# Every FDA-approved PEGylated drug, 1990 to 2026. PurePEG Research, purepeg.com/research/fda-approved-pegylated-drugs/. License: CC BY 4.0.
# Sources: openFDA Drugs@FDA API + Drugs@FDA data file (11 Nov 2026); FDA Purple Book data file (Oct 2026); FDA labels via openFDA label API and DailyMed. Retrieved 12-13 Nov 2026.
category,brand,active_ingredient,application,application_type,fda_center,approval_date,approval_year,modality,peg_as_described_on_label,stated_peg_moiety_kda,current_application_holder,status_nov_2026,label_source
PEG conjugate,Adagen,pegademase bovine,BLA019818,BLA 351(a),CDER,1990-03-21,1990,Enzyme,"Many linear mPEG strands, 5 kDa each",5,"Leadiant Biosciences, Inc",License revoked,"openFDA drug label API set 9880b900-ea23-11dc-ad56-0002a5d5c51b, version date 20190626"
PEG conjugate,Oncaspar,pegaspargase,BLA103411,BLA 351(a),CDER,1994-02-01,1994,Enzyme,"69 to 82 mPEG chains, about 5 kDa each",5,Servier Pharmaceuticals LLC,Marketed,"openFDA drug label API set ac7b6a6f-6ddb-48c6-8088-d8a8e3fea6ce, version date 20241007"
PEG-lipid particle,Doxil,doxorubicin hydrochloride (liposomal),NDA050718,NDA,CDER,1995-11-17,1995,PEGylated liposome,PEG-lipid MPEG-DSPE (PEG 2000) in the liposome,2,BAXTER HLTHCARE CORP,Marketed,"openFDA drug label API set 1c153e9e-4cf2-4ac7-9cf9-16f9b48d7dce, version date 20220531"
PEG conjugate,PegIntron / Sylatron,peginterferon alfa-2b,BLA103949,BLA 351(a),CDER,2001-01-19,2001,Protein (interferon),"mPEG, 12 kDa",12,Merck Sharp & Dohme LLC,License revoked,"openFDA drug label API set 3874c95c-092e-4cd5-b104-6ed2bc391b0e, version date 20210903"
PEG-lipid particle,Definity,perflutren lipid microsphere,NDA021064,NDA,CDER,2001-07-31,2001,PEGylated lipid microsphere (imaging),PEG-lipid MPEG5000-DPPE (PEG 5000) in lipid microspheres,5,LANTHEUS MEDCL,Marketed,"openFDA drug label API set 7b9de6ab-a3ac-40c9-8103-139dc7a464a2, version date 20240313"
PEG conjugate,Neulasta,pegfilgrastim,BLA125031,BLA 351(a),CDER,2002-01-31,2002,Protein (G-CSF),One 20 kDa mPEG at the N-terminus,20,Amgen Inc.,Marketed,"openFDA drug label API set fdfe5d72-6b80-435a-afa4-c5d74dd852ce, version date 20260805"
PEG conjugate,Pegasys,peginterferon alfa-2a,BLA103964,BLA 351(a),CDER,2002-10-16,2002,Protein (interferon),One branched 40 kDa PEG,40,pharmaand GmbH,Marketed,"openFDA drug label API set d9290e5b-6d40-2318-e053-2995a90a9916, version date 20261016"
PEG conjugate,Somavert,pegvisomant,BLA021106,BLA 351(a),CDER,2003-03-25,2003,Protein (GH receptor antagonist),"Several PEG chains, about 5 kDa each",5,Pharmacia & Upjohn Company LLC,Marketed,"openFDA drug label API set 3cbb485b-6df1-49ce-8747-592b395b1988, version date 20251218"
PEG conjugate,Macugen,pegaptanib sodium,NDA021756,NDA,CDER,2004-09-17,2004,Aptamer (oligonucleotide),Two 20 kDa mPEG units on one linker,20,BAUSCH AND LOMB INC,Discontinued,"openFDA drug label API set 45d03177-5d52-492c-b2e0-01afc7c8d2e0, version date 20160701"
