Clinical Trials

Multiple clinical trials evaluate allicin and garlic-derived preparations across diverse indications, including cardiovascular and metabolic conditions—such as atherosclerosis, hypercholesterolemia, hypertriglyceridemia, and hyperglycemia—along with follicular lymphoma, nosocomial infections, HIV infections, and dietary metabolism in healthy cohorts. Sponsored by academic institutions and research organizations, these studies encompass Early Phase I, Phase II, Phase III, and unspecified phase designs. Recruitment statuses across these trials include completed, enrolling by invitation, withdrawn, and unknown.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT06833125 ENROLLING_BY_INVITATION
Nosocomial Infection
Alexandria University
2025-03-01 PHASE3
NCT04545879 COMPLETED
Atherosclerosis
National Taiwan University Hospital
2019-03-18
NCT00874666 UNKNOWN
Healthy
Silliker, Inc.
2009-04 EARLY_PHASE1
NCT00455416 UNKNOWN
Follicular Lymphoma
Oslo University Hospital
2007-04 PHASE2
NCT00029250 WITHDRAWN
HIV Infections; Hypercholesterolemia; Hypertriglyceridemia; Hyperglycemia
National Center for Complementary and Integrative Health (NCCIH)
2001-11 PHASE2

(data from https://clinicaltrials.gov, updated on 2025-10-07)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

As a reactive organosulfur thiosulfinate, allicin covalently interacts with critical sulfhydryl groups on essential cellular and microbial enzymes, thereby inhibiting thiol-dependent metabolic pathways and triggering potent antimicrobial and antioxidant responses. This broad-spectrum enzymatic reactivity suppresses microbial growth and modulates lipid metabolism, supporting its clinical investigation in managing atherosclerosis, metabolic dysregulation, and infectious conditions.

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>).

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