Methyl acetoacetate Clinical Trials

Size	Price	Qty
100mg	USD 97

Clinical Trials

Several clinical trials evaluate non-pharmacological, behavioral, and physiological health interventions for conditions including sensorineural hearing impairment, cognitive impairment, depression, caregiver burden, and substance use disorders. Sponsored by academic institutions such as Texas Tech University and Kingston University alongside government entities like the National Institute on Deafness and Other Communication Disorders, these studies carry unassigned or non-applicable phase classifications. Recruitment status varies across the portfolio, ranging from completed protocols to actively recruiting and pending studies.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT06377215	Not yet recruiting	Hearing Impairment Sensorineural\|Spatial Perception\|Aging\|Hearing Aids	University of South Florida\|National Institute on Deafness and Other Communication Disorders (NIDCD)	2024-04-15	--
NCT06289426	Recruiting	Perceived Stress\|Depression\|Anxiety\|Mindfulness\|Self-Compassion\|Compassion\|Work Engagement\|Productivity\|Heart Rate Variability\|Mental Wellbeing\|Musculoskeletal Pain	Kingston University	2024-02-15	Not Applicable
NCT06130878	Completed	Cognitive Impairment	University of Jaén	2024-01-08	Not Applicable
NCT06055322	Not yet recruiting	Suicide\|Depression\|Caregiver Burden\|Physical Health\|Inflammation	Texas Tech University	2024-01-01	Not Applicable
NCT06402240	Recruiting	Substance Use Disorders\|Alcohol Use Disorder\|Depression\|Anxiety	University of Windsor\|Centre for Addiction and Mental Health	2024-01-01	Not Applicable

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Methyl acetoacetate functions as an endogenous acetoacetate ester and metabolic intermediate that interacts with metabolic pathways to regulate downstream acetoacetate processing and cellular ketone biochemistry. By driving energetic substrate availability, this ester alters mitochondrial bioenergetics and cellular respiration, supporting cellular resilience relevant to clinical investigations in cognitive impairment and neurological health.

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>).