Clinical Trials

Numerous clinical trials evaluate the therapeutic potential of fucoidan across diverse indications, including oncology (head and neck squamous cell carcinomas, advanced NSCLC), inflammatory and autoimmune disorders (rheumatoid arthritis, ulcerative colitis), wound healing, bone regeneration, and aging. Spanning Early Phase 1 through Phase 3, these investigations are supported by academic institutions, medical centers, and biotechnology sponsors such as Hi-Q Marine Biotech International Ltd. and Peking University People's Hospital. Trial recruitment statuses range from actively recruiting and completed—including Phase 2 head and neck cancer evaluations—to terminated, withdrawn, and unknown.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07786389 ENROLLING_BY_INVITATION
Ulcerative Colitis (UC)
Allama Iqbal Medical College
 2026-08 PHASE1; PHASE2
NCT07500649 RECRUITING
Aging
National University of Singapore
 2025-07-01
NCT06855524 RECRUITING
Malignant Digestive System Neoplasm; Malignant Female Reproductive System Neoplasm
Mayo Clinic
 2025-03-06 PHASE2
NCT06295588 RECRUITING
Fatigue; Inflammation
University of Rochester
 2025-07-26 PHASE2
NCT07045896 RECRUITING
Arthritis, Rheumatoid
Peking University People's Hospital
 2026-01-10
NCT07451496 RECRUITING
Ageing
National University of Singapore
 2025-09-29
NCT07736287 COMPLETED
Wound Healing; Bone Regeneration
Krishnadevaraya College of Dental Sciences & Hospital
 2025-05-11 PHASE3
NCT07804641 COMPLETED
Diabetic Kidney Disease (DKD)
Taipei Medical University WanFang Hospital
 2024-11-06 PHASE2
NCT06487871 COMPLETED
Benign Prostatic Hyperplasia
Vedic Lifesciences Pvt. Ltd.
 2024-08-05
NCT05616507 UNKNOWN
Radiation Toxicity
Taipei Medical University WanFang Hospital
 2022-03-30
NCT04597476 UNKNOWN
Squamous Cell Carcinomas of the Head and Neck
Hi-Q Marine Biotech International, Ltd.
 2020-10-07 PHASE2
NCT04066660 TERMINATED
Advanced Hepatocellular Carcinoma
Hi-Q Marine Biotech International, Ltd.
 2019-10-01
NCT05461508 UNKNOWN
Helicobacter Pylori Infection; Intestinal Bacteria Flora Disturbance
Nanjing First Hospital, Nanjing Medical University
 2022-10-01 PHASE1; PHASE2
NCT05623852 UNKNOWN
Cachexia
Taipei Medical University WanFang Hospital
 2022-01-30
NCT05437887 UNKNOWN
Atopic Dermatitis
Chang Gung Memorial Hospital
 2022-10-04
NCT06959966 COMPLETED
Uterine Leiomyoma
Taipei Medical University
 2019-08-14 EARLY_PHASE1
NCT05277727 COMPLETED
Inflammatory Response
Marinova Pty Ltd
 2022-01-05
NCT04597476 Recruiting
Squamous Cell Carcinomas of the Head and Neck
Hi-Q Marine Biotech International Ltd.
 2020-10-07 Phase 2
NCT03130829 WITHDRAWN
NSCLC Stage IV; NSCLC, Stage III
Hi-Q Marine Biotech International, Ltd.
 2017-04-26
NCT04342949 Unknown status
To Observe Whether the Fucoidan Can Improve the Quality of Life of the Such Patients Receiving the Neoadjuvant CCRT
Kaohsiung Medical University Chung-Ho Memorial Hospital
 2018-11-09 --
NCT03422055 UNKNOWN
Healthy Volunteer
Assistance Publique - Hôpitaux de Paris
 2018-02 PHASE1
NCT03422055 Unknown status
Healthy Volunteer
Assistance Publique - Hôpitaux de Paris
 2018-02 Phase 1
NCT02875392 COMPLETED
Non-alcoholic Fatty Liver Disease
Taipei Medical University WanFang Hospital
 2016-11
NCT01399216 COMPLETED
Low Basal Body Temperature
Hiroshima University
 2011-07
NCT02682017 COMPLETED
Antioxidant Status, Inflammation
University of Ulster
 2011-08
NCT01063101 COMPLETED
Healthy Volunteers
Baxalta now part of Shire
 2010-01-29 PHASE1

(data from https://clinicaltrials.gov, updated on 2026-08-26)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

As an anionic sulfated polysaccharide, fucoidan interacts with cell-surface receptors and extracellular matrix proteins, thereby inhibiting pro-inflammatory signaling cascades, pro-angiogenic factors, and selectin-mediated cell adhesion. This molecular suppression reduces inflammatory cell infiltration and attenuates tumor cell proliferation, providing a mechanistic rationale for its clinical evaluation in conditions such as head and neck squamous cell carcinoma, non-small cell lung cancer, and rheumatoid arthritis.

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>).

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Note: Technical data last updated: Sep 1, 2026.