Pancrelipase protease

Identification

Name
Pancrelipase protease
Accession Number
DB11066
Type
Biotech
Groups
Approved
Biologic Classification
Protein Based Therapies
Other protein based therapies
Description

Pancrelipase, in general, is composed of a mixture of pancreatic enzymes which include amylases, lipases, and proteases. These enzymes are extracted from porcine pancreatic glands.2 The pancrelipase protease is a mix of enzymes, formed by trypsin and chymotrypsin, that proteolytically cleave peptide bonds and are involved in food digestion.1,4 The pancrelipase mixture, including pancrelipase protease, was developed by Ortho-McNeil-Janssen Pharmaceuticals, Inc and FDA approved on April 12, 2010.3

Protein chemical formula
Not Available
Protein average weight
Not Available
Sequences
>sp|P00761|TRYP_PIG Trypsin OS=Sus scrofa OX=9823 PE=1 SV=1
FPTDDDDKIVGGYTCAANSIPYQVSLNSGSHFCGGSLINSQWVVSAAHCYKSRIQVRLGE
HNIDVLEGNEQFINAAKIITHPNFNGNTLDNDIMLIKLSSPATLNSRVATVSLPRSCAAA
GTECLISGWGNTKSSGSSYPSLLQCLKAPVLSDSSCKSSYPGQITGNMICVGFLEGGKDS
CQGDSGGPVVCNGQLQGIVSWGYGCAQKNKPGVYTKVCNYVNWIQQTIAAN
>AEC11098.1 chymotrypsin C [Sus scrofa]
MLGITVLAALLAYASSCGVPSFPPNLSARVVGGENAVPHSWPWQISLQYLSGDTWKHTCG
GTLITSTHVLTAAHCISNSRTYRVALGKNNLEVEDEEGSLVVGVDSIFVHEKWNSLLIRN
DIALIKLAEPVELSDTIQVLCLPEEGSLLPQDYPCYVTGWGRLWTNGPIAAELQQGLQPV
VDHATCSQRDWWGSTVRDTMVCAGGDGVISACNGDSGGPLNCQAENGSWEVRGIVSFGSG
LGCNTYKKPTVFTRVSAYIDWIDQKIQL
Download FASTA Format
Synonyms
  • Protease, pancreatic
Product Images
Mixture Products
NameIngredientsDosageRouteLabellerMarketing StartMarketing End
CotazymPancrelipase protease (35000 units) + Pancrelipase amylase (40000 units) + Pancrelipase lipase (10000 units)CapsuleOralMerck Ltd.1973-12-31Not applicableCanada
Cotazym Ecs 20Pancrelipase protease (100000 units) + Pancrelipase amylase (100000 units) + Pancrelipase lipase (25000 units)Capsule, delayed releaseOralMerck Ltd.1989-12-31Not applicableCanada
Cotazym Ecs 4Pancrelipase protease (11000 unit) + Pancrelipase amylase (11000 unit) + Pancrelipase lipase (4000 unit)CapsuleOralMerck Ltd.1997-08-182012-01-23Canada
Cotazym Ecs 8Pancrelipase protease (45000 units) + Pancrelipase amylase (42000 units) + Pancrelipase lipase (10800 units)Capsule, delayed releaseOralMerck Ltd.1980-12-31Not applicableCanada
CreonPancrelipase protease (19000 [USP'U]/1) + Pancrelipase amylase (30000 [USP'U]/1) + Pancrelipase lipase (6000 [USP'U]/1)Capsule, delayed release pelletsOralAtlantic Biologicals Corps.2010-08-13Not applicableUs17856 120620171018 3478 1x59skm
CreonPancrelipase protease (114000 [USP'U]/1) + Pancrelipase amylase (180000 [USP'U]/1) + Pancrelipase lipase (36000 [USP'U]/1)Capsule, delayed release pelletsOralAbbVie Inc.2013-03-14Not applicableUs0032 301620171018 3478 1xzy1f3
CreonPancrelipase protease (9500 [USP'U]/1) + Pancrelipase amylase (15000 [USP'U]/1) + Pancrelipase lipase (3000 [USP'U]/1)Capsule, delayed releaseOralAbbVie Inc.2009-04-30Not applicableUs
CreonPancrelipase protease (76000 [USP'U]/1) + Pancrelipase amylase (120000 [USP'U]/1) + Pancrelipase lipase (24000 [USP'U]/1)Capsule, delayed release pelletsOralAbbVie Inc.2009-04-30Not applicableUs0032 122420171018 3478 3zx10l
CreonPancrelipase protease (38000 [USP'U]/1) + Pancrelipase amylase (60000 [USP'U]/1) + Pancrelipase lipase (12000 [USP'U]/1)Capsule, delayed release pelletsOralAbbVie Inc.2009-04-30Not applicableUs0032 121220171018 3478 1gpsri6
CreonPancrelipase protease (19000 [USP'U]/1) + Pancrelipase amylase (30000 [USP'U]/1) + Pancrelipase lipase (6000 [USP'U]/1)Capsule, delayed release pelletsOralAbbVie Inc.2009-04-30Not applicableUs0032 120620170907 23695 1ti1sat
Unapproved/Other Products
NameIngredientsDosageRouteLabellerMarketing StartMarketing End
Creon 10 MinimicrospheresPancrelipase protease (37500 [USP'U]/1) + Pancrelipase amylase (33200 [USP'U]/1) + Pancrelipase lipase (10000 [USP'U]/1)Capsule, delayed releaseOralPhysicians Total Care, Inc.2006-09-122009-09-30Us
Creon 20 MinimicrospheresPancrelipase protease (75000 [USP'U]/1) + Pancrelipase amylase (66400 [USP'U]/1) + Pancrelipase lipase (20000 [USP'U]/1)Capsule, delayed releaseOralPhysicians Total Care, Inc.1995-01-172009-09-30Us
PancrelipasePancrelipase protease (44000 [USP'U]/1) + Pancrelipase amylase (56000 [USP'U]/1) + Pancrelipase lipase (20000 [USP'U]/1)Capsule, delayed releaseOralKaiser Foundations Hospitals2010-02-012010-12-31Us
Categories
Not Available
UNII
3560D81V50
CAS number
9001-94-9

