Pentosan Polysulfate Sodium clinical trials
Pentosan Polysulfate Sodium is named as an intervention in 3 current clinical trials in our USA, Australia and Taiwan registers. 1 is recruiting patients now. The most common phase is Phase 2/3. The sponsor with the most trials is Paradigm Biopharmaceuticals USA (INC) (1). The most-studied condition is Osteoarthritis, Knee.
Where Pentosan Polysulfate Sodium is approved
All regulators →Of the three regulators tracked here, the first to approve Pentosan Polysulfate Sodium was the US, on 26 Sep 1996. It is approved in 2 of the 3 regulators tracked here.
- 5 EU orphan designations, most recently for treatment of mucopolysaccharidosis VI (Maroteaux-Lamy syndrome) (21 Aug 2020, positive)
From the regulators' own registers: FDA Drugs@FDA, the EMA medicines list and Health Canada's Notice of Compliance database. Dates are the first listed approval of a product containing only this substance; combination products and nationally authorised EU medicines are not counted.
What health systems spend on Pentosan Polysulfate Sodium
All medicines →From NHSBSA Prescription Cost Analysis (Open Government Licence v3.0) and CMS State Drug Utilization Data. Both are gross amounts: neither system publishes its discounts or rebates per drug. Products combining several substances are not counted here.
How Pentosan Polysulfate Sodium works
All drug targets →- Gastrointestinal hemorrhagePhase 3
- Diarrheal diseasePhase 3
- OsteoarthritisPhase 3
- ProctitisPhase 3
- Chronic prostatitisPhase 2
- Psychotic disorderPhase 2
Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL1201516, CC BY-SA 3.0. The Guide to Pharmacology has no record of this medicine, so its targets rest on ChEMBL alone. Trial phases are not approvals: approved uses are shown from the regulators' own records where we hold them.
NICE appraisals of Pentosan Polysulfate Sodium
All NICE appraisals →NICE, which decides whether the NHS in England should fund new medicines, has published 1 technology appraisal of Pentosan Polysulfate Sodium. 1 is current, and 1 of it recommends it for at least some patients.
| Appraisal | NICE recommendation | Published | Status |
|---|---|---|---|
| Pentosan polysulfate sodium for treating bladder pain syndrome NICE TA610 | Optimised | 13 Nov 2019 | Current |
NICE decisions apply to the NHS in England. In Ireland the HSE decides on reimbursement, advised by the National Centre for Pharmacoeconomics. Titles, categories and dates link to the guidance on nice.org.uk. © NICE 2026 technology appraisal guidance. Available from www.nice.org.uk/guidance. All rights reserved. Subject to Notice of rights. NICE guidance is prepared for the National Health Service in England. All NICE guidance is subject to regular review and may be updated or withdrawn. NICE accepts no responsibility for the use of its content in this product/publication.
Patient leaflets for Pentosan Polysulfate Sodium
The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.
- IEIreland: 1 product on the HPRA listEach product record links to the HPRA, which publishes the leaflet and SmPC.
- EUEuropean Union: ElmironEMA product information: package leaflet and summary of product characteristics in every EU language.
- UKUnited Kingdom: Search MHRA ProductsPatient information leaflets and SmPCs for UK-licensed products.
- USUnited States: Search DailyMedFDA-approved labels, including patient and medication guides.
Leaflets differ between brands and countries; always read the one that comes with your own medicine. This is regulatory information, not medical advice.
Trials by status
Trials by phase
Clinical trials of Pentosan Polysulfate Sodium
3 trials| Study | Phase | Status | Lead sponsor | Registers |
|---|---|---|---|---|
|
Radiation Cystitis Treated With Pentosan Polysulfate Sodium Trial
NCT05245591 · ClinicalTrials.gov ↗ · Radiation Cystitis
|
Phase 2/3 | Recruiting | National Taiwan University Hospital | Taiwan |
|
A Study to Investigate the Treatment Effect of Subcutaneous Injections of Pentosan Polysulfate Sodium Compared With Placebo in Adult Participants With Knee Osteoarthritis Pain.
