Drugs / Pentosan Polysulfate Sodium
Pentosan Polysulfate Sodium
also known as
PPS · Cartrophen · ELMIRON · Fibrase · Fibrezym · Hemoclar · Lysosan · NSC-626201 · +10 more
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Elmiron | — | 2017-06-02 | europa.eu ↗ |
| Approved | US (FDA) | ELMIRON | — | 1996-09-26 | fda.gov ↗ |
Trials 7
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 23 trials | ||||||
| Phase 2 | NCT03549650 | May 2019 → Feb 2022 | urinary bladder carcinoma | Sir Mortimer B. Davis - Jewish General Hospital | Terminated | No outcome recorded |
| Phase 2 | NCT02930005 | Aug 2015 → Oct 2016 | bipolar disorder, schizoaffective disorder, schizophrenia | The University of Texas Health Science Center, Houston | Completed | No outcome recorded |
| Phase 2 | NCT00236990 | ? → Sep 2005 | chronic prostatitis | McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc. | Completed | No outcome recorded |
| Phase 2/32 trials · 1 met primary | ||||||
| Phase 2/3 | NCT05245591 | Apr 2022 → Nov 2024 overdue | radiation cystitis | National Taiwan University Hospital | Recruiting | No outcome recorded |
| Phase 2/3 | NCT04809376 | Oct 2021 → Oct 2024 overdue | osteoarthritis, knee | Paradigm Biopharmaceuticals USA (INC) | Active not recruiting | Met primary |
| Phase 31 trial · 1 missed | ||||||
| Phase 3 | NCT00003825 | Jun 1999 → Apr 2006 | diarrheal disease, enteritis | Radiation Therapy Oncology Group | Completed | Missed primary |
| Phase 41 trial | ||||||
| Phase 4 | NCT00086684 | Sep 2003 → Jun 2011 | interstitial cystitis | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | Terminated | No outcome recorded |
| Comparator or background therapy1 trial | ||||||
| Phase 3 | NCT06917404 Comparator | May 2025 → Jul 2027 expected | osteoarthritis, knee | Paradigm Biopharmaceuticals Ltd. | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 53
| Date | Issuer | Release |
|---|---|---|
| 2026-04-28 | Paradigm Biopharmaceuticals Ltd. | Results OARSI Theatre Presentation Showcases iPPS Biomarker Data paradigmbiopharma.com ↗ |
| 2026-02-10 | Paradigm Biopharmaceuticals Ltd. | Results Published Canine Study Strengthens iPPS Phase 3 Rationale paradigmbiopharma.com ↗
PPS-treated dogs demonstrated sustained reductions in chronic pain and normalization of gait symmetry through 26 weeks (six months), compared with placebo. |
| 2026-01-28 | Paradigm Biopharmaceuticals Ltd. | Results iPPS Phase 2 Biomarker Results Published in Leading Journal paradigmbiopharma.com ↗
Synovial fluid ARGS (aggrecanase-derived aggrecan neoepitope), a direct marker of cartilage matrix breakdown, was significantly reduced in iPPS-treated patients versus placebo at Day 56 (p=0.028) and remained significantly reduced at Day 168 (p=0.024). |
| 2025-02-23 | Paradigm Biopharmaceuticals Ltd. | Regulatory Paradigm Secures Ethics Approval for Phase 3 Trial paradigmbiopharma.com ↗
Successful submission and approval of the ethics application to Australia's centralised Human Research Ethics Committee for the pivotal PARA_OA_012 phase 3 trial. |
| 2024-02-08 | Paradigm Biopharmaceuticals Ltd. | Results Primary Endpoint Achieved in Phase 2 MPS VI Trial paradigmbiopharma.com ↗
Paradigm Biopharmaceuticals Ltd (ASX: PAR) (“Paradigm” or “the Company”), a late-stage drug development company focused on delivering new therapies to address unmet medical needs, is pleased to announce the multi-centre double-blind randomised phase 2 clinical trial PARA_MPSVI_001, has successfully met the primary endpoint. |
| 2023-10-17 | Paradigm Biopharmaceuticals Ltd. | Results iPPS Increases Cartilage Thickness in Phase 2 Trial paradigmbiopharma.com ↗
A 6-week twice weekly course of subcutaneous iPPS was shown to increase cartilage thickness and volume and reduce bone marrow lesions and synovitis on MRI follow-up at 6 months. |
| 2023-10-09 | Paradigm Biopharmaceuticals Ltd. | Results iPPS SIGNIFICANT OA PAIN REDUCTION AT 12 MONTHS paradigmbiopharma.com ↗
Study data for the PARA_OA_008 demonstrates duration of effect with 12 months of pain reduction and functional improvements in a phase 2 clinical trial of knee osteoarthritis (OA). |