Pharmacology

Indication

Please refer to Pancrelipase.

Associated Conditions
Pharmacodynamics

Please refer to Pancrelipase.

Mechanism of action

Pancrelipase protease acts on the peptide bonds within the proteins. The two constituents of the pancrelipase protease, trypsin, and chymotrypsin, are grouped under the family of serine proteases. Trypsin acts on lysine and arginine residues while chymotrypsin acts in hydrophobic residues such as tryptophan, tyrosine and phenylalanine. Both constituents present a catalytic site in the S1 binding pocket formed by a triad of serine, histidine and aspartate.5

TargetActionsOrganism
ADietary protein
cleavage
Humans
Additional Data Available
Adverse Effects

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Additional Data Available
Contraindications

Structured data covering drug contraindications. Each contraindication describes a scenario in which the drug is not to be used. Includes restrictions on co-administration, contraindicated populations, and more.

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Additional Data Available
Blackbox Warnings

Structured data representing warnings from the black box section of drug labels. These warnings cover important and dangerous risks, contraindications, or adverse effects.

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Absorption

Please refer to Pancrelipase.

Volume of distribution

Please refer to Pancrelipase.

Protein binding

Please refer to Pancrelipase.

Metabolism

Please refer to Pancrelipase.

Route of elimination

Please refer to Pancrelipase.

Half life

Please refer to Pancrelipase.

Clearance

Please refer to Pancrelipase.

Toxicity

Please refer to Pancrelipase.

