Watertown, MA — October 22, 2024 — Biopharma PEG is proud to offer a wide range of polyethylene glycol (PEG) products, including monofunctional, homobifunctional, heterobifunctional, and multi-arm PEGs, specifically designed for PEGylation in biopharmaceutical development. With over 40 PEGylated drugs currently approved on the market, PEGylation is increasingly recognized for its ability to enhance therapeutic efficacy.
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| List of PEGylated drugs approved by the FDA |
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| Entry | Trade Name | Company | PEGylated entity | Indications | Average MW of PEGs | Approved Year |
| Macromolecular Drugs |
| 1 | YORVIPATH
(Palopegteriparatide) | Ascendis Pharma | parathyroid hormone | hypoparathyroidism | 2 x 20 kDa | 2024 |
| 2 | Izervay
(avacincaptad pegol) | Iveric Bio | ribonucleic acid aptamer | geographic atrophy (GA) | ~43 kDa | 2023 |
| 3 | Elfabrio
(pegunigalsidase alfa-iwxj) | Chiesi Global Rare Diseases/Protalix | recombinant human GLA enzyme | Fabry disease | ~2 kDa | 2023 |
| 4 | SYFOVRE (pegcetacoplan injection) | Apellis | Pentadecapeptide | geographic atrophy (GA) | 40 kDa | 2023 |
| 5 | Rolvedon (eflapegrastim-xnst) | Spectrum Pharmaceuticals | G-CSF | febrile neutropenia | 3.4 kDa | 2022 |
| 6 | Stimufend (pegfilgrastim-fpgk) | Fresenius Kabi | G-CSF | neutropenia | 20 kDa | 2022 |
| 7 | Fylnetra (pegfilgrastim-pbbk) | Amneal Pharmaceuticals LLC | G-CSF | neutropenia | 20 kDa | 2022 |
| 8 | BESREMi (ropeginterferon alfa-2b) | PharmaEssentia Corp | Interferon | polycythemia vera | 40 kDa | 2021 |
| 9 | Skytrofa (Lonapegsomatropin) | Ascendis | human growth hormone | Growth hormone deficiency | 4 x 10 kDa | 2021 |
| 10 | Empaveli (Pegcetacoplan) | Apellis | Pentadecapeptide | Paroxysmal nocturnal hemoglobinuria (PNH) | 40 kDa | 2021 |
| 11 | Nyvepria (pegfilgrastim-apgf) | Pfizer Inc. | G-CSF | Neutropenia Associated with Chemotherapy | 20 kDa | 2020 |
| 12 | Esperoct (turoctocog alfa pegol) | Novo Nordisk | recombinant antihemophilic factor | hemophilia A | 40 kDa | 2019 |
| 13 | Ziextenzo (pegfilgrastim-bmez) | Sandoz | G-CSF | infection during chemotherapy | 20 kDa | 2019 |
| 14 | Udenyca (Pegfilgrastim-cbqv Injection) | Coherus Biosciences | G-CSF | infection during chemotherapy | 20 kDa | 2018 |
| 15 | Palynziq (Pegvaliase) | BioMarin Pharmaceutical | recombinant phenylalanine ammonia lyase | phenylketonuria | ~ 9 X 20 kDa | 2018 |
| 16 | Revcovi (Elapegademase-lvlr) | Leadiant Bioscience | recombinant adenosine deaminase | ADA-SCID | 80 kDa | 2018 |
| 17 | Fulphila (pegfilgrastim-jmdb) | Mylan GmbH | G-CSF | infection during chemotherapy | 20 kDa | 2018 |
| 18 | Asparlas (Calaspargase pegol) | Servier Pharma | L-asparaginase | leukemia | 31-39 x 5 kDa | 2018 |
| 19 | Jivi (Damoctocog alfa pegol) | Bayer Healthcare | recombinant antihemophilic factor | hemophilia A | 2 X 30 kDa | 2017 |
| 20 | Rebinyn | Novo Nordisk | recombinant coagulation factor lX | hemophilia B | 40 kDa | 2017 |
| 21 | Adynovate | Baxalta | recombinant antihemophilic factor | hemophilia A | ≥1 X 20 kDa | 2015 |
| 22 | Plegridy (peginterferon beta-1a) | Biogen | peginterferon beta-1a | multiple sclerosis | 20 kDa | 2014 |
| 23 | Omontys (Peginesatide ) | Takeda | erythropoietin | anemia | 2 X 20 kDa | 2012 |
| 24 | Sylatron (Peginterferon alfa-2b) | Merck | peginterferon-alfa-2b | melanoma | 12 kDa | 2011 |
| 25 | Krystexxa (Pegloticase) | Horizon Pharma | recombinant uricase protein | gout | 40 X 10 kDa | 2010 |