| 2023-07-26 | Paradigm Biopharmaceuticals Ltd. | Results Study demonstrates Bene PPS is unique paradigmbiopharma.com ↗
The collaborative study has demonstrated that Paradigm's pentosan polysulfate sodium (PPS) drug substance is different from other available PPS drug substances, both with respect to their respective structure and biological characteristics. |
| 2023-06-06 | Paradigm Biopharmaceuticals Ltd. | Results Primary and Secondary endpoints met in MPS I Trial paradigmbiopharma.com ↗
Primary Endpoint attained: iPPS was well tolerated with no serious adverse events reported out to 73 weeks. |
| 2023-05-31 | Paradigm Biopharmaceuticals Ltd. | Results iPPS shows 3-year equivalent durability in OA Canine Study paradigmbiopharma.com ↗
iPPS was shown to stabilise disease progression at week 8 and week 26 in osteoarthritic dogs. |
| 2023-04-03 | Paradigm Biopharmaceuticals Ltd. | Results iPPS Demonstrates Multiple DMOAD Signals in Phase 2 Study paradigmbiopharma.com ↗
Day 168 data from Paradigm’s phase 2 PARA_OA_008 clinical trial demonstrates multiple signals that injectable pentosan polysulfate sodium (iPPS) may slow disease progression in knee osteoarthritis (OA). |
| 2023-03-13 | Paradigm Biopharmaceuticals Ltd. | Regulatory PAR Receives European Regulatory and Ethics Approval paradigmbiopharma.com ↗
Regulatory and ethics approvals have been received via Europe’s Clinical Trial Information System (CTIS) for Paradigm’s pivotal PARA_OA_002 clinical trial. |
| 2022-10-03 | Paradigm Biopharmaceuticals Ltd. | Results PAR Reports Successful Primary Endpoint in Phase 2 Trial paradigmbiopharma.com ↗
Primary endpoint relating to synovial fluid biomarkers achieved and positive top-line results reported for the PARA_OA_008 phase 2 clinical trial (n=61). |
| 2022-09-25 | Paradigm Biopharmaceuticals Ltd. | Results Successful MPSVI Safety Review and PARA OA 008 Update paradigmbiopharma.com ↗
The safety monitoring physician for this trial being conducted in Brazil has confirmed a safety review has been completed with no serious adverse events |
| 2022-07-05 | Paradigm Biopharmaceuticals Ltd. | Regulatory Paradigm reports global progress in phase 3 study paradigmbiopharma.com ↗
Paradigm is also pleased to announce that the global PARA_OA_002 phase 3 osteoarthritis clinical trial has regulatory approval from Health Canada. |
| 2022-04-12 | Paradigm Biopharmaceuticals Ltd. | Regulatory FDA Grants Paradigm Fast Track Designation For OA paradigmbiopharma.com ↗
The FDA Fast Track program offers a number of benefits to help advance development and expedite the review of novel therapies for serious conditions for which there is an unmet medical need, with the aim of getting important new therapies to patients more quickly. |
| 2021-12-16 | Paradigm Biopharmaceuticals Ltd. | Results PAR REPORTS POSTIVE TOPLINE RESULTS IN HEART FAILURE MODEL paradigmbiopharma.com ↗
Pentosan polysulfate sodium (PPS) treatment demonstrated potential improvement in cardiovascular function and tissue preservation in an industry standard model of heart failure with preserved ejection fraction (HFpEF). |
| 2021-11-22 | Paradigm Biopharmaceuticals Ltd. | Results Preliminary Results from Phase 2 MPS I Study paradigmbiopharma.com ↗
PPS was well tolerated with no serious adverse events reported over a 24-week period. |
| 2021-11-02 | Paradigm Biopharmaceuticals Ltd. | Regulatory PARADIGM CLEARED FOR PHASE 3 TRIAL BY US FDA paradigmbiopharma.com ↗
Paradigm’s IND application to commence its phase 3 pivotal clinical trial investigating Pentosan Polysulphate Sodium (PPS) for the treatment of pain associated with knee osteoarthritis (the Trial) has been cleared by the US FDA. |
| 2021-10-12 | Paradigm Biopharmaceuticals Ltd. | Results POSITIVE TOP-LINE RESULTS FROM PRECLINICAL STUDY IN ARDS paradigmbiopharma.com ↗ |
| 2021-09-23 | Paradigm Biopharmaceuticals Ltd. | Regulatory AUS ETHICS APPROVAL RECEIVED FOR PHASE 3 TRIAL paradigmbiopharma.com ↗ |
| 2021-09-12 | Paradigm Biopharmaceuticals Ltd. | Results CHIKV study data published in Peer-Reviewed Journal paradigmbiopharma.com ↗
