HECTOROL
LOE ApproachingNDAORALCAPSULE
Approved
Jun 1999
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
6
Data completeness
2/8 — Basic
Drug data last refreshed 15h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
HECTOROL is an oral capsule small-molecule drug approved by Sanofi in June 1999. The specific indication and mechanism of action are not publicly detailed in available data, but the product has been in the market for over two decades. It is formulated as a capsule for oral administration.
LOE Approaching1.8 years to LOE
Product is approaching loss of exclusivity by mid-2028, signaling a shrinking brand team and transition toward generic competition management.
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 (6)
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.