PARSABIV

PeakPeptide

etelcalcetide

NDAINTRAVENOUSSOLUTION
Approved
Feb 2017
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
12

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.

Clinical Trials (5)

NCT03969329Phase 3Recruiting

A Phase 3 Study of Etelcalcetide in Children With Secondary Hyperparathyroidism Receiving Hemodialysis

Started Dec 2019
24 enrolled
Secondary Hyperparathyroidism
NCT03795558Phase 2Completed

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
NCT03633708Phase 3Recruiting

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
NCT03299244Phase 3Completed

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
NCT03182699Phase 4Completed

Effect of Etelcalcetide on Cardiac Hypertrophy in Hemodialysis Patients

Started Oct 2017
62 enrolled
Secondary HyperparathyroidismChronic Kidney Disease Requiring Chronic DialysisLeft Ventricular Hypertrophy

Loss of Exclusivity

LOE Date
Jun 27, 2034
101 months away
Patent Expiry
Jun 27, 2034

Patent Records (5)

Patent #ExpiryTypeUse Code
9278995
Jul 29, 2030
Substance
—
9701712
Jul 29, 2030
SubstanceProduct
U-2014
8377880
Jul 29, 2030
SubstanceProduct
—
8999932
Feb 7, 2031
SubstanceProduct
U-2014
9820938
Jun 27, 2034
Product
—
External Resources
DailyMed
Full prescribing information
FDA Drugs@FDA
FDA approval history
RxNorm
Drug nomenclature & identifiers