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 .

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 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
No HSA approvals found for this drug.

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
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
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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