Clinical Trials

A Phase 2 clinical trial sponsored by the Sheppard Pratt Health System evaluated potential therapeutic interventions for cognitive impairments associated with schizophrenia and schizoaffective disorder. However, study recruitment was officially terminated prior to completion, halting further patient enrollment and data collection. Consequently, clinical evidence regarding the compound's efficacy and safety in these psychiatric populations remains limited.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT02234752 Terminated
Schizophrenia|Schizoaffective Disorder
Sheppard Pratt Health System
 2014-09 Phase 2

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

Check the Picolinic acid (PCL 016) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Picolinic acid directly binds to zinc ions associated with zinc finger proteins, inducing structural modifications that disrupt downstream biochemical signaling and inhibit normal cellular protein function. By altering these zinc-dependent regulatory proteins and modulating cellular immune responses, this mechanism provides therapeutic relevance to clinical evaluations addressing neuropsychiatric conditions such as schizophrenia and schizoaffective 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.