Clinical Trials

Numerous clinical trials evaluate chondroitin sulfate across diverse indications, predominantly focusing on musculoskeletal, urological, and oncological conditions such as knee osteoarthritis, interstitial cystitis, and bladder cancers. Spanning Phase 1 through Phase 4 evaluations as well as non-interventional studies, these trials include completed, recruiting, and active non-recruiting statuses. Supported by academic medical centers, university hospitals, and pharmaceutical sponsors, these research initiatives assess both oral and intravesical administration modalities.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT06547424 WITHDRAWN
Necrotizing Enterocolitis; Intestinal Ischemia
Indiana University
 2025-01 PHASE1
NCT07727174 NOT_YET_RECRUITING
Joint Health
Lesaffre International
 2026-08-26
NCT07495072 RECRUITING
Urinary Bladder Neoplasms; BCG-Induced Cystitis
BLAD-HYA Group
 2025-11-03
NCT06096038 RECRUITING
Head and Neck Cancer; Relapse; Recurrent; Refractory Cancer
UNC Lineberger Comprehensive Cancer Center
 2024-04-05 PHASE1
NCT07119645 RECRUITING
Activity-Related Knee Discomfort; Joint Discomfort; Functional Joint Pain; Functional Knee Pain; Knee Acute and Chronic Pain
Hofseth Biocare ASA
 2025-01-20
NCT06917287 ACTIVE_NOT_RECRUITING
Knee Osteoarthritis (OA)
Vedic Lifesciences Pvt. Ltd.
 2025-04-20
NCT05632783 WITHDRAWN
Knee Osteoarthritis
IBSA Institut Biochimique SA
 2023-12 PHASE3
NCT07746466 COMPLETED
Knee Osteoarthritis (Kellgren-Lawrence Grade 1-3)
Liaquat National Hospital & Medical College
 2023-06-01
NCT05687019 COMPLETED
Prostatic Adenoma
GCS Ramsay Santé pour l'Enseignement et la Recherche
 2023-09-12
NCT06798428 COMPLETED
Grade I and II Knee Meniscal Injuries
Eslam Elsayed Ali Shohda
 2022-10-01
NCT05212259 UNKNOWN
Joint Pain
Vedic Lifesciences Pvt. Ltd.
 2022-10-10
NCT05474586 COMPLETED
Osteoarthritis, Knee
Vedic Lifesciences Pvt. Ltd.
 2022-08-08
NCT04702776 COMPLETED
Dry Eye
Laboratorios Sophia S.A de C.V.
 2021-12-09 PHASE4
NCT04202692 COMPLETED
Gastro Esophageal Reflux
SOFAR S.p.A.
 2019-11-05
NCT05385562 COMPLETED
Macula Edema
Al-Azhar University
 2020-01-02
NCT05321836 COMPLETED
Knee Osteoarthritis
Muhammad salman, PT
 2021-07-26
NCT07476508 COMPLETED
Meniscus Lesion; Knee Injuries; Medial Meniscus Tear
Collegium Medicum w Bydgoszczy
 2019-10-10
NCT03883074 COMPLETED
Gastro Esophageal Reflux
SOFAR S.p.A.
 2018-12-20
NCT04470336 COMPLETED
Knee Osteoarthritis
Vedic Lifesciences Pvt. Ltd.
 2020-07-09
NCT03936192 WITHDRAWN
Knee Osteoarthritis
Eurofarma Laboratorios S.A.
 2019-01 PHASE3
NCT04665804 COMPLETED
Knee Osteoarthritis
Foundation University Islamabad
 2020-06-10
NCT04654871 COMPLETED
Osteoarthritis; Osteoarthritis, Knee
Foundation University Islamabad
 2020-01-01
NCT04507074 Active not recruiting
Low Back Pain|Obesity
Poznan University of Physical Education
 2020-09-01 Not Applicable
NCT03463499 COMPLETED
Interstitial Cystitis
Samsung Medical Center
 2017-09-22
NCT02830919 COMPLETED
Osteoarthritis of Knee
Eurofarma Laboratorios S.A.
 2016-12-05 PHASE3
NCT03963323 COMPLETED
Healthy Subject
Fred Hutchinson Cancer Center
 2018-05-11 PHASE1
NCT03913052 UNKNOWN
Knee Osteoarthritis
Istanbul Bilgi University
 2018-11-02
NCT03827161 COMPLETED
Healthy Subject; Overweight
Fred Hutchinson Cancer Center
 2017-08-01 PHASE1
NCT04358120 COMPLETED
Osteo Arthritis Knee
Fidia Farmaceutici s.p.a.
 2017-11-28
NCT03731793 COMPLETED
Knee Osteoarthritis
Azienda di Servizi alla Persona di Pavia
 2017-01-01 PHASE4
NCT02366676 COMPLETED
Recurrent Cystitis
Samsung Medical Center
 2014-01 PHASE4
NCT03463499 Completed
Interstitial Cystitis
Samsung Medical Center
 2017-09-22 Not Applicable
