Clinical Trials

Multiple clinical trials are currently on record evaluating Salvianolic acid A, consisting exclusively of early-stage Phase I studies designed to assess the compound's safety, tolerability, food effects, and pharmacokinetic characteristics in healthy volunteers, individuals with diabetes, and patients with diabetic neuropathy. Involving collaborative sponsorships between academic medical centers and industrial partners, these trials currently maintain an unknown recruitment status.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT03908242 UNKNOWN
Diabetes
Peking University First Hospital
 2019-04-08 PHASE1
NCT03908242 Unknown status
Diabetes
Peking University First Hospital
 2019-04-08 Phase 1
NCT03791125 UNKNOWN
Neuropathy of Diabetes
Peking University First Hospital
 2018-11-20 PHASE1
NCT03791463 UNKNOWN
Healthy
Peking University First Hospital
 2018-12-20 PHASE1
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 2019-04-09)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Salvianolic acid A directly inhibits protein-protein interactions mediated by the SH2 domains of Src-family kinases, including Src and Lck, while simultaneously acting as a potent antioxidant that neutralizes reactive oxygen species. By blocking downstream SH2-dependent kinase signaling pathways and suppressing oxidative stress, the compound attenuates cellular inflammation and vascular endothelial dysfunction, which is relevant to mitigating microvascular damage in conditions such as 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.