MedPath

Pepsin

Generic Name
Pepsin
Drug Type
Biotech
CAS Number
9001-75-6
Unique Ingredient Identifier
GID333S43J

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 .

Background

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

FDA Approved Products

Product Name
Manufacturer
Route
Strength
Approved
NDC Code
ORAL
12 [hp_C] in 1 mL
2025/05/27
43742-1324

EMA Approved Products

Medicine Name
EMA Number
Auth. Holder
Country
Drug Type
Status
Issued
Opinion
Revision

No EMA products found

No EMA products found for this drug

HSA Approved Products

Product Name
Manufacturer
Dosage Form
Strength
Approved
Approval No.

No HSA products found

No HSA products found for this drug

NMPA Approved Products

Product Name
Approval No.
Manufacturer
Dosage Form
Trade Name
Strength
Type
Status
Date
Import
国药准字H37020911
原料药
N/A
N/A
Chemical Drug
Approved
2015/02/28
Domestic
国药准字H51021300
N/A
N/A
1g:1200单位
Chemical Drug
Approved
2010/12/24
Domestic
国药准字H14020533
散剂
N/A
1g:120单位
Chemical Drug
Approved
2015/03/11
Domestic
国药准字H21023795
N/A
N/A
1g:120单位
Chemical Drug
Approved
2003/05/31
Domestic
国药准字H62020049
散剂
N/A
1g :1200单位
Chemical Drug
Approved
2020/01/14
Domestic
国药准字H43020593
散剂
N/A
1g:120单位
Chemical Drug
Approved
2002/07/10
Domestic
国药准字H21021495
散剂
N/A
1g:120单位
Chemical Drug
Approved
2020/06/04
Domestic
国药准字H37020078
散剂
N/A
1g:120单位
Chemical Drug
Approved
2015/07/24
Domestic
国药准字H14022179
散剂
N/A
1g:120单位
Chemical Drug
Approved
2020/08/06
Domestic
国药准字H51021301
N/A
N/A
1g:120单位
Chemical Drug
Approved
2010/12/24
Domestic

PPB Approved Products

Product Name
Registration Code
Company
Category
Sale Type
Reg. Date

No PPB products found

No PPB products found for this drug

TGA Approved Products

Product Name
ARTG ID
Sponsor
Status
Reg. Date
Ingredient
16589
Active
1991/09/20
Pepsin
19983
Active
1991/10/03
Pepsin
15464
Active
1991/09/27
Pepsin
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