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EMA-approvedaka Parsabiv

Etelcalcetide β€” Complete Research Guide (2026)

Last updated 2026-06-30

TL;DR

Etelcalcetide (also known as Parsabiv) is a peptide catalogued under Therapeutic Peptides (Calcimimetic (D-amino acid heptapeptide)). It is described as: CaSR. Documented context: Secundaire hyperparathyroidism (CKD). Neutral reference entry; EU status: EU-approved prescription medicine.

What is Etelcalcetide?

Etelcalcetide (brand name Parsabiv) is a synthetic peptide calcimimetic approved for secondary hyperparathyroidism (SHPT) in adults with chronic kidney disease on haemodialysis. It received US FDA approval in February 2017 and is given intravenously at the end of dialysis sessions.

The evidence base is strong and human: two pivotal placebo-controlled phase 3 trials plus a randomized active-comparator trial against oral cinacalcet, all published in JAMA in 2017, support its efficacy for lowering parathyroid hormone.

How does Etelcalcetide work?

Etelcalcetide is an allosteric activator of the calcium-sensing receptor on parathyroid chief cells, increasing the receptor's sensitivity to extracellular calcium.

This suppresses parathyroid hormone (PTH) secretion and secondarily lowers serum calcium and phosphate.

What does the research say about Etelcalcetide?

  • In two pivotal phase 3 trials, intravenous etelcalcetide markedly lowered serum parathyroid hormone versus placebo in haemodialysis patients with secondary hyperparathyroidism. [1]
  • In a head-to-head randomized trial, etelcalcetide was non-inferior to (and on some measures better than) oral cinacalcet for reducing parathyroid hormone. [2]
  • An open-label extension showed PTH reductions were sustained over one year of treatment. [3]

Clinical research & studies

The references below are the primary sources cited throughout this guide. Each links directly to PubMed or the regulator. Where evidence is preclinical (animal or in-vitro), that is stated rather than implied.

  • [1] Effect of Etelcalcetide vs Placebo on Serum Parathyroid Hormone in Patients Receiving Hemodialysis With Secondary Hyperparathyroidism: Two Randomized Clinical Trials β€” Block GA et al., JAMA 2017. (Two phase 3 randomized controlled trials)
  • [2] Effect of Etelcalcetide vs Cinacalcet on Serum Parathyroid Hormone in Patients Receiving Hemodialysis With Secondary Hyperparathyroidism: A Randomized Clinical Trial β€” Block GA et al., JAMA 2017. (Randomized active-comparator trial)
  • [3] One-year safety and efficacy of intravenous etelcalcetide in patients on hemodialysis with secondary hyperparathyroidism β€” Bushinsky DA et al., Nephrology Dialysis Transplantation 2020. (Open-label extension study)
  • [4] An integrated analysis of safety and tolerability of etelcalcetide in patients receiving hemodialysis with secondary hyperparathyroidism β€” Block GA et al., PLoS One 2019. (Integrated (pooled) safety analysis)
  • [5] Role of etelcalcetide in the management of secondary hyperparathyroidism in hemodialysis patients: a review on current data and place in therapy β€” Friedl C et al., Drug Design, Development and Therapy 2018. (Narrative review)

Dosing context

This is not medical advice or a usage recommendation. Dosing figures are reported research context only, cited from the published literature.

The approved route is intravenous bolus into the dialysis circuit three times weekly at the end of haemodialysis, with the dose titrated to PTH and calcium levels.

All administration is nephrologist-directed within a dialysis programme, so it is not a self-administered agent.

Side effects & safety profile

The most important and expected risk is hypocalcaemia, a direct consequence of lowering PTH; serum calcium must be measured before starting and monitored during treatment, and symptomatic hypocalcaemia can cause paraesthesias, muscle cramps, QT prolongation, and seizures.

Other common effects include nausea, vomiting, diarrhoea, muscle spasms, and worsening heart failure signals in some analyses.

It is indicated only for patients on haemodialysis and is not established for CKD patients not on dialysis or on peritoneal dialysis.

Stacking & combinations

In practice it is used alongside standard SHPT management (vitamin D analogues and phosphate binders) under specialist supervision, not with recreational or research peptides.

Finding Etelcalcetide vendors

Finding Etelcalcetide vendors

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Frequently asked questions

It treats secondary hyperparathyroidism in adults with chronic kidney disease who are on haemodialysis, by lowering elevated parathyroid hormone.

References

  1. [1] Effect of Etelcalcetide vs Placebo on Serum Parathyroid Hormone in Patients Receiving Hemodialysis With Secondary Hyperparathyroidism: Two Randomized Clinical Trials β€” Block GA et al., JAMA 2017. PMID: 28097355. View sourceStudy: Two phase 3 randomized controlled trialsEtelcalcetide significantly reduced serum PTH compared with placebo in haemodialysis patients.
  2. [2] Effect of Etelcalcetide vs Cinacalcet on Serum Parathyroid Hormone in Patients Receiving Hemodialysis With Secondary Hyperparathyroidism: A Randomized Clinical Trial β€” Block GA et al., JAMA 2017. PMID: 28097356. View sourceStudy: Randomized active-comparator trialIntravenous etelcalcetide was non-inferior to oral cinacalcet for reducing PTH.
  3. [3] One-year safety and efficacy of intravenous etelcalcetide in patients on hemodialysis with secondary hyperparathyroidism β€” Bushinsky DA et al., Nephrology Dialysis Transplantation 2020. PMID: 30859218. View sourceStudy: Open-label extension studyPTH-lowering efficacy was maintained with an acceptable safety profile over one year.
  4. [4] An integrated analysis of safety and tolerability of etelcalcetide in patients receiving hemodialysis with secondary hyperparathyroidism β€” Block GA et al., PLoS One 2019. PMID: 30875390. View sourceStudy: Integrated (pooled) safety analysisHypocalcaemia and gastrointestinal effects were the most common adverse events across pooled trials.
  5. [5] Role of etelcalcetide in the management of secondary hyperparathyroidism in hemodialysis patients: a review on current data and place in therapy β€” Friedl C et al., Drug Design, Development and Therapy 2018. PMID: 29910605. View sourceStudy: Narrative reviewPositions etelcalcetide as an effective intravenous calcimimetic option with hypocalcaemia as the key monitoring concern.
This article is for educational and research purposes only. Peptides discussed here are not approved for human consumption by the FDA, EMA, or equivalent regulators outside of specific clinical contexts. Always consult a licensed medical professional before any therapeutic use.