Cleared Nanoparticles for Medical Use

Nanoparticles Approved in the United States (US) and Europe (EU) for Medical Applications

This list includes all nanoparticles currently approved for medical use in the United States by the Food and Drug Administration (FDA) and in Europe by the European Medicines Agency (EMA).  download list

Name
(developer)
Nanoparticle Class Indication(s)
[Approval Year & Region]
Links

Adagen®

Pegademase bovine

(Sigma-Tau Pharmaceuticals)

Polymer Nanoparticle

Adensine deaminase (ADA) deficiency in patients with severe combined immunodeficiency disease (SCID)

[1990 US]

www.adagen.com

Adynovate®

Antihemophilic factor (recombinant), PEGylated

(Shire)

Polymer Nanoparticle

Hemophilia

[2015 US]

www.adynovate.com

Cimzia®

Certolizumab pegol

(UCB)

Polymer Nanoparticle Crohn’s disease

    [2008 US] [2009 EU]

    Rheumatoid arthritis

      [2009 US] [2009 EU]

      Psoriatic arthritis

        [2013 US] [2009 EU]

        Ankylosing spondylitis

          [2013 US] [2009 EU]

          www.cimzia.com

          Wikipedia

          Copaxone®; Glatopa ®

          Glatiramer acetate

          (Teva Neuroscience)

          Polymer Nanoparticle

          Multiple sclerosis (MS)

          [1996 US]

          www.copaxone.com

          www.glatopa.com

          Wikipedia

          Eligard®

          Leuprolide acetate

          (Tolmar Pharmaceuticals)

          Polymer Nanoparticle

          Prostate cancer

          [2002 US]

          www.eligard.com

          Wikipedia

          Krystexxa®

          Pegloticase

          (Crealta Pharmaceuticals)

          Polymer Nanoparticle

          Chronic gout

          [2010 US] [2013 EU]

          www.krystexxa.com

          Wikipedia

          LC Bead LUMITM/DC Bead LUMITM

          (Biocompatibles UK) 

          Polymer Nanoparticle

          Hypervascular tumors and arteriovenous malformations (AVMs)

          [2015 US] [2017 EU]

          Drugs@FDA - 510(k) Summary

          LC-BeadLUMI.com

          Macugen®

          Pegaptanib

          (Bausch & Lomb)

          Polymer Nanoparticle

          Neovascular age-related macular degeneration

          [2004 US] [2006 EU]

          Macugen.com

          Wikipedia

          Mircera®

          mPEG-epoetin beta

          (Roche)

          Polymer Nanoparticle

          Anemia associated with chronic kidney disease

          [2007 US/EU]

          Micera -Product Details

          Wikipedia

          Neulasta®

          Pegfilgrastim

          (Amgen)

          Polymer Nanoparticle

          Chemotherapy induced neutropenia

          [2002 US/EU]

          www.neulasta.com/

          Wikipedia

          Oncaspar®

          Pegaspargase

          (Shire)

          Polymer Nanoparticle

          Acute lymphoblastic leukemia

          [1994 US] [2016 EU]

          www.oncaspar.com

          Wikipedia

          Pegasys®

          Peginterferon alpha-2a

          (Roche)

          Polymer Nanoparticle

          Hepatitis B and C

          [2002 US/EU]

          Pegasys.com

          Wikipedia

          PegIntron®

          Peginterferon alpha-2a

          (Merck)

          Polymer Nanoparticle

          Hepatitis C

          [2001 US] [2000 EU]

          Discontinued in 2015

          Wikipedia

          Plegridy®

          Peginterferon beta-1a

          (Biogen)

          Polymer Nanoparticle

          Multiple sclerosis (MS)

          [2014 US/EU]

          www.plegridy.com

          Wikipedia

          Renvela®/Renagel®

          Sevelamer hydrochloride

          (Genzyme)

          Polymer Nanoparticle

          Chronic kidney disease

          [2000 US/EU]

          www.renvela.com

          Wikipedia

          Somavert®

          Pegvisomant

          (Pfizer)

          Polymer Nanoparticle

          Acromegaly

          [2003 US] [2002 EU]

          www.somavert.com

          Wikipedia

          Welchol®

          Colesevelam hydrochloride

          (Daiichi-Sankyo)

          Polymer Nanoparticle

          Type II diabetes

          [2000 US]

          welchol.com

          Wikipedia

          Abelcet®

          Amphotericin B

          (Sigma-Tau Pharmaceuticals)

          Liposome Nanoparticle

          Fungal infections

          [1995 US]

          abelcet.com

          Wikipedia

          AmBisome®

          Amphotericin B

          (Gilead Sciences)

          Liposome Nanoparticle

          Fungal/protozoal infections

          [1997 US]

          www.ambisome.com

          Wikipedia

          Curosurf®

          Poractant alpha

          (Chiesei)

