CDEK
← All drugs Report issue

pancrelipase

Trade name: creon

Biologicalapproved

Approved

Dec 9, 1996

Pancreatic enzymes, also known as pancreases, pancrelipases or pancreatins are commercial mixtures of amylase, lipase, protease and lactase obtained from pigs. The components are digestive enzymes similar to those normally produced by the human pancreas. They help in the digestion of fats, starches, and proteins. They are used to treat malabsorption syndrome due to certain pancreatic insufficiencies. These pancreatic problems may be due to cystic fibrosis, surgical removal of the pancreas, long-term pancreatitis, pancreatic cancer, or MODY 5, among others. The preparation is taken by mouth. The treatment is also known as pancreatic enzyme replacement therapy or PERT. — Wikipedia

Clinical trial activity

67 trials · 79 clinical orgs · 8 marketing orgs

Phase 1
7
Phase 2
32
Phase 3
23
Phase 4
19

Earliest trial started Mar 1, 1999 (NCT00003851)

Timeline

1990s

  1. Mar 1, 1995

    Solvay — IND Organization

  2. Mar 1, 1995

    Solvay — IND Organization

  3. Dec 9, 1996

    Earliest FDA Approval

  4. Dec 9, 1996

    Organon — NDA Secondary Org

2000s

  1. Jan 1, 2000

    Solvay — Earliest Phase 3 Sponsor(trial)

  2. Jan 1, 2005

    Earliest Phase 2 Sponsor(trial)

  3. Jan 1, 2008

    Earliest Phase 1 Sponsor(trial)

  4. Apr 30, 2009

    Solvay — First NDA Organization

  5. Apr 30, 2009

    Solvay — Marketing Organization

  6. Apr 30, 2009

    Solvay — NDA Organization

  7. Apr 30, 2009

    AbbVie — NDA Secondary Org

  8. Aug 27, 2009

    Eurand Pharmaceuticals — Marketing Organization

  9. Aug 27, 2009

    Forest Laboratories — NDA Secondary Org

  10. Aug 27, 2009

    Eurand Pharmaceuticals — NDA Secondary Org

2010s

  1. Apr 12, 2010

    Vivus — NDA Secondary Org

  2. Mar 1, 2012

    Allergan PLC (2015) — Marketing Organization

  3. Mar 1, 2012

    Allergan PLC (2015) — NDA Secondary Org

  4. May 17, 2012

    Digestive Care, Inc. — NDA Secondary Org

Indications

Approved for

Studied for

Mechanism of action

  • Fatty acidsHYDROLYTIC ENZYME

    Fatty acids hydrolytic enzyme

  • PolypeptidesHYDROLYTIC ENZYME

    Polypeptides hydrolytic enzyme

  • StarchHYDROLYTIC ENZYME

    Starch hydrolytic enzyme

Combination products

Approval history

  • approvedDec 9, 1996

Chemistry & pharmacology

Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Oral
Availability
Prescription Only

Oral

Yes

Parenteral

No

Topical

No

Sources

Also known as

  • accelerase
  • combizym
  • cotazym
  • cotazym
  • cotazym-s
  • c-pert
  • creon
  • creon
  • creon 10000
  • creon 25000
  • creon 40000
  • creon micro
  • entolase
  • eur-1008
  • eurobiol 25000
  • ilozyme
  • kreon for kinder
  • ku-zyme hp
  • lipancreatin
  • lipase
  • lipase
  • lipase (pancrelipase)
  • nutrizym
  • nutrizym 10
  • nutrizym 22
  • nutrizym gr
  • pancelipase
  • pancrealipase
  • pancrease
  • pancrease hl
  • pancreatic enzymes
  • pancreatic extract pancrelipase
  • pancreatic extract pancrelipase
  • pancreatic protease
  • pancreatin
  • pancreatin
  • pancreatin
  • pancreatin
  • pancreatin
  • pancreatinum
  • pancrelipase
  • pancrelipase
  • pancrelipase
  • pancrelipase
  • pancrelipase
  • pancrelipase
  • pancrelipase
  • pancrelipase
  • pancrelipase (amylase;lipase;protease)
  • pancrelipase (amylase;lipase;protease)
  • pancrex v
  • pancrex v 125
  • pancrex v fte
  • pankreon 700
  • panrease
  • panreatin
  • panteric
  • panzytrat
  • panzytrat 10000
  • panzytrat 25000
  • protease
  • protease
  • ultrase mt20
  • viokase
  • viokase
  • zymase
  • zymase

