MedPath

Pancrelipase

Generic Name
Pancrelipase
Drug Type
Biotech
CAS Number
53608-75-6
Unique Ingredient Identifier
FQ3DRG0N5K
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 mixture was developed by Ortho-McNeil-Janssen Pharmaceuticals, Inc and FDA approved on April 12, 2010. For further information on the components of this mixture please visit Pancrelipase amylase, Pancrelipase protease and Pancrelipase lipase.

Indication

The use of pancrelipase amylase is part of the pancreatic enzyme replacement therapy. This therapy is indicated for the treatment of pancreatic insufficiency attributed to cystic fibrosis, chronic pancreatitis or any other medically defined pancreatic disease that might require it. Pancreatic diseases are associated with the deterioration of pancreatic parenchyma and of the dual physiological functions of the pancreas. Once established, pancreatic insufficiency results in malnutrition, weight loss, and steatorrhea.

Associated Conditions
Aerophagy, Deficiency Digestive enzymes, Diarrhea, Dyspepsia, Exocrine Pancreatic Insufficiency, Flatulence, Gastrointestinal Discomfort, Pancreatic Insufficiency, Post Operative Gas, Pre-operative Gas, Fat malabsorption, Meteorism
Associated Therapies
Bile Duct Disorders, Carbohydrate Digestion, Digestive Aid, Fat Digestion, Liver Metabolism, Protein Digestion

Pancreatic Enzyme Replacement Therapy for Acute Pancreatitis-Associated Exocrine Pancreatic Insufficiency

Phase 4
Recruiting
Conditions
Exocrine Pancreatic Insufficiency
Interventions
First Posted Date
2024-06-27
Last Posted Date
2025-05-14
Lead Sponsor
Ohio State University
Target Recruit Count
60
Registration Number
NCT06477159
Locations
🇺🇸

University of Illinois Chicago, Chicago, Illinois, United States

🇺🇸

New York University Langone Medical Center, New York, New York, United States

🇺🇸

The Ohio State University, Columbus, Ohio, United States

and more 2 locations

The Effect of PERT on Patients Undergoing Pancreaticoduodenectomy

Phase 4
Recruiting
Conditions
Pancreatic Exocrine Insufficiency
Pancreaticoduodenectomy
Pancreatic Enzyme Replacement Therapy
Interventions
Other: Routine treatment plan
First Posted Date
2023-11-07
Last Posted Date
2023-11-07
Lead Sponsor
Ruijin Hospital
Target Recruit Count
100
Registration Number
NCT06119880
Locations
🇨🇳

Shanghai Ruijin Hospital, Shanghai, Shanghai, China

Efficacy of PERT for PEI in Unresectable Pancreatic Cancer.

Phase 4
Not yet recruiting
Conditions
Unresectable Pancreatic Cancer
Interventions
Other: Best Standarard of Care
First Posted Date
2023-10-25
Last Posted Date
2023-10-25
Lead Sponsor
Hospital Clinico Universitario de Santiago
Target Recruit Count
100
Registration Number
NCT06099119

Pancreatic Enzyme Replacement and Glucose Regulation in Type 1 Diabetes

Early Phase 1
Completed
Conditions
Type 1 Diabetes
Interventions
Drug: Placebo
First Posted Date
2022-03-04
Last Posted Date
2025-03-28
Lead Sponsor
Vanderbilt University Medical Center
Target Recruit Count
11
Registration Number
NCT05266963
Locations
🇺🇸

Vanderbilt University Medical Center, Nashville, Tennessee, United States

Endotherapy for Painless Chronic Pancreatitis

Not Applicable
Conditions
Exocrine Pancreatic Insufficiency
Pancreatitis, Chronic
Cholangiopancreatography, Endoscopic Retrograde
Abdominal Pain
Interventions
First Posted Date
2022-03-02
Last Posted Date
2022-03-02
Lead Sponsor
Changhai Hospital
Target Recruit Count
60
Registration Number
NCT05261997
Locations
🇨🇳

Changhai Hospital, Shanghai, China

Study to Evaluate Symptoms of Exocrine Pancreatic Insufficiency in Adult Participants With Cystic Fibrosis or Chronic Pancreatitis Treated With Creon

Phase 4
Completed
Conditions
Cystic Fibrosis
Chronic Pancreatitis
Interventions
First Posted Date
2021-10-06
Last Posted Date
2024-07-23
Lead Sponsor
AbbVie
Target Recruit Count
30
Registration Number
NCT05069597
Locations
🇺🇸

Valley Children's Hospital /ID# 231452, Madera, California, United States

🇺🇸

Cleveland Clinic Main Campus /ID# 245864, Cleveland, Ohio, United States

🇺🇸

Asr, Llc /Id# 239566, Nampa, Idaho, United States

and more 18 locations

Effect of CREON on Exocrine Pancreatic Insufficiency (EPI) Symptoms

Completed
Conditions
Chronic Pancreatitis
Interventions
First Posted Date
2021-07-02
Last Posted Date
2024-03-28
Lead Sponsor
AbbVie
Target Recruit Count
63
Registration Number
NCT04949828
Locations
🇺🇸

John Hopkins University /ID# 227061, Baltimore, Maryland, United States

🇺🇸

Baylor College of Medicine - Baylor Medical Center /ID# 227067, Houston, Texas, United States

🇺🇸

NYU Langone Health /ID# 230818, New York, New York, United States

and more 3 locations

Study Of Effects Of Oral CREON Capsules In Adult Participants With Exocrine Pancreatic Insufficiency Not Due To Cystic Fibrosis, Chronic Pancreatitis, Pancreatectomy, Or Pancreatic Cancer

Phase 4
Withdrawn
Conditions
Exocrine Pancreatic Insufficiency (EPI)
Interventions
First Posted Date
2020-03-19
Last Posted Date
2021-11-08
Lead Sponsor
AbbVie
Registration Number
NCT04315311

Pancreaze (Pancrelipase) for Patients With Pancreatic Adenocarcinoma With Cachexia and Exocrine Pancreatic Insufficiency

Phase 2
Active, not recruiting
Conditions
Pancreatic Adenocarcinoma
Interventions
First Posted Date
2019-09-23
Last Posted Date
2025-03-07
Lead Sponsor
Andrew Hendifar, MD
Target Recruit Count
36
Registration Number
NCT04098237
Locations
🇺🇸

Cedars-Sinai Medical Center, Los Angeles, California, United States

A Study of Oryz-Aspergillus Enzyme and Pancreatin Tablet in Patients With Cirrhosis and Malnutrition

Not Applicable
Conditions
Cirrhosis
Interventions
First Posted Date
2019-08-15
Last Posted Date
2019-08-15
Lead Sponsor
Shenzhen Kangzhe Pharmaceutical Co., Ltd.
Target Recruit Count
132
Registration Number
NCT04057326
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