A Phase 3, Randomised, Double-Blind, Placebo-Controlled Multi-Centre Study to Evaluate the Treatment Effect of Pentosan Polysulfate Sodium Compared to Placebo in Participants With Knee Osteoarthritis Pain

The purpose of this study is to measure the change in pain and function with subcutaneous injections of pentosan polysulfate sodium (PPS) compared with subcutaneous injections of placebo in participants with knee OA pain.
Study details include:
* The study duration will be up to 64 weeks.
* The treatment duration will be 6 weeks.
* The visit frequency will be twice weekly during treatment.
* The visit/contact frequency will be every 4-6 weeks during the 52-week Follow-up period.
* Approximately 466 participants will be enrolled into this study.

Start Date29 May 2025

Sponsor / Collaborator

Paradigm Biopharmaceuticals Ltd.

CTRI/2024/01/061184

/ Not yet recruitingPhase 2IIT

A randomized, open-label, parallel, Proof of concept, Investigator Initiated study to evaluate the efficacy and safety of Pentosan polysulfate sodium in adult patients with Diabetic Nephropathy - NIL

Start Date11 Jan 2024

Sponsor / Collaborator-

ACTRN12621000654853

/ RecruitingPhase 2IIT

A Double-Blind, RandoMised, Placebo-Controlled Study to Assess theEfficacy and Safety of oRal deliVery of sodium Pentosan Polysulfate (PPS)compared to placebo in participants with symptomatic kneE osteoarthritis(OA) and dysLipidemia (MaRVeL Study)

Start Date05 Jul 2023

Sponsor / Collaborator

The University of Sydney

100 Clinical Results associated with Pentosan Polysulfate Sodium

100 Translational Medicine associated with Pentosan Polysulfate Sodium

100 Patents (Medical) associated with Pentosan Polysulfate Sodium

1,240

Literatures (Medical) associated with Pentosan Polysulfate Sodium

01 Jan 2026·Ophthalmology science

Pigmentary Maculopathy in Patients with Interstitial Cystitis: Association with Pentosan Polysulfate and Other Therapies

Article

Author: Jeong, Chaewon ; Qin, Sunny ; Havunjian, Margaret ; Evans, Joni K ; Greven, Margaret A ; Ong, Sally S ; Jain, Nieraj

Purpose:

To examine the association between the development of pigmentary maculopathy and exposure to pentosan polysulfate sodium (PPS) and other therapies in patients with interstitial cystitis (IC).

Design:

Single-center retrospective study.

Subjects:

Patients diagnosed with IC who had ≥2 eye examinations at Wake Forest School of Medicine between January 2011 and August 2021.

Methods:

Two masked retina specialists evaluated available multimodal imaging for pigmentary maculopathy using the established criteria, with any disagreements adjudicated by a third reviewer. Cases were categorized by severity and analyzed for associations with medication exposure.

Main Outcome Measures:

Association between the development of pigmentary maculopathy with PPS exposure duration and cumulative dose, and concurrent IC medication use.

Results:

A total of 336 patients with IC (176 with PPS exposure, 160 without) were included. Patients with PPS exposure had increased odds of exposure to hydroxyzine (odds ratio [OR]: 4.76, P < 0.0001), amitriptyline (OR: 2.62, P < 0.0002), phenazopyridine or pyridium (OR: 1.68, P = 0.036), narcotics (OR: 2.68, P < 0.0001), oxybutynin (OR: 1.93, P = 0.041), cystoscopy with hydrodistention (OR: 4.001, P < 0.0001), bladder instillation (OR: 6.83, P < 0.0001), and vaginal valium (OR: 9.515, P = 0.033). Of the 122 patients with retinal imaging (71 with PPS exposure, 51 without), 8 patients (16 eyes) were graded to have pigmentary maculopathy and all 8 patients had PPS exposure. The median duration of PPS exposure in patients with moderate/severe maculopathy was 121 months (interquartile range [IQR] 117, 121) with a median cumulative dose of 929 200 mg (IQR 799 200; 1 109 100), which were significantly higher than patients with mild or no maculopathy (median duration 35 months [IQR 10, 63], P = 0.002 and median dose 166 800 mg [IQR 44 600; 569 100], P = 0.004). Higher proportions of patients with pigmentary maculopathy than those without had concurrent exposure to PPS and amitriptyline/nortriptyline (75% vs. 34.9%, P = 0.015) or PPS and cyclosporine (37.5% vs. 1.6%, P = 0.003).

