Succinic acid Clinical Trials

Size	Price	Qty
25mg	USD 97
1g	USD 970

Clinical Trials

Succinic acid has been evaluated in multiple completed clinical trials spanning Phase 1 through Phase 3, as well as non-applicable phase designations. Sponsored by pharmaceutical entities alongside academic and government institutions, these studies investigate diverse conditions including acute ischemic stroke, closed head trauma, peripheral vascular disease, diabetic neuropathies, lead poisoning, autism, gallstone disease, obstructive jaundice, and metabolic or sleep disturbances. Overall, these evaluations assess succinic acid-containing therapeutic regimens for clinical efficacy and neurological recovery.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05935787	COMPLETED	Stroke	POLYSAN Scientific & Technological Pharmaceutical Company	2023-06-30	PHASE3
NCT04631484	COMPLETED	Head Trauma,Closed	POLYSAN Scientific & Technological Pharmaceutical Company	2020-11-22	PHASE3
NCT05319262	Completed	Noise Exposure\|Sleep Disturbance\|Sleep Hygiene\|Metabolic Disturbance\|Cognitive Change	Göteborg University\|University of Pennsylvania\|University of Manitoba	2022-04-24	Not Applicable
NCT04649203	COMPLETED	Diabetic Neuropathies	POLYSAN Scientific & Technological Pharmaceutical Company	2020-11-25	PHASE3
NCT03028285	Completed	Peripheral Vascular Disease	POLYSAN Scientific & Technological Pharmaceutical Company	2016-07-15	Phase 1
NCT00811083	COMPLETED	Autism	Southwest College of Naturopathic Medicine	2005-05	PHASE1; PHASE2
NCT00004838	COMPLETED	Lead Poisoning	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	1997-09

(data from https://clinicaltrials.gov, updated on 2026-04-14)

Check the Succinic 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 key metabolic intermediate, succinic acid binds to succinate dehydrogenase and succinate receptor 1, stimulating mitochondrial electron transport and driving oxidative ATP synthesis. By restoring cellular energy homeostasis and mitigating hypoxic cell damage, this biochemical action supports metabolic recovery and tissue viability in clinical conditions such as acute stroke, head trauma, and metabolic disturbances.

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>).