Larazotide Clinical Trials

Size	Price	Qty
5mg	USD 190

Clinical Trials

Multiple completed clinical trials have evaluated Larazotide, focusing on its safety, tolerability, and therapeutic efficacy in patients with celiac disease, alongside assessing baseline pharmacokinetics in healthy volunteers. The clinical development program encompasses Phase 1 safety and pharmacokinetic assessments as well as Phase 2 dose-ranging efficacy trials. These studies were conducted by industry sponsors, including 9 Meters Biopharma Inc. and Teva Pharmaceuticals USA.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT01396213	Completed	Celiac Disease	9 Meters Biopharma Inc.\|Teva Pharmaceuticals USA	2011-11-07	Phase 2
NCT00620451	Completed	Celiac Disease	9 Meters Biopharma Inc.	2008-02	Phase 2
NCT00362856	Completed	Celiac Disease	9 Meters Biopharma Inc.	2006-09-13	Phase 2
NCT00386490	Completed	Healthy	9 Meters Biopharma Inc.	2006-01-10	Phase 1
NCT00386165	Completed	Celiac Disease	9 Meters Biopharma Inc.	2005-11-29	Phase 1

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Larazotide acts as a synthetic antagonist of zonulin, binding to zonulin-responsive cell surface receptors to inhibit downstream signal transduction pathways that drive tight junction disassembly. By preserving intestinal mucosal tight junction integrity and suppressing pathologically elevated paracellular permeability, this molecular inhibition prevents luminal antigen passage relevant to the management of celiac disease.

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>).