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)
Mechanism and Biochemical Profile
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>).