Pancreatin Clinical Trials

Size	Price	Qty
25mg	USD 97

Clinical Trials

Several clinical trials evaluate pancreatic dysfunction, including acute pancreatitis, chronic pancreatitis, exocrine pancreatic insufficiency, pancreatic fistula, and postoperative complications. These actively recruiting and completed protocols range from Phase I and Phase II evaluations to observational registries and single-center prospective studies. Sponsoring entities encompass both academic medical research institutions and biotechnology companies.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT06023771	Recruiting	Acute Pancreatitis	Peking Union Medical College Hospital	2023-10	--
NCT05450627	Recruiting	Exocrine Pancreatic Insufficiency	Hospital Clinico Universitario de Santiago	2021-06-01	--
NCT05132309	Completed	Chronic Pancreatitis\|Pancreatic Exocrine Insufficiency	Federal Research and Clinical Center of Physical-Chemical Medicine\|Moscow State University of Medicine and Dentistry	2020-11-01	--
NCT04195347	Recruiting	Acute Pancreatitis	St. Jude Children''s Research Hospital\|CalciMedica Inc.	2020-09-04	Phase 1\|Phase 2
NCT04917172	Completed	Acute Pancreatitis\|Pancreatic Fistula\|Postoperative Complications	Azienda Ospedaliera Universitaria Integrata Verona	2019-04-10	--

(data from https://clinicaltrials.gov, updated on 2024-05-22)

Check the Pancreatin product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Pancreatin is an enzymatic mixture comprising amylase, lipase, and protease that directly hydrolyzes dietary starches, lipids, and proteins into absorbable oligosaccharides, fatty acids, and amino acids within the intestinal lumen. By compensating for endogenous pancreatic enzyme deficiencies and facilitating gastrointestinal nutrient absorption, this catalytic activity restores digestive function and addresses clinical conditions such as exocrine pancreatic insufficiency, chronic pancreatitis, and acute pancreatitis.

Appendix RUO and cGMP Quality Standards

Quality Dimension	RUO (Research Use Only)	cGMP (Current Good Manufacturing Practice)
Clinical Applicability	Prohibited in human clinical trials or medical diagnostics.	Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status	Non-regulated grade; exempt from drug manufacturing laws.	Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment	Unclassified analytical or research laboratories.	Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control	Basic purity and activity testing.	Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation	Basic equipment calibration; no process validation required.	Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance	Vendor self-declared without required formal QMS.	Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact	High risk of IND rejection if used as a critical raw material.	Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).