Pancrelipase protease
Identification
- Summary
Pancrelipase protease is a lipase used to treat pancreatic exocrine insufficiency.
- Brand Names
- Cotazym, Creon, Pancrease MT, Pancreaze, Pertzye, Viokace, Zenpep
- Generic Name
- Pancrelipase protease
- DrugBank Accession Number
- DB11066
- Background
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
- Type
- Biotech
- Groups
- Approved
- Biologic Classification
- Protein Based Therapies
Other protein based therapies - 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
Pharmacology
- Indication
Please refer to Pancrelipase.
Reduce drug development failure ratesBuild, train, & validate machine-learning modelswith evidence-based and structured datasets.Build, train, & validate predictive machine-learning models with structured datasets.- Associated Conditions
Indication Type Indication Combined Product Details Approval Level Age Group Patient Characteristics Dose Form Used in combination to treat Exocrine pancreatic insufficiency Combination Product in combination with: Pancrelipase amylase (DB11065) •••••••••••• Used in combination to treat Exocrine pancreatic insufficiency Combination Product in combination with: Pancrelipase amylase (DB11065) •••••••••••• ••••••• ••••••• - Contraindications & Blackbox Warnings
- Prevent Adverse Drug Events TodayTap into our Clinical API for life-saving information on contraindications & blackbox warnings, population restrictions, harmful risks, & more.Avoid life-threatening adverse drug events with our Clinical API
- 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
Target Actions Organism ADietary protein cleavageHumans - 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.
- Adverse Effects
- Improve decision support & research outcomesWith structured adverse effects data, including: blackbox warnings, adverse reactions, warning & precautions, & incidence rates. View sample adverse effects data in our new Data Library!Improve decision support & research outcomes with our structured adverse effects data.
- Toxicity
Please refer to Pancrelipase.
- 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
- Take with food.
Products
- Drug product information from 10+ global regionsOur datasets provide approved product information including:dosage, form, labeller, route of administration, and marketing period.Access drug product information from over 10 global regions.
- Product Images
- Mixture Products
Name Ingredients Dosage Route Labeller Marketing Start Marketing End Region Image Cotazym Pancrelipase protease (35000 units) + Pancrelipase amylase (40000 units) + Pancrelipase lipase (10000 units) Capsule Oral Organon Canada Inc. 1973-12-31 Not applicable Canada Cotazym Ecs 20 Pancrelipase protease (100000 units) + Pancrelipase amylase (100000 units) + Pancrelipase lipase (25000 units) Capsule, delayed release Oral Organon Canada Inc. 1989-12-31 Not applicable Canada Cotazym Ecs 4 Pancrelipase protease (11000 unit) + Pancrelipase amylase (11000 unit) + Pancrelipase lipase (4000 unit) Capsule Oral Merck Ltd. 1997-08-18 2012-01-23 Canada Cotazym Ecs 8 Pancrelipase protease (45000 units) + Pancrelipase amylase (42000 units) + Pancrelipase lipase (10800 units) Capsule, delayed release Oral Organon Canada Inc. 1980-12-31 Not applicable Canada Creon Pancrelipase protease (19000 [USP'U]/1) + Pancrelipase amylase (30000 [USP'U]/1) + Pancrelipase lipase (6000 [USP'U]/1) Capsule, delayed release pellets Oral AbbVie Inc. 2023-10-12 Not applicable US - Unapproved/Other Products
Name Ingredients Dosage Route Labeller Marketing Start Marketing End Region Image Creon 10 Minimicrospheres Pancrelipase protease (37500 [USP'U]/1) + Pancrelipase amylase (33200 [USP'U]/1) + Pancrelipase lipase (10000 [USP'U]/1) Capsule, delayed release Oral Physicians Total Care, Inc. 2006-09-12 2009-09-30 US Creon 20 Minimicrospheres Pancrelipase protease (75000 [USP'U]/1) + Pancrelipase amylase (66400 [USP'U]/1) + Pancrelipase lipase (20000 [USP'U]/1) Capsule, delayed release Oral Physicians Total Care, Inc. 1995-01-17 2009-09-30 US Pancrelipase Pancrelipase protease (44000 [USP'U]/1) + Pancrelipase amylase (56000 [USP'U]/1) + Pancrelipase lipase (20000 [USP'U]/1) Capsule, delayed release Oral Kaiser Foundations Hospitals 2010-02-01 2010-12-31 US
Categories
- Drug Categories
- Chemical TaxonomyProvided by Classyfire
- 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
- Affected organisms
- Humans and other mammals
Chemical Identifiers
- UNII
- 3560D81V50
- CAS number
- 9001-94-9
References
- General References
- 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. [Article]
- Creon monograph [Link]
- FDA approval [Link]
- VIVO pathophysiology [Link]
- EMBL-EBI [Link]
- External Links
- FDA label
- Download (483 KB)
Clinical Trials
- Clinical Trials
Phase Status Purpose Conditions Count 4 Completed Not Available Human Immunodeficiency Virus (HIV) Infections / Proteinuria 1 4 Completed Other Coinfection, HIV / Hepatitis C Virus (HCV) Infection 1 4 Completed Treatment Cystic Fibrosis (CF) 1 4 Completed Treatment Cystic Fibrosis (CF) / Exocrine Pancreatic Insufficiency 2 4 Completed Treatment Cystic Fibrosis (CF) / Pancreatitis, Chronic 1
Pharmacoeconomics
- Manufacturers
- Not Available
- Packagers
- Not Available
- Dosage Forms
Form Route Strength Capsule, delayed release pellets Oral Capsule, delayed release Oral Capsule, delayed release pellets Not applicable Capsule, delayed release pellets Granule, delayed release Oral Capsule Oral Tablet, coated Oral Capsule, coated pellets Oral Capsule, extended release Oral Capsule, coated Oral 22500 U Ph.Eu Tablet Oral Powder Oral - Prices
- Not Available
- Patents
Patent Number Pediatric Extension Approved Expires (estimated) Region US9198871 No 2015-12-01 2030-02-07 US US8562979 No 2013-10-22 2028-02-20 US US8562980 No 2013-10-22 2028-02-20 US US8562981 No 2013-10-22 2028-02-20 US US8221747 No 2012-07-17 2028-02-20 US US8562978 No 2013-10-22 2028-02-20 US US8246950 No 2012-08-21 2028-02-20 US US7658918 No 2010-02-09 2028-02-20 US
Properties
- State
- Solid
- Experimental Properties
Property Value Source water solubility 1 mg/ml Monograph
Targets
Drug created at December 03, 2015 16:51 / Updated at May 21, 2021 10:21