PPS showed significant functional joint improvement as measured by grip strength and anti-inflammatory effect by the reduction in hind limb foot swelling compared to infected control animals in the mouse model of CHIKV induced arthralgia. |
| 2021-06-17 | Paradigm Biopharmaceuticals Ltd. | Regulatory PARADIGM RECEIVES KEY REGULATORY APPROVALS FOR MPS VI STUDY paradigmbiopharma.com ↗
Regulatory approval from Brazil’s National Health Surveillance Agency (Agência Nacional de Vigilância Sanitária (ANVISA)) for a Phase 2 clinical trial evaluating safety and tolerability of injectable (SC) pentosan polysulfate sodium (iPPS) versus placebo in subjects with Mucopolysaccharidosis type VI (MPS VI). |
| 2021-03-17 | Paradigm Biopharmaceuticals Ltd. | Results PHASE 2 RRV DATA PUBBLISHED IN PEER-REVIEWED JOURNAL paradigmbiopharma.com ↗ |
| 2021-02-17 | Paradigm Biopharmaceuticals Ltd. | Regulatory Ethics Approval Received for Synovial Fluid Biomarker Study paradigmbiopharma.com ↗
Ethics committee approval received for Phase 2 exploratory study to evaluate the Treatment Effect of Pentosan Polysulfate Sodium (PPS) (Zilosul®) compared with Placebo on Synovial Fluid Biomarkers in participants with Knee Osteoarthritis (OA) Pain. |
| 2021-02-02 | Paradigm Biopharmaceuticals Ltd. | Results Consistent pain reduction and improvement in function data paradigmbiopharma.com ↗
Pain reduction in 89 SAS patients (13 new patient data) being treated using the Phase 3 product (Zilosul®) are consistent with prior reports under TGA SAS. |
| 2020-08-10 | Paradigm Biopharmaceuticals Ltd. | Regulatory MPS RECEIVES CRITICAL APPROVALS AND FEEDBACK FROM AGENCIES paradigmbiopharma.com ↗
MPS-VI receives Orphan Status from the European Medical Agency. |
| 2020-07-29 | Paradigm Biopharmaceuticals Ltd. | Results EAP - 65% PAIN REDUCTION IN 10 OA PATIENTS IN USA paradigmbiopharma.com ↗
Paradigm Biopharmaceuticals Ltd (ASX: PAR) is pleased to announce a mean pain reduction of 65% at week 12 (Day 81-83), across the ten patients treated with Zilosul® under the FDA approved Expanded Access Program (EAP) in the US. |
| 2020-04-06 | Paradigm Biopharmaceuticals Ltd. | Results Paradigm Reports Very Encouraging Real World Data paradigmbiopharma.com ↗
The chronic pain response as measured by the WOMAC pain score demonstrated a mean reduction of 44.9%. |
| 2019-09-29 | Paradigm Biopharmaceuticals Ltd. | Results Osteoarthritis pain reduced by Paradigms Zilosul (PPS) paradigmbiopharma.com ↗
The answers to the scientific questions are Yes, the bone cells do produce high levels of the pain mediator NGF and Yes, the drug pentosan polysulfate can reduce the production of NGF by those bone cells. |
| 2019-09-09 | Paradigm Biopharmaceuticals Ltd. | Regulatory PAR Expanded Access IND Cleared by US FDA paradigmbiopharma.com ↗
Paradigm is pleased to report that its first Investigational New Drug (IND) application (Filed 7 August 2019) has been cleared by the US FDA within the 30-day review period. |
| 2019-08-28 | Paradigm Biopharmaceuticals Ltd. | Results PARs drug reduces cartilage degradation in subjects with OA paradigmbiopharma.com ↗
Paradigm is pleased to report an exciting new discovery within its prespecified exploratory endpoints (serum biomarkers of cartilage destruction) from its Phase 2b Osteoarthritis (OA) clinical trial. |
| 2019-08-06 | Paradigm Biopharmaceuticals Ltd. | Regulatory PARADIGM FILES FIRST IND WITH US FDA paradigmbiopharma.com ↗
Paradigm has filed its first IND submission to the US FDA for an Expanded Access Program under which ten people from the USA may be treated with ZilosulÒ (iPPS). |
| 2019-06-03 | Paradigm Biopharmaceuticals Ltd. | Results PAR REPORTS SUCCESSFUL ROSS RIVER PHASE 2 CLINICAL TRIAL paradigmbiopharma.com ↗
Participants with RRV-induced arthralgia treated with iPPS met the aims for the pilot Phase 2a study by demonstrating safety outcomes (primary endpoint) and effects on reduced disease symptoms (secondary endpoint). |
| 2019-05-27 | Paradigm Biopharmaceuticals Ltd. | Results PAR reports consistent pain reduction in knee OA of patients paradigmbiopharma.com ↗
