Methylmalonate Clinical Trials

Size	Price	Qty
25mg	USD 127
1g	USD 490

Clinical Trials

Multiple clinical trials incorporate methylmalonate monitoring or related physiological evaluations across observational, dietary, digital, and pharmacological interventions for conditions including type 2 diabetes, cardiovascular diseases, hypertension, relapsing-remitting multiple sclerosis, and chronic heart failure. Currently designated under unassigned or non-standard phases, these trials remain in a not yet recruiting status. The initiatives are sponsored by diverse academic, governmental, and pharmaceutical organizations, including the German Federal Institute for Risk Assessment, Hoffmann-La Roche, and Elpen Pharmaceutical Co. Inc.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT06323538	Not yet recruiting	Dietary Exposure\|Diabetes Mellitus Type 2\|Cardiovascular Diseases\|Bone Loss\|Sustainability\|Exposure\|Obesity\|Vitamin Deficiency\|Mineral Deficiency	German Federal Institute for Risk Assessment\|Max Rubner-Institut\|University of Bonn\|Research Institute for Plant-Based Nutrition\|University of Jena\|University of Regensburg\|Heidelberg University\|University of Vienna	2024-04-01	--
NCT06242483	Not yet recruiting	Hypertension	Hospital Israelita Albert Einstein\|Elfie Pte. Ltd.	2024-04-01	Not Applicable
NCT05949580	Not yet recruiting	Relapsing Remitting Multiple Sclerosis	Hoffmann-La Roche\|icometrix	2024-04-30	--
NCT06117722	Not yet recruiting	Chronic Heart Failure	Elpen Pharmaceutical Co. Inc.	2024-03-01	--

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Methylmalonate, a dicarboxylic acid metabolite derived from methylmalonyl-coenzyme A, binds to mitochondrial succinate dehydrogenase and inhibits its enzymatic conversion of succinate to fumarate. This biochemical blockade impairs mitochondrial oxidative phosphorylation and reduces cellular energy generation, leading to metabolic stress relevant to clinical studies in type 2 diabetes, chronic heart failure, and relapsing remitting multiple sclerosis.

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>).