XAV-939 Clinical Trials

Size	Price	Qty
10mg	USD 147
50mg	USD 370

Clinical Trials

A combined Phase 1/Phase 2 clinical trial sponsored by industry partner Eluciderm Inc is actively recruiting participants to evaluate ELU42, a topical formulation of XAV-939, in patients with chronic open wounds, specifically Wagner Grade 1 and Grade 2 diabetic foot ulcers. The study aims to determine the early-stage safety profile and therapeutic potential of localized tankyrase inhibition and Wnt pathway modulation in promoting tissue repair within impaired wound environments.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT07396376	RECRUITING	Diabetic Foot Ulcer; Wagner Grade 1 - 2; Chronic Wound; Open Wound	Eluciderm Inc	2025-11-10	PHASE1; PHASE2

(data from https://clinicaltrials.gov, updated on 2026-02-12)

Check the XAV-939 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

XAV-939 selectively binds to and inhibits tankyrase 1 and tankyrase 2, thereby blocking the poly-ADP-ribosylation and ubiquitin-proteasome-mediated degradation of the axin protein. The resulting stabilization of axin promotes beta-catenin degradation to suppress Wnt/beta-catenin-mediated gene transcription, providing a mechanistic foundation for modulating cellular responses in chronic open wounds such as diabetic foot ulcers.

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>).