Clinical Trials

A clinical trial sponsored by industry partner Haisco Pharmaceutical Group Co. Ltd. is currently recruiting participants to evaluate the clinical efficacy and safety of O-Acetyl-L-carnitine hydrochloride. The investigation targets diabetic peripheral neuropathic pain using therapeutic combination regimens involving carnitine hydrochloride formulations. This study has a trial phase status designated as Not Applicable.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT06122012 Recruiting
Diabetic Peripheral Neuropathic Pain
Haisco Pharmaceutical Group Co. Ltd.
 2023-05-01 Not Applicable

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

Check the O-Acetyl-L-carnitine hydrochloride product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

O-Acetyl-L-carnitine facilitates the transport of long-chain fatty acids into the mitochondrial matrix, thereby promoting mitochondrial beta-oxidation and ATP generation. By optimizing mitochondrial bioenergetics and suppressing cellular oxidative stress, it supports peripheral neuronal survival and axon maintenance, which contributes to therapeutic relief in diabetic peripheral neuropathic pain.

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>).

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Note: Technical data last updated: Sep 1, 2026.