Colesevelam Hydrochloride Clinical Trials

Size	Price	Qty
5mg	USD 147

Clinical Trials

Multiple Phase 3 clinical trials sponsored by Daiichi Sankyo have evaluated colesevelam hydrochloride for the treatment of type 2 diabetes, with all studies achieving completed recruitment status. These investigations encompass double-blind, placebo-controlled safety and efficacy evaluations as well as an open-label extension study examining long-term tolerability. Together, these trials provide robust data regarding the therapeutic utility of colesevelam hydrochloride for glycemic control.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT00151762	Completed	Type 2 Diabetes	Daiichi Sankyo	2004-12	Phase 3
NCT00147719	Completed	Type 2 Diabetes	Daiichi Sankyo	2004-06	Phase 3
NCT00147758	Completed	Type 2 Diabetes	Daiichi Sankyo	2004-06	Phase 3

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Colesevelam hydrochloride functions as a non-absorbable polymeric sequestrant that binds bile acids, including glycocholic acid, with high affinity within the intestinal lumen to prevent their reabsorption. By interrupting enterohepatic circulation and depleting the hepatic bile acid pool, this binding action drives compensatory liver cholesterol clearance and alters metabolic signaling, thereby enhancing glycemic regulation in type 2 diabetes.

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>).