Clinical Trials

Several clinical trials investigate conditions associated with catechol-related therapies and physiological pathways, encompassing stress response, Menkes disease, Occipital Horn Syndrome, alcohol use disorder, and stable angina. Spanning Phase 1, Phase 2, and non-phased designs, these studies are sponsored by academic and healthcare entities. Currently, these trials report recruiting, completed, or unknown recruitment statuses.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT05825677 Recruiting
Stress Response
Hôpital le Vinatier
 2023-04-11 Not Applicable
NCT04977388 Recruiting
Menkes Disease|Occipital Horn Syndrome
Stephen G. Kaler MD|Nationwide Children''s Hospital
 2021-07-12 Phase 1|Phase 2
NCT03530384 Completed
Alcohol Use Disorder
Assistance Publique - Hôpitaux de Paris
 2019-02-25 Not Applicable
NCT03306550 Unknown status
Angina Stable
Xiyuan Hospital of China Academy of Chinese Medical Sciences
 2017-10-10 Not Applicable

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Catechol acts as a structural core and redox-active substrate that directly interacts with oxidative enzymes and catecholaminergic targets, inhibiting aberrant downstream oxidative reactions and cellular signal cascades. This regulation of neurochemical pathways and enzymatic metabolism provides clinical relevance for managing stress response, Menkes disease, alcohol use disorder, and stable angina.

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.