NCT02178137 COMPLETED
Osteo Arthritis of the Knees
Indus Hospital and Health Network
 2014-06 PHASE4
NCT03827161 Completed
Healthy Subject|Overweight
Fred Hutchinson Cancer Center
 2017-08-01 Phase 1
NCT02823548 UNKNOWN
Hand Osteoarthritis
Bioiberica
 2016-08 PHASE4
NCT01813565 TERMINATED
Interstitial Cystitis
Asan Medical Center
 2013-03-20
NCT02079727 COMPLETED
Knee Osteoarthritis
IBSA Institut Biochimique SA
 2014-06-12 PHASE3
NCT01354145 COMPLETED
Knee Osteoarthritis
Bioiberica
 2011-06 PHASE3
NCT01893905 COMPLETED
Knee Osteoarthritis
Tedec-Meiji Farma, S.A.
 2013-06 PHASE3
NCT01856218 Completed
Mucopolysaccharidosis Type 7
Ultragenyx Pharmaceutical Inc
 2013-11 Phase 1|Phase 2
NCT04268810 TERMINATED
Painful Bladder Syndrome; Interstitial Cystitis
National Multiple Sclerosis Center
 2010-03 PHASE4
NCT01682694 COMPLETED
Inflammation
Fred Hutchinson Cancer Center
 2012-09
NCT01233739 UNKNOWN
Rhizarthrosis
Juan A. Arnaiz
 2011-03 PHASE4
NCT01425853 COMPLETED
Knee Osteoarthritis
Bioiberica
 2011-09 PHASE4
NCT01293305 UNKNOWN
Osteoarthritis
Azidus Brasil
 2011-11 PHASE3
NCT00691678 COMPLETED
Breast Cancer; Joint Pain
Dawn L. Hershman
 2008-10 PHASE2
NCT01245088 WITHDRAWN
Crohn's Disease
University Hospitals Cleveland Medical Center
 2011-01 PHASE1; PHASE2
NCT01226615 UNKNOWN
Knee Osteoarthritis
Bioiberica
 2010-10 PHASE4
NCT00513422 UNKNOWN
Osteoarthritis, Knee
University of Sydney
 2007-10 PHASE4
NCT03209895 COMPLETED
Joint Pain
U.S. Nutraceuticals, LLC
 2010-10-08
NCT00955552 COMPLETED
Osteoarthritis of the Knee
Eurofarma Laboratorios S.A.
 2010-08 PHASE3
NCT00919113 COMPLETED
Interstitial Cystitis; Painful Bladder Syndrome
Watson Pharmaceuticals
 2009-07 PHASE2
NCT02010918 COMPLETED
Knee Osteoarthritis
Ache Laboratorios Farmaceuticos S.A.
 2009-02 PHASE3
NCT00805519 COMPLETED
Osteoarthritis of the Knee
Ardabil University of Medical Sciences
 2009-02 PHASE4
NCT00291499 COMPLETED
Osteoarthrosis
IBSA Institut Biochimique SA
 2005-06 PHASE3
NCT00604539 COMPLETED
Synovitis; Osteoarthritis; Joint Diseases; Muskuloskeletal Diseases
Bioiberica
 2008-02 PHASE3
NCT00860873 COMPLETED
Osteoarthrosis
Azidus Brasil
 2009-10 PHASE3
NCT00527917 COMPLETED
Interstitial Cystitis
Watson Pharmaceuticals
 2007-09 PHASE2
NCT01271218 COMPLETED
Knee Osteoarthritis
Texas A&M University
 2005-11 PHASE4
NCT00298441 COMPLETED
Chronic Renal Failure; Hemodialysis; Renal Anemia; Iron Deficiency Anemia
Kumamoto University
 2005-06 PHASE4
NCT00086229 COMPLETED
Osteoarthritis
National Center for Complementary and Integrative Health (NCCIH)
 2004-04
NCT01172249 UNKNOWN
Osteoarthritis, Knee
Mantecorp Industria Quimica e Farmaceutica Ltd.
 PHASE3
NCT00032890 COMPLETED
Osteoarthritis
US Department of Veterans Affairs
 2000-04 PHASE3
NCT00669123 COMPLETED
Osteoarthritis; Psoriasis; Joint Diseases; Muskuloskeletal Diseases; Skin Diseases
Bioiberica
 PHASE4
NCT01469507 WITHDRAWN
Knee Osteoarthritis
Pierre Fabre Medicament

(data from https://clinicaltrials.gov, updated on 2025-10-10)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Chondroitin sulfate functions as a sulfated glycosaminoglycan constituent of extracellular matrix proteoglycans that inhibits interleukin-1β-induced nuclear factor-kappa B nuclear translocation in chondrocytes, thereby mitigating mechanical compression and downregulating downstream pro-inflammatory cascades. This suppression of inflammatory signaling and preservation of extracellular matrix structural integrity provide the rationale for its clinical application in relieving joint pain and managing conditions such as knee osteoarthritis and interstitial cystitis.

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.