NDAINTRAVENOUSSOLUTION
Approved
Feb 2017
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
12
Data completeness
4/8 — Partial
PARSABIV (etelcalcetide) by Lavipharm is calcium-sensing receptor (casr). First approved in 2017.
Drug data last refreshed 5h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
PARSABIV (etelcalcetide) is an intravenous calcimimetic that binds to the calcium-sensing receptor on parathyroid cells to enhance activation by extracellular calcium, thereby reducing PTH secretion. It is indicated for secondary hyperparathyroidism in patients with chronic kidney disease on hemodialysis. The drug represents a novel IV alternative to oral calcimimetics in the nephrology space.
Peak7.8 years to LOE
Product is in peak commercial phase; brand teams are focused on market penetration and maintaining dialysis center relationships rather than growth initiatives.
Mechanism of Action
calcium-sensing receptor (CaSR). Etelcalcetide binds to the CaSR and enhances activation of the receptor by extracellular calcium. Activation of the CaSR on parathyroid chief cells decreases PTH secretion.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (12)
A Phase 3 Study of Etelcalcetide in Children With Secondary Hyperparathyroidism Receiving Hemodialysis
Started Dec 2019
24 enrolled
Secondary Hyperparathyroidism
A Study to Investigate the Influence of PTH-lowering by Etelcalcetide (Parsabiv®) on the Calcification Propensity of Serum in Dialysis Patients
Started May 2019
37 enrolled
End Stage Renal Disease
A Trial of Etelcalcetide in Pediatric Participants With Secondary Hyperparathyroidism and Chronic Kidney Disease on Hemodialysis
Started Apr 2019
56 enrolled
Secondary HyperparathyroidismChronic Kidney Disease
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
Effect of Etelcalcetide on Cardiac Hypertrophy in Hemodialysis Patients
Started Oct 2017
62 enrolled
Secondary HyperparathyroidismChronic Kidney Disease Requiring Chronic DialysisLeft Ventricular Hypertrophy
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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.