NDAORALTABLETPriority Review
Approved
Mar 2004
Lifecycle
Post-LOE
Competitive Pressure
35/100
Clinical Trials
24
Data completeness
4/8 — Partial
Priority Review
Drug data last refreshed 22h ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
SENSIPAR (cinacalcet hydrochloride) is an oral small-molecule calcimimetic agent approved in 2004 that treats secondary hyperparathyroidism in patients with chronic kidney disease on dialysis by allosteric modulation of the calcium-sensing receptor. It reduces parathyroid hormone (PTH) and serum calcium levels in patients inadequately controlled by standard therapies.
$0.003BPart D
LOE ApproachingPost-LOEProduct nearing loss of exclusivity with modest Part D spending signals a contracting commercial footprint requiring defensive strategies and potential team restructuring.
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 (24)
Head-to-Head Study of Etelcalcetide and Cinacalcet in Asian Hemodialysis Patients With Secondary Hyperparathyroidism (SHPT)
Started May 2018
637 enrolled
Secondary HyperparathyroidismChronic Kidney Disease
Extension Study of Cinacalcet for Treatment of Secondary Hyperparathyroidism (SHPT) in Pediatric Patients With Chronic Kidney Disease on Dialysis
Started Jun 2015
28 enrolled
Secondary Hyperparathyroidism, Chronic Kidney Disease
Efficacy and Safety of Cinacalcet in Pediatric Patients With Secondary Hyperparathyroidism (SHPT) and Chronic Kidney Disease (CKD) on Dialysis
Started Nov 2014
55 enrolled
Chronic Kidney Disease, Secondary Hyperparathyroidism
Head-to-Head Study of Etelcalcetide (AMG 416) and Cinacalcet
Started Aug 2013
683 enrolled
Secondary HyperparathyroidismChronic Kidney Disease
Study to Assess the Impact on Calcium Levels When Hemodialysis Patients With Secondary Hyperparathyroidism (SHPT) Switch From Cinacalcet to Etelcalcetide
Started Aug 2013
158 enrolled
Hyperparathyroidism, Secondary
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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.