At a glance
- Peginesatide was approved by the FDA (Omontys, March 27, 2012), but the products are no longer marketed.
- PubMed lists 86 publications mentioning it, including 3 randomized controlled trials and 9 animal-only studies.
- ClinicalTrials.gov lists 19 registered studies testing it (0 active).
- FDA's adverse event system (FAERS) holds 214 reports mentioning it; 103 classified as serious. Reports do not prove causation.
Research topics
Most frequent MeSH subject headings in the latest PubMed records (English, as indexed).
Regulatory status
Drugs@FDA applications
| Application | Product | Status | First approval | Sponsor |
|---|---|---|---|---|
| NDA202799 | OMONTYS, OMONTYS PRESERVATIVE FREE | Approved, discontinued | March 27, 2012 | TAKEDA PHARMS USA |
Source: Drugs@FDA (openFDA) · verified October 30, 2026 · API query
FDA compounding safety list
Not on FDA's list of bulk drug substances that may present significant safety risks in compounding.
Source: FDA.gov — Category 2 bulk drug substances · verified October 30, 2026
Removal of a substance from a regulatory list does not mean it has been approved. A "research use only" label does not make a product safe or legal for human use.
Scientific publications
Counts are PubMed records that mention the peptide in the title or abstract. Categories overlap, and a mention is not the same as testing the peptide as a treatment. Each number opens the exact PubMed search. Effects seen in laboratory or animal studies may not occur in humans. A registered clinical trial does not show that a substance is effective or safe.
Latest publications
- The Pharmaceutical Industry in 2024: An Analysis of the FDA Drug Approvals from the Perspective of Molecules.
- The Pharmaceutical Industry in 2023: An Analysis of FDA Drug Approvals from the Perspective of Molecules.
- A singlicate immunogenicity method to detect anti-polyethylene glycol antibodies: pre- and post-dose of PEGylated therapies.
- Commentary: Multiplex dPCR and SV-AUC are Promising Assays to Robustly Monitor the Critical Quality Attribute of AAV Drug Product Integrity.
- Pharmacokinetics of 40 kDa Polyethylene glycol (PEG) in mice, rats, cynomolgus monkeys and predicted pharmacokinetics in humans.
- Investigating Serious Adverse Drug Reactions in Patients Receiving Erythropoiesis-Stimulating Agents: A Root Cause Analysis Using the "ANTICIPATE" Framework.
- Design, synthesis, and activity evaluation of novel erythropoietin mimetic peptides.
- Erythropoietin mimetic peptides and erythropoietin fusion proteins for treating anemia of chronic kidney disease.
- Flow Microscopy Imaging Is Sensitive to Characteristics of Subvisible Particles in Peginesatide Formulations Associated With Severe Adverse Reactions.
- Watch out for a revival of peginesatide in sports.
Source: PubMed (NCBI) · verified October 30, 2026
Clinical trials
- Registered
- 19
- Active
- 0
- With posted results
- 13
Conditions studied
Show 9 more studies
All 19 studies on ClinicalTrials.gov ↗
Source: ClinicalTrials.gov · verified October 30, 2026
Adverse event reports
- Reports
- 214
- Serious
- 103
- With death outcome
- 28
Most reported reactions
Adverse event reports do not prove that the substance caused these effects. Side effects not listed here may still occur. Reaction terms are MedDRA terms as reported to FAERS.
Source: FDA FAERS (FAERS data as of July 30, 2026) · verified October 30, 2026 · API query
Change history
No changes since monitoring began on October 30, 2026.