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
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Trade Name
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Creon, Pancreaze, Pertzye, Viokace, Zenpep (discontinued: Cotazym)
Drug Products
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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
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| creon | Biologic Licensing Application | 2024-02-28 |
| festal plus | unapproved drug other | 2024-09-03 |
| pancreaze | Biologic Licensing Application | 2025-06-06 |
| pertzye | Biologic Licensing Application | 2024-03-11 |
| stozyme | unapproved drug other | 2019-11-04 |
| viokace | Biologic Licensing Application | 2025-08-14 |
| zenpep | Biologic Licensing Application | 2025-11-14 |
Indications
FDA
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Agency Specific
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Clinical
Clinical Trials
83 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 | 15 | 7 | 45 |
| Cystic fibrosis | D003550 | EFO_0000390 | E84 | — | 1 | 10 | 6 | 4 | 21 |
| Pancreatic neoplasms | D010190 | EFO_0003860 | C25 | 4 | 4 | — | 3 | 5 | 14 |
| Chronic pancreatitis | D050500 | EFO_0000342 | K86.1 | 3 | 1 | 4 | 4 | 2 | 14 |
| Fibrosis | D005355 | — | — | — | 1 | 7 | 1 | 3 | 12 |
| Pancreatitis | D010195 | EFO_0000278 | K85 | 2 | 1 | 3 | 1 | 3 | 10 |
| Steatorrhea | D045602 | — | — | 1 | 1 | 4 | 1 | — | 7 |
| Irritable bowel syndrome | D043183 | EFO_0000555 | K58 | — | — | — | 1 | 1 | 2 |
| Diarrhea | D003967 | — | R19.7 | — | — | — | 1 | 1 | 2 |
| Dyspepsia | D004415 | EFO_0008533 | K30 | — | — | — | 1 | 1 | 2 |
Show 8 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Malnutrition | D044342 | EFO_0008572 | E40-E46 | — | 1 | 1 | — | 2 | 3 |
| Malabsorption syndromes | D008286 | EFO_0009554 | K90 | — | 1 | 1 | — | — | 2 |
| Pancreatectomy | D010180 | EFO_0002581 | — | — | — | 2 | — | — | 2 |
| Abdominal pain | D015746 | EFO_0003766 | R10.9 | — | — | 1 | — | 1 | 2 |
| Sepsis | D018805 | EFO_0001420 | A41.9 | — | 1 | 1 | — | — | 1 |
| Child nutrition disorders | D015362 | — | — | — | 1 | 1 | — | — | 1 |
| Chronic kidney failure | D007676 | EFO_0003884 | N18.6 | — | — | 1 | — | — | 1 |
| Renal insufficiency | D051437 | — | 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 |
|---|---|---|---|---|---|---|---|---|---|
| Short bowel syndrome | D012778 | — | K90.82 | — | 1 | — | — | — | 1 |
| Pancreatic ductal carcinoma | D021441 | — | — | 1 | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Neoplasms | D009369 | — | C80 | 2 | — | — | — | — | 2 |
| Cerebral palsy | D002547 | — | G80 | 1 | — | — | — | — | 1 |
| Hypoglycemia | D007003 | — | E16.2 | 1 | — | — | — | — | 1 |
| Type 1 diabetes mellitus | D003922 | EFO_0001359 | E10 | 1 | — | — | — | — | 1 |
| Renal cell carcinoma | D002292 | EFO_0000376 | — | 1 | — | — | — | — | 1 |
| Carcinoma | D002277 | — | C80.0 | 1 | — | — | — | — | 1 |
| Hepatocellular carcinoma | D006528 | — | C22.0 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Digestive system diseases | D004066 | EFO_0000405 | K92.9 | — | — | — | — | 3 | 3 |
| Pancreatic diseases | D010182 | — | K86.9 | — | — | — | — | 3 | 3 |
| Gastrointestinal diseases | D005767 | — | — | — | — | — | — | 2 | 2 |
| Lung neoplasms | D008175 | — | C34.90 | — | — | — | — | 1 | 1 |
| Hemorrhage | D006470 | MP_0001914 | R58 | — | — | — | — | 1 | 1 |
| Postoperative complications | D011183 | — | — | — | — | — | — | 1 | 1 |
| Pancreatic fistula | D010185 | — | — | — | — | — | — | 1 | 1 |
| Gastroparesis | D018589 | EFO_1000948 | K31.84 | — | — | — | — | 1 | 1 |
| Fistula | D005402 | — | — | — | — | — | — | 1 | 1 |
| Acute hemorrhagic pancreatitis | D000081032 | — | — | — | — | — | — | 1 | 1 |
Show 6 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 | FQ3DRG0N5K (ChemIDplus, GSRS) |
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Pancreaze – Vivus
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Zenpep – Allergan
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Zenpep – Warner Chilcott
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Creon – Viatris
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Creon – AbbVie
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Pancrelipase
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Pancrelipase
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Trends
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Safety
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Adverse Events
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19,115 adverse events reported
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