Multiple clinical trials, spanning Early Phase 1 through Phase 2, evaluate the therapeutic potential, pharmacokinetics, and biological activity of xanthohumol in healthy cohorts and patients with conditions such as metabolic syndrome, viral respiratory infections including COVID-19, Crohn's disease, pneumonia, acute respiratory distress syndrome, and septic shock. Sponsored primarily by academic and government entities—including Oregon State University, the University of Vienna, and the Medical University of Lublin—these studies range in status from active and recruiting to completed. Across these investigations, key endpoints include anti-inflammatory efficacy, plasmakinetics, resting energy expenditure, metabolic signatures, and oxidative stress.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT06286657 | RECRUITING | Infection Viral |
University of Vienna |
2023-08-01 | |
| NCT06286644 | RECRUITING | Inflammatory Response |
University of Vienna |
2022-05-30 | |
| NCT06225258 | RECRUITING | Septic Shock; Pneumonia; ARDS |
Medical University of Lublin |
2023-01-09 | PHASE2 |
| NCT06745102 | RECRUITING | Inflammatory Response |
University of Vienna |
2024-02-01 | |
| NCT04590508 | ACTIVE_NOT_RECRUITING | Crohn Disease |
National University of Natural Medicine |
2020-10-01 | PHASE2 |
| NCT05711212 | COMPLETED | Resting Energy Expenditure |
University of Bonn |
2023-02-15 | |
| NCT06225258 | Recruiting | Septic Shock|Pneumonia|ARDS |
Medical University of Lublin |
2023-05-09 | Phase 2 |
| NCT05524714 | COMPLETED | Plasmakinetics of Xanthohumol |
University of Bonn |
2022-08-01 | |
| NCT05463393 | SUSPENDED | COVID-19 Respiratory Infection |
Medical University of Lublin |
2020-10-01 | EARLY_PHASE1 |
| NCT04847193 | COMPLETED | Inflammatory Response |
University of Vienna |
2019-06-13 | |
| NCT03735420 | UNKNOWN | Healthy |
National University of Natural Medicine |
2019-08-12 | PHASE1 |
| NCT03735420 | Active not recruiting | Healthy |
National University of Natural Medicine|Oregon State University|Pacific Northwest National Laboratory |
2019-08-12 | Phase 1 |
| NCT03561116 | UNKNOWN | Metabolic Syndrome |
Universidade do Porto |
2018-05-19 | |
| NCT02432651 | COMPLETED | Oxidative Stress |
Oregon State University |
2015-03 | PHASE1 |
| NCT01367431 | Completed | Metabolic Syndrome |
Oregon State University|Oregon Health and Science University|National Center for Complementary and Integrative Health (NCCIH) |
2011-08 | -- |
(data from https://clinicaltrials.gov, updated on 2025-04-15)
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>).