Clinical Trials

Several clinical trials have evaluated the safety, tolerability, and pharmacokinetics of SP-8356, a synthetic verbenone derivative intended for therapeutic application in atherosclerosis and ischemic stroke. Conducted as industry-sponsored Phase I studies by Shin Poong Pharmaceutical Co. Ltd., these early-stage trials were ultimately terminated. Consequently, clinical development of this compound for vascular and cerebrovascular indications is presently halted pending future investigation.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT05574166 TERMINATED
Atherosclerosis; Ischemic Stroke
Shin Poong Pharmaceutical Co. Ltd.
 2021-01-03 PHASE1
NCT05574166 Terminated
Atherosclerosis|Ischemic Stroke
Shin Poong Pharmaceutical Co. Ltd.
 2021-01-03 Phase 1

(data from https://clinicaltrials.gov, updated on 2022-10-10)

Check the SP-8356 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

SP-8356 functions as a synthetic verbenone-derived inhibitor of extracellular matrix metalloproteinase inducer (CD147), binding to the target receptor to suppress downstream inflammatory signaling cascades and matrix metalloproteinase secretion. By inhibiting CD147-mediated cellular activation and vascular tissue remodeling, the compound reduces inflammatory progression to mitigate plaque instability and ischemic injury in clinical conditions such as atherosclerosis and ischemic stroke.

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.