Talniflumate Clinical Trials

Size	Price	Qty
5mg	USD 147
25mg	USD 370

Clinical Trials

A clinical trial evaluates the therapeutic application of Talniflumate for the management of breast cancer. Sponsored by Shandong University, an academic sponsor, this Phase 4 trial investigates neoadjuvant chemotherapy regimens administered with or without Talniflumate to assess potential clinical benefit. The study maintains an official status of not yet recruiting.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT06777537	NOT_YET_RECRUITING	Breast Cancer	Shandong University	2025-06-01	PHASE4

(data from https://clinicaltrials.gov, updated on 2025-01-16)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Talniflumate functions as an anti-inflammatory mucin regulator by inhibiting human calcium-activated chloride channels, thereby blocking chloride ion transport and downregulating downstream inflammatory signal transduction. By suppressing hypersecretory and inflammatory cellular responses, this mechanism offers therapeutic relevance in breast cancer trials by potentially modulating inflammatory microenvironments that promote tumor growth.

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>).