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT06477159Phase 4Feb 1, 2024AbbVie, New York University, Ohio State University, University of Illinois at Chicago, University of Pittsburgh, University of Southern California
NCT06099119Phase 4Nov 30, 2023Clinica Universidad de Navarra, Karolinska Institute, University of Milan, University of Santiago de Compostela
NCT05642962Phase 1/Phase 2 (Phase 2)Nov 30, 2022Memorial Sloan-Kettering Cancer Center
NCT05266963Early Phase 1 (Phase 1)Sep 2, 2022Vanderbilt University
NCT05069597Phase 4Oct 14, 2021AbbVie
NCT05042284N/ASep 1, 2021Asian Institute of Gastroenterology
NCT04098237Phase 2Dec 17, 2020Cedars-Sinai Medical Center, Vivus
NCT04542473Phase 2/Phase 3 (Phase 3)Nov 1, 2020International Center for Diarrheal Disease Research, Kenya Medical Research Institute, Makerere University, Oregon Health and Science University, Queen Elizabeth Central Hospital, Blantyre, Malawi, University of Amsterdam, University of Oxford, University of Toronto, University of Washington, Wellcome Trust
NCT04315311Phase 4May 6, 2020AbbVie
NCT03859869Phase 4Jun 28, 2019AbbVie
NCT03924947Phase 4May 10, 2019AbbVie
NCT03469258Phase 2Apr 16, 2018Allergan, Harvard University
NCT03450772Phase 3Aug 31, 2017Abbott
NCT03097029Phase 2Mar 24, 2017AbbVie, University of Pennsylvania
NCT02985801Phase 1/Phase 2 (Phase 2)Dec 1, 2016Digestive Care, Inc., Mayo Clinic
NCT02849704Phase 2Jul 1, 2016AbbVie, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Phoenix Indian Medical Center, University of Pennsylvania
NCT02706236Phase 2Apr 1, 2016Dartmouth University
NCT02475369Phase 4May 1, 2015Actavis, Harvard University
NCT02415959Phase 2Mar 1, 2015Abbott, AbbVie, Linical Co., Ltd., Parexel
NCT02372383N/AOct 1, 2014Cystic Fibrosis Foundation Therapeutics, University of Colorado, University of Colorado, Denver
Showing 20 of 67 trials
Page 1 / 4

Organizations

Research & Development (79)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Forest LaboratoriesFor profit111122006
AbbottFor profit9832008
SolvayFor profit9632000
AbbVieFor profit8422015
Digestive Care, Inc.For profit5442007
University of FloridaAcademic/Hospital3122008
AxcanFor profit2122008
AzidusFor profit2212007
Harvard UniversityAcademic/Hospital2222015
Johnson and JohnsonFor profit2222008
Mayo ClinicAcademic/Hospital2112008
Sheffield Hallam UniversityAcademic/Hospital2122012
University of PennsylvaniaAcademic/Hospital2212016
University of PittsburghAcademic/Hospital2122007
AAIPharmaFor profit1012008
ActavisFor profit1012015
AllerganFor profit1012018
American Academy of Family PhysiciansAcademic/Hospital1112010
Asian Institute of GastroenterologyAcademic/Hospital1112021
AstraZenecaFor profit1012009
79 organizations
Page 1 / 4

Marketing (13)

OrganizationOrg typeRelationshipDate
AbbVieFor profitNDA2Apr 30, 2009
Allergan PLC (2015)For profitMKTGMar 1, 2012
Allergan PLC (2015)For profitNDA2Mar 1, 2012
Digestive Care, Inc.For profitNDA2May 17, 2012
Eurand PharmaceuticalsFor profitMKTGAug 27, 2009
Eurand PharmaceuticalsFor profitNDA2Aug 27, 2009
Eurand PharmaceuticalsFor profitMKTGAug 27, 2009
Forest LaboratoriesFor profitNDA2Aug 27, 2009
OrganonFor profitNDA2Dec 9, 1996
SolvayFor profitMKTGApr 30, 2009
SolvayFor profitNDAApr 30, 2009
SolvayFor profitINDMar 1, 1995
VivusFor profitNDA2Apr 12, 2010