Sodium Tauroursodeoxycholate (TUDC) Clinical Trials

Size	Price	Qty
100mg	USD 147

Clinical Trials

Sodium Tauroursodeoxycholate (TUDC) is currently being evaluated in multiple clinical trials targeting neurodegenerative and inflammatory conditions. An actively recruiting Phase III open-label extension study, sponsored by a multicenter consortium including Humanitas Mirasole SpA and the University of Ulm, assesses the long-term safety, tolerability, and efficacy of TUDC in Amyotrophic Lateral Sclerosis. Additionally, a Phase I trial supported by Washington University School of Medicine and the Crohn's and Colitis Foundation investigates its safety and efficacy in Ulcerative Colitis, currently holding an unknown recruitment status.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05753852	Recruiting	Amyotrophic Lateral Sclerosis	Humanitas Mirasole SpA\|University of Ulm\|University of Sheffield\|University Hospital Tours\|KU Leuven\|UMC Utrecht\|University of Dublin Trinity College\|Bruschettini S.r.l.\|Istituto Superiore di Sanità\|Motor Neurone Disease Association	2021-10-25	Phase 3
NCT04114292	Unknown status	Ulcerative Colitis	Washington University School of Medicine\|Crohn''s and Colitis Foundation	2019-01-17	Phase 1

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

Check the Sodium Tauroursodeoxycholate (TUDC) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Sodium tauroursodeoxycholate modulates endoplasmic reticulum stress and suppresses the mitochondrial apoptotic pathway by preventing cytochrome c release and inhibiting downstream caspase activation. By preserving cellular integrity and mitigating inflammation, this cytoprotective mechanism provides therapeutic rationale for its investigation in clinical trials for Amyotrophic Lateral Sclerosis and Ulcerative Colitis.

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>).