PEG conjugate,Mircera,methoxy polyethylene glycol-epoetin beta,BLA125164,BLA 351(a),CDER,2007-11-14,2007,Protein (epoetin),"mPEG butanoic acid, about 30 kDa",30,Vifor (International) Inc.,Marketed,"openFDA drug label API set 22c56f2a-f73c-60e7-e054-00144ff88e88, version date 20260814"
PEG conjugate,Cimzia,certolizumab pegol,BLA125160,BLA 351(a),CDER,2008-04-22,2008,Antibody fragment (Fab'),About 40 kDa PEG (PEG2MAL40K),40,"UCB, Inc.",Marketed,"openFDA drug label API set b4c2c9dc-a0bb-4d64-a667-a67ebe88392d, version date 20261029"
PEG conjugate,Krystexxa,pegloticase,BLA125293,BLA 351(a),CDER,2010-09-14,2010,Enzyme,"mPEG, 10 kDa",10,Horizon Therapeutics Ireland DAC,Marketed,"openFDA drug label API set 6e566303-d93a-4130-b764-25749829aa95, version date 20261102"
PEG conjugate,Omontys,peginesatide acetate,NDA202799,NDA,CDER,2012-03-27,2012,Peptide,One branched 40 kDa PEG,40,TAKEDA PHARMS USA,Discontinued,"openFDA drug label API set d0c236d5-7ca2-11e0-819a-0800200c9a66, version date 20130223"
PEG conjugate,Plegridy,peginterferon beta-1a,BLA125499,BLA 351(a),CDER,2014-08-15,2014,Protein (interferon),One linear 20 kDa mPEG,20,Biogen Inc.,Marketed,"openFDA drug label API set 08f0ea03-4e6d-195d-aef4-886e32befa95, version date 20251112"
PEG conjugate,Movantik,naloxegol oxalate,NDA204760,NDA,CDER,2014-09-16,2014,Small molecule,Short discrete mPEG chain (seven ether oxygens in the chemical name),,AVERITAS,Marketed,"openFDA drug label API set 28596788-b73f-4247-85fc-3105f51fff5a, version date 20260901"
PEG-lipid particle,Onivyde,irinotecan hydrochloride (liposomal),NDA207793,NDA,CDER,2015-10-22,2015,PEGylated liposome,PEG-lipid MPEG-2000-DSPE in the liposome,2,IPSEN,Marketed,"openFDA drug label API set c8b58efa-1820-48a4-b70d-62918fc4abfc, version date 20250303"
PEG conjugate,Adynovate,"antihemophilic factor (recombinant), PEGylated",BLA125566,BLA 351(a),CBER,2015-11-13,2015,Protein (factor VIII),One or more 20 kDa PEG chains,20,"Takeda Pharmaceuticals U.S.A., Inc.",Marketed,"openFDA drug label API set ef290433-997f-4e98-86d6-42f6a99d6d18, version date 20260528"
PEG conjugate,Rebinyn,"coagulation factor IX (recombinant), glycoPEGylated",BLA125611,BLA 351(a),CBER,2017-05-31,2017,Protein (factor IX),One 40 kDa PEG on an N-linked glycan (glycoPEGylation),40,Novo Nordisk Inc.,Marketed,"openFDA drug label API set 0ea37235-35fd-410d-b8c4-40ba15fe1294, version date 20220811"
PEG conjugate,Palynziq,pegvaliase-pqpz,BLA761079,BLA 351(a),CDER,2018-05-24,2018,Enzyme,About nine 20 kDa PEG chains per enzyme subunit,20,BioMarin Pharmaceutical Inc.,Marketed,"openFDA drug label API set 6dba844a-db02-44f8-8593-ce497ed9406c, version date 20260302"
PEG-lipid particle,Onpattro,patisiran,NDA210922,NDA,CDER,2018-08-10,2018,Lipid nanoparticle (siRNA),PEG-lipid PEG2000-C-DMG in the lipid nanoparticle,2,ALNYLAM PHARMS INC,Marketed,"openFDA drug label API set e87ec36f-b4b4-49d4-aea4-d4ffb09b0970, version date 20250908"
