Overview
Pepsin is a potent enzyme in gastric juice that digests proteins such as those in meat, eggs, seeds, and dairy products . Studies on gastric digestion from 1820-1840 led to the discovery of pepsin as the substance which, in the presence of stomach acid, causes nutrients including meat or coagulated egg whites to dissolve. Soon afterward, it was shown that these protein nutrients were cleaved by pepsin to products called peptones . Pepsin is often used as a replacement enzyme for those with pancreatic insufficiency . Stimulation of the pancreas and therefore enzymatic digestion of food is a tightly controlled and is a hormonally mediated process. Any changes or conditions affecting metabolic steps for successful digestion and absorption negatively affect pancreatic enzymatic secretion, entry into the intestine, functionality once inside the intestine, and appropriate mixing with foods/nutrients. Many causes of pancreatic insufficiency require that enzyme replacement therapy is started, including cystic fibrosis, pancreatic cancer, acute and chronic pancreatitis, as well as pancreatic surgery . Pepsin is approved by the FDA and is used in food at levels not to exceed current good manufacturing practice . Interestingly, it has been used as a marker for laryngopharyngeal reflux (LPR), which is a common illness of otolaryngology (ear, nose and throat specialist) visits . Interestingly, recent research has suggested that pepsin participates in the digestion of nucleic acids .
Indication
Used as a pancreatic enzyme replacement in pancreatic insufficiency . It is intended to mimic naturally produced human pepsin . Pepsin powder is prepared from the gastric mucosa of pigs, cattle or sheep . In the laboratory, it is primarily used for the unspecific hydrolysis of proteins and peptides in acidic media. In addition, it provides limited hydrolysis of native immunoglobulins, yielding biologically active fragments . In certain supplements, pepsin may be combined with betaine and HCl (hydrochloric acid) to aid in digestion in various gastrointestinal conditions , .
Associated Conditions
- Diarrhea
- Gastritis Chronic
- Hypochlorhydria
- Postoperative digestive insufficiency
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2017/03/10 | N/A | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
---|---|---|---|---|---|
Deseret Biologicals, Inc. | 43742-1324 | ORAL | 12 [hp_C] in 1 mL | 5/27/2025 |
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 |
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No HSA approvals found for this drug. |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
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No NMPA approvals found for this drug. |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
---|---|---|---|---|---|
No PPB approvals found for this drug. |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
---|---|---|---|---|---|
ENZYME | 16589 | Medicine | A | 9/20/1991 | |
Orthoplex Hydrozyme | 19983 | Medicine | A | 10/3/1991 | |
EAGLE DIGESTAID tablet film-coated bottle | 15464 | Medicine | A | 9/27/1991 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
---|---|---|---|---|---|
DIGESTAID TAB | anabolic laboratories inc. | 00046728 | Tablet - Oral | 16 MG | 12/31/1964 |
ENZYME TABLETS | general nutrition canada inc. | 02181312 | Tablet - Oral | 65 MG | 10/20/2001 |
THERAPLEX E WITH COMFREY PEPSIN | therapeutic foods co. | 00191221 | Capsule - Oral | .0217 MG / CAP | 4/2/1980 |
DYGEST | creative nutrition canada corp. | 00665975 | Tablet - Oral | 125 MG | 12/31/1987 |
BETAINE HCL AND PEPSIN | rheingold food international ltd. | 00633690 | Tablet - Oral | 135 MG | 12/31/1985 |
MEDICHOL | medic laboratory ltée | 00134759 | Tablet - Oral | 200 MG | 12/31/1959 |
HERB DIGESTIVE CAP | gahler enterprises ltd. | 00727164 | Capsule - Oral | 100 MG / CAP | 12/31/1991 |
PRO GEST TAB | pure life international prods inc. | 01946803 | Tablet - Oral | 32.4 MG | 12/31/1992 |
DUCHOL ECT | 00391484 | Tablet (Enteric-Coated) - Oral | 200 MG | 12/31/1977 | |
BEMOSIN TAB | therapeutic foods co. | 00482412 | Tablet - Oral | 130 MG | 12/31/1988 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
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No CIMA AEMPS (Spain) approvals found for this drug. |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Philippines FDA approvals found for this drug. |
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Saudi SFDA approvals found for this drug. |
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Malaysia NPRA approvals found for this drug. |
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
---|---|---|---|---|---|
No UK EMC drug information found for this drug. |
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