2-Hydroxybutyric acid Clinical Trials

Size	Price	Qty
25mg	USD 70
50mg	USD 97

Clinical Trials

A completed clinical trial conducted by academic sponsors—including Göteborg University, the University of Pennsylvania, and the University of Manitoba—evaluated 2-hydroxybutyric acid in the context of noise-induced sleep disruption. Operating without a formal phase designation, the study monitored parameters associated with sleep hygiene, metabolic disturbance, and cognitive change. Ultimately, this effort highlights the utility of 2-hydroxybutyric acid as a biomarker for physiological stress and metabolic dysfunction.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05319262	Completed	Noise Exposure\|Sleep Disturbance\|Sleep Hygiene\|Metabolic Disturbance\|Cognitive Change	Göteborg University\|University of Pennsylvania\|University of Manitoba	2022-04-24	Not Applicable

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

Check the 2-Hydroxybutyric acid product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

As an endogenous metabolite produced during hepatic L-threonine catabolism and glutathione synthesis, 2-hydroxybutyric acid reflects cellular oxidative stress and alterations in lipid oxidation balance. By indexing shifts in intracellular redox status and hepatic transsulfuration flux, this compound serves as a clinical biomarker for evaluating metabolic disturbance and cognitive change associated with sleep disturbance.

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>).