Malonic acid Clinical Trials

Size	Price	Qty
100mg	USD 99
1g	USD 217

Clinical Trials

Multiple clinical trials evaluate interventions across diverse neurological, psychiatric, and behavioral conditions, including autism spectrum disorder, neuropathy, schizophrenia, and emotional dysregulation. Sponsored primarily by academic medical centers and health organizations, these studies frequently evaluate digital applications or observational cohorts, leaving trial phases unassigned or categorized as Not Applicable. Recruitment statuses encompass actively enrolling studies—focusing on stress management and mental health outcomes—as well as withdrawn protocols.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05277194	Recruiting	Autism Spectrum Disorder	University of Pennsylvania\|Alevio LLC	2023-09-26	Not Applicable
NCT05469321	Recruiting	Neuropathy	Centre Hospitalier Universitaire de Nīmes	2022-08-22	--
NCT04316338	Withdrawn	Autism Spectrum Disorder	Stanford University	2022-05-01	Not Applicable
NCT05159349	Recruiting	Schizophrenia	Shanghai Mental Health Center\|Fudan University	2021-12-01	--
NCT04732806	Recruiting	Emotional Dysregulation	Neuromotion Labs\|National Institute of Mental Health (NIMH)\|Magellan Healthcare	2021-03-10	Not Applicable

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Malonic acid acts as a competitive inhibitor of succinate dehydrogenase, binding directly to its active site and blocking the conversion of succinate to fumarate within the tricarboxylic acid cycle. This enzyme blockade disrupts mitochondrial respiration and cellular ATP generation, providing a critical model for investigating bioenergetic impairment and oxidative stress in neurodevelopmental and psychiatric conditions such as autism spectrum disorder and schizophrenia.

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>).