Trypsin Clinical Trials

Size	Price	Qty
100mg	USD 79
1g	USD 397

Clinical Trials

Multiple clinical trials investigate trypsin-related biomarkers and therapeutic strategies across diverse conditions, including eosinophilic esophagitis, acute ST-segment elevation myocardial infarction, pre-eclampsia, protein-losing enteropathy, pancreatic neuroendocrine tumors, and malnutrition. Encompassing Phase 2 studies and observational protocols, these trials range in recruitment status from not yet recruiting to completed. Research efforts are supported by diverse sponsors, including academic medical centers, university hospitals, global research institutes, CSL Behring, and the National Institutes of Health.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05485155	Recruiting	Eosinophilic Esophagitis	Children''s Hospital Medical Center Cincinnati\|CSL Behring\|National Institutes of Health (NIH)	2024-03-01	Phase 2
NCT05802667	Not yet recruiting	Inflammation\|Acute ST Segment Elevation Myocardial Infarction\|Prognosis	Peking University Third Hospital	2023-04-01	--
NCT05622838	Not yet recruiting	alpha1 Anti-trypsin\|Pre-Eclampsia\|Intrauterine Growth Restriction	Assiut University	2022-12	--
NCT05474664	Not yet recruiting	Fontan Operation\|Protein-Losing Enteropathy\|Camostat Mesylate	Seoul National University Hospital	2022-08-01	Phase 2
NCT05037461	Recruiting	Neuroendocrine Tumor of Pancreas\|Multiple Endocrine Neoplasia Type 1	J.M. de Laat\|Radboud University Medical Center\|Erasmus Medical Center\|Maastricht University Medical Center\|Leiden University Medical Center\|University Medical Center Groningen\|UMC Utrecht	2022-05-01	Not Applicable
NCT05083637	Completed	Malnutrition	International Centre for Diarrhoeal Disease Research Bangladesh	2021-10-19	Not Applicable

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Trypsin functions as a serine protease that hydrolyzes proteins at the carboxyl side of lysine and arginine residues while activating protease-activated receptors PAR2 and PAR4 to trigger downstream signaling cascades that promote cellular proliferation, differentiation, and membrane fusion. This protease activity and receptor activation modulate tissue remodeling and cellular signaling, which directly relates to its involvement in inflammatory responses and gastrointestinal pathologies such as eosinophilic esophagitis and protein-losing enteropathy.

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>).