Numerous clinical trials evaluate astaxanthin across Phase 1 to Phase 4 as well as nutritional studies, targeting conditions associated with oxidative stress and inflammation, including knee osteoarthritis, dyslipidemias, acute cerebral stroke, digital eye strain, and metabolic disorders. Sponsored by diverse academic centers, health systems, and commercial entities, these investigations exhibit varying recruitment statuses, encompassing active recruiting, completed, withdrawn, and terminated protocols.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT07379437 | NOT_YET_RECRUITING | Brain Aging |
Capital Medical University |
2026-05-01 | |
| NCT07684391 | NOT_YET_RECRUITING | COPD |
China-Japan Friendship Hospital |
2026-07-01 | |
| NCT07063056 | RECRUITING | Triglycerides |
Medinutra LLC |
2025-07-18 | |
| NCT07507682 | RECRUITING | Asthma (Diagnosis); Airway Inflammation; Airway Hyperresponsiveness |
Middlesex University |
2026-05-15 | |
| NCT07630870 | ACTIVE_NOT_RECRUITING | Healthy |
China Medical University Hospital |
2025-08-01 | |
| NCT07509970 | COMPLETED | Conditions or Focus of Study; Exercise-Induced Fatigue; Soccer Performance |
Beijing Sport University |
2026-01-01 | |
| NCT06589128 | RECRUITING | Digital Eye Strain (DES) |
Universiti Sains Malaysia |
2024-10-01 | |
| NCT06642363 | RECRUITING | PCO - Polycystic Ovaries; Obesity and Obesity-related Medical Conditions |
Isfahan University of Medical Sciences |
2024-07-22 | PHASE1 |
| NCT06429059 | COMPLETED | Amyotrophic Lateral Sclerosis ALS |
Duke University |
2024-06-12 | PHASE2 |
| NCT06460181 | COMPLETED | Mental Fatigue |
University of North Alabama |
2024-08-01 | PHASE4 |
| NCT06334874 | UNKNOWN | Community-acquired Pneumonia |
Future University in Egypt |
2024-04-01 | PHASE4 |
| NCT05015374 | COMPLETED | To Evaluate the Possible Benefit of Astaxanthin on Alzheimer Disease |
Kaohsiung Medical University Chung-Ho Memorial Hospital |
2018-11-14 | |
| NCT06511960 | COMPLETED | Dietary Supplements |
Hacettepe University |
2023-09-01 | |
| NCT05941949 | UNKNOWN | Dietary Supplement; Cognition; Healthy |
Pharmanex |
2023-07-05 | |
| NCT05138549 | TERMINATED | Osteoarthritis, Knee; Osteoarthritis Knees Both; Joint Inflammation |
Prisma Health-Midlands |
2022-09-02 | PHASE2; PHASE3 |
| NCT05882084 | UNKNOWN | Photoaging |
Integrative Skin Science and Research |
2023-07-24 | |
| NCT05437601 | COMPLETED | Osteoarthritis, Knee |
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh |
2022-07-31 | PHASE2 |
| NCT05376501 | COMPLETED | Healthy |
LycoRed Ltd. |
2022-06-08 | |
| NCT05138549 | Terminated | Osteoarthritis Knee|Osteoarthritis Knees Both|Joint Inflammation |
Prisma Health-Midlands |
2022-09-02 | Phase 2|Phase 3 |
| NCT05409092 | COMPLETED | Inflammatory Response; Metabolic Disturbance; Immune Suppression |
Appalachian State University |
2022-01-19 | |
| NCT06593535 | COMPLETED | Healthy Volunteer |
China Medical University Hospital |
2022-06-25 | |
| NCT05437601 | Completed | Osteoarthritis Knee |
Bangabandhu Sheikh Mujib Medical University Dhaka Bangladesh |
2022-07-31 | Phase 2 |
| NCT05009810 | UNKNOWN | Refractive Errors |
Chulalongkorn University |
2021-08-15 | |
| NCT05376501 | Completed | Healthy |
LycoRed Ltd.|Nutrasource Pharmaceutical and Nutraceutical Services Inc. |
2022-06-08 | Not Applicable |
| NCT03664466 | WITHDRAWN | Osteoarthritis, Knee |
Saint Luke's Health System |
2021-04-29 | |
| NCT04689984 | UNKNOWN | Painful Diabetic Neuropathy |
Duta Wacana Christian University |
2020-11-03 | PHASE2; PHASE3 |
| NCT05282355 | COMPLETED | Metabolic Flexibility |
University of North Alabama |
2021-05-12 | |
| NCT03310359 | COMPLETED | Metabolic Syndrome X |
University of California, San Diego |
2016-07 | |
| NCT05508529 | COMPLETED | Stress |
3 Waves Wellness |
2020-07-01 | |
| NCT04249128 | COMPLETED | Hair Loss; Skin Laxity; Cosmetic Acne; Nails; Soft; Skin Aging |
ProofPilot |
2020-01-15 | PHASE3 |
| NCT03991286 | COMPLETED | PCOS |
Tehran University of Medical Sciences |
2020-01-20 | |
| NCT03443882 | UNKNOWN | Healthy Volunteers |
Algatechnologies Ltd. |
2018-03-25 | EARLY_PHASE1 |
| NCT02310087 | COMPLETED | Infertility, Male |
University Medical Centre Ljubljana |
2014-11 | |
| NCT03807050 | COMPLETED | Absorption; Chemicals |
NextFerm Technologies LTD |
2018-11-19 | |
| NCT04583722 | COMPLETED | Bioavailability |
Yoav D. Livney |
2018-07-15 | |
| NCT03460860 | COMPLETED | Skin Aging; Wrinkles |
United Laboratories |
2018-03-05 | |
| NCT03906825 | COMPLETED | Inflammation; Endothelial Dysfunction |
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center |
2018-05-17 | |
| NCT03368872 | COMPLETED | Sarcopenia |
Astavita, Inc. |
2015-10 | |
| NCT02397811 | COMPLETED | Bioavailability of Astaxanthin Formulations |
Cyanotech Corporation |
2015-06 | |
| NCT02373111 | COMPLETED | Ageing; Photo-aging |
Seoul National University Hospital |
2015-03 | |
| NCT02343497 | COMPLETED | Dyslipidemias |
Ajinomoto Foods Europe SAS |
2014-08 | |
| NCT02088242 | UNKNOWN | Body Temperature Regulation |
Sheba Medical Center |
2014-05 | |
| NCT02087033 | TERMINATED | Arrhythmia |
IRCCS Policlinico S. Donato |
2013-12 | |
| NCT02343497 | Completed | Dyslipidemias |
Ajinomoto Foods Europe SAS|Institut Polytechnique LaSalle Beauvais|Naturalpha |
2014-08 | Not Applicable |
| NCT01241877 | UNKNOWN | Athletic Performance |
Maastricht University Medical Center |
2010-11 | |
| NCT01167205 | UNKNOWN | Healthy; Overweight; Obesity |
Seoul National University Hospital |
2010-08 | |
| NCT03945526 | COMPLETED | Cerebral Stroke; Malondialdehyde; Oxidative Stress |
Indonesia University |
2010-03-23 | PHASE1 |
| NCT03945526 | Completed | Cerebral Stroke|Malondialdehyde|Oxidative Stress |
Indonesia University |
2010-03-23 | Phase 1 |
(data from https://clinicaltrials.gov, updated on 2026-01-30)
Check the
Astaxanthin
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.