Conclusions:

Pentosan polysulfate sodium exposure, and not IC itself, was associated with the development of pigmentary maculopathy. Longer duration and higher cumulative dose were associated with worse maculopathy. Patients on PPS were more likely to be on multiple other therapies for IC. Concurrent exposure to PPS and amitriptyline/nortriptyline or cyclosporine may increase the risk of developing maculopathy but these results should be validated by larger prospective studies.

Financial Disclosures:

Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.

31 Dec 2025·Prion

Differential pathology of P102L-associated Gerstmann–Stäussler–Scheinker disease: exclusive presence of 8-kDa protease-resistant prion protein vs. co-existence of 8-kDa and type-1 protease-resistant prion protein, with a focus on codon 129 polymorphism

Article

Author: Aishima, Shinichi ; Kanemaru, Takaaki ; Shijo, Masahiro ; Koyama, Sachiko ; Sasagasako, Naokazu ; Watanabe, Akihiro ; Tsuboi, Yoshio ; Sakurada, Naonori ; Honda, Hiroyuki ; Noguchi, Hideko ; Koike, Haruki ; Yoshimura, Motoi ; Kai, Keita

Gerstmann - Sträussler - Scheinker disease (GSS) is a hereditary prion disease characterized by clinicopathological heterogeneity. In Japan, the most common mutation is P102L, typically associated with prion protein (PrP) plaques, spongiform changes, and synaptic PrP deposits. Two major protease-resistant PrP (PrP^res) types occur: type-1 PrP^res (21 kDa) and 8-kDa PrP^res. The PRNP codon 129 polymorphism (methionine or valine) influences disease phenotype, but factors underlying exclusive 8-kDa PrP^res expression remain unclear. We analysed two sibling P102L GSS cases exclusively exhibiting 8-kDa PrP^res (Case 1: 129 MM, haplotype: P102L-129 M, treated with pentosan polysulfate; Case 2: 129 MV, haplotype: P102L-129 M, treated with quinacrine hydrochloride and quinine hydrochloride) and four P102L-129 MM GSS cases exhibiting type-1 and 8-kDa PrP^res (Cases 3-6) to elucidate the clinicopathological effect of 8-kDa PrP^res and PRNP codon 129 polymorphisms. Case 1 predominantly exhibited amyloidogenic PrP plaques; Case 2 exhibited non-amyloidogenic cotton-wool PrP plaques, with minimal synaptic PrP deposits. Despite prolonged survival ( > 20 years), spongiform degeneration and neuronal loss were mild. Cases 3-6 showed numerous amyloidogenic PrP plaques, moderate-to-severe synaptic PrP deposits, and significant tissue damage. Homoeostatic microglial markers were preserved in Cases 1 and 2 but absent in Cases 3-6. Cotton-wool PrP plaques lacked amyloid cores and were associated with 8-kDa PrP^res and codon 129 V from the normal allele. Tissue damage was mild in P102L GSS cases exhibiting 8-kDa PrP^res, suggesting lower pathogenicity. Cotton-wool PrP plaque formation likely involves 8-kDa PrP^res and codon 129 V. Further large-scale studies are warranted to elucidate these mechanisms.

01 Dec 2025·Current Urology Reports

Management Strategies for Patients with Non-Infectious Cystitis: A Review of the Literature

Review

Author: Sawyer, Kathryn ; Zheng, Yu ; Gupta, Priyanka ; Aqeel, Jawad

PURPOSE OF REVIEW:

The management of noninfectious cystitis continues to evolve as new treatments continue to be developed and investigated. This review aims to synthesize the most recent data regarding management strategies for noninfectious cystitis focused on non-ulcerative, ulcerative, eosinophilic, and ketamine-induced cystitis.

RECENT FINDINGS:

Several novel treatments have shown promise as management options including combination antihistamine therapy, phosphodiesterase 5 inhibitors, alpha lipoic acid supplements, and onabotulinumtoxin A. Recent studies have also found pentosan polysulfate sodium to have adverse ophthalmologic effects. For patients with ulcerative cystitis, recent research has shown that fulguration with or without triamcinolone injections should not be delayed. The treatment of noninfectious cystitis should be patient specific based on factors including etiology and symptom profile. Multimodal regimens are often the most effective. Treatment should be started with conservative options and escalated as necessary to oral treatments, intravesical options, or procedural management.

