Clinical Trials

A clinical trial sponsored by Oryzon Genomics S.A. evaluated the therapeutic potential, safety, and efficacy of vafidemstat in adult patients with borderline personality disorder. This completed, double-blind, randomized, placebo-controlled Phase II study assessed functional improvements and symptom reduction over an extended treatment period. The investigation highlights the clinical progression of vafidemstat as an oral therapeutic for complex psychiatric disorders.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT04932291 COMPLETED
Borderline Personality Disorder
Oryzon Genomics S.A.
 2021-03-26 PHASE2

(data from https://clinicaltrials.gov, updated on 2026-05-05)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Vafidemstat functions as a brain-penetrant dual inhibitor of lysine-specific histone demethylase 1 (LSD1/KDM1A) and monoamine oxidase B (MAO-B) with nanomolar potency, suppressing aberrant epigenetic demethylation and monoamine catabolism in the central nervous system. By modulating histone methylation patterns and neurotransmitter stability, vafidemstat normalizes neuronal gene expression and synaptic function, providing clinical relevance for mitigating cognitive and behavioral alterations in psychiatric conditions such as borderline personality disorder.

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>).

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