NCT06917404 · Osteoarthritis, Knee
|
Phase 3 | Active, closed | Paradigm Biopharmaceuticals Ltd | USA, Australia |
|
Treatment Effects of Subcutaneous Injections of Pentosan Polysulfate Sodium vs Placebo in Participants With Knee OA Pain
NCT04809376 · Osteoarthritis, Knee
|
Phase 2/3 | Active, closed | Paradigm Biopharmaceuticals USA (INC) | USA, Australia |
Registers list studies that are recruiting, about to open, active but closed to enrolment, or enrolling by invitation. The UK and USA registers cover industry-sponsored studies only. Trial titles and statuses are copied from the registry as published.
Pentosan Polysulfate Sodium across our data
Ireland · EU · USThe same active substance in our other registers, matched by its exact name. Each entry links to the register record it comes from.
Licensed in Ireland (HPRA)
1 single-substance product containing Pentosan Polysulfate Sodium on the HPRA medicines list.
- elmiron 100 mg capsules, hardbene-Arzneimittel GmbH · EU/1/17/1189/001-002
Supply shortages
No entry for Pentosan Polysulfate Sodium in the EMA, FDA or German BfArM shortage lists we track.
Conditions studied with Pentosan Polysulfate Sodium
2 conditionsSponsors
lead sponsor per trial| Lead sponsor | Trials |
|---|---|
| Paradigm Biopharmaceuticals USA (INC) | 1 |
| Paradigm Biopharmaceuticals Ltd | 1 |
| National Taiwan University Hospital | 1 |
By country register
| Register | Trials | Recruiting |
|---|---|---|
| Clinical trials in USA | 2 | 0 |
| Clinical trials in Australia | 2 | 0 |
| Clinical trials in Taiwan | 1 | 1 |
A trial with sites in more than one country appears in each of those registers.
Related compounds
Questions about Pentosan Polysulfate Sodium trials
How many clinical trials are testing Pentosan Polysulfate Sodium?
3 current trials in our USA, Australia and Taiwan registers name Pentosan Polysulfate Sodium as a drug or biological intervention, as of the registry sync on 10 November 2026. Completed and withdrawn studies are not counted.
Are Pentosan Polysulfate Sodium trials recruiting patients?
Yes. 1 of the 3 trials is recruiting: 1 with sites in Taiwan. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.
Who sponsors Pentosan Polysulfate Sodium clinical trials?
Paradigm Biopharmaceuticals USA (INC) (1), Paradigm Biopharmaceuticals Ltd (1) and National Taiwan University Hospital (1). The number in brackets is how many trials each organisation leads.
Is Pentosan Polysulfate Sodium licensed in Ireland?
Yes. The HPRA medicines list includes 1 single-substance product containing Pentosan Polysulfate Sodium, for example elmiron 100 mg capsules, hard (bene-Arzneimittel GmbH). A licence does not mean a product is currently marketed or reimbursed; see each product's record.
Is there a Pentosan Polysulfate Sodium shortage?
Not in the lists we track: Pentosan Polysulfate Sodium has no entry in the EMA, FDA or German BfArM shortage registers as of their latest sync.
Where does this information come from?
Every trial, status, phase and sponsor on this page is copied from public ClinicalTrials.gov records by a daily sync. Nothing here describes how Pentosan Polysulfate Sodium works or whether it is effective, and it is not medical advice.
How this page is built
Everything on this page is copied from public ClinicalTrials.gov registry records — it is not written from memory, and nothing here describes how Pentosan Polysulfate Sodium works or whether it is effective. Each trial links to its own record so you can check it yourself.
- ClinicalTrials.gov (U.S. National Library of Medicine) ↗ Trial IDs, titles, intervention names and synonyms, phase, overall status, lead sponsor and conditions for every trial on this page
This page is built automatically: a daily sync job reads the registry records behind our country trial registers, collects every trial that lists Pentosan Polysulfate Sodium (or a registered synonym) as a drug or biological intervention, and tabulates the registry fields directly. Placebos and generic comparators are excluded. There is no AI drafting and no per-compound editorial pass, and the page has not been clinically reviewed. The “last verified” date above is the timestamp of that sync, not a review date. Our general editorial approach is described in our editorial standards and corrections policy. The ClinicalTrials.gov data on this page was last retrieved on 10 Nov 2026. How every register is built: methodology · fixes we have made: corrections log.