Clinical Trials

Multiple completed clinical trials sponsored primarily by academic and medical research institutions have evaluated physiological conditions associated with H-Abu-OH. Classified with a phase designation of Not Applicable, these studies examined metabolic, cognitive, and sleep disturbances stemming from noise exposure and sleep hygiene issues, as well as chronic and traumatic brain injuries in relation to the gut microbiome. Overall, these investigations explore the metabolic, cognitive, and neurological implications of H-Abu-OH in relevant clinical contexts.

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
NCT04949607 Completed
Brain Injury Chronic|Brain Injuries Traumatic
Centre for Neuro Skills|University of Texas
 2021-07-28 Not Applicable

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

As a non-proteinogenic amino acid, H-Abu-OH acts as a substrate utilized by nonribosomal peptide synthases, thereby modulating nonribosomal peptide biosynthesis and downstream metabolic pathways. This regulation of cellular metabolic flux and metabolite profiles provides functional relevance to clinical conditions involving metabolic, cognitive, and neurological perturbations, such as traumatic brain injury and 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>).

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Note: Technical data last updated: Sep 1, 2026.