L-2-Hydroxyglutaric acid disodium Clinical Trials

Size	Price	Qty
5mg	USD 97
25mg	USD 289

Clinical Trials

Several clinical trials are currently evaluating conditions associated with metabolic dysregulation, oncology, and rare genetic disorders, including gestational diabetes, acute myeloid leukemia, myelodysplastic syndromes, and combined D,L-2-hydroxyglutaric aciduria. Spanning early Phase 1 through Phase 1/Phase 2 and non-applicable classifications, these studies are supported by academic medical centers, hospital networks, pharmaceutical corporations, and independent sponsors. Their recruitment statuses range from not yet recruiting and active recruiting to active not recruiting and enrolling by invitation, reflecting ongoing research into metabolite biomarkers and therapeutic interventions.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT07125066	ENROLLING_BY_INVITATION	Combined D,L-2-hydroxyglutaric Aciduria	Jerry Vockley, MD, PhD	2025-07-30	PHASE1
NCT06343974	Not yet recruiting	Pregnancy in Diabetic\|Diabetes Mellitus Type 1	Turku University Hospital	2024-06-01	--
NCT06127823	Recruiting	GDM\|Gestational Diabetes\|Nutritional and Metabolic Diseases\|Nutrition Therapy\|Medical Nutrition Therapy	Steno Diabetes Center Copenhagen\|Herlev Hospital\|Rigshospitalet Denmark	2024-01-03	Not Applicable
NCT06218771	Recruiting	Acute Myeloid Leukemia\|Myelodysplastic Syndromes	Chia Tai Tianqing Pharmaceutical Group Co. Ltd.	2023-07-10	Phase 1\|Phase 2
NCT05430204	Active not recruiting	Gestational Diabetes	The University of Texas Health Science Center Houston\|DexCom Inc.	2023-03-07	Not Applicable

(data from https://clinicaltrials.gov, updated on 2026-06-08)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

L-2-Hydroxyglutaric acid disodium functions as an epigenetic modifier by inhibiting histone demethylases and mitochondrial creatine kinase, thereby increasing histone methylation and altering cellular bioenergetics. By suppressing demethylation and metabolic turnover, the compound blocks aberrant cellular proliferation and metabolic reprogramming, providing mechanistic relevance to clinical investigations in hematologic malignancies like acute myeloid leukemia and metabolic diseases such as combined D,L-2-hydroxyglutaric aciduria.

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>).