| 26 | Cimzia (Certolizumab pegol) | UCB | antitumor necrosis factor | rheumatoid arthritis | 40 kDa | 2008 |
| 27 | Mircera | Roche | erythropoietin | anemia | 30 kDa | 2007 |
| 28 | Macugen (Pegaptanib) | Pfizer | aptamer | macular degeneration | 2 X 20 kDa | 2004 |
| 29 | Somavert (Pegvisomant) | Pfizer | human growth hormone | acromegaly | 4-6 X 5 kDa | 2003 |
| 30 | Neulasta (Pegfilgrastim) | Amgen | G-CSF | infection during chemotherapy | 20 kDa | 2002 |
| 31 | Pegasys (Peginterferon alfa-2a) | Roche | peginterferon-alfa-2a | hepatitis B and C | 40 kDa | 2002 |
| 32 | Pegintron (Peginterferon alfa-2b) | Schering | peginterferon-alfa-2b | hepatitis C, melanoma | 12 kDa | 2001 |
| 33 | Oncaspar (Pegaspargase) | Enzon | asparaginase | leukemia | 69-82 X 5 kDa | 1994 |
| 34 | Adagen (pegademase bovine) | Enzon | adenosine deaminase | ADA-SCIO | 11-17 X 5 kDa | 1990 |
| Small Molecular Drugs |
| 35 | Movantik (Naloxegol) | AstraZeneca | naloxone | constipation | 339 Da | 2014 |
| 36 | Asclera (polidocanol) | Chemische Fabrik Kreussler & Co. | dodecanol | varicose veins | 400Da | 2010 |
| Nanoparticles |
| 37 | Doxil (Doxorubicin) | Schering | liposomal | ovarian cancer, multiple myeloma | 2 kDa | 1995 |
| 38 | Onivyde (irinotecan liposomal) | Merrimack Pharmaceuticals, Inc. | liposomal | Pancreatic Cancer | 2 kDa | 2015 |
| 39 | Onpattro® (Patisiran) | Alnylam Pharmaceuticals | LNPs | Polyneuropathy of hereditary transthyretin-mediated amyloidosis | 2 kDa | 2018 |
| 40 | Comirnaty™ | BioNTech/Pfizer | lipid nanoparticles | Prevention of COVID-19 | 2 kDa | 2020 |
| 41 | Spikevax® | Moderna | lipid nanoparticles | Prevention of COVID-19 | 2 kDa | 2020 |
| The list of drugs containing peg is indicated (number of units) x (MW of each PEG unit). G-CSF: growth colony-stimulating factor. |
| ADA-SCIO: adenosine deaminase severe combined immune deficiency. |
Table. FDA apporved PEGylated Drugs by 2024
PEGylation delivers numerous benefits, such as improved solubility, bioavailability, and pharmacokinetics. While most approved PEGylated drugs utilize polydispersed PEGs, only two drugs have employed monodispersed PEGs to date.
However, interest in monodispersed PEGs is growing due to their advantages. For example, Movantik, which utilizes a monodisperse PEGylation (m-PEG7 linker), demonstrates significant improvements in solubility and overall effectiveness compared to conventional options.Another notable example is Asclera (Polidocanol), which incorporates an m-PEG9 entity. This formulation can serve as a local anesthetic in topical ointments or be injected to treat varicose veins, highlighting the versatility and enhanced performance of PEGylated compounds.
"Our mission at Biopharma PEG is to support your PEGylated drug development with tailored solutions that maximize therapeutic potential," said Jack Deng, CEO at Biopharma PEG. "Our specialized PEGs enhance drug properties and streamline the development process for pharmaceutical companies."
As the biopharmaceutical landscape evolves, Biopharma PEG remains dedicated to providing high-quality PEGylation solutions that meet the diverse needs of drug developers. To learn more about our products and how we can assist in your PEGylated drug development, please visit www.biochempeg.com or contact us directly at sales@biochempeg.com.
About Biopharma PEG
Biopharma PEG specializes in delivering innovative PEGylation solutions for the biopharmaceutical sector. Our extensive portfolio of PEG products and customized services empowers researchers and developers to create more effective and safer therapies.