ReviewExpert opinion on drug safety2016
Peginesatide for the treatment of anemia due to chronic kidney disease - an unfulfilled promise.
Review in Expert opinion on drug safety, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
17 citing papers in PubMed, 47 citations in OpenAlex.
- Therapeutic Peptides: Recent Advances in Discovery, Synthesis, and Clinical Translation.International journal of molecular sciences · 2025Review
- Randomized Trial of Pegmolesatide for the Treatment of Anemia in Patients With Nondialysis CKD.Kidney international reports · 2025Article
- Festschrift in honor of Dr. Jeffrey Hymes.Frontiers in nephrology · 2025Article
- Lipidization as a tool toward peptide therapeutics.Drug delivery · 2023Review
- Antibodies against Poly(ethylene glycol) Activate Innate Immune Cells and Induce Hypersensitivity Reactions to PEGylated Nanomedicines.ACS nano · 2023Article
- A Reactive Oxygen Species-Scavenging 'Stealth' Polymer, Poly(thioglycidyl glycerol), Outperforms Poly(ethylene glycol) in Protein Conjugates and Nanocarriers and Enhances Protein Stability to Environmental and Biological Stressors.Journal of the American Chemical Society · 2022Article
- A Novel Plant-Produced Asialo-rhuEPO Protects Brain from Ischemic Damage Without Erythropoietic Action.Translational stroke research · 2022Article
- Polyethylene Glycol-Like Brush Polymer Conjugate of a Protein Drug Does Not Induce an Antipolymer Immune Response and Has Enhanced Pharmacokinetics than Its Polyethylene Glycol Counterpart.Advanced science (Weinheim, Baden-Wurttemberg, Germany) · 2022Article
- Cyclic peptide drugs approved in the last two decades (2001-2021).RSC chemical biology · 2022Review
- Investigating Severe Adverse Reactions: Examples of the ANTICIPATE Methodology at Work.Cancer treatment and research · 2022Article
- Anaphylaxis associated with the mRNA COVID-19 vaccines: Approach to allergy investigation.Clinical immunology (Orlando, Fla.) · 2021Article
- Trends in peptide drug discovery.Nature reviews. Drug discovery · 2021Article
- Resolution of epoetin-induced pure red cell aplasia, successful re-challenge with roxadustat.International journal of laboratory hematology · 2020Article
- The "Square Box": Therapeutic Equivalence as a Foundation of the WHO Model List of Essential Medicines.Frontiers in pharmacology · 2020Article
- Updates on Novel Erythropoiesis-Stimulating Agents: Clinical and Molecular Approach.Indian journal of hematology & blood transfusion : an official journal of Indian Society of Hematology and Blood Transfusion · 2020Review
- New Molecular Insights into the Inhibition of Dipeptidyl Peptidase-4 by Natural Cyclic Peptide Oxytocin.Molecules (Basel, Switzerland) · 2019Article
- HIF stabilizers in the management of renal anemia: from bench to bedside to pediatrics.Pediatric nephrology (Berlin, Germany) · 2019Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors at 3 institutions in 3 countries.
Funding
Abstract
introductionThe introduction of recombinant human erythropoietin revolutionized the management of anemia in patients with chronic kidney disease (CKD). In order to circumvent costly recombinant DNA technology, synthetic chemistry techniques were used to manufacture peginesatide, a synthetic peptide that bore no resemblance to previous erythropoiesis-stimulating agents (ESAs), and yet was capable of stimulating erythropoiesis. Compared with other ESAs, peginesatide was deemed to have advantages related to immunogenicity, administration schedule, and cost. Marketing approval was restricted to CKD patients on dialysis because cardiovascular events were more common with peginesatide than with darbepoetin in non-dialysis CKD patients. Unfortunately, unexplained serious adverse drug reactions (sADR) led to quick withdrawal of peginesatide from the market. AREAS COVERED: This review describes the efficacy and safety of peginesatide in pre-approval clinical trials, sADRs after marketing approval, and lessons learned during its short life-span. EXPERT OPINION: The case of peginesatide illustrates the difficulties in detecting rare sADRs in trials with limited patient populations and the need for improved pharmacovigilance after marketing approval. However, the need for simpler drug production methods as a result of non-dependence on recombinant DNA techniques and mammalian cell lines remains. Lessons learned during the scientific development of peginesatide can be used in developing other drugs.
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What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.