Balsalazide disodium Clinical Trials

Size	Price	Qty
25mg	USD 157

Clinical Trials

Multiple clinical trials have evaluated balsalazide disodium for gastrointestinal conditions, specifically ulcerative colitis and inflammatory bowel disease, alongside bioequivalence assessments in healthy volunteers. Conducted by industry sponsors such as Bausch Health Americas, Inc., Roxane Laboratories, and Mylan Pharmaceuticals Inc., all recorded Phase 1 and Phase 3 studies have reached completion. These trials investigated pharmacokinetic parameters of generic capsule formulations under fasting and fed conditions, as well as the safety, efficacy, and long-term tolerability of novel tablet formulations and twice-daily dosing regimens.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT00486031	COMPLETED	Inflammatory Bowel Disease; Ulcerative Colitis	Bausch Health Americas, Inc.	2006-10	PHASE3
NCT00408174	COMPLETED	Inflammatory Bowel Disease; Ulcerative Colitis	Bausch Health Americas, Inc.	2006-05	PHASE3
NCT00269438	COMPLETED	Ulcerative Colitis	Bausch Health Americas, Inc.	2005-12	PHASE3
NCT00649480	COMPLETED	Healthy	Mylan Pharmaceuticals Inc	2007-01	PHASE1
NCT00618202	COMPLETED	Ulcerative Colitis	Roxane Laboratories	2005-05
NCT00648531	COMPLETED	Healthy	Mylan Pharmaceuticals Inc	2004-05	PHASE1
NCT00618228	COMPLETED	Ulcerative Colitis	Roxane Laboratories	2004-01

(data from https://clinicaltrials.gov, updated on 2019-08-15)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Balsalazide disodium functions as an oral aminosalicylate prodrug that undergoes enzymatic cleavage in the colon to release active mesalazine, which subsequently modulates the IL-6/STAT3 signaling pathway and suppresses pro-inflammatory cytokine cascades. This targeted anti-inflammatory activity dampens colonic tissue damage and inhibits colitis-associated carcinogenesis, directly underlying its clinical utility in managing ulcerative colitis and inflammatory bowel 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>).