HECTOROL
LOE ApproachingNDAINJECTIONINJECTABLE
Approved
Apr 2000
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
7
Data completeness
2/8 — Basic
Drug data last refreshed 2d ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
HECTOROL is an injectable small-molecule vitamin D analog approved in 2000 for treating secondary hyperparathyroidism in patients with chronic kidney disease stage 5. The drug works by binding to vitamin D receptors to reduce PTH synthesis and increase calcium absorption, addressing metabolic complications of renal failure.
LOE Approaching
Product nearing end of exclusivity with minimal disclosed spending; brand team likely focused on defending legacy position against growing generic and branded competition.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (7)
Safety and Efficacy of Hectorol in Pediatric Patients With Chronic Kidney Disease Stage 3 and 4 With Secondary Hyperparathyroidism Not Yet on Dialysis
Started Jan 2017
21 enrolled
Secondary Hyperparathyroidism-Chronic Kidney Disease
Comparison of I.V. CTAP201 and Doxercalciferol (Hectorol) in Subjects With Chronic Kidney Disease (CKD) and Secondary Hyperparathyroidism (SHPT)
Started Nov 2008
24 enrolled
Chronic Kidney DiseaseSecondary HyperparathyroidismChronic Renal Insufficiency+1 more
A Phase 4 Study to Determine Dosing of Hectorol® Capsules When Converting From Zemplar® Injection
Started Apr 2007
36 enrolled
Secondary Hyperparathyroidism
A Phase 4 Pharmacokinetic Study of Hectorol Injection and Zemplar Injection in CKD Subjects on Hemodialysis
Started Feb 2007
12 enrolled
Secondary Hyperparathyroidism
A Phase 4, Conversion Study of Hectorol® Injection to Hectorol® Capsules in Stage 5 CKD Patients on Dialysis
Started Nov 2006
36 enrolled
Secondary Hyperparathyroidism
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.