PEG conjugate,Jivi,"antihemophilic factor (recombinant), PEGylated-aucl",BLA125661,BLA 351(a),CBER,2018-08-29,2018,Protein (factor VIII),"One branched 60 kDa PEG (two 30 kDa arms), site-specific",60,Bayer HealthCare LLC,Marketed,"openFDA drug label API set f04e5bd5-d7e2-453b-a407-2616d81a695d, version date 20260302"
PEG conjugate,Revcovi,elapegademase-lvlr,BLA761092,BLA 351(a),CDER,2018-10-05,2018,Enzyme,mPEG via succinimidyl carbamate linker; PEG size not stated,,"Chiesi USA, Inc.",Marketed,"openFDA drug label API set 8c073f84-cdd0-40e4-b3a9-172687267f28, version date 20260531"
PEG conjugate,Asparlas,calaspargase pegol-mknl,BLA761102,BLA 351(a),CDER,2018-12-20,2018,Enzyme,"31 to 39 mPEG chains, about 5 kDa each",5,Servier Pharmaceuticals LLC,Marketed,"openFDA drug label API set 6585bd0d-bd78-4341-9e87-0f7664821f05, version date 20241008"
PEG conjugate,Esperoct,"antihemophilic factor (recombinant), glycoPEGylated-exei",BLA125671,BLA 351(a),CBER,2019-02-19,2019,Protein (factor VIII),One 40 kDa PEG on an O-glycan (glycoPEGylation),40,Novo Nordisk Inc.,Marketed,"openFDA drug label API set 562f94e8-825f-4d7f-b93c-b783ac3a43bc, version date 20240701"
PEG conjugate,Empaveli,pegcetacoplan,NDA215014,NDA,CDER,2021-05-14,2021,Peptide,Linear 40 kDa PEG with a peptide on each end,40,APELLIS PHARMS,Marketed,"openFDA drug label API set c23d89e9-b00b-4520-e053-2995a90a95af, version date 20260821"
PEG-lipid particle,Comirnaty,"COVID-19 vaccine, mRNA",BLA125742,BLA 351(a),CBER,2021-08-23,2021,Lipid nanoparticle (mRNA vaccine),PEG-lipid (PEG 2000) in the lipid nanoparticle,2,BioNTech Manufacturing GmbH,Marketed,"DailyMed SPL (NLM) set 48c86164-de07-4041-b9dc-f2b5744714e5, version date 20260902"
PEG conjugate,Skytrofa,lonapegsomatropin-tcgd,BLA761177,BLA 351(a),CDER,2021-08-25,2021,Protein (growth hormone prodrug),"mPEG carrier, 4 x 10 kDa, releasable linker",10,Ascendis Pharma Endocrinology Division A/S,Marketed,"openFDA drug label API set 9229f871-bc61-4ddc-8122-d126d40e36ac, version date 20261021"
PEG conjugate,Besremi,ropeginterferon alfa-2b-njft,BLA761166,BLA 351(a),CDER,2021-11-12,2021,Protein (interferon),One 40 kDa mPEG at the N-terminus,40,PharmaEssentia Corporation,Marketed,"openFDA drug label API set 9583405d-53a0-49dc-88eb-5e6384ebabcb, version date 20260825"
PEG-lipid particle,Spikevax,"COVID-19 vaccine, mRNA",BLA125752,BLA 351(a),CBER,2022-01-31,2022,Lipid nanoparticle (mRNA vaccine),PEG-lipid PEG2000-DMG in the lipid nanoparticle,2,"ModernaTX, Inc.",Marketed,"DailyMed SPL (NLM) set f96b315c-fa57-4876-a7e5-a9b584d8e6e6, version date 20260817"
PEG conjugate,Rolvedon,eflapegrastim-xnst,BLA761148,BLA 351(a),CDER,2022-09-09,2022,Protein (G-CSF),One 3.4 kDa PEG linker joining the G-CSF analog and an Fc fragment,3.4,"Assertio Specialty Pharmaceuticals, LLC",Marketed,"openFDA drug label API set 2dc62c46-bb10-4a62-a459-d3eeeb6dd82f, version date 20260211"
PEG conjugate,Syfovre,pegcetacoplan,NDA217171,NDA,CDER,2023-02-17,2023,Peptide,Linear 40 kDa PEG with a peptide on each end,40,APELLIS PHARMS,Marketed,"openFDA drug label API set b4434e61-9ec9-4e0e-bd60-45aaa0a87e64, version date 20250916"
