Every FDA-Approved PEGylated Drug, 1990 to 2026

FDA approvals of PEGylated drugs by year

By decade

The full list: 41 original approvals

Each row is one original FDA approval (an NDA or a 351(a) BLA). The PEG description is taken from the description section of the product's current FDA label; we did not estimate sizes the label does not state. 4 of the 41 are no longer marketed or licensed: Adagen (license revoked), PegIntron / Sylatron (license revoked), Macugen (discontinued), Omontys (discontinued).

Biosimilars: 8 pegfilgrastim products

All PEGylated biosimilars in the Purple Book are biosimilars to Neulasta (pegfilgrastim). They are counted separately because they share Neulasta's molecule type rather than adding a new one.

Generics: 8 liposomal doxorubicin approvals

Abbreviated new drug applications (ANDAs) for doxorubicin hydrochloride liposome injection, the generic form of Doxil. One naloxegol generic has tentative approval only, so it is not counted.

How we built the list

What counts as PEGylated

We count a product when its FDA label describes polyethylene glycol as part of the active molecule (the words PEG, mPEG, PEGylated, polyethylene glycol or poly(oxyethylene), or a chemical name with a chain of seven or more ethylene-oxide units), or, for lipid particles, lists a PEG-lipid as a component of the particle. We do not count PEG used as a free excipient (for example PEG 3350 in a formulation), PEG laxatives and bowel preparations, PEG hydrogels and other device-like matrices, or short two-unit spacers that labels do not call PEG.

How we found the products

1. Name search of the openFDA Drugs@FDA API (active ingredient, generic and brand names containing PEG) and of every proper name in the FDA Purple Book data file (October 2026).
2. Full-text search of the openFDA drug label API for PEG conjugation terms (pegylated, methoxypolyethylene, monomethoxy, mPEG, polyethylene glycol near covalently, conjugated, attached or kDa, and PEG-lipid terms).
3. A check of known edge cases (lipid particles, mRNA vaccines, antibody-drug conjugates, lipidated peptides) against their labels on DailyMed.
4. For every product we kept, a script confirms that the quoted PEG description is present in the label text, and records the approval date from Drugs@FDA (original application approval) or, for biologics licensed by CBER, the Purple Book.

How PEG size is counted

The size figures use the size of each PEG unit as the label states it. Branched PEGs that the label sizes as one moiety count at that size (Pegasys and Omontys 40 kDa, Izervay 43 kDa, Yorvipath 40 kDa, Jivi 60 kDa). Where the label describes several PEG units on one linker or carrier, each unit counts at its own size: Macugen (two 20 kDa units), Skytrofa (4 x 10 kDa) and Yuviwel (two 20 kDa branched moieties) therefore fall below 40 kDa. Counted by their combined PEG mass, those three would also reach 40 kDa, and the figure would be 14 of 28. Proteins with many separate PEG chains (for example Oncaspar or Palynziq) count at the size of one chain.

Edge cases

• Zynlonta (loncastuximab tesirine-lpyl) and Trodelvy (sacituzumab govitecan-hziy) are antibody-drug conjugates whose FDA labels, as retrieved, do not describe a PEG component, so they are not counted.
• Syfovre and Empaveli contain the same molecule (pegcetacoplan) but are separate NDAs, so both are listed; the list holds 40 distinct molecules or products.
• Zilbrysq (zilucoplan) is not named as a PEGylated drug, but its label's chemical name contains a 24-unit ethylene-oxide chain and the label reports anti-PEG antibody testing. Without it the total is 40.
• Definity (perflutren lipid microsphere, an ultrasound imaging agent) counts only because its lipid microspheres contain a PEG-lipid (MPEG5000 DPPE); the active gas, perflutren, is not PEGylated.
• Two combination-pack licenses (Pegasys with Copegus, 2004; PegIntron with Rebetol, 2008) packaged an already-listed PEG molecule with ribavirin and are not counted again. Sylatron is a product under the PegIntron license (BLA 103949), so it shares PegIntron's row.

How this compares with the “41” in the literature

A 2025 review in Pharmaceutics (Fu et al., "Anti-PEG Antibodies and Their Biological Impact on PEGylated Drugs", published 20 Aug 2025) states that FDA has approved 41 PEGylated drugs: 2 small molecules, 5 nanomedicines and 34 macromolecular drugs. The review does not list them, so a product-by-product match is not possible. Our list up to 20 Aug 2025 holds 38 original approvals: 30 conjugates (2 of them small-molecule or imaging agents: Movantik, Lumisight) and 8 lipid-particle products. The review's class totals match ours if its 34 macromolecular drugs include the 6 pegfilgrastim biosimilars approved by then (28 + 6 = 34) and if it counts only 5 of our 8 lipid-particle products. That is our reading, not something the review states.

Limits

• Labels change. We used the label versions retrieved on 12 Nov 2026; the CSV records each label's set ID and version date.
• Four older products (Adagen, PegIntron, Macugen, Omontys) are no longer on DailyMed; their PEG text comes from archived labels in the openFDA label API.
• Approval dates are original approval dates. Later approvals of new strengths, devices or uses of the same product are not counted.
• Status is from the FDA listings in November 2026 (Drugs@FDA marketing status; Purple Book marketing status and licensure).

Sources

• U.S. Food and Drug Administration, openFDA Drugs@FDA API, api.fda.gov/drug/drugsfda.json, retrieved 12 Nov 2026 (data last updated 12 Nov 2026).
• FDA, Drugs@FDA data file (drugsatfda.zip, files dated 11 Nov 2026), fda.gov.
• FDA, Purple Book data download, October 2026, purplebooksearch.fda.gov/downloads.
• FDA labels via the openFDA drug label API (api.fda.gov/drug/label.json) and the National Library of Medicine's DailyMed (dailymed.nlm.nih.gov), retrieved 12 Nov 2026.
• Fu et al., "Anti-PEG Antibodies and Their Biological Impact on PEGylated Drugs", Pharmaceutics 2025;17(8):1074, mdpi.com.

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