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Pancrelipase
Creon, Pancreaze, Pertzye, Viokace, Zenpep (pancrelipase) is an enzyme pharmaceutical. Pancrelipase was first approved as Cotazym on 1996-12-09. It is used to treat exocrine pancreatic insufficiency in the USA.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
digestive system diseasesD004066
Trade Name
FDA
EMA
Creon, Pancreaze, Pertzye, Viokace, Zenpep (discontinued: Cotazym)
Drug Products
FDA
EMA
Reference product - 351(a)
Reference product - 351(a)
Interchangeable product - 351(k)
Interchangeable product - 351(k)
Biosimilar product - 351(k)
Biosimilar product - 351(k)
Pancrelipase
Tradename
Proper name
Company
Number
Date
Products
CreonpancrelipaseAbbVieN-20725 RX2009-04-30
5 products
PertzyepancrelipaseDigestive CareN-22175 RX2012-05-17
4 products
PancreazepancrelipaseVivusN-22523 RX2010-04-12
6 products
ViokacepancrelipaseViokaceN-22542 RX2012-03-01
2 products
ZenpeppancrelipaseZenpepN-22210 RX2009-08-27
7 products
Show 1 discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
pancreazeBiologic Licensing Application2021-04-13
pertzyeBiologic Licensing Application2020-03-24
viokaceBiologic Licensing Application2020-03-23
zenpepBiologic Licensing Application2020-03-23
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
exocrine pancreatic insufficiencyD010188K86.81
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
ATC Codes
No data
HCPCS
No data
Clinical
Clinical Trials
52 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Multiple myelomaD009101C90.0331117
Non-hodgkin lymphomaD008228C85.914116
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
LymphomaD008223C85.94519
LeukemiaD007938C953328
MucositisD052016EFO_10018982146
StomatitisD013280EFO_1001904K12.12125
Head and neck neoplasmsD0062582235
NeoplasmsD009369C80123
Colonic neoplasmsD003110C18111
PainD010146EFO_0003843R5211
Squamous cell neoplasmsD01830711
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Myelodysplastic syndromesD009190D462416
Myeloid leukemia acuteD015470C92.01214
Graft vs host diseaseD006086D89.812314
Precursor cell lymphoblastic leukemia-lymphomaD054198C91.01113
Bcr-abl positive chronic myelogenous leukemiaD015464EFO_0000340213
Hodgkin diseaseD006689C811112
X-linked combined immunodeficiency diseasesD053632EFO_1001451222
Plasma cell leukemiaD007952C90.1111
Hematologic neoplasmsD01933711
Non-small-cell lung carcinomaD00228911
Show 7 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients11
Epidermolysis bullosaD004820Q8111
Hematopoietic stem cell transplantationD01838011
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Primary myelofibrosisD055728D47.411
B-cell chronic lymphocytic leukemiaD015451C91.111
Myelomonocytic leukemia chronicD015477C93.111
Leukemia myeloid chronic atypical bcr-abl negativeD054438C92.211
B-cell lymphoma marginal zoneD018442C88.411
Follicular lymphomaD008224C8211
Mantle-cell lymphomaD020522C83.111
Myeloid leukemia chronic-phaseD01546611
Large b-cell lymphoma diffuseD016403C83.311
Myeloid leukemia accelerated phaseD01546511
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common namePANCRELIPASE
INN
Description
Pancreatic enzymes, also known as pancreases or pancrelipase and pancreatin, are commercial mixtures of amylase, lipase, and protease. They are used to treat malabsorption syndrome due to certain pancreatic problems. 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.
Classification
Enzyme
Drug classenzymes
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)
Identifiers
PDB
CAS-ID
RxCUI
ChEMBL IDCHEMBL2108074
ChEBI ID
PubChem CID
DrugBankDB00085
UNII ID
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
Creon - Viatris
$
£
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Creon - AbbVie
$
£
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Zenpep - Allergan
$
£
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Zenpep - Warner Chilcott
$
£
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Pancreaze - Vivus
$
£
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 785 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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464 adverse events reported
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