AOA (Aminooxyacetic acid) hemihydrochloride Clinical Trials

Size	Price	Qty
25mg	USD 147
1g	USD 490

Clinical Trials

Multiple clinical trials evaluate aminooxyacetic acid applications across conditions such as primary infertility, embryo development disorders, in vitro fertilization failure, surgical anesthesia monitoring, glioma, and ataxia-oculomotor apraxia 1, with an emphasis on improving fertilization rates and embryonic outcomes. Spanning Phase 1 through Phase 4 interventional stages alongside observational protocols, these studies are funded by diverse academic and corporate sponsors, including Maria Fertility Hospital and GE Healthcare. Across this research, recruitment statuses include completed, currently recruiting, and unknown.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT06818175	RECRUITING	Low Back Pain; Chronic Low-back Pain; Acute Low Back Pain	Edward Via Virginia College of Osteopathic Medicine	2023-09-01
NCT06111248	COMPLETED	All Conditions Requiring Non-cardiac Surgery	Centre Hospitalier Universitaire de Nīmes	2024-02-05
NCT05402605	UNKNOWN	in Vitro Fertilization	Mỹ Đức Hospital	2022-08-29
NCT04519918	UNKNOWN	Fertilization	Tang-Du Hospital	2020-10-01
NCT03354013	COMPLETED	Embryo; Embryo Disorder; Genetic Disease	University Hospital, Ghent	2018-01-15
NCT04744753	COMPLETED	Infertility Primary	MOHAMED BEHERY	2017-07-15	PHASE4
NCT02333305	COMPLETED	Ataxia-oculomotor Apraxia 1	Assistance Publique - Hôpitaux de Paris	2013-06	PHASE3
NCT01928875	COMPLETED	Surgical Procedure, Unspecified	GE Healthcare	2013-12
NCT01595815	COMPLETED	Infertility	Maria Fertility Hospital	2007-05
NCT00526812	COMPLETED	Glioma	Biogen	2005-11-30	PHASE1

(data from https://clinicaltrials.gov, updated on 2026-03-13)

Check the AOA (Aminooxyacetic acid) hemihydrochloride product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Aminooxyacetic acid hemihydrochloride selectively inhibits key metabolic enzymes including aminobutyrate aminotransferase and cystathionine β-synthase, thereby disrupting the malate-aspartate shuttle and suppressing downstream amino acid and polyamine biosynthetic pathways. This metabolic blockade impairs mitochondrial energy transfer and alters intracellular amino acid homeostasis, ultimately regulating metabolic activity in disease models and clinical conditions such as glioma and reproductive disorders studied in clinical trials.

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>).