Clinical Trials

A completed clinical trial associated with this compound evaluated therapeutic outcomes in individuals affected by rheumatoid arthritis. Sponsored by the industry sponsor Hoffmann-La Roche, this comparative observational study had no assigned formal phase and assessed patient responses to specific treatment protocols. Overall, the clinical landscape for this compound consists of observational research within the domain of autoimmune inflammatory conditions.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT02679001 Completed
Rheumatoid Arthritis
Hoffmann-La Roche
2016-03-24 --

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

Check the Wnt-C59 (C59) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Wnt-C59 potently inhibits the O-acyltransferase Porcupine (PORCN), which blocks Wnt protein palmitoylation and prevents Wnt3A-mediated downstream activation of TCF transcriptional responses. This targeted disruption of canonical Wnt signaling suppresses aberrant cellular proliferation and pathway-driven inflammatory signaling, which is clinically relevant to hyperproliferative and autoimmune conditions such as rheumatoid arthritis.

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>).

Note: Technical data last updated: Sep 1, 2026.