Clinical Trials

Several Phase I clinical trials are evaluating Salvianolic acid C to assess its safety, tolerability, pharmacokinetic properties, and potential food-effect interactions in healthy participants as well as patients with diabetes and diabetic neuropathy. Sponsored by academic and corporate entities—including Peking University First Hospital, Shandong Huizhi Pharmaceutical Technology Co. Ltd., and the Cancer Institute and Hospital Chinese Academy of Medical Sciences—these early-stage studies presently maintain an unknown recruitment status.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT03908242 Unknown status
Diabetes
Peking University First Hospital
 2019-04-08 Phase 1
NCT03791463 Unknown status
Healthy
Peking University First Hospital
 2018-12-20 Phase 1
NCT03791125 Unknown status
Neuropathy of Diabetes
Peking University First Hospital|Shandong Huizhi Pharmaceutical Technology Co. Ltd.|Cancer Institute and Hospital Chinese Academy of Medical Sciences
 2018-11-20 Phase 1

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Salvianolic acid C functions as a non-competitive inhibitor of Cytochrome P450 2C8 (CYP2C8) and a moderate mixed inhibitor of Cytochrome P450 2J2 (CYP2J2), binding these hepatic and extrahepatic enzymes to suppress the oxidative clearance of xenobiotics and endogenous lipid mediators. This catalytic blockade alters cellular metabolic processing and eicosanoid bioavailability, which directly influences drug disposition and physiological signaling in clinical target populations suffering from diabetes and diabetic neuropathy.

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.