Thioctic acid Clinical Trials

Size	Price	Qty
25mg	USD 97
1g	USD 970

Clinical Trials

The clinical trial landscape for Thioctic acid includes a completed Phase 1 study sponsored by Unimed Pharmaceuticals. This randomized, open-label trial evaluated the safety parameters and pharmacokinetic drug interaction profile of the compound under a multiple-dosing schedule in healthy human participants. Consequently, current clinical research on Thioctic acid is limited to early-phase pharmacological evaluation rather than therapeutic efficacy in specific patient populations.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT01808300	Completed	Healthy	Unimed Pharmaceuticals	2013-02	Phase 1

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Thioctic acid functions as a cyclic disulfide antioxidant that interconverts with its reduced dithiol form, directly neutralizing reactive oxygen species and modulating downstream biochemical redox pathways. By suppressing oxidative cellular damage and modulating metabolic pathways, this redox activity provides the mechanistic foundation for assessing its pharmacokinetic and drug interaction profiles in healthy trial participants.

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>).