PEG conjugate,Elfabrio,pegunigalsidase alfa-iwxj,BLA761161,BLA 351(a),CDER,2023-05-09,2023,Enzyme,About nine 2.3 kDa PEG crosslinks per dimer,2.3,Chiesi Farmaceutici S.p.A.,Marketed,"openFDA drug label API set 6fb674bf-744e-431f-92ef-b2a5a66c8cf3, version date 20240708"
PEG conjugate,Izervay,avacincaptad pegol sodium,NDA217225,NDA,CDER,2023-08-04,2023,Aptamer (oligonucleotide),One branched 43 kDa PEG,43,ASTELLAS,Marketed,"openFDA drug label API set 1642fe6a-dc26-4d20-ae6e-654af744e3bd, version date 20260903"
PEG conjugate,Zilbrysq,zilucoplan,NDA216834,NDA,CDER,2023-10-17,2023,Peptide,Discrete 24-unit ethylene-oxide spacer to a palmitoyl group (chemical name); label reports anti-PEG antibody testing,,UCB INC,Marketed,"DailyMed SPL (NLM) set 9f1d53d6-e495-4a3a-8bb9-680a15d25034, version date 20260203"
PEG conjugate,Lumisight,pegulicianine acetate,NDA214511,NDA,CDER,2024-04-17,2024,Imaging agent,"One mPEG chain, about 450 repeat units (molecule 20-25 kDa)",,LUMICELL,Marketed,"openFDA drug label API set 7160e774-663a-43e4-ba4a-06cc57830e66, version date 20260109"
PEG-lipid particle,mRESVIA,respiratory syncytial virus vaccine (mRNA),BLA125796,BLA 351(a),CBER,2024-05-31,2024,Lipid nanoparticle (mRNA vaccine),PEG-lipid PEG2000-DMG in the lipid nanoparticle,2,"ModernaTX, Inc.",Marketed,"DailyMed SPL (NLM) set e5c837e7-41e8-496a-9c85-6b0453b35948, version date 20260807"
PEG conjugate,Yorvipath,palopegteriparatide,NDA216490,NDA,CDER,2024-08-09,2024,Peptide (PTH prodrug),"Branched 40 kDa mPEG carrier (2 x 20 kDa), releasable linker",40,ASCENDIS PHARMA BONE,Marketed,"openFDA drug label API set a1fa23fd-c434-443e-9a17-5750578c8602, version date 20261103"
PEG-lipid particle,mNEXSPIKE,"COVID-19 vaccine, mRNA",BLA125835,BLA 351(a),CBER,2025-05-30,2025,Lipid nanoparticle (mRNA vaccine),PEG-lipid PEG2000-DMG in the lipid nanoparticle,2,"ModernaTX, Inc.",Marketed,"DailyMed SPL (NLM) set 97c27eb6-1d2e-4953-afac-882ada70c6f8, version date 20260817"
PEG conjugate,Loargys,pegzilarginase-nbln,BLA761211,BLA 351(a),CDER,2026-02-23,2026,Enzyme,6 to 12 mPEG chains of 5 kDa per subunit,5,Immedica Pharma AB,Marketed,"openFDA drug label API set d5ceabf2-43a0-4746-9371-d98a39cf6cfc, version date 20260223"
PEG conjugate,Yuviwel,navepegritide,NDA219164,NDA,CDER,2026-02-27,2026,Peptide (CNP prodrug),"Two branched 20 kDa mPEG moieties, releasable linker",20,ASCENDIS,Marketed,"openFDA drug label API set e01c1197-338f-414c-b804-808e129ebc8c, version date 20260325"
PEG-lipid particle,mFLUSIVA,"influenza vaccine, mRNA",BLA125869,BLA 351(a),CBER,2026-08-05,2026,Lipid nanoparticle (mRNA vaccine),PEG-lipid PEG2000-DMG in the lipid nanoparticle,2,"ModernaTX, Inc.",Marketed,"DailyMed SPL (NLM) set 3dd1c6d2-b054-4803-bb21-460b1b090d4c, version date 20260805"
Biosimilar (pegfilgrastim),Fulphila,pegfilgrastim-jmdb,BLA761075,BLA 351(k) biosimilar,CDER,2018-06-04,2018,Protein (G-CSF),Same molecule type as Neulasta (pegfilgrastim),20,Biocon Biologics Inc.,Marketed,
