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IndexedBuilt automatically from public databases on 2026-09-30. Not yet hand-reviewed by PLOBT.How this works →

Etelcalcetide

FDA approved · Rx

Calcimimetic peptide

Also known as: Parsabiv, Velcalcetide, KAI-4169, Telcalcetide, AMG-416, Etelcalcetida, KAI 4169, ONO-5163

Evidence score
91/ 100
Strong evidence

Strong, human-grade evidence

  • Regulatory standing. FDA-approved prescription medicine
  • Human trials. Backed by controlled human studies
  • Registered human trials. 23 registered studies on ClinicalTrials.gov, most advanced Phase 4
  • 2 cited sources. Includes primary / regulatory sources

Computed with the same four public criteria as every profile. The human-evidence grade on an indexed profile is set automatically and may change when it is hand-reviewed. It is not a safety score, not a purity rating, and not medical advice, and not a claim that this compound treats, cures, or prevents any condition.

What it is

Etelcalcetide, sold as Parsabiv, is a synthetic peptide calcimimetic given intravenously. It binds to and activates the calcium-sensing receptor on parathyroid gland cells, which lowers the secretion of parathyroid hormone.

What the evidence shows

Automatic summaryHuman trials

It is FDA-approved for the treatment of secondary hyperparathyroidism in adults with chronic kidney disease on hemodialysis, supported by randomized trials and 23 registered human studies reaching Phase 4. It is not approved for other uses, and its long-term effects on outcomes such as fractures or cardiovascular events are less clearly established.

Key facts

Molecular formula
C38H73N21O10S2
Molecular weight
1048.3 g/mol
FDA approval
Confirmed on openFDA

Registered human trials

Live from ClinicalTrials.gov, refreshed daily.

23registered studies
Phase 4most advanced phase
19completed (sample)
2recruiting (sample)

Study to Assess the Impact on Calcium Levels When Hemodialysis Patients With Secondary Hyperparathyroidism (SHPT) Switch From Cinacalcet to Etelcalcetide

Phase 3CompletedNCT01932970

Extension Study of Etelcalcetide in the Treatment of Secondary Hyperparathyroidism (SHPT) in Patients With Chronic Kidney Disease (CKD) on Hemodialysis

Phase 3CompletedNCT01785875

Pharmacokinetics and Excretion of [¹⁴C]Etelcalcetide (AMG 416) in Patients With End Stage Renal Disease (ESRD) Receiving Dialysis

Phase 1CompletedNCT02054572

Efficacy and Safety of Etelcalcetide (AMG 416) in the Treatment of Secondary Hyperparathyroidism (SHPT) in Patients With Chronic Kidney Disease on Hemodialysis

Phase 3CompletedNCT01785849

Published literature

Live from Europe PMC. This is how much has been published, not how much is proven in humans.

150papers referencing Etelcalcetide

Effect of Etelcalcetide vs Cinacalcet on Serum Parathyroid Hormone in Patients Receiving Hemodialysis With Secondary Hyperparathyroidism: A Randomized Clinical Trial.

JAMA2017

Effect of Etelcalcetide vs Placebo on Serum Parathyroid Hormone in Patients Receiving Hemodialysis With Secondary Hyperparathyroidism: Two Randomized Clinical Trials.

JAMA2017

International Union of Basic and Clinical Pharmacology. CVIII. Calcium-Sensing Receptor Nomenclature, Pharmacology, and Function.

Pharmacol Rev2020

Comparative Effectiveness of Calcimimetic Agents for Secondary Hyperparathyroidism in Adults: A Systematic Review and Network Meta-analysis.

Am J Kidney Dis2020

Sources

Risks, side effects and study doses are only published on hand-reviewed profiles. Want this one reviewed, or spotted something wrong? Tell us.