Chlorogenic acid is evaluated in numerous clinical trials across Phase 1 through Phase 3 and non-interventional designs, targeting indications ranging from metabolic health and healthy states to advanced solid tumors. Sponsored by both academic medical centers and industry leaders, these studies assess pharmacokinetic profiles, safety, and therapeutic tolerance, with recruitment statuses encompassing completed, terminated, and withdrawn.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT05757154 | Completed | Healthy |
Chalmers University of Technology|Paulig Group |
2023-03-31 | Not Applicable |
| NCT02524938 | TERMINATED | Diabetes Mellitus, Type 2; Renal Insufficiency, Chronic |
NHS Greater Glasgow and Clyde |
2016-06-01 | |
| NCT05547204 | Completed | Skill Performance|Soccer Performance|Coffeeberry Effects |
PepsiCo Global R&D |
2022-06-30 | Not Applicable |
| NCT03751592 | UNKNOWN | Advanced Lung Cancer |
Sichuan J.Z. Bio-chemical Science and Technology Development Co., Ltd |
2018-07-17 | PHASE1; PHASE2 |
| NCT03758014 | UNKNOWN | GBM |
Sichuan J.Z. Bio-chemical Science and Technology Development Co., Ltd |
2018-11-27 | PHASE2; PHASE3 |
| NCT02887950 | TERMINATED | Overweight |
Fondazione IRCCS Policlinico San Matteo di Pavia |
2016-09 | |
| NCT03520452 | COMPLETED | Endothelial Dysfunction |
Société des Produits Nestlé (SPN) |
2018-03-14 | |
| NCT02929901 | COMPLETED | Type 2 Diabetes Nonalcoholic Fatty Liver |
National Nutrition and Food Technology Institute |
2016-12 | PHASE2; PHASE3 |
| NCT03520452 | Completed | Endothelial Dysfunction |
Société des Produits Nestlé (SPN) |
2018-03-14 | Not Applicable |
| NCT03444558 | COMPLETED | Metabolic Syndrome |
University of Palermo |
2017-06-01 | |
| NCT03019263 | COMPLETED | Dyslipidemia |
Fondazione IRCCS Policlinico San Matteo di Pavia |
2017-03-31 | |
| NCT02728349 | COMPLETED | Glioblastoma |
Sichuan J.Z. Bio-chemical Science and Technology Development Co., Ltd |
2016-04-12 | PHASE1 |
| NCT02245204 | COMPLETED | Advanced Cancer |
Sichuan J.Z. Bio-chemical Science and Technology Development Co., Ltd |
2014-09 | PHASE1 |
| NCT02728349 | Completed | Glioblastoma |
Sichuan J.Z. Bio-chemical Science and Technology Development Co. Ltd|Beijing Shijitan Hospital Capital Medical University |
2016-04-12 | Phase 1 |
| NCT02621060 | COMPLETED | Impaired Glucose Tolerance |
University of Guadalajara |
2015-09 | PHASE2 |
| NCT02136342 | TERMINATED | Advanced Cancer |
Chinese Academy of Medical Sciences |
2014-05 | PHASE1 |
| NCT02388672 | WITHDRAWN | Blood Pressure |
University Hospital Tuebingen |
2015-03 | |
| NCT02245204 | Completed | Advanced Cancer |
Sichuan J.Z. Bio-chemical Science and Technology Development Co. Ltd|Peking University Cancer Hospital & Institute |
2014-09 | Phase 1 |
| NCT02136342 | Terminated | Advanced Cancer |
Chinese Academy of Medical Sciences|Sichuan J.Z. Bio-chemical Science and Technology Development Co. Ltd|ChineseAMS |
2014-05 | Phase 1 |
| NCT01523028 | COMPLETED | Healthy |
Société des Produits Nestlé (SPN) |
2011-09 |
(data from https://clinicaltrials.gov, updated on 2024-05-22)
Check the
Chlorogenic Acid
product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.
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>).
Note: Technical data last updated: Sep 1, 2026.