PurePEG Research · Statistics

PEGylation and Bioconjugation Statistics (2026)

Key numbers on PEGylated drugs, clinical trials and research output, each with its source and date: FDA has granted 41 original approvals to PEGylated drugs since 1990, ClinicalTrials.gov listed 640 active ADC studies on 12 Nov 2026, and PubMed lists 1,059 PROTAC records published in 2025.

By PurePEG · Published 12 Nov 2026 · Data retrieved 12 Nov 2026

Every figure below comes from one of our three studies, which publish the exact source query, the date and a CSV. Jump to: FDA approvals · clinical trials · publications.

FDA-approved PEGylated drugs

41

original FDA approvals of PEGylated drugs (NDAs and 351(a) BLAs), 21 Mar 1990 to 5 Aug 2026.Source: our FDA list (Drugs@FDA, FDA Purple Book, FDA labels; retrieved 12 Nov 2026)

32

of them are PEG conjugates: PEG attached to a protein, enzyme, antibody fragment, peptide, aptamer, small molecule or imaging agent.Source: our FDA list (Drugs@FDA, FDA Purple Book, FDA labels; retrieved 12 Nov 2026)

9

are lipid-particle products with a PEG-lipid: 2 PEGylated liposomes, 1 lipid microsphere and 6 lipid nanoparticles.Source: our FDA list (Drugs@FDA, FDA Purple Book, FDA labels; retrieved 12 Nov 2026)

17

approvals from 2020 to 5 Aug 2026, against 13 in 2010-2019, 8 in 2000-2009 and 3 in 1990-1999.Source: our FDA list (Drugs@FDA, FDA Purple Book, FDA labels; retrieved 12 Nov 2026)

8

pegfilgrastim biosimilars, the only PEGylated biosimilars in the Purple Book.Source: our FDA list (Drugs@FDA, FDA Purple Book, FDA labels; retrieved 12 Nov 2026)

8

generic (ANDA) approvals of liposomal doxorubicin, the generic form of Doxil.Source: our FDA list (Drugs@FDA, FDA Purple Book, FDA labels; retrieved 12 Nov 2026)

11 of 28

PEG conjugates with a stated PEG size use a PEG moiety of 40 kDa or more; the largest is a 60 kDa branched PEG (Jivi).Source: our FDA list (Drugs@FDA, FDA Purple Book, FDA labels; retrieved 12 Nov 2026)

6 of 6

lipid nanoparticle products list a PEG 2000 lipid.Source: our FDA list (Drugs@FDA, FDA Purple Book, FDA labels; retrieved 12 Nov 2026)

4

of the 41 are no longer marketed or licensed (Adagen, PegIntron / Sylatron, Macugen, Omontys).Source: our FDA list (Drugs@FDA, FDA Purple Book, FDA labels; retrieved 12 Nov 2026)

Clinical trials

1,506

registered studies match the term "PEGylated"; 107 started in 2011, the peak year from 2005 to 2025, and 36 in 2025.Source: our trials study (ClinicalTrials.gov API v2, data as of 12 Nov 2026)

1,004

studies match "antibody-drug conjugate(s)": 26 started in 2015, 150 in 2025, and 210 list a 2026 start date.Source: our trials study (ClinicalTrials.gov API v2, data as of 12 Nov 2026)

191

studies match lipid nanoparticle terms: 2 started in 2015, 27 in 2025, and 52 list a 2026 start date.Source: our trials study (ClinicalTrials.gov API v2, data as of 12 Nov 2026)

59.2%

of LNP studies starting 2021-2025 were Phase 1 or 1/2 (ADC 47.8%, PEGylated 22.9%).Source: our trials study (ClinicalTrials.gov API v2, data as of 12 Nov 2026)

63.3%

of ADC studies starting 2021-2025 had an industry lead sponsor (LNP 47.6%, PEGylated 38.1%).Source: our trials study (ClinicalTrials.gov API v2, data as of 12 Nov 2026)

640

ADC studies were recruiting, about to recruit or active on 12 Nov 2026 (PEGylated 175, LNP 97).Source: our trials study (ClinicalTrials.gov API v2, data as of 12 Nov 2026)

Research output (PubMed)

1,059

PubMed records on PROTACs in 2025, against 10 in 2015 (105.9x).Source: our publication study (PubMed E-utilities, queried 12 Nov 2026)

2,207

PubMed records on lipid nanoparticles in 2025, against 334 in 2015 (6.6x).Source: our publication study (PubMed E-utilities, queried 12 Nov 2026)

2,020

PubMed records on antibody-drug conjugates in 2025, against 310 in 2015 (6.5x).Source: our publication study (PubMed E-utilities, queried 12 Nov 2026)

1,008

PubMed records on click chemistry in 2025, against 745 in 2015 (1.4x).Source: our publication study (PubMed E-utilities, queried 12 Nov 2026)

1,068

PubMed records on PEGylation in 2025, against 1,561 in 2015 (0.7x).Source: our publication study (PubMed E-utilities, queried 12 Nov 2026)

56.7

PEGylation records per 100,000 PubMed records in 2025, down from 124.1 in 2015.Source: our publication study (PubMed E-utilities, queried 12 Nov 2026)

22,520

PubMed records on PEGylation in all years (title or abstract).Source: our publication study (PubMed E-utilities, queried 12 Nov 2026)

How to use these numbers

  • Quote a figure with its source and date, and link to the study page; each study explains what is counted and what is not.
  • Counts of FDA approvals depend on the definition of "PEGylated". Ours is stated on the FDA list page, with edge cases.
  • Registry and PubMed counts measure activity, not results.
Research use only. PurePEG supplies PEG linkers and conjugation reagents for laboratory research. They are not drugs, are not GMP material and are not for use in humans or animals. This page reports public regulatory and research data from the sources named below. It is not medical advice and says nothing about the safety or effectiveness of any product.

Sources

  • FDA: openFDA Drugs@FDA API and drug label API; Drugs@FDA data file (11 Nov 2026); Purple Book data download (October 2026).
  • National Library of Medicine: DailyMed; ClinicalTrials.gov API v2; PubMed via NCBI E-utilities.

Data: FDA list (CSV) · trials by year (CSV) · PubMed counts (CSV). CC BY 4.0.

Cite this page

PurePEG. (2026). PEGylation and bioconjugation statistics (2026). PurePEG Research. https://purepeg.com/research/pegylation-statistics/ (data retrieved 12 Nov 2026).

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