Overview
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. The pancrelipase lipase is an enzyme secreted by the pancreas that is responsible for the hydrolysis of dietary fat molecules in the human digestive system. The pancrelipase mixture, including pancrelipase lipase, was developed by Ortho-McNeil-Janssen Pharmaceuticals, Inc and FDA approved on April 12, 2010.
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. The pancrelipase lipase is an enzyme secreted by the pancreas that is responsible for the hydrolysis of dietary fat molecules in the human digestive system. The pancrelipase mixture, including pancrelipase lipase, was developed by Ortho-McNeil-Janssen Pharmaceuticals, Inc and FDA approved on April 12, 2010.
Indication
Please refer to Pancrelipase.
Associated Conditions
- Exocrine Pancreatic Insufficiency
- Pancreatic Insufficiency
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/02/13 | Not Applicable | Not yet recruiting | |||
2022/12/08 | Phase 1 | Active, not recruiting | |||
2010/07/09 | Phase 1 | Terminated | Forest Laboratories |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Aimmune Therapeutics, Inc. | 73562-115 | ORAL | 5000 [USP'U] in 1 1 | 10/27/2023 | |
| Physicians Total Care, Inc. | 54868-6435 | ORAL | 10000 [USP'U] in 1 1 | 9/15/2014 | |
| AbbVie Inc. | 0032-2636 | ORAL | 24000 [USP'U] in 1 1 | 3/6/2024 | |
| AbbVie Inc. | 0032-1212 | ORAL | 12000 [USP'U] in 1 1 | 3/6/2024 | |
| AbbVie Inc. | 0032-3016 | ORAL | 36000 [USP'U] in 1 1 | 3/6/2024 | |
| Aimmune Therapeutics, Inc. | 73562-112 | ORAL | 20000 [USP'U] in 1 1 | 10/27/2023 | |
| Atlantic Biologicals Corps | 17856-1212 | ORAL | 12000 [USP'U] in 1 1 | 1/27/2012 | |
| AbbVie Inc. | 0032-2637 | ORAL | 36000 [USP'U] in 1 1 | 3/6/2024 | |
| Physicians Total Care, Inc. | 54868-6067 | ORAL | 12000 [USP'U] in 1 1 | 2/6/2012 | |
| Aimmune Therapeutics, Inc. | 73562-116 | ORAL | 25000 [USP'U] in 1 1 | 10/27/2023 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| ENZYPLEX TABLET | SIN06211P | ENTERIC COATED TABLET | 240 u | 5/3/1991 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| TAITIAN STOMACH TAB | N/A | N/A | N/A | 5/17/1999 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| Digestive Zyme | 328366 | Interclinical Laboratories Pty Ltd | Medicine | A | 1/8/2020 |
| Multizyme | 350976 | Medicine | A | 12/7/2020 | |
| Ultra Inflamase | 351743 | Medicine | A | 12/15/2020 | |
| NutriVital Professional Digestive Enzyme Balance | 375622 | Medicine | A | 9/30/2021 | |
| Plexus ProBioFit | 353839 | Medicine | A | 1/29/2021 | |
| Bloating Relief | 486010 | Medicine | A | 4/14/2025 | |
| Bio-Film Clear | 290546 | Medicine | A | 6/22/2017 | |
| Eagle Vegie Digestaid | 330721 | Medicine | A | 3/4/2020 | |
| Henry Blooms Complete Digestion | 369253 | Medicine | A | 6/15/2021 | |
| Executive Digestive | 351741 | Medicine | A | 12/15/2020 |