News (Medical) associated with Pentosan Polysulfate Sodium

10 Nov 2025

·www.prnewswire.com

Parker Waichman LLP Files Lawsuit on behalf of Florida Resident Alleging Development of Irreversible Eye Condition, NAION, after taking Ozempic

Parker Waichman, a national law firm, has now filed multiple lawsuits where each Plaintiff alleged that he or she developed NAION after taking Novo Nordisk's Ozempic or Wegovy. PORT WASHINGTON, N.Y., Nov. 10, 2025 /PRNewswire/ -- Parker Waichman has now filed multiple lawsuits in New Jersey state court on behalf of victims who were prescribed Ozempic or Wegovy and developed NAION, an irreversible eye condition that causes partial or complete permanent vision loss in one or both eyes. Most recently, on November 6, 2025, the Firm filed a lawsuit on behalf of a Florida resident who developed NAION after taking Ozempic. See Martin v. Novo Nordisk Inc., Docket No: MID-L-007920-25. Parker Waichman continues to file additional cases and urges individuals who have suffered serious eye injuries after taking these widely prescribed GLP-1 receptor agonist medications to contact them for a free case review. These medications, originally developed to treat Type 2 diabetes, have surged in popularity for weight loss. However, recent studies have uncovered a disturbing link between semaglutide (Ozempic/Wegovy) and NAION, a condition that causes permanent vision loss by cutting off blood flow to the optic nerve. Patients who took these drugs have reported sudden blindness, optic nerve damage, and other irreversible complications, raising concerns about the failure of drug manufacturers to warn consumers and medical professionals about these risks. A 2025 study published in JAMA Ophthalmology examined nine patients who developed optic nerve disorders after using GLP-1 medications, with the majority suffering from NAION-like symptoms. Additional research from Harvard's Mass Eye and Ear Institute found that diabetic users of semaglutide were four times more likely to develop NAION, while non-diabetic users taking the drug for weight loss faced a sevenfold increased risk. Despite growing scientific evidence, Novo Nordisk continues to downplay the dangers associated with these medications, failing to include adequate warnings about the risk of permanent blindness. Parker Waichman LLP Fights for Victims Nationwide "NAION is a devastating, and permanent, eye injury diagnosis. Studies from multiple, reputable institutions, have shown a statistically significant relationship between semaglutide (the active ingredient in Ozempic and Wegovy) and NAION. Despite this evidence, Novo Nordisk continues to deny reality by failing to warn consumers and medical professionals about this horrific injury and must be held accountable," said Jason S. Goldstein, Senior Litigation Counsel at Parker Waichman LLP. Parker Waichman LLP is currently accepting cases nationwide for individuals who have suffered vision loss, blindness, or serious optic nerve damage after taking Ozempic or Wegovy. Victims may be entitled to compensation for medical expenses, lost wages, pain and suffering, and other damages. Free Case Review for Affected Individuals If you or a loved one experienced sudden vision loss, blindness, or optic nerve damage after using Ozempic or Wegovy, you may have a legal claim against the drug manufacturers. Parker Waichman LLP is offering free, no-obligation case evaluations to help victims understand their rights and pursue justice. Contact Parker Waichman LLP Today For a free consultation, call 1-800-YOUR-LAWYER (1-800-968-7529) or visit YourLawyer.com to learn more about your legal options and how to protect your rights. About Parker Waichman LLP Parker Waichman LLP is a nationally recognized law firm dedicated to fighting for victims of defective drugs, dangerous products, accidents, and corporate negligence. Specifically, the Firm is quite experienced in representing eye injury victims due to the negligence of pharmaceutical companies. Representative cases include In Re Elmiron (Pentosan Polysulfate Sodium) Products Liability Litigation and Bausch & Lomb Contact Lens Solutions Prod. Liab. Litig. With a proven track record of holding pharmaceutical companies accountable, the firm has secured billions in settlements and verdicts for injured clients. Media Contact: Jason Goldstein Phone: 516-466-6500 Email: [email protected] SOURCE Parker Waichman LLP 21% more press release views with Request a Demo

Patent Infringement

29 Sep 2025

·www.prnewswire.com

Parker Waichman LLP Files Lawsuit on behalf of Georgia Resident Alleging Development of Irreversible Eye Condition, NAION, after taking Wegovy