          Liposome Nanoparticle

          Respiratory distress syndrome

          [1999 US]

          www.curosurf.com

          Wikipedia

          DaunoXome®

          Daunorubicin

          (Galen)

          Liposome Nanoparticle

          Kaposi’s sarcoma

          [1996 US]

          Discontinued 2016

          www.galen.co.uk

          Wikipedia

          DepoCyt©

          Cytarabine

          (Pacira Pharmaceuticals)

          Liposome Nanoparticle

          Lymphomatous meningitis

          [1999 US] [2001 EU]

          www.depocyt.com

          Wikipedia

          DepoDur®

          Morphine sulfate

          (Pacira Pharmaceuticals)

          Liposome Nanoparticle

          Analgesia (post-operative)

          [2004 US]

          depodur.com

          Wikipedia

          Doxil®/CaelyxTM

          Doxorubicin

          (Janssen)

          Liposome Nanoparticle

          Karposi’s sarcoma

          [1995 US] [1996 EU]

          Ovarian cancer

          [2005 US] [1996 EU]

          Multiple myeloma

          [2008 US] [1996 EU]

          Breast cancer

          [1996 EU]

          www.doxil.com

          Wikipedia

          Marqibo®

          Vincristine sulfate

          (Spectrum Pharmaceuticals)

          Liposome Nanoparticle

          Acute lymphoblastic leukemia

          [2012 US]

          www.marqibo.com

          Wikipedia

          Mepact®

          Mifamurtide

          (IDM Pharma)

          Liposome Nanoparticle

          Bone cancer

          [2009 EU]

          mepact.com

          Wikipedia

          Myocet®  

          Doxorubicin

          (Teva UK)

          Liposome Nanoparticle

          Bone cancer

          [2000 EU]

          myocet.com

          Wikipedia

          Onivyde®

          Irinotecan hydrochloride

          (Ipsen Biopharmaceuticals)

          Liposome Nanoparticle

          Pancreatic cancer

          [2015 US] [2016 EU]

          www.onivyde.com

          Wikipedia

          Visudyne®

          Verteporfin

          (Novartis)

          Liposome Nanoparticle

          Age-related macular degeneration

          [2000 US/EU]

          Pathologic myopia

          [2000 US/EU]

          Ocular histoplasmosis

          [2000 US/EU]

          Visudyne.com

          Wikipedia

          EstrasorbTM

          Estradiol hemihydrate

          (Novavax/Graceway)

          Micellar Nanoparticle

          Menopausal therapy

          [2003 US]

          Drugs@FDA - Prescribing Information 

          Wikipedia

          Taxol®

          Paclitaxel

          (Bristol Myres Squibb)

          Micellar Nanoparticle

          Ovarian cancer

          [1992 US]

          Breast cancer

          [1994 US]

          Kaposi’s sarcoma

          [1997 US]

          Non-small cell lung cancer

          [1998 US]

          Drugs@FDA - Patient Information

          Wikipedia

          Taxotere®

          Docetaxel

          (Sanofi-Aventis)

          Micellar Nanoparticle

          Breast Cancer

          [1996 US] [1995 EU]

          Non-small cell lung cancer

          [1999 US] [1995 EU]

          Prostate cancer

          [2004 US] [1995 EU]

          Gastric cancer

          [2006 US] [1995 EU]

          Head and neck cancer

          [2006 US] [1995 EU]

          taxotere.com

          Wikipedia

          Abraxane®

          ABI-007 Protein-bound paclitaxel

          (Celgene)

          Protein Nanoparticle

          Breast cancer

          [2005 US] [2008 EU]

          Non-small cell lung cancer

          [2012 US] [2005 EU]

          Pancreatic cancer  

          [2013 US] [2008 EU]

          www.abraxane.com

          Wikipedia

          Ontak®

          Denileukin diftitox

          (Eisai)

          Protein Nanoparticle

          Cutaneous T-cell lymphoma

          [1999 US]

          Discontinued 2014

          Wikipedia

          Avinza®

          Morphine sulfate

          (Pfizer)

          Nanocrystals

          Pain management

          [2002 US]

          Discontinued 2015

          avinza.com

          Wikipedia

          Emend®

          Aprepitant

          (Merck)

          Nanocrystals

          Antiemetic

          [2003 US/EU]

          www.emend.com

          Wikipedia

          EquivaBone®

          (Zimmer Biomet) 

          Nanocrystals

          Bone substitute

          [2009 US]

          equivabone.com

          Focalin XR®

          Dexmethylphenidate hydrochloride

          (Novartis)

          Nanocrystals

          Attention deficit hyperactivity disorder

          [2005 US]

          www.focalinxr.com

          Wikipedia

          Invega Sustenna®/Xeplion®

          Paliperidone palmitate

          (Janssen Pharms)

