Bones & muscles Calcimimetic peptide
Etelcalcetide
Regulatory status
Status at a glance
503A compounding status
Not nominated
We found no pending nomination for the 503A bulks list. Unless the substance has another legal pathway (for example, a USP monograph or use in an FDA-approved drug), 503A pharmacies generally may not compound with it.
- FDA approval
- An FDA-approved product contains this peptide
- 503B outsourcing
- Not determined
- Anti-doping (WADA)
- Not on the WADA Prohibited List
- DEA schedule
- Not a controlled substance
About peptide status
Most peptides discussed here are not FDA-approved for any use, and products labeled “research use only” are not for human use. Removal from Category 2 does not authorize compounding. PCAC votes are non-binding recommendations; FDA and HHS make the final decisions.
This is not medical or legal advice, and we do not publish dosing, sourcing or reconstitution information. Talk with a licensed clinician before using any peptide.
If you think you are having a medical emergency, call 911.
Key takeaway
Etelcalcetide (sold as Parsabiv) is a peptide that activates the calcium-sensing receptor to lower parathyroid hormone, used for secondary hyperparathyroidism in people on dialysis for kidney disease. Unlike parathyroid hormone replacement, it suppresses an overactive parathyroid signal, and it is given intravenously at the end of each dialysis session. It has been FDA-approved in the U.S. since 2017.
At a glance
- What it is
- A peptide calcimimetic that activates the calcium-sensing receptor
- Approved for
- Secondary hyperparathyroidism in adults on hemodialysis
- Key fact
- In a head-to-head trial it lowered parathyroid hormone at least as well as, and on some measures better than, oral cinacalcet
- Route
- Intravenous injection at the end of hemodialysis, three times a week
- Evidence strength
- FDA approved
Summary
Etelcalcetide (Parsabiv) is an intravenous peptide that lowers parathyroid hormone in people on dialysis. Learn how it works and what it is approved for.
What is etelcalcetide?
Etelcalcetide, sold under the brand Parsabiv, is a synthetic peptide "calcimimetic," a drug that makes the parathyroid glands behave as if blood calcium were higher than it is, so they release less parathyroid hormone. It is used in secondary hyperparathyroidism, a common complication of advanced kidney disease in which the parathyroid glands become overactive. It was developed under the codes AMG 416 and velcalcetide and approved in the United States in 2017.
How does etelcalcetide work?
Etelcalcetide binds and activates the calcium-sensing receptor on the parathyroid glands, increasing the receptor's sensitivity to calcium. The glands interpret this as a signal that calcium is adequate and reduce their secretion of parathyroid hormone, which in turn lowers the high calcium and phosphate turnover that drives bone and cardiovascular problems in dialysis patients. This is the opposite approach to parathyroid hormone replacement: etelcalcetide turns the hormone down rather than supplying it.
Because it is a peptide given intravenously into the dialysis circuit, it does not depend on a patient taking a daily pill, which can improve adherence. In a head-to-head randomized trial, intravenous etelcalcetide lowered parathyroid hormone at least as effectively as oral cinacalcet, with a greater proportion of patients achieving large reductions.
Is it FDA-approved?
Editor’s note
Status: Yes. Etelcalcetide was approved by the FDA in 2017 for secondary hyperparathyroidism in adults on hemodialysis. It is administered as an intravenous bolus at the end of each dialysis session, three times a week.
Category: FDA-approved · Primary body area: Bones & muscles
Yes. Etelcalcetide was approved by the FDA in 2017 for secondary hyperparathyroidism in adults on hemodialysis. It is administered as an intravenous bolus at the end of each dialysis session, three times a week.
What is etelcalcetide prescribed for?
Etelcalcetide is prescribed for secondary hyperparathyroidism in adults with chronic kidney disease who are on hemodialysis. It is not recommended for people with kidney disease who are not on dialysis, or for primary hyperparathyroidism.
What are the side effects?
According to the prescribing information, common side effects include:
- Low blood calcium
- Muscle spasms
- Nausea, vomiting, and diarrhea
- Headache
More serious considerations include:
- Serious low calcium, which can cause seizures or heart-rhythm changes, so calcium is monitored
- Worsening heart failure in some patients
- Upper gastrointestinal bleeding
Sources: FDA prescribing information for Parsabiv; the etelcalcetide-versus-cinacalcet trial (Block et al., JAMA, 2017, DOI: 10.1001/jama.2016.19468), indexed on PubMed. This document is educational and does not constitute medical advice.
Registered human trials
0 registered human trials on ClinicalTrials.gov that we reviewed
Sources
- [1]
- [2]
approved (PDF)
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