Paradigm is pleased to report a greater than 50% reduction in pain across 205 patients with knee osteoarthritis (OA). |
| 2019-04-14 | Paradigm Biopharmaceuticals Ltd. | Results PARADIGM UPDATED CORPORATE PRESENTATION paradigmbiopharma.com ↗
PHASE 2B SECONDARY ENDPOINTS MET |
| 2019-04-14 | Paradigm Biopharmaceuticals Ltd. | Results PARADIGMS SECONDARY ENDPOINTS SUCCESSFULLY MET paradigmbiopharma.com ↗
PARADIGM SUCCESSFULLY MEETS ITS PRIMARY ENDPOINT AND SECONDARY ENDPOINTS OF ITS PHASE 2B TRIAL IN OSTEOARTHRITIS OF THE KNEE. |
| 2018-12-19 | Paradigm Biopharmaceuticals Ltd. | Results PARADIGMS SUPPLEMENTARY PHASE 2B DATA paradigmbiopharma.com ↗
Paradigm Biopharmaceuticals Ltd (ASX: PAR) is pleased to announce it has met its primary endpoint of its phase 2b randomised double-blind placebo-controlled multi-centre clinical trial. |
| 2018-12-17 | Paradigm Biopharmaceuticals Ltd. | Results PAR REPORTS SUCCESSFUL PHASE 2 CLINICAL TRIAL paradigmbiopharma.com ↗
Paradigm Biopharmaceuticals Ltd (ASX: PAR) is pleased to announce it has met its primary endpoint of its phase 2b randomised double -blind placebo-controlled multi-centre clinical trial. |
| 2018-12-17 | Paradigm Biopharmaceuticals Ltd. | Results PRESENTATION OF PHASE 2 CLINICAL TRIAL RESULTS paradigmbiopharma.com ↗ |
| 2018-08-14 | Paradigm Biopharmaceuticals Ltd. | Results PAR ACHIEVES 60 PER CENT REDUCTION IN OSTEOARTHRITIS PAIN paradigmbiopharma.com ↗
Paradigm is pleased to report that a 60.5% reduction in pain (on average) has been achieved, from an additional 25 patients with osteoarthritis after treatment with the injectable Pentosan Polysulfate Sodium ( iPPS). |
| 2018-06-14 | Paradigm Biopharmaceuticals Ltd. | Results PAR - 50% REDUCTION IN OSTEOARTHRITIS PAIN MAINTAINED paradigmbiopharma.com ↗
Paradigm Biopharmaceuticals Ltd (ASX: PAR) is pleased to announce that in the 75 patients treated, 84.0% responded with both a reduction in joint pain and an improvement in knee function. |
| 2018-02-28 | Paradigm Biopharmaceuticals Ltd. | Results PARADIGM REPORTS OSTEOARTHRITIS PAIN REDUCED BY 50% paradigmbiopharma.com ↗
Patients, self-reported pain scores were reduced by 50% (on average) from baseline pain scores in 45 patients with knee osteoarthritis (OA) and concurrent Bone Marrow Lesions (BML). |
| 2018-01-15 | Paradigm Biopharmaceuticals Ltd. | Regulatory PARs European Patent Granted for Bone Marrow Edema Lesions paradigmbiopharma.com ↗
Paradigm Biopharmaceuticals Ltd (ASX: PAR) is pleased to announce that it has been granted a European patent for the treatment of Bone Marrow Edema Lesions with Pentosan Polysulfate Sodium (PPS). |
| 2017-11-13 | Paradigm Biopharmaceuticals Ltd. | Results Paradigms ACL Phase 2 Clinical Trial Success paradigmbiopharma.com ↗
The company received the top line results following analysis of safety data on 11 people who participated in the phase 2a open label trial to evaluate pentosan polysulfate (PPS) for the treatment of bone marrow lesions associated with acute anterior cruciate ligament (ACL) injuries. |
| 2017-06-15 | Paradigm Biopharmaceuticals Ltd. | Results Hay Fever Trial Update paradigmbiopharma.com ↗
Paradigm Biopharmace uticals Ltd (ASX:PAR) today announced that its Phase 2a allergic rhinitis (hay fever) clinical trial did not meet its primary endpoints (total nasal symptom score and peak nasal respiratory flow) using the current nasal formulation. |
| 2017-05-21 | Paradigm Biopharmaceuticals Ltd. | Regulatory Paradigm Receives Ethics Approval for Ross River Trial paradigmbiopharma.com ↗ |
| 2017-05-15 | Paradigm Biopharmaceuticals Ltd. | Results Paradigms preclinical hay fever trial published paradigmbiopharma.com ↗ |
| 2016-09-15 | Paradigm Biopharmaceuticals Ltd. | Results Preclinical study underpins efficacy of Paradigm's RhinosulR paradigmbiopharma.com ↗
Paradigm Biopharmaceuticals Ltd (Paradigm) is delighted to report the presentation of crucial preclinical data highlighting the efficacy of PPS in a translational model of allergic rhinitis. |
