Pancrelipase
Creon, Pancreaze, Pertzye, Viokace, Zenpep (pancrelipase) is an enzyme pharmaceutical. Pancrelipase was first approved as Cotazym on 1996-12-09.
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Commercial
Therapeutic Areas
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Trade Name
FDA
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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 |
|---|---|---|---|---|---|
| Creon | pancrelipase | AbbVie | N-20725 RX | 2009-04-30 | 5 products |
| Pertzye | pancrelipase | Digestive Care | N-22175 RX | 2012-05-17 | 4 products |
| Pancreaze | pancrelipase | Vivus | N-22523 RX | 2010-04-12 | 6 products |
| Viokace | pancrelipase | Viokace | N-22542 RX | 2012-03-01 | 2 products |
| Zenpep | pancrelipase | Zenpep | N-22210 RX | 2009-08-27 | 8 products |
Show 1 discontinued
Indications
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Agency Specific
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Clinical
Clinical Trials
209 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Exocrine pancreatic insufficiency | D010188 | — | K86.81 | 3 | 5 | 17 | 14 | 6 | 43 |
| Diabetes mellitus | D003920 | HP_0000819 | E08-E13 | 6 | 2 | 1 | 2 | 27 | 38 |
| Pancreatic neoplasms | D010190 | EFO_0003860 | C25 | 6 | 13 | 2 | 3 | 16 | 37 |
| Fibrosis | D005355 | — | — | — | 2 | 12 | 6 | 8 | 28 |
| Cystic fibrosis | D003550 | EFO_0000390 | E84 | — | 2 | 12 | 7 | 7 | 28 |
| Pancreatitis | D010195 | HP_0001733 | K85 | 6 | 3 | 4 | 6 | 6 | 24 |
| Chronic pancreatitis | D050500 | EFO_0000342 | K86.1 | 4 | 3 | 4 | 5 | 3 | 18 |
| Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | — | — | — | 1 | 5 | 6 |
| Pancreatic diseases | D010182 | — | K86.9 | — | — | — | 1 | 5 | 6 |
| Steatorrhea | D045602 | — | — | 1 | 1 | 3 | 1 | — | 6 |
Show 13 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Type 1 diabetes mellitus | D003922 | EFO_0001359 | E10 | 9 | 9 | 7 | — | 55 | 76 |
| Chronic kidney failure | D007676 | EFO_0003884 | N18.9 | — | — | 1 | — | 2 | 3 |
| Malabsorption syndromes | D008286 | EFO_0009554 | K90 | — | 2 | 1 | — | — | 3 |
| Malnutrition | D044342 | EFO_0008572 | E40-E46 | — | 1 | 1 | — | 2 | 3 |
| Pancreatectomy | D010180 | EFO_0002581 | — | — | — | 3 | — | — | 3 |
| Diabetic nephropathies | D003928 | EFO_0000401 | — | — | — | 1 | — | — | 1 |
| Sepsis | D018805 | HP_0100806 | A41.9 | — | 1 | 1 | — | — | 1 |
| Child nutrition disorders | D015362 | — | — | — | 1 | 1 | — | — | 1 |
| Renal insufficiency | D051437 | HP_0000083 | N19 | — | — | 1 | — | — | 1 |
| Eructation | D004884 | — | R14.2 | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Adenocarcinoma | D000230 | — | — | 2 | 5 | — | — | 4 | 10 |
| Pancreatic ductal carcinoma | D021441 | — | — | 1 | 1 | — | — | 1 | 2 |
| Carcinoma | D002277 | — | C80.0 | 1 | 1 | — | — | 1 | 2 |
| Neoplasms | D009369 | — | C80 | 1 | 1 | — | — | 1 | 2 |
| Short bowel syndrome | D012778 | — | K90.82 | — | 1 | — | — | — | 1 |
| Cachexia | D002100 | HP_0004326 | R64 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pancreatic cyst | D010181 | HP_0001737 | K86.2 | 1 | — | — | — | 4 | 5 |
| Hypoglycemia | D007003 | HP_0001943 | E16.2 | 1 | — | — | — | 3 | 4 |
| Cysts | D003560 | — | — | 1 | — | — | — | 2 | 3 |
| Abdominal pain | D015746 | HP_0002027 | R10.9 | 1 | — | — | — | 1 | 2 |
| Graft pancreatitis | D055589 | — | — | 1 | — | — | — | — | 1 |
| Pancreaticojejunostomy | D010193 | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hyperglycemia | D006943 | HP_0003074 | R73.9 | — | — | — | — | 3 | 3 |
| Gastrointestinal diseases | D005767 | — | — | — | — | — | — | 3 | 3 |
| Digestive system diseases | D004066 | HP_0011024 | K92.9 | — | — | — | — | 3 | 3 |
| Pancreatic fistula | D010185 | — | — | — | — | — | — | 2 | 2 |
| Fistula | D005402 | — | — | — | — | — | — | 2 | 2 |
| Obesity | D009765 | EFO_0001073 | E66.9 | — | — | — | — | 2 | 2 |
| Lung neoplasms | D008175 | HP_0100526 | C34.90 | — | — | — | — | 1 | 1 |
| Kidney transplantation | D016030 | — | — | — | — | — | — | 1 | 1 |
| Organ transplantation | D016377 | — | — | — | — | — | — | 1 | 1 |
| Hemorrhage | D006470 | MP_0001914 | R58 | — | — | — | — | 1 | 1 |
Show 34 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Pancrelipase |
| INN | — |
| Description | Pancreatic enzymes, also known as pancreases or pancrelipase and pancreatin, are commercial mixtures of amylase, lipase, protease and lactase. 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 class | enzymes |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | — |
Identifiers
| PDB | — |
| CAS-ID | — |
| RxCUI | — |
| ChEMBL ID | CHEMBL2108074 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | DB00085 |
| UNII ID | — |
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Pancreaze – Vivus
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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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Estimated US medical usage
Pancrelipase
Total medical expenditures per year (USD, in millions)
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Trends
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Safety
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12,684 adverse events reported
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