PeptideTrace
ApprovedCalcimimetic PeptideMetabolic

Etelcalcetide (Parsabiv)

A

Evidence Grade A — Regulatory approved. 140 published studies. 23 registered clinical trials.

23 trials140 studiesUSEUCA

Medically reviewed by a licensed medical professional

Licensed Indications

  • Secondary Hyperparathyroidism

User Experience Reports

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Overview

Etelcalcetide (sold as Parsabiv) is a medication given intravenously during dialysis to treat overactive parathyroid glands in people with chronic kidney disease. When the kidneys fail, calcium and phosphorus regulation goes awry, causing the parathyroid glands to produce too much hormone — which can lead to bone disease and dangerous calcium build-up in blood vessels. Parsabiv helps bring parathyroid hormone levels back under control.

Also Known As

Etelcalcetide is also known by these brand and alternate names:

Research Activity

140studies
Human 96
Animal 5
In-vitro 12
Reviews 34

140 published studies: 96 human, 5 animal, 12 in-vitro, 34 reviews

Regulatory Status

US
FDA-approved(FDA)
EU
EMA-authorised(EMA)
CA
Not approved by Health Canada(Health Canada)

Legal Status

USPrescription drug (Rx)
EUPrescription medicine (EU centralised authorisation)
CANot applicable (not approved)

Summary

Etelcalcetide is marketed as Parsabiv (approved February 2017) for secondary hyperparathyroidism in adults with chronic kidney disease on haemodialysis. It is administered intravenously three times per week at the end of dialysis sessions.

In a head-to-head trial against cinacalcet (an oral calcimimetic), etelcalcetide was superior — 68.2% of patients achieved a meaningful PTH reduction compared to 57.7% with cinacalcet. The key practical advantage is that it is given by dialysis staff during treatment sessions, eliminating the need for patients to remember daily oral medication. However, it cannot be used by kidney disease patients who are not yet on dialysis, where the oral alternative cinacalcet remains the option.

Mechanism of Action

In chronic kidney disease, the body's calcium regulation goes awry, and the parathyroid glands produce too much parathyroid hormone (PTH), leading to bone disease and vascular calcification. Etelcalcetide works by enhancing the calcium-sensing receptor on parathyroid cells, essentially making these cells more sensitive to calcium in the blood. This tricks the glands into thinking calcium levels are adequate, causing them to reduce PTH production. It physically attaches to the receptor via a chemical bond, providing a sustained effect.

Research Summary

In a head-to-head trial against the oral alternative cinacalcet, etelcalcetide was statistically superior — 68% of patients achieved a meaningful reduction in parathyroid hormone compared to 58% with cinacalcet. The key practical advantage is compliance: because dialysis staff administer it during treatment sessions, patients do not need to remember a daily pill. For a population already managing complex medication regimens, this guaranteed adherence is valuable. The main limitations are that it can only be used by patients on haemodialysis (not earlier-stage kidney disease) and it carries a risk of low calcium levels (hypocalcaemia) that requires monitoring. Research is ongoing into potential cardiovascular benefits and effects on vascular calcification in dialysis patients.

Clinical Trials

PeptideTrace tracks 23 registered clinical trials for Etelcalcetide sourced from ClinicalTrials.gov.

NCT06690242Phase IICompleted

MT1013 Injection for the Treatment of Secondary Hyperparathyroidism in Patients With Chronic Kidney Disease

Shaanxi Micot Pharmaceutical Technology Co., Ltd.Endpoint: Percentage of participants with > 30% reduction from baseline in mean iPTH during the efficacy assessment phaseCompletion: 2025-10-15
NCT06352957N/ANot Yet Recruiting

Use of ETElcalcetidefor pReserving vitamiN K-dependent proteIn activiTY ITAlian Study

Istituto di Fisiologia Clinica CNREndpoint: Levels of VKDPCompletion: 2027-12-31
NCT03969329Phase IIIRecruiting

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

AmgenEndpoint: Percent Change From Baseline in iPTH at Weeks 20 to 26Completion: 2027-06-30
NCT03795558Phase IICompleted