Affected organisms
  • Humans and other mammals
Pathways
Not Available
Pharmacogenomic Effects/ADRs
Not Available

Interactions

Drug Interactions
This information should not be interpreted without the help of a healthcare provider. If you believe you are experiencing an interaction, contact a healthcare provider immediately. The absence of an interaction does not necessarily mean no interactions exist.
Not Available
Food Interactions
Not Available

References

General References
  1. Schauperl M, Fuchs JE, Waldner BJ, Huber RG, Kramer C, Liedl KR: Characterizing Protease Specificity: How Many Substrates Do We Need? PLoS One. 2015 Nov 11;10(11):e0142658. doi: 10.1371/journal.pone.0142658. eCollection 2015. [PubMed:26559682]
  2. Creon monograph [Link]
  3. FDA approval [Link]
  4. VIVO pathophysiology [Link]
  5. EMBL-EBI [Link]
External Links
RxNav
1427034
FDA label
Download (483 KB)

Clinical Trials

Clinical Trials
PhaseStatusPurposeConditionsCount
1CompletedOtherHIV-DDI1
1CompletedPreventionHookworm Disease / Hookworm Infection1
1TerminatedTreatmentHypoglycemia1
1TerminatedTreatmentPancreatitis, Chronic1
1, 2CompletedTreatmentChronic Hepatitis C Virus (HCV) Infection1
1, 2CompletedTreatmentHepatitis C Virus Infection1
1, 2RecruitingTreatmentMalignant Neoplasm of Pancreas / Pancreatic enzyme abnormality / Pancreatic Insufficiency1
2CompletedNot AvailableExocrine Pancreatic Insufficiency in Subjects With Cystic Fibrosis1
2CompletedDiagnosticPancreatitis, Chronic1
2CompletedTreatmentFibrosis, Liver / Hepatitis C Viral Infection / Human Immunodeficiency Virus (HIV) Infections1
2CompletedTreatmentHepatitis C Viral Infection1
2CompletedTreatmentHuman Immunodeficiency Virus (HIV) Infections1
2CompletedTreatmentHuman Immunodeficiency Virus Type 1 (HIV-1)1
2CompletedTreatmentShort bowel condition / Short Bowel Syndrome (SBS)1
2TerminatedSupportive CareMalignant Neoplasm of Pancreas1
3Active Not RecruitingTreatmentHuman Immunodeficiency Virus Type 1 (HIV-1)1
3Active Not RecruitingTreatmentHuman Immunodeficiency Virus Type 1 (HIV-1) Infection1
3CompletedTreatmentCystic Fibrosis (CF) / Exocrine Pancreatic Insufficiency1
3CompletedTreatmentExocrine Pancreatic Insufficiency: Cystic Fibrosis1
3CompletedTreatmentExocrine Pancreatic Insufficiency / Pancreatitis, Chronic1
3CompletedTreatmentHepatitis C Viral Infection1
3CompletedTreatmentHuman Immunodeficiency Virus (HIV) Infections4
3CompletedTreatmentHuman Immunodeficiency Virus Type 1 (HIV-1) Infection1
3CompletedTreatmentPancreatic Exocrine Insufficiency1
3CompletedTreatmentPancreatic Exocrine Insufficiency Due to Cystic Fibrosis1
3CompletedTreatmentPostprandial Belching / Postprandial Bloating / Postprandial Eructation1
3RecruitingTreatmentPancreatic Insufficiency1
3TerminatedTreatmentHuman Immunodeficiency Virus Type 1 (HIV-1) Infection / Treatment Resistant Disorders / Viral sepsis1
3TerminatedTreatmentFat malabsorption1
4CompletedNot AvailableHuman Immunodeficiency Virus (HIV) Infections / Proteinuria1
4CompletedOtherCoinfection, HIV / Hepatitis C Viral Infection1
4CompletedTreatmentCystic Fibrosis (CF) / Exocrine Pancreatic Insufficiency2
4CompletedTreatmentHIV-Associated Lipodystrophy Syndrome1
4CompletedTreatmentHuman Immunodeficiency Virus (HIV) Infections1
4CompletedTreatmentHuman Immunodeficiency Virus Type 1 (HIV-1)1
4CompletedTreatmentHuman Immunodeficiency Virus Type 1 (HIV-1) Infection1
4CompletedTreatmentPancreatic Insufficiency1
4CompletedTreatmentPancreatitis, Chronic1
4Not Yet RecruitingTreatmentExocrine Pancreatic Insufficiency (EPI)1
4RecruitingTreatmentCystic Fibrosis (CF)1
4RecruitingTreatmentExocrine Pancreatic Insufficiency (EPI)1
4TerminatedTreatmentHIV Lipodystrophy Syndrome / Human Immunodeficiency Virus (HIV) Infections1
4TerminatedTreatmentHIV-Associated Lipodystrophy Syndrome / Human Immunodeficiency Virus (HIV) Infections1
4TerminatedTreatmentPatients With Coeliac Disease and Chronic Diarrhoea (>3 Loose/ Liquid Motions a Day for More Than 4 Weeks) / Patients With Pancreatic Exocrine Insufficiency1
4Unknown StatusTreatmentAcquired Immune Deficiency Syndrome (AIDS) / Human Immunodeficiency Virus (HIV) Infections1
4WithdrawnTreatmentExocrine Pancreatic Insufficiency in Subjects With Diabetes Mellitus Type 21
Not AvailableActive Not RecruitingNot AvailableBenign and Malignant Hematologic Diseases1
Not AvailableCompletedNot AvailableHuman Immunodeficiency Virus Type 1 (HIV-1) Infection1
Not AvailableCompletedBasic SciencePancreatitis1
Not AvailableCompletedTreatmentAcquired Immune Deficiency Syndrome (AIDS) / Human Immunodeficiency Virus (HIV) Infections / Pregnancy1
Not AvailableCompletedTreatmentBMI >30 kg/m21
Not AvailableCompletedTreatmentCystic Fibrosis (CF)1
Not AvailableNot Yet RecruitingNot AvailableAdenocarcinoma of the Pancreas1
Not AvailableRecruitingNot AvailableFibrosing colonopathy / Fibrosing Colonopathy in Patients With Cystic Fibrosis1
Not AvailableUnknown StatusNot AvailableHCV Viral Load / Hepatitis C Virus (HCV) Infection1

