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 43m ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
HECTOROL is an injectable small-molecule pharmaceutical approved by Sanofi in April 2000. The specific indication and mechanism of action are not publicly documented in available data, limiting assessment of therapeutic positioning. As an NDA-approved injection, it serves a defined patient population requiring parenteral administration.
LOE Approaching
With LOE approaching and moderate competitive pressure (30/100), this product is entering a consolidation phase where brand teams face urgency to maximize remaining exclusivity or transition to post-LOE strategy.
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.