Clinical Trials
Multiple clinical trials evaluate pentosan polysulfate sodium across Phase 2 through Phase 4 and non-interventional studies, primarily targeting urologic and gastrointestinal conditions such as interstitial cystitis, bladder pain syndrome, chronic prostatitis, and radiation enteritis. Sponsored by pharmaceutical companies, academic medical institutions, and cooperative groups—including Johnson & Johnson, McNeil Consumer & Specialty Pharmaceuticals, Samsung Medical Center, and the Radiation Therapy Oncology Group—these studies encompass active, recruiting, completed, and terminated protocols.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT06917404 | ACTIVE_NOT_RECRUITING | Osteoarthritis, Knee |
Paradigm Biopharmaceuticals Ltd. |
2025-05-29 | PHASE3 |
| NCT05245591 | RECRUITING | Radiation Cystitis |
National Taiwan University Hospital |
2022-04-29 | PHASE2; PHASE3 |
| NCT04809376 | ACTIVE_NOT_RECRUITING | Osteoarthritis, Knee |
Paradigm Biopharmaceuticals USA (INC) |
2021-10-19 | PHASE2; PHASE3 |
| NCT06334523 | Not yet recruiting | Extremely Low Birthweight Infant|Continuous Tracheal Gas Insufflation|Medical Device|Lung Protection|Ventilator-Induced Lung Injury |
Centre Hospitalier Intercommunal Creteil |
2024-05-01 | Phase 2 |
| NCT06375876 | Not yet recruiting | Domestic Violence |
Yale University|Office on Violence Against Women (OVW) |
2024-04 | Not Applicable |
| NCT05900336 | Recruiting | Dysmenorrhea|Menstrual Pain|Non-steroidal Anti-inflammatory Drug |
Mclean Hospital|United States Department of Defense|NorthShore University HealthSystem |
2024-03-25 | Phase 4 |
| NCT03549650 | TERMINATED | Lower Urinary Tract Symptoms; Bladder Carcinoma; BCG |
Sir Mortimer B. Davis - Jewish General Hospital |
2019-05-03 | PHASE2 |
| NCT05744908 | COMPLETED | Chronic Interstitial Cystitis |
Hisar Intercontinental Hospital |
2018-01-01 | |
| NCT02930005 | COMPLETED | Psychotic Disorders; Schizophrenia; Schizoaffective Disorder; Bipolar Disorder |
The University of Texas Health Science Center, Houston |
2015-08-07 | PHASE2 |
| NCT00086684 | TERMINATED | Interstitial Cystitis |
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
2003-09 | PHASE4 |
| NCT00003825 | COMPLETED | Diarrhea; Radiation Enteritis |
Radiation Therapy Oncology Group |
1999-06 | PHASE3 |
| NCT00236990 | COMPLETED | Prostatitis |
McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc. |
PHASE2 |
(data from https://clinicaltrials.gov, updated on 2026-09-01)
Compliance for Clinical Use
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>).