Evidence map›Paper›PMID 40264371›Full record

ReviewDrug delivery2025

PEGylation technology: addressing concerns, moving forward.

Dmitri Simberg, Yechezkel Barenholz, Steve R Roffler, Katharina Landfester, Alexander V Kabanov, Seyed M Moghimi

Abstract readReview
In one paragraph

Review in Drug delivery, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 25 papers.

0numbers the graph read from it
0cells of the map it votes in
25citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

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.

2 · The registry

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.

3 · Its place in the literature

Who cites it

25 citing papers in PubMed.

  1. Review
  2. Article
  3. Article
  4. Review
  5. Review
  6. Article
  7. Review
  8. Recombinant Protein Drugs: A 2025 Update.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2026
    Review
  9. Article
  10. Article
  11. Review
  12. Review
  13. Article
  14. Article
  15. Review
  16. Review
  17. Review
  18. Article
  19. Review
  20. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors.

Dmitri SimbergDepartment of Pharmaceutical Sciences, The Skaggs School of Pharmacy and Pharmaceutical Sciences and Colorado Center for Nanomedicine and Nanosafety, University of Colorado Anschutz Medical Campus, Aurora, CO, USA.
Yechezkel BarenholzDepartment of Biochemistry and Molecular Biology, Hebrew University-Hadassah Medical School, Jerusalem, Israel.
Steve R RofflerInstitute of Biomedical Sciences, Academia Sinica, Taipei, Taiwan.
Katharina LandfesterDepartment of Physical Chemistry of Polymers, Max Planck Institute for Polymer Research, Mainz, Germany.
Alexander V KabanovEshelman School of Pharmacy, University of North Carolina, Chapel Hill, NC, USA.
Seyed M MoghimiDepartment of Pharmaceutical Sciences, The Skaggs School of Pharmacy and Pharmaceutical Sciences and Colorado Center for Nanomedicine and Nanosafety, University of Colorado Anschutz Medical Campus, Aurora, CO, USA.

Funding

The Alternative Complement Pathway and Hemocompatibility of NanosurfacesR01AI154959 · NIAID · UNIVERSITY OF COLORADO DENVER · PI Dmitri Simberg · 2020 to 2026
$3.5M
Fluorescent Indocarbocyanine PEGylated Lipid Nanoparticles for Understanding and Overcoming Barriers to Drug Delivery in Invasive GlioblastomaR01CA257958 · NCI · UNIVERSITY OF COLORADO DENVER · PI Irina V Balyasnikova, Dmitri Simberg · 2022 to 2026
$2.7M
TOWARD TRANSLATION OF NANFORMULATED PACLITAXEL-PLATINUM COMBINATIONR01CA264488 · NCI · UNIV OF NORTH CAROLINA CHAPEL HILL · PI KABANOV, ALEXANDER V · 2021 to 2024
$2.5M
Reducing Off-Target Accumulation of Chemotherapeutic NanomedicinesR01CA289447 · NCI · UNIVERSITY OF COLORADO DENVER · PI THOMAS ANCHORDOQUY, Dmitri Simberg · 2025 to 2026
$875k
NCI NIH HHS R01 CA257958NCI NIH HHS R01 CA264488NCI NIH HHS R01 CA289447NIAID NIH HHS R01 AI154959
6 · The paper itself

Abstract

PEGylation technology, that is grafting of poly(ethylene glycol)(PEG) to biologics, vaccines and nanopharmaceuticals, has become a cornerstone of modern medicines with over thirty products used in the clinic. PEGylation of therapeutic proteins, nucleic acids and nanopharmaceuticals improves their stability, pharmacokinetic and biodistribution. While PEGylated medicines are safe in the majority of patients, there are growing concerns about the emergence of anti-PEG antibodies and their impact on the therapeutic efficacy of PEGylated medicines as well as broader immune responses, particularly in complement activation and hypersensitivity reactions. These concerns are beginning to scrutinize the future viability of PEGylation technology in medicine design. Here, we outline these concerns, encourage more efforts into looking for comprehensive scientific evidence on the role of anti-PEG antibodies in hypersensitivity reactions, discuss alternatives to PEG and propose strategies for moving PEGylation technology forward.

Indexed as

Polyethylene GlycolsAnimalsBiological ProductsHumansBiological ProductsPolyethylene GlycolsAnti-poly(ethylene glycol) antibodiescomplement systemimmunogenicitynanomedicinePEGylated therapeutics

Identifiers

PMID40264371
PMCPMC12020137

What Socratic holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

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 Socratic graph.