Tegaserod Maleate Clinical Trials

Size	Price	Qty
25mg	USD 147
1g	USD 970

Clinical Trials

Numerous clinical trials spanning Phase 2 through Phase 4 have evaluated Tegaserod Maleate for various gastrointestinal conditions, including chronic constipation, dyspepsia, heartburn, gastroesophageal reflux disease, and diabetic gastroparesis. Sponsored by organizations such as Novartis, Braintree Laboratories, and the Hospital Authority, Hong Kong, these studies are predominantly completed, though several were withdrawn, terminated, or remain of unknown recruitment status. Overall, this clinical landscape reflects extensive research into gut motility, gastric emptying, and gastrointestinal symptom relief.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT00414024	TERMINATED	Opioid-induced Constipation	Novartis	2007-02	PHASE3
NCT00365820	TERMINATED	Constipation	Novartis	2006-07	PHASE2; PHASE3
NCT00399659	TERMINATED	Opioid-induced Constipation	Novartis	2006-11	PHASE3
NCT00348634	TERMINATED	Chronic Constipation	Novartis	2006-07	PHASE4
NCT00390975	TERMINATED	Gastroparesis; Diabetes	Novartis	2007-01	PHASE4
NCT00232089	COMPLETED	Dyspepsia	Novartis	2004-05	PHASE3
NCT00171431	TERMINATED	Constipation Predominant; Irritable Bowel Syndrome (IBS-C)	Novartis Pharmaceuticals	2004-11	PHASE3
NCT00149851	COMPLETED	Symptomatic Gastroespohageal Reflux Disease	Novartis	2004-01	PHASE2
NCT00142974	TERMINATED	Diabetic Gastropathy	Novartis	2004-05	PHASE2
NCT00153140	COMPLETED	Constipation	Braintree Laboratories	2004-07	PHASE4
NCT00171522	COMPLETED	Constipation	Novartis	2005-05	PHASE4
NCT00171457	COMPLETED	Heartburn; Dyspepsia	Novartis	2005-04	PHASE3
NCT00277550	WITHDRAWN	Constipation and Dyspepsia	Novartis		PHASE4
NCT00171470	COMPLETED	Dyspepsia	Novartis	2005-04	PHASE3
NCT00171483	COMPLETED	Gastroesophageal Reflux Disease (GERD)	Novartis	2004-01	PHASE3
NCT00139568	COMPLETED	Constipation	Novartis	2005-02	PHASE3
NCT00142987	COMPLETED	IBS-C and IBS With Mixed Bowel Habits	Novartis	2004-04	PHASE4
NCT00141089	COMPLETED	Chronic Constipation	Novartis	2004-03	PHASE3
NCT00232037	COMPLETED	Dyspepsia	Novartis	2004-09	PHASE3
NCT00232102	COMPLETED	Dyspepsia	Novartis	2004-09	PHASE3
NCT00563615	UNKNOWN	Constipation	Hospital Authority, Hong Kong	2004-11
NCT00149877	COMPLETED	Chronic Constipation	Novartis	2004-04	PHASE4
NCT00563758	TERMINATED	Constipation; Chronic Disease	Hospital Authority, Hong Kong	2004-12
NCT00171418	COMPLETED	Gastroesophageal Reflux Disease (GERD)	Novartis	2003-06	PHASE3
NCT00232024	COMPLETED	Dyspepsia	Novartis	2004-01	PHASE3

(data from https://clinicaltrials.gov, updated on 2012-04-20)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Tegaserod Maleate acts as a high-affinity partial agonist at 5-HT4 receptors, triggering intracellular cAMP production and promoting presynaptic release of neurotransmitters such as acetylcholine within the enteric nervous system. This signaling cascade enhances peristaltic reflexes and accelerates gastrointestinal transit, thereby alleviating symptoms in motility disorders such as chronic constipation, dyspepsia, and gastroparesis.

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>).