Parker Waichman, a national law firm, has now filed multiple lawsuits where each Plaintiff alleged that he or she developed NAION after taking Novo Nordisk's Ozempic or Wegovy. PORT WASHINGTON, N.Y., Sept. 29, 2025 /PRNewswire/ -- Parker Waichman has now filed multiple lawsuits in New Jersey state court on behalf of victims who were prescribed Ozempic or Wegovy and developed NAION, an irreversible eye condition that causes partial or complete permanent vision loss in one or both eyes. Most recently, on September 26, 2025, the Firm filed a lawsuit on behalf of a Georgia resident who developed NAION after taking Wegovy. See Wirth v. Novo Nordisk Inc., Docket No: MID-L-006890-25. Parker Waichman continues to file additional cases and urges individuals who have suffered serious eye injuries after taking these widely prescribed GLP-1 receptor agonist medications to contact them for a free case review. These medications, originally developed to treat Type 2 diabetes, have surged in popularity for weight loss. However, recent studies have uncovered a disturbing link between semaglutide (Ozempic/Wegovy) and NAION, a condition that causes permanent vision loss by cutting off blood flow to the optic nerve. Patients who took these drugs have reported sudden blindness, optic nerve damage, and other irreversible complications, raising concerns about the failure of drug manufacturers to warn consumers and medical professionals about these risks. A 2025 study published in JAMA Ophthalmology examined nine patients who developed optic nerve disorders after using GLP-1 medications, with the majority suffering from NAION-like symptoms. Additional research from Harvard's Mass Eye and Ear Institute found that diabetic users of semaglutide were four times more likely to develop NAION, while non-diabetic users taking the drug for weight loss faced a sevenfold increased risk. Despite growing scientific evidence, questions remain as to whether Novo Nordisk's warnings adequately reflect the potential risk of permanent blindness associated with these medications. Parker Waichman LLP Fights for Victims Nationwide "NAION is a devastating, and permanent, eye injury diagnosis. Studies from multiple, reputable institutions, have shown a statistically significant relationship between semaglutide (the active ingredient in Ozempic and Wegovy) and NAION. Despite this evidence, Novo Nordisk continues to deny reality by failing to warn consumers and medical professionals about this horrific injury and must be held accountable." said Jason S. Goldstein, Senior Litigation Counsel at Parker Waichman LLP. Parker Waichman LLP is currently accepting cases nationwide for individuals who have suffered vision loss, blindness, or serious optic nerve damage after taking Ozempic or Wegovy. Victims may be entitled to compensation for medical expenses, lost wages, pain and suffering, and other damages. Free Case Review for Affected Individuals If you or a loved one experienced sudden vision loss, blindness, or optic nerve damage after using Ozempic or Wegovy, you may have a legal claim against the drug manufacturers. Parker Waichman LLP is offering free, no-obligation case evaluations to help victims understand their rights and pursue justice. Contact Parker Waichman LLP Today For a free consultation, call 1-800-YOUR-LAWYER (1-800-968-7529) or visit YourLawyer.com to learn more about your legal options and how to protect your rights. About Parker Waichman LLP Parker Waichman LLP is a nationally recognized law firm dedicated to fighting for victims of defective drugs, dangerous products, accidents, and corporate negligence. Specifically, the Firm is quite experienced in representing eye injury victims due to the negligence of pharmaceutical companies. Representative cases include In Re Elmiron (Pentosan Polysulfate Sodium) Products Liability Litigation and Bausch & Lomb Contact Lens Solutions Prod. Liab. Litig. With a proven track record of holding pharmaceutical companies accountable, the firm has secured billions in settlements and verdicts for injured clients. Media Contact: Parker Waichman LLP Phone: 1-800-YOUR-LAWYER (1-800-968-7529) Website: SOURCE Parker Waichman LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Patent Infringement

16 Sep 2025

·www.prnewswire.com

Parker Waichman LLP Files Lawsuit on Behalf of Baltimore Resident Alleging Irreversible Eye Condition After Taking Ozempic

