3-Methylglutaric acid Clinical Trials

Size	Price	Qty
100mg	USD 97

Clinical Trials

Multiple clinical trials evaluate MGA-associated protocols across oncology indications, including non-resectable or metastatic pancreatic cancer, acute myeloid leukemia, and localized prostate cancer. Spanning Phase 2 evaluations and Phase Not Applicable categories, these studies report recruitment statuses of recruiting, active not recruiting, and completed. Sponsorship is driven by collaborations between academic centers—including the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins and the National Cancer Institute—and industry partners such as Incyte Corporation, MacroGenics, and Carevive Systems Inc.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT04116073	Recruiting	Pancreatic Cancer Non-resectable\|Pancreatic Cancer Metastatic	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins\|Incyte Corporation\|National Cancer Institute (NCI)	2020-04-09	Phase 2
NCT04158726	Completed	Acute Myeloid Leukemia	Carevive Systems Inc.	2019-04-26	Not Applicable
NCT02923180	Active not recruiting	Prostate Cancer	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins\|MacroGenics	2017-02-14	Phase 2

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

Check the 3-Methylglutaric acid product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

As a C6 dicarboxylic organic acid metabolite, 3-methylglutaric acid binds to target metabolic enzymes, inhibiting downstream dicarboxylic acid processing and altering intracellular metabolite homeostasis. This disruption of cellular biochemical pathways impairs cell proliferation, providing potential therapeutic relevance in conditions evaluated in clinical trials such as pancreatic cancer, acute myeloid leukemia, and prostate cancer.

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>).