NDAINTRAVENOUSSOLUTION
Approved
Feb 2016
Lifecycle
Peak
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
4/8 — Partial
PARICALCITOL (paricalcitol) by Accord Biopharma is synthetic, biologically active vitamin d 2 analog. Approved for secondary hyperparathyroidism, chronic kidney disease, end stage renal disease. First approved in 2016.
Drug data last refreshed Yesterday · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Paricalcitol is a synthetic vitamin D2 analog approved in 2016 that selectively activates vitamin D receptor pathways to reduce PTH synthesis and secretion. It is administered intravenously as a solution and treats secondary hyperparathyroidism in chronic kidney disease and end-stage renal disease patients. The drug also shows potential benefits in reducing proteinuria, albuminuria, and cardiovascular complications associated with renal disease.
Peak
Product is at peak lifecycle stage with moderate competitive pressure (30/100), suggesting a stable but maturing commercial profile with limited growth opportunities.
Mechanism of Action
synthetic, biologically active vitamin D 2 analog. Preclinical and in vitro studies have demonstrated that paricalcitol's biological actions are mediated through binding of the vitamin D receptor (VDR), which results in the selective activation of vitamin D responsive pathways. Vitamin D and…
Pharmacologic Class:
Vitamin D2 Analog
Indications (3)
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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.