Peginesatide (Omontys)

Peptide

Peginesatide is a synthetic PEGylated dimeric peptide erythropoiesis-stimulating agent for renal anemia. FDA-approved March 2012. WITHDRAWN February 2013 due to fatal anaphylaxis (0.02% rate). EMERALD trials (n=1608): Once-monthly peginesatide noninferior to epoetin for hemoglobin maintenance in dialysis patients. PEARL trials: Cardiovascular events and mortality INCREASED in non-dialysis CKD patients vs darbepoetin. Unique: No structural homology to erythropoietin - effective even with anti-EPO antibodies. SAFETY CONCERN: Fatal anaphylactic reactions led to worldwide market withdrawal. For educational/historical reference only.

Quick Answer

What it is

Peginesatide is a synthetic PEGylated dimeric peptide erythropoiesis-stimulating agent for renal anemia. FDA-approved March 2012.

Key findings

Grade A: Hemoglobin Maintenance (Dialysis) (Renal Anemia)
Grade A: Cardiovascular Safety (Non-Dialysis) (Renal Anemia)
Grade A: Anaphylaxis Risk (Renal Anemia)

Safety

No specific caution or interaction language was detected in the current summary/outcome notes.

⚠️ Research Notice

This peptide information is for educational and research purposes only. Peptides may not be FDA-approved for human use and may only be legally available for research purposes. Consult qualified healthcare professionals before considering any peptide compounds.

ℹ️ Quick Facts: Peginesatide (Omontys)

Quick Facts: Peginesatide (Omontys)

Best Evidence:Grade A
Conditions Studied:1
Research Outcomes:7
Grade A Findings:3
Grade B Findings:3
Key Effect:Renal Anemia

1 conditions · 7 outcomes

Detailed Outcomes

Hemoglobin Maintenance (Dialysis)

EMERALD 1+2 trials (n=1608): Once-monthly peginesatide noninferior to epoetin (1-3x weekly) for maintaining Hgb 10-12 g/dL over 52+ weeks. Similar mean Hgb levels. Similar transfusion requirements. Approved only for dialysis patients.

none

Cardiovascular Safety (Non-Dialysis)

SAFETY CONCERN - PEARL trials (n=1066 non-dialysis CKD): Cardiovascular events and mortality INCREASED with peginesatide vs darbepoetin. FDA declined approval for non-dialysis patients. Mechanism unclear - may relate to higher dose requirements.

moderate↓Worsens

Anaphylaxis Risk

SAFETY CONCERN - DRUG WITHDRAWN: Post-marketing: 0.2% severe allergic reactions, 0.02% fatal anaphylaxis rate. 13 cases of serious hypersensitivity within 30 min of first dose reported. Voluntary worldwide recall February 2013 - 11 months after FDA approval.

moderate↑Worsens

Pure Red Cell Aplasia Treatment

Unique application: Effective in anti-EPO antibody-mediated pure red cell aplasia (PRCA) due to no structural homology to EPO. Could stimulate erythropoiesis in heavily transfusion-dependent PRCA patients who failed all recombinant EPO therapies.

large↑Improves