeletal growth, and on the parathyroid glands to suppress PTH synthesis and secretion. These functions are mediated by the interaction of these biologically active metabolites with specific receptor proteins in the various target tissues. In uremic patients, deficient production of biologically active vitamin metabolites (due to lack of or insufficient 25-hydroxyvitamin D-1-alpha-hydroxylase activity) leads to secondary hyperparathyroidism, which contributes to the development of metabolic bone disease in patients with renal failure.
Approved indications
- Hyperparathyroidism Secondary to Chronic Renal Failure with Dialysis
Common side effects
- Weight increase
- Nausea/Vomiting
- Malaise
- Headache
- Body as Whole Abscess
- Edema
- Dyspnea
- Dizziness
- Bradycardia
- Pruritus
- Anorexia
- Constipation
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)
- Vitamin D and Carboxy PTH Fragments in Coronary Calcification (PHASE4)
- Doxercalciferol Before Surgery in Treating Localized Prostate Cancer (PHASE2)
- Study of Docetaxel With Doxercalciferol or Placebo for Advanced Prostate Cancer (PHASE2)
- Doxercalciferol in Treating Patients With Myelodysplastic Syndrome or Chronic Myelomonocytic Leukemia (PHASE2)
- Pilot Study Evaluating Doxercalciferol Replacement Therapy in Kidney Transplant Recipients (PHASE4)
- Compare the Efficacy of Cinacalcet vs Traditional Vitamin D for Secondary Hyperparathyroidism (SHPT) Among Subjects Undergoing Hemodialysis (PHASE4)
- Trial to Optimize Mineral Outcomes in Dialysis Patients (PHASE4)
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 |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| 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:
- Hectorol CI brief — competitive landscape report
- Hectorol updates RSS · CI watch RSS
- Sanofi portfolio CI