Evidence review: Open Peptide Project (verified against primary PubMed, ClinicalTrials.gov & FDA records) · Last checked 2026-10-27. ← Back to Evidence Library

Etelcalcetide (Parsabiv, AMG 416): what the evidence says

At a glance

What it is: a synthetic peptide of seven D-amino acids linked by a disulfide bond to an L-cysteine, which activates the calcium-sensing receptor. Given IV at dialysis; approved as Parsabiv in Feb 2017. R1, R2

What the evidence says: Human in a double-blind trial in 683 hemodialysis patients, it was non-inferior and then superior to oral cinacalcet at lowering parathyroid hormone over 26 weeks (68% vs 58% reached a >30% drop). R3

Biggest risks: low blood calcium (sometimes severe, with seizures or QT prolongation) and possible worsening heart failure. R2

Rating
Human Human evidence Strong: head-to-head RCT (n = 683) R3
Animal Animal / lab evidence Not reviewed
Regulatory FDA-approved R1 · not on FDA's 503A or 503B bulk-substance category lists and not on FDA's compounding safety-risk page R4, R5, R6 · not named by WADA R7
Established human dose Yes, label dose (see Study details)

Evidence verdict: Secondary hyperparathyroidism on hemodialysis: Strong (RCTs incl. head-to-head vs cinacalcet)

This page reports what studies used. It is not dosing advice.

Legend: HUMAN data · ANIMAL / LAB data · UNKNOWN · UNVERIFIED: not yet confirmed against a primary source

About the evidence: strong on lab endpoints (PTH); the trial authors note longer-term clinical outcomes still need study. R3 UNVERIFIED the two placebo-controlled phase 3 trials (not opened).

What is it?

Related pages: calcitonin, teriparatide.

Does it work?

Is it safe?

Gray-market vials: extra risks

A gray-market vial has no quality control and no guarantee of identity, strength or sterility. We test retail vials blind under the Open Peptide Standard; see /tests/. A passing test covers one batch on one date and does not mean the compound is safe.

Is it legal?

Study details
Study details

These are amounts researchers used, not recommendations.

Study People / model Route Amount used Follow-up Reported Citation
Block 2017 683 hemodialysis patients IV Per study 26 weeks Non-inferior and superior to cinacalcet PMID 28097356

Full reference list (PubMed, CT.gov, FDA and WADA checked Oct 27, 2026)

  1. R1 Drugs@FDA, Parsabiv (etelcalcetide), application NDA208325 (openFDA drugsfda record checked Oct 27, 2026). https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=NDA208325
  2. R2 Parsabiv prescribing information, label published Mar 8, 2026 (DailyMed, checked Oct 27, 2026). https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=cd270093-c6a8-4596-a4ab-e6aa0a2c8a0c
  3. R3 Block GA, et al. JAMA. 2017. PMID 28097356
  4. R4 FDA, 503A bulk drug substances categories list (updated May 14, 2026). https://www.fda.gov/media/94155/download
  5. R5 FDA, 503B bulk drug substances categories list (updated Mar 21, 2025). https://www.fda.gov/media/94164/download
  6. R6 FDA, Certain bulk drug substances for use in compounding that may present significant safety risks (content current Apr 22, 2026). https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks
  7. R7 WADA. The 2026 Prohibited List, full list checked; compound not named. https://www.wada-ama.org/sites/default/files/2025-09/2026list_en_final_clean_september_2025.pdf

Disclaimer

This page is for education and harm reduction, not medical advice or a recommendation to use Etelcalcetide (Parsabiv, AMG 416). This is a prescription medicine. Use it only under the care of a licensed clinician; do not buy it from research-chemical or gray-market sellers. Report problems to FDA MedWatch (https://www.fda.gov/safety/medwatch).