Peptide Association

Insights

NewsBlog
Start free intake

DisclosurePeptide Association LLC is a for-profit company. We receive compensation from the clinical providers listed on this site. We are not an accrediting body, a licensing board, or a government-affiliated organization. See exactly how we make money.

All peptides

Hematology · FDA Approved

Peginesatide (Omontys)

FDA-approved

How to ask your doctor
Written by Peptide Association Editorial TeamLast reviewed Editorial policy

01 · Overview

Peginesatide is a synthetic pegylated peptide-based erythropoiesis-stimulating agent that activates the erythropoietin receptor despite having no sequence homology with erythropoietin (PMID 23343061). Pegylation prolongs its action, allowing once-monthly dosing in dialysis-dependent chronic kidney disease (PMID 23343061).

It was approved by the FDA in March 2012 under NDA 202799 as Omontys, and all product presentations are now listed as discontinued in the FDA drug approval database following the 2013 market withdrawal.

02 · Research summary & key findings

Approval in March 2012 for anemia of dialysis-dependent chronic kidney disease was supported by the EMERALD 1 and EMERALD 2 randomized trials, in which once-monthly peginesatide was non-inferior to epoetin given one to three times weekly for maintaining hemoglobin, with a similar cardiovascular safety profile in pooled analyses (PMID 23343061). The comparator in these dialysis trials was epoetin rather than darbepoetin alfa. Peginesatide was voluntarily withdrawn from the market less than a year after launch after 49 reported cases of anaphylaxis, including 7 deaths; an FDA analysis linked the hypersensitivity cases to a multiuse vial presentation containing more subvisible particles than the single-use presentation used in the phase 3 studies (PMID 26886324, PMID 24849101).

03 · Regulatory status

Peginesatide (Omontys) has received FDA approval and is available for clinical use under appropriate medical supervision. Consult a qualified healthcare provider for prescribing information.

Peginesatide (Omontys) is an FDA-approved medicine prescribed for the conditions on its label. It is not part of our intake, so we do not propose protocols for it. If you think it may be relevant to you, talk to your own doctor. How to ask your doctor.

04 · Administration routes

  • Intravenous
  • Subcutaneous injection

References

  1. [1]Peginesatide in patients with anemia undergoing hemodialysis N Engl J Med, 2013. PMID 23343061
  2. [2]Anaphylaxis and hypotension after administration of peginesatide N Engl J Med, 2014. PMID 24849101
  3. [3]Subvisible Particle Content, Formulation, and Dose of an Erythropoietin Peptide Mimetic Product Are Associated With Severe Adverse Postmarketing Events J Pharm Sci, 2016. PMID 26886324

Primary literature

Related peptides in Hematology

Disclaimer: This information is provided for educational and research purposes only. It is not intended as medical advice, diagnosis, or treatment. Always consult a qualified healthcare provider before starting any peptide therapy. The Peptide Association does not endorse or recommend any specific treatment protocol. See our editorial policy for how this content is produced and reviewed. Clinicians: join the network.