Clinical Trials

Multiple clinical trials are currently evaluating the therapeutic potential of honokiol in Phase 1 and Phase 3 studies targeting non-small-cell lung carcinoma and acne vulgaris. These investigations are sponsored by individual clinical investigators alongside academic and medical research institutes, such as The Methodist Hospital Research Institute. With recruitment statuses ranging from actively recruiting to not yet recruiting, these studies demonstrate ongoing clinical evaluation of honokiol across diverse indications.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT06566443 RECRUITING
Carcinoma, Non-Small-Cell Lung
The Methodist Hospital Research Institute
2025-02-13 PHASE1
NCT06775314 NOT_YET_RECRUITING
Acne Vulgaris
Dr.dr.Irma Bernadette, SpKK (K)
2025-03-01 PHASE3

(data from https://clinicaltrials.gov, updated on 2026-05-28)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Honokiol inhibits Akt phosphorylation and modulates the ROS/ERK1/2 and nuclear factor kappa B signaling pathways, thereby downregulating critical pro-survival and angiogenic factors such as COX-2 and VEGF. This targeted pathway inhibition induces G0/G1 cell cycle arrest, caspase-dependent apoptosis, and autophagy, providing a mechanistic rationale for suppressing cell proliferation and tumor progression in conditions such as non-small-cell lung carcinoma.

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.