PORT WASHINGTON, N.Y., Sept. 16, 2025 /PRNewswire/ -- National law firm Parker Waichman LLP has filed another lawsuit in New Jersey state court on behalf of an individual who developed non-arteritic anterior ischemic optic neuropathy (NAION) after taking Ozempic, a widely prescribed GLP-1 receptor agonist. The latest case, Christensen v. Novo Nordisk Inc., Docket No. MID-L-0056489-25, was filed September 8, 2025, on behalf of a Baltimore, Maryland resident. This filing adds to a growing number of lawsuits brought by Parker Waichman on behalf of patients who suffered irreversible eye injuries, including partial or complete vision loss, after being prescribed Ozempic or Wegovy. Serious Risks Tied to Popular Diabetes and Weight Loss Drugs Originally developed to treat Type 2 diabetes, semaglutide (marketed as Ozempic and Wegovy) has skyrocketed in use for weight loss. However, recent research has linked the drug to NAION, a permanent condition that cuts off blood flow to the optic nerve and can result in blindness. A 2025 study in JAMA Ophthalmology reported multiple cases of optic nerve disorders among GLP-1 users, most with NAION-like symptoms. Separately, researchers at Harvard's Mass Eye and Ear Institute found that diabetic patients using semaglutide faced a fourfold increased risk of NAION, while non-diabetic users taking it for weight loss had a sevenfold increased risk. Despite mounting evidence, Novo Nordisk has not issued adequate warnings about the risk of blindness associated with these drugs. Parker Waichman LLP Advocates for Victims Nationwide "NAION is a devastating, permanent eye injury," said Jason S. Goldstein, Senior Litigation Counsel at Parker Waichman LLP. "Multiple studies from respected institutions confirm a statistically significant link between semaglutide and NAION. Yet, Novo Nordisk continues to deny reality by failing to warn the public and medical professionals. They must be held accountable." Parker Waichman LLP is actively reviewing cases nationwide for individuals who have suffered sudden vision loss, blindness, or optic nerve damage after using Ozempic or Wegovy. Potential compensation may include coverage for medical costs, lost income, pain and suffering, and other damages. Free Case Evaluations Available Individuals who experienced serious eye injuries after taking Ozempic or Wegovy are encouraged to contact Parker Waichman LLP for a free, no-obligation case review. Contact Parker Waichman LLP Today For a free consultation, call 1-800-YOUR-LAWYER (1-800-968-7529) or visit . About Parker Waichman LLP Parker Waichman LLP is a nationally recognized law firm committed to protecting victims of defective drugs, dangerous products, accidents, and corporate negligence. The firm has extensive experience representing clients in pharmaceutical eye injury cases, including In Re Elmiron (Pentosan Polysulfate Sodium) Products Liability Litigation and Bausch & Lomb Contact Lens Solutions Products Liability Litigation. Parker Waichman has secured billions of dollars in verdicts and settlements on behalf of injured clients. Media Contact: Parker Waichman LLP Phone: 1-800-YOUR-LAWYER (1-800-968-7529) Website: SOURCE Parker Waichman LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Patent Infringement

100 Deals associated with Pentosan Polysulfate Sodium

External Link

KEGG	Wiki	ATC	Drug Bank
D05428	Pentosan Polysulfate Sodium	C05BA04 G04BX15	DBSALT000991

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Cystitis, Interstitial	United States	Janssen Pharmaceuticals, Inc.	26 Sep 1996

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Osteoarthritis, Knee	Phase 3	European Union	Paradigm Biopharmaceuticals Ltd.	18 Mar 2022
Osteoarthritis	Phase 3	Australia	Paradigm Biopharmaceuticals Ltd.	30 Jan 2022
Cystitis	Phase 3	Taiwan Province	TCM Biotech International Corp.	14 Oct 2020
Urinary Tract Infections	Phase 3	Taiwan Province	TCM Biotech International Corp.	14 Oct 2020
Mucopolysaccharidosis I	Phase 2	Australia	Paradigm Biopharmaceuticals Ltd.	30 Jan 2022
Mucopolysaccharidosis VI	Phase 2	Australia	Paradigm Biopharmaceuticals Ltd.	30 Jan 2022
Rhinitis, Allergic	Phase 2	Australia	Paradigm Biopharmaceuticals Ltd.	30 Jan 2022
Ross River Fever	Phase 2	Australia	Paradigm Biopharmaceuticals Ltd.	30 Jan 2022
Chronic prostatitis	Phase 2	-	McNeil Consumer & Specialty Pharmaceuticals, Inc.	12 Oct 2005
Chronic prostatitis	Phase 2	-	ALZA Corp.	12 Oct 2005

Clinical Result

Indication

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


2021 ARVO Annual Meeting (ARVO2021)	Not Applicable	Dystrophy, Macular	-	Pentosan Polysulfate	lpteuttxir(fbhhjvctuz) = jlmxmigaja hkqswcwsfh (kxobazmiko, 238 - 290) View more	Negative	01 Jun 2021
NCT02930005 (CTgov)	Phase 2	Bipolar Disorder \| Bipolar I disorder \| Schizoaffective disorder ... View more	8	Meclofenamic acid (Meclofenamic Acid)	zwwxxhjixc = ezhyftybns aznmbpsofq (yvhawyzojx, omiojxyvoq - tbcpxpjclv) View more	-	26 Mar 2019
NCT02930005 (CTgov)	Phase 2		8	Pentosan polysulfate sodium (Pentosan Polysulfate Sodium)	zwwxxhjixc = tyavvgaxth aznmbpsofq (yvhawyzojx, mguztzatjl - jtdhlocqve) View more	-	26 Mar 2019
NCT00086684 (CTgov)	Phase 4	Cystitis, Interstitial	369	Placebo	aqfnfxewaa = cigbnrsvjk owlpzwalad (qrdxejujfy, uxlvyiraro - qdzzcnkwzu) View more	-	06 Jul 2012

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