Pharmacoeconomics

Manufacturers
Not Available
Packagers
Not Available
Dosage forms
FormRouteStrength
Capsule, delayed release pelletsOral
Capsule, delayed releaseOral
Granule, delayed releaseOral
CapsuleOral
Capsule, extended releaseOral
TabletOral
PowderOral
Prices
Not Available
Patents
Patent NumberPediatric ExtensionApprovedExpires (estimated)
US9198871No2015-12-012030-02-07Us
US8562979No2013-10-222028-02-20Us
US8562980No2013-10-222028-02-20Us
US8562981No2013-10-222028-02-20Us
US8221747No2012-07-172028-02-20Us
US8562978No2013-10-222028-02-20Us
US8246950No2012-08-212028-02-20Us
US7658918No2010-02-092028-02-20Us
Additional Data Available
  • Filed On
    Filed On

    The date on which a patent was filed with the relevant government.

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Properties

State
Solid
Experimental Properties
PropertyValueSource
water solubility1 mg/mlMonograph

Taxonomy

Description
Not Available
Kingdom
Organic Compounds
Super Class
Organic Acids
Class
Carboxylic Acids and Derivatives
Sub Class
Amino Acids, Peptides, and Analogues
Direct Parent
Peptides
Alternative Parents
Not Available
Substituents
Not Available
Molecular Framework
Not Available
External Descriptors
Not Available

Targets

1. Dietary protein
Kind
Group
Organism
Humans
Pharmacological action
Yes
Actions
Cleavage
References
  1. EMBL-EBI [Link]

Drug created on December 03, 2015 09:51 / Updated on June 12, 2020 10:53

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