6-Diazo-5-oxo-L-norleucine (Diazooxonorleucine) Clinical Trials

Size	Price	Qty
2mg	USD 197
5mg	USD 370

Clinical Trials

Multiple clinical trials evaluate this compound across indications including Alzheimer disease, multiple sclerosis, pediatric neuromuscular conditions, and cerebral malaria. These studies encompass Phase 1 pharmacokinetic evaluations, Phase 1/2 safety and dose-escalation protocols, and non-phase observational or device trials, with statuses listed as completed, actively recruiting, or not yet recruiting. Research support comes from commercial developers such as Shanghai Synergy Pharmaceutical Sciences and ABLE Human Motion, along with research institutes and academic investigators.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05478720	RECRUITING	Malaria, Cerebral	Douglas Postels, MD, MS	2022-08-16	PHASE1; PHASE2
NCT06373094	Not yet recruiting	Alzheimer Disease	Shanghai Synergy Pharmaceutical Sciences Co. Ltd.\|Zhejiang Huahai Pharmaceutical Co. Ltd.	2024-06-01	Phase 1
NCT06261541	Recruiting	Multiple Sclerosis	ABLE Human Motion S.L.\|Fundación Esclerosis Múltiple Madrid (FEMM)	2024-04-08	Not Applicable
NCT06167954	Recruiting	Cerebral Palsy\|Acquired Brain Injury\|Spinal Muscular Atrophy	MarsiBionics\|Hospital Infantil Universitario Niño Jesús Madrid Spain\|Hospital Universitario La Paz\|Hospital Universitario 12 de Octubre\|Hospital General Universitario Gregorio Marañon	2023-12-04	Not Applicable
NCT05914818	Completed	Cerebral Palsy\|Acquired Brain Injury\|Neuromuscular Diseases in Children	MarsiBionics\|National Research Council Spain\|Hospital Infantil Universitario Niño Jesús Madrid Spain\|Hospital Universitario La Paz\|Hospital Universitario 12 de Octubre\|Hospital General Universitario Gregorio Marañon	2023-06-23	Not Applicable

(data from https://clinicaltrials.gov, updated on 2026-06-29)

Check the 6-Diazo-5-oxo-L-norleucine (Diazooxonorleucine) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

6-Diazo-5-oxo-L-norleucine functions as a glutaminase antagonist that binds to and inhibits kidney-type glutaminase, thereby blocking critical downstream glutamine metabolism pathways essential for cellular survival and growth. This target-specific metabolic disruption impairs aberrant cellular energy production, providing therapeutic potential for clinical conditions such as neurodegenerative disorders and cerebral malaria.

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>).