Biosimilar (pegfilgrastim),Udenyca,pegfilgrastim-cbqv,BLA761039,BLA 351(k) biosimilar,CDER,2018-11-02,2018,Protein (G-CSF),Same molecule type as Neulasta (pegfilgrastim),20,Accord BioPharma Inc.,Marketed,
Biosimilar (pegfilgrastim),Ziextenzo,pegfilgrastim-bmez,BLA761045,BLA 351(k) biosimilar,CDER,2019-11-04,2019,Protein (G-CSF),Same molecule type as Neulasta (pegfilgrastim),20,Sandoz Inc.,Marketed,
Biosimilar (pegfilgrastim),Nyvepria,pegfilgrastim-apgf,BLA761111,BLA 351(k) biosimilar,CDER,2020-06-10,2020,Protein (G-CSF),Same molecule type as Neulasta (pegfilgrastim),20,"Hospira Inc., a Pfizer Company",Marketed,
Biosimilar (pegfilgrastim),Fylnetra,pegfilgrastim-pbbk,BLA761084,BLA 351(k) biosimilar,CDER,2022-05-26,2022,Protein (G-CSF),Same molecule type as Neulasta (pegfilgrastim),20,"Kashiv BioSciences, LLC",Marketed,
Biosimilar (pegfilgrastim),Stimufend,pegfilgrastim-fpgk,BLA761173,BLA 351(k) biosimilar,CDER,2022-09-01,2022,Protein (G-CSF),Same molecule type as Neulasta (pegfilgrastim),20,"Fresenius Kabi USA, LLC",Marketed,
Biosimilar (pegfilgrastim),Armlupeg,pegfilgrastim-unne,BLA761212,BLA 351(k) biosimilar,CDER,2025-11-28,2025,Protein (G-CSF),Same molecule type as Neulasta (pegfilgrastim),20,Lupin Limited (Biotech Division),Marketed,
Biosimilar (pegfilgrastim),Ennumo,pegfilgrastim-pccg,BLA761147,BLA 351(k) biosimilar,CDER,2026-05-07,2026,Protein (G-CSF),Same molecule type as Neulasta (pegfilgrastim),20,Accord BioPharma Inc.,Marketed,
Generic (ANDA),Doxorubicin Hydrochloride (Liposomal),doxorubicin hydrochloride,ANDA203263,ANDA,CDER,2013-02-04,2013,PEGylated liposome,Generic of Doxil (doxorubicin HCl liposome injection),,SUN PHARM,,
Generic (ANDA),Doxorubicin Hydrochloride (Liposomal),doxorubicin hydrochloride,ANDA207228,ANDA,CDER,2021-10-12,2021,PEGylated liposome,Generic of Doxil (doxorubicin HCl liposome injection),,AYANA PHARMA LTD,,
Generic (ANDA),Doxorubicin Hydrochloride (Liposomal),doxorubicin hydrochloride,ANDA208657,ANDA,CDER,2017-05-15,2017,PEGylated liposome,Generic of Doxil (doxorubicin HCl liposome injection),,DR REDDYS,,
Generic (ANDA),Doxorubicin Hydrochloride (Liposomal),doxorubicin hydrochloride,ANDA212219,ANDA,CDER,2022-10-19,2022,PEGylated liposome,Generic of Doxil (doxorubicin HCl liposome injection),,BAXTER HLTHCARE CORP,,
Generic (ANDA),Doxorubicin Hydrochloride (Liposomal),doxorubicin hydrochloride,ANDA212299,ANDA,CDER,2020-09-10,2020,PEGylated liposome,Generic of Doxil (doxorubicin HCl liposome injection),,ZYDUS LIFESCIENCES,,
Generic (ANDA),Doxorubicin Hydrochloride (Liposomal),doxorubicin hydrochloride,ANDA215178,ANDA,CDER,2024-07-16,2024,PEGylated liposome,Generic of Doxil (doxorubicin HCl liposome injection),,LUPIN,,
Generic (ANDA),Doxorubicin Hydrochloride (Liposomal),doxorubicin hydrochloride,ANDA219199,ANDA,CDER,2025-06-27,2025,PEGylated liposome,Generic of Doxil (doxorubicin HCl liposome injection),,ALEMBIC,,
Generic (ANDA),Doxorubicin Hydrochloride,doxorubicin hydrochloride,ANDA219881,ANDA,CDER,2026-02-03,2026,PEGylated liposome,Generic of Doxil (doxorubicin HCl liposome injection),,QILU PHARM HAINAN,,