Clinical Trials

Multiple clinical trials with non-standard phase designations are currently evaluating therapeutic strategies for diverse conditions, including cerebral palsy, stable angina, cardiovascular disease, alcohol use disorder, HIV risk, and substance use disorders. Sponsored by academic research institutions and government entities, these evaluations focus on symptomatic management and preventive care interventions. Current recruitment status across these trials ranges from not yet recruiting to recruiting.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT06372041 Not yet recruiting
Cerebral Palsy
IRCCS Eugenio Medea|IRCCS National Neurological Institute C. Mondino Foundation|Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
2024-04-15 Not Applicable
NCT06372028 Not yet recruiting
Cerebral Palsy
IRCCS Eugenio Medea|IRCCS National Neurological Institute C. Mondino Foundation|Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
2024-04-15 Not Applicable
NCT05828849 Not yet recruiting
Cardiovascular Disease|Alcohol Use Disorder|HIV Risk|Substance Use Disorders
NYU Langone Health|National Institute on Alcohol Abuse and Alcoholism (NIAAA)
2024-04-15 Not Applicable
NCT06311461 Recruiting
Angina Stable
University of California Los Angeles|University of Illinois at Chicago
2024-04-01 Not Applicable

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Acetohydroxamic acid functions as a targeted inhibitor that directly binds the active-site nickel ions of bacterial urease, thereby blocking the enzymatic hydrolysis of urea into ammonia and carbamate. This biochemical block prevents urinary alkalinization and impairs bacterial biofilm formation, offering clinical utility in reducing bacterial complication risks in complex patient cohorts, such as those with cardiovascular disease or stable angina studied in clinical trial settings.

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.