A Study to Investigate the Influence of PTH-lowering by Etelcalcetide (Parsabiv®) on the Calcification Propensity of Serum in Dialysis Patients

Prim. Priv. Doz. Dr. Daniel CejkaEndpoint: T50-Laboratory Test for measuring calcificationCompletion: 2022-03-01
NCT03633708Phase IIIRecruiting

A Trial of Etelcalcetide in Pediatric Participants With Secondary Hyperparathyroidism and Chronic Kidney Disease on Hemodialysis

AmgenEndpoint: Percentage of Participants Achieving a ≥ 30% Reduction from Baseline in Mean iPTH During the Efficacy Assessment Period (EAP)Completion: 2029-01-31
View all 23 trials on ClinicalTrials.gov →

Regulatory Timeline

2016
Regulatory

EMA Marketing Authorisation

2017
Regulatory

FDA ORIG 1

2018
Regulatory

FDA SUPPL 1

2019
Regulatory

FDA SUPPL 2

2021
Regulatory

FDA SUPPL 5

Scientific Detail

Overview (Scientific)

Etelcalcetide is a 7-amino-acid peptide composed entirely of D-amino acids (D-Cys-D-Ala-D-Arg-D-Arg-D-Arg-D-Ala-D-Arg) with an L-Cys attached via a disulfide bond. Its all-D-amino-acid backbone provides complete resistance to proteolytic degradation. It is classified as a calcimimetic peptide.

Mechanism of Action (Scientific)

Etelcalcetide acts as a positive allosteric modulator of the calcium-sensing receptor (CaSR) on parathyroid chief cells. It forms a covalent disulfide bond with Cys482 in the CaSR extracellular domain, enhancing the receptor's sensitivity to extracellular calcium. This increased calcium sensitivity suppresses PTH secretion. Unlike cinacalcet (oral small molecule calcimimetic), etelcalcetide is administered intravenously during hemodialysis sessions.

Summary (Scientific)

Etelcalcetide is marketed as Parsabiv (approved February 7, 2017) for secondary hyperparathyroidism (SHPT) in adult patients with CKD on hemodialysis. Administered IV 3 times per week at dialysis. In a head-to-head trial versus cinacalcet (N=683), etelcalcetide was superior: ≥30% PTH reduction achieved in 68.2% versus 57.7% (P=0.004); ≥50% reduction in 52.4% versus 40.2%. The IV administration during dialysis eliminates oral medication burden and GI side effects associated with cinacalcet.

Related Compounds

Linaclotide

Approved
Guanylate Cyclase-C Agonist

Linaclotide is marketed as Linzess (approved August 2012). It is taken as a daily oral capsule on an empty stomach, at least 30 minutes before the first meal. The recommended dose is 290 mcg for IBS-C and 72 or 145 mcg for chronic constipation. In clinical trials, approximately 34% of IBS-C patients met the composite improvement endpoint compared to 17% on placebo. Diarrhoea is the most common side effect (approximately 20%) and the leading reason for discontinuation. Linaclotide has a boxed warning against use in children under 6 years due to deaths in young mice, though no such events have been reported in humans. It competes with plecanatide (which targets the same pathway) and other IBS-C treatments.

Elamipretide

Approved
Mitochondria-Targeted Tetrapeptide (Approved)

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Glucagon

Approved
Counter-Regulatory Peptide Hormone

Glucagon has been available as an emergency injection since the 1960s and remains the standard rescue treatment for severe hypoglycaemia. Recent innovation has focused on making it easier to administer in emergencies. Baqsimi, approved in 2019, was the first needle-free option as a nasal powder. Gvoke, also approved in 2019, eliminated the need to mix and reconstitute the medication before injection — a significant advance since severe hypoglycaemia often impairs the ability to follow complex preparation steps. Dasiglucagon (Zegalogue), a next-generation stable liquid glucagon approved in 2021, further improved on the convenience of rescue administration. Beyond emergency rescue, glucagon's receptor is now a major research target — dual and triple agonists combining glucagon receptor activity with GLP-1 (such as survodutide and retatrutide) are in advanced clinical trials for obesity and metabolic disease.

Related Research

This content is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional before making decisions about your health.