          Nanocrystals

          Schizophrenia

          [2009 US] [2011 EU]

          www.invegasustenna.com

          Wikipedia

          Megace ES®

          Megestrol acetate

          (Endo Pharms)

          Nanocrystals

          Anti-anorexic

          [2005 US]

          Wikipedia

          NanOss®

          (Rti Surgical) 

          Nanocrystals

          Bone substitute

          [2005 US]

          nanoss.com

          OsSatura®

          (IsoTis Orthobiologics) 

          Nanocrystals

          Bone substitute

          [2003 US]

          Recalled 2006

          Ostim®

          (Heraseus Kulzer) 

          Nanocrystals

          Bone substitute

          [2004 US]

          Ostim - Product Information

          Rapamune®

          Sirolimus

          (Pfizer)

          Nanocrystals

          Immunosuppresent

          [1999 US] [2001 EU]

          rapamune.com

          Wikipedia

          Ritalin LA®

          Methylphenidate hydrochloride

          (Novartis)

          Nanocrystals

          Attention deficit hyperactivity disorder

          [2002 US]

          Ritalin LA - Prescribing Information

          Wikipedia

          Ryanodex®

          Dantrolene sodium

          (Eagle Pharmaceuticals)

          Nanocrystals

          Malignant hypothermia

          [2014 US]

          www.ryanodex.com

          Wikipedia

          Tricor®

          Fenofibrate

          (AbbVie)

          Nanocrystals

          High cholesterol and high triglyceride levels

          [2004 US]

          Wikipedia

          Triglide®

          Fenofibrate

          (SkyePharma AG)

          Nanocrystals

          High cholesterol and triglycerides

          [2005 US]

          Drugs@FDA - Prescribing Information

          Vitoss®

          (Stryker) 

          Nanocrystals

          Bone substitute

          [2003 US]

          vitoss.com

          Vitoss Synthetic Cancellous Bone

          Zanaflex®

          Tizanidine hydrochloride

          (Acorda)

          Nanocrystals

          Muscle relaxant

          [1996 US]

          zanaflex.com

          Wikipedia

          Dexferrum®/ DexIron®

          (Luitpold Pharmaceuticals) 

          Inorganic and Metallic Nanoparticles

          Iron deficiency

          [1996 US]

          Dexiron - Therapeutic Classification

          Dexferrum - MSDS

          Wikipedia

          FerahemeTM/Rienso®

          Ferumoxytol

          (AMAG pharmaceuticals)

          Inorganic and Metallic Nanoparticles

          Iron deficiency anemia in chronic kidney disease

          [2009 US] [2012 EU]

          www.feraheme.com

          Wikipedia

          Feridex®/Endorem®

          (AMAG pharmaceuticals) 

          Inorganic and Metallic Nanoparticles

          Magnetic Resonance Imaging (MRI) agent

          [1996 US]

          Discontinued 2008

          Freidex - Archive

          Wikipedia

          Ferrlecit®

          (Sanofi Avertis) 

          Inorganic and Metallic Nanoparticles

          Iron deficiency anemia in chronic kidney disease

          [1999 US]

          www.ferrlecit.com

          Wikipedia

          GastroMARKTM/ Lumirem®

          (AMAG pharmaceuticals) 

          Inorganic and Metallic Nanoparticles

          Magnetic Resonance Imaging (MRI) agent

          [1996 US/EU]

          Discontinued 2012

          Wikipedia

          INFeD®

          (Allergan Pharma) 

          Inorganic and Metallic Nanoparticles

          Iron deficiency anemia in chronic kidney disease

          [1974 US]

          INFed - Product Information

          Wikipedia

          Injectafer®/Ferinject®

          (Luitpold Pharmaceuticals) 

          Inorganic and Metallic Nanoparticles

          Iron deficiency anemia in chronic kidney disease

          [2013 US]

          www.injectafer.com

          Ferinject - Prescribing Information

          eMC - Product Information

          Wikipedia

          Resovist®/CliavistTM

          (Bayer Schering Pharma) 

          Inorganic and Metallic Nanoparticles

          Magnetic Resonance Imaging (MRI) agent

          [2001 EU]

          Abandoned 2009

          Wikipedia

          Venofer®

          (Luitpold Pharmaceuticals) 

          Inorganic and Metallic Nanoparticles

          Iron deficiency anemia in chronic kidney disease

          [2000 US]

          www.venofer.com

          Wikipedia

          Inflexal® V

          (Berna Biotech/Crucell) 

          Virosome Nanoparticle Influenza eMC - Patient Information

           

          Last Updated: July 28, 2017

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          Nanoparticles Approved in the United States (US) and Europe (EU) for Medical Applications:

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