| 2016-09-06 | Paradigm Biopharmaceuticals Ltd. | Results Paradigm PPS a potential in the treatment of viral arthritis paradigmbiopharma.com ↗
In a preclinical study of alphavirus infection pentosan polysulfate sodium ( PPS) significantly alleviated the severity of disease and reduced both the inflammatory response and the loss of articular cartilage; |
| 2015-12-02 | Paradigm Biopharmaceuticals Ltd. | Results Elite Athlete successfully treated with Paradigm's Zilosul paradigmbiopharma.com ↗
Initial clinical response to the ZILOSUL® therapy has shown encouraging results – detailed results to follow in coming months. |
| 2015-11-22 | Paradigm Biopharmaceuticals Ltd. | Regulatory Paradigm Biopharmaceuticals Receives Ethics Approval paradigmbiopharma.com ↗
Paradigm Biopharmaceuticals Limited (ASX:PAR) has been granted approval by the Human Research Ethics Committee (HREC) to proceed with the open-label pilot clinical trial to determine the safety and tolerability of ZILOSUL® in patients with a BME lesion. |
| 2015-08-25 | Paradigm Biopharmaceuticals Ltd. | Regulatory Paradigm Secures Key US Patent paradigmbiopharma.com ↗
Paradigm Biopharmaceuticals Limited (ASX:PAR) has been granted a patent by the United States Patent and Trademark Office (USPTO) to use the drug Pentosan Polysulphate Sodium (PPS) for treatment of bone marrow (o)edema. |
All press releases naming this drug 53 releases
Evidence & citations 21 cited values
Every value below carries the sentence it was read from. 11 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Pentosan Polysulfate Sodium | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05245591 ↗ |
| Known as | Cartrophen | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201516 ↗ |
| Known as | ELMIRON | “An Effectiveness and Safety Study of ELMIRON (Pentosan Polysulfate Sodium) for the Treatment of Chronic Non-Bacterial Inflammation of the Prostate Gland” NCT00236990 ↗ |
| Known as | Fibrase | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201516 ↗ |
| Known as | Fibrezym | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201516 ↗ |
| Known as | Hemoclar | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201516 ↗ |
| Known as | Lysosan | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201516 ↗ |
| Known as | NSC-626201 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201516 ↗ |
| Known as | Pentosan Polysulfate | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03549650 ↗ |
| Known as | Pentosan polysulfate sodium salt | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201516 ↗ |
| Known as | Pentosan Polysulphate | “Pentosan Polysulphate (PPS), is an oral medication with unique analgesic properties used to relieve bladder pain and discomfort related to other conditions, has been...” NCT03549650 ↗ |
| Known as | Pentosan polysulphate sodium | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201516 ↗ |
| Known as | Pentosane polysulfate sodique | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201516 ↗ |
| Known as | Pentosano polisulfato de sodio | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201516 ↗ |
| Known as | PPS | “Pentosan Polysulphate (PPS), is an oral medication with unique analgesic properties used to relieve bladder pain and discomfort related to other conditions, has been...” NCT03549650 ↗3“Phase III study of pentosanpolysulfate (PPS) in treatment of gastrointestinal tract sequelae of radiotherapy.” PMID 16601430 ↗ Apr 2006 “we focus on three interventions: antidepressants, pentosan polysulfate (PPS) and neuromuscular blockade.” PMID 32734597 ↗ Jul 2020 “pentosan polysulfate sodium (PPS)” NCT04809376 ↗ |
| Known as | PZ-68 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201516 ↗ |
| Known as | Sodium pentosan polysulphate | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201516 ↗ |
| Known as | SP-54 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201516 ↗ |
| Known as | Thrombocid | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201516 ↗ |
| Modality | Small molecule | — CHEMBL1201516 ↗ |
| Route | Oral | “Patients receive oral pentosan polysulfate three times a day for 2-6 months.” NCT00003825 ↗ |