Clinical Trials

Multiple clinical trials evaluate apigenin across healthy volunteer studies and diverse therapeutic applications, including sepsis and septic shock, rheumatoid arthritis, Parkinson's disease, neurodegenerative disorders, hypercholesterolemia, and localized bone regeneration in closed sinus lifting. Sponsored primarily by academic and clinical institutions, these studies encompass Phase 1, Phase 2, and unphased nutraceutical and pharmacokinetic evaluations. Trial recruitment statuses range from completed investigations to studies enrolling by invitation or having an unknown status.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07678749 ENROLLING_BY_INVITATION
Closed Sinus Lift; Apigenin Loaded Scaffold
Al-Azhar University
 2025-11-05
NCT06889584 COMPLETED
Healthy
University of South Carolina
 2025-02-15
NCT05788705 UNKNOWN
Rheumatoid Arthritis
Adel A.Gomaa
 2023-07
NCT06560216 COMPLETED
Healthy
Chulalongkorn University
 2024-10-28
NCT05999682 COMPLETED
Sepsis; Septic Shock
Zhujiang Hospital
 2023-09-01 PHASE1; PHASE2
NCT05696665 UNKNOWN
Parkinson Disease; Neurodegenerative Diseases
Jinnah Postgraduate Medical Centre
 2022-07-05
NCT04114916 COMPLETED
Cholesterol
Universidad Católica San Antonio de Murcia
 2016-10-01
NCT03526081 COMPLETED
Healthy
University of California, Davis
 2015-01-20

(data from https://clinicaltrials.gov, updated on 2026-07-01)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Apigenin acts as a potent inhibitor of cytochrome P450 CYP2C9 while modulating key cellular pathways to induce autophagy and alter inflammatory mediator signaling cascades. By regulating metabolic turnover and inflammatory response pathways, apigenin exerts immunomodulatory and cytoprotective effects relevant to managing inflammatory and systemic conditions such as sepsis, rheumatoid arthritis, and neurodegenerative diseases.

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.