Pancrelipase protease

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 protease is a mix of enzymes, formed by trypsin and chymotrypsin, that proteolytically cleave peptide bonds and are involved in food digestion. The pancrelipase mixture, including pancrelipase protease, 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

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Interaction With HIV Antiretroviral Agents	2015/09/22	NCT02556268	Phase 1	Completed	Bayer
Management of Participants With Low-level Persistent Viremia (ANRS 161 L-VIR)	2014/09/25	NCT02247687	Phase 3	Terminated	ANRS, Emerging Infectious Diseases
Multicentre Study To Assess Changes In Bone Mineral Density Of The Switch From Protease Inhibitors To Dolutegravir In HIV-1-Infected Subjects With Low Bone Mineral Density	2013/10/22	NCT01966822	Phase 3	Completed	Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
Influence of Nevirapine on HCV Viral Load	2011/01/17	NCT01277627	Not Applicable	UNKNOWN	Valme University Hospital
Raltegravir Switch Study to Reduce Liver Fibrosis Progression in HIV-Hepatitis C Co-infection	2010/11/01	NCT01231685	Phase 2	Completed	McGill University Health Centre/Research Institute of the McGill University Health Centre
Protease Inhibitor Monotherapy Versus Ongoing Triple-therapy in the Long Term Management of HIV Infection (PIVOT)	2010/10/29	NCT01230580	Phase 4	UNKNOWN	Medical Research Council
A Study With TMC125 in Human Immunodeficiency Virus (HIV) Type 1 Infected Patients, Who Were Treated With TMC125 Arm in a Sponsor-Selected TMC125 Study	2005/08/10	NCT00128830	Phase 2	Completed	Tibotec Pharmaceuticals, Ireland
Study Evaluating the Impact on Fat Distribution of Nucleoside Reverse Transcriptase Inhibitor (NRTI)-Sparing Regimens in Antiretroviral Experienced Patients With Lipoatrophy	2005/07/22	NCT00122655	Phase 4	Terminated	French National Agency for Research on AIDS and Viral Hepatitis
Evaluation of the Occurrence of Lipoatrophy in HIV-1 Infected Naive Patients	2005/07/22	NCT00122668	Phase 4	Terminated	French National Agency for Research on AIDS and Viral Hepatitis
Dose Ranging Trial of Tipranavir/Ritonavir in Treatment-Experienced HIV Infected Individuals	2002/05/03	NCT00034866	Phase 2	Completed	Boehringer Ingelheim

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Zenpep	Aimmune Therapeutics, Inc.	73562-115	ORAL	17000 [USP'U] in 1 1	10/27/2023
ZENPEP	Physicians Total Care, Inc.	54868-6435	ORAL	34000 [USP'U] in 1 1	9/15/2014
Creon	AbbVie Inc.	0032-2636	ORAL	76000 [USP'U] in 1 1	3/6/2024
Creon	AbbVie Inc.	0032-1212	ORAL	38000 [USP'U] in 1 1	3/6/2024
Creon	AbbVie Inc.	0032-3016	ORAL	114000 [USP'U] in 1 1	3/6/2024
Zenpep	Aimmune Therapeutics, Inc.	73562-112	ORAL	63000 [USP'U] in 1 1	10/27/2023
Creon	Atlantic Biologicals Corps	17856-1212	ORAL	38000 [USP'U] in 1 1	1/27/2012
Creon	AbbVie Inc.	0032-2637	ORAL	114000 [USP'U] in 1 1	3/6/2024
Creon	Physicians Total Care, Inc.	54868-6067	ORAL	38000 [USP'U] in 1 1	2/6/2012
Zenpep	Aimmune Therapeutics, Inc.	73562-116	ORAL	79000 [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	PT MEDIFARMA LABORATORIES INC	SIN06211P	ENTERIC COATED TABLET	9000 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
No PPB approvals found for this drug.

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	Mega Lifesciences (Australia) Pty Ltd	Medicine	A	12/7/2020
Ultra Inflamase	351743	Plant Base Health Pty Ltd	Medicine	A	12/15/2020
NutriVital Professional Digestive Enzyme Balance	375622	Nutrivital Pty Ltd	Medicine	A	9/30/2021
Plexus ProBioFit	353839	Plexus Australia Pty Ltd	Medicine	A	1/29/2021
ProBioFit	483565	Plexus Australia Pty Ltd	Medicine	A	3/21/2025
Bio-Film Clear	290546	FIT-BioCeuticals Pty Ltd	Medicine	A	6/22/2017
Eagle Vegie Digestaid	330721	Integria Healthcare Australia Pty Ltd	Medicine	A	3/4/2020
Henry Blooms Complete Digestion	369253	Phytologic Holdings Pty Limited	Medicine	A	6/15/2021
Executive Digestive	351741	Plant Base Health Pty Ltd	Medicine	A	12/15/2020

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
CREON MINIMICROSPHERES 6	BGP Pharma ULC	02415194	Capsule - Oral	19000 UNIT	12/20/2013
THERAPY FORMULAS MULTI-ENZYME FORMULA-CAP	general nutrition canada inc.	02216736	Capsule - Oral	50 MG	10/15/2001
METAZYME CAP	METAGENICS, INC.	00837059	Capsule - Oral	3600 UNIT / CAP	12/29/1996
CREON MINIMICROSPHERES 35	BGP Pharma ULC	02494639	Capsule (Delayed Release) - Oral	2240 UNIT	1/26/2021
PANCREASE ENTERIC COATED CAP	mcneil pharmaceutical, division of ortho-mcneil inc.	00591548	Capsule (Enteric-Coated) - Oral	25000 UNIT / CAP	12/31/1984
PANCREASE MT 4	vivus llc.	00789445	Capsule (Delayed Release) - Oral	10000 UNIT	12/31/1988
CREON MINIMICROSPHERES 20	BGP Pharma ULC	02494620	Capsule (Delayed Release) - Oral	1460 UNIT	N/A
ULTRESA	Aptalis Pharma Canada ULC	02045834	Capsule (Delayed Release) - Oral	53400 UNIT	1/20/1998
ULTRESA	Aptalis Pharma Canada ULC	02439115	Capsule (Delayed Release) - Oral	80000 UNIT	N/A
PANCREASE CAPSULES	Janssen Inc	02242374	Capsule (Sustained-Release) - Oral	25000 UNIT / SRC	5/11/2001

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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