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

1,236

Literatures (Medical) associated with Pentosan Polysulfate Sodium

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.

01 Oct 2025·FOOD CHEMISTRY

In vitro simulated digestion and fermentation characteristics of pumpkin polysaccharides and their effects on the human gut microbiota

Article

Author: Cao, Hongyuan ; Lin, Changbin ; Ge, Lihong ; Wang, Chun ; Xia, Chen ; Miao, Yuzhi ; Li, Kejuan ; Li, Qi ; Li, Jiajun ; Zhu, Yuanting

Although pumpkin polysaccharides have numerous health benefits, limited studies have investigated the impact of pumpkin polysaccharide digestion and fermentation characteristics on its biological activity. Herein, pumpkin polysaccharides (PPs) were subjected to simulated saliva-gastric-small intestinal digestion, followed by in vitro fermentation using healthy human faecal microbiota. Results indicate that PPs, acidic heteropolysaccharide with a molecular weight of 2.93 × 10² kDa, mainly composed glucose and D-galacturonic acid and remained stable under simulated salivary and gastric conditions; however, they slightly degraded during intestinal digestion. During in vitro faecal fermentation, PPs stimulated the production of short-chain fatty acids, particularly acetic acid, which lowered pH, promoted the abundance of beneficial bacteria such as Lactobacillus, and inhibited harmful bacteria such as Escherichia-Shigella and Phascolarctobacterium. PICRUSt analysis suggested that the gut microbiota regulation of PPs was linked to metabolic pathways and amino acid biosynthesis, indicating the potential prebiotic properties and health benefits of PPs.

01 Sep 2025·Ophthalmology Retina

Risk and Dose–Response Relationship for Pentosan Polysulfate Sodium Maculopathy

Review

Author: Lim, Kate ; Tao, Brendan K ; Dhivagaran, Thanansayan ; Gupta, Rudra Rishi ; Butt, Fahad ; Mishra, Amit ; Sawires, Korolos

TOPIC:

To determine the pooled relative risk (RR) of pentosan polysulfate sodium maculopathy (PPSM) in patients using pentosan polysulfate sodium (PPS) and model the dose-response relationship of this association from existing literature.

CLINICAL RELEVANCE:

Pentosan polysulfate sodium maculopathy is an acquired, progressive retinal pigmentary disease associated with oral PPS use. Although several observational studies suggest a dose-response relationship of this association, to date, there remains no literature-pooled synthesis on the risk of PPSM across strata of cumulative dose.

METHODS:

Systematic review and meta-analysis (CRD42024623179). Medline, Embase, and Cochrane Central Register of Controlled Trials were searched from inception to September 15, 2024. We included studies reporting the incidence of PPS-associated maculopathy and including cumulative PPS dose information. Two independent reviewers completed study screening, data extraction, and risk of bias (ROB) assessment using the ROB in nonrandomized studies of exposures tool, and a third reviewer was consulted to resolve conflicts. The primary outcome was the RR of PPSM among patients exposed to PPS compared with nonexposed individuals, stratified by cumulative PPS dose.

RESULTS:

We included 5 studies encompassing 141 785 patients and 6432 PPSM cases. The linear dose-response regression model estimated a 0.1% increase in RR of maculopathy per g increase in cumulative PPS dose (log-transformed RR = 0.00101; 95% confidence interval, 0.0005-0.0015; P < 0.0001). Patients with cumulative doses ≥2000 g exhibited an RR of 7.39 (95% confidence interval, 4.17-13.10), while those with a dose between 1 and 500 g had an RR of 1.65 (95% confidence interval, 1.12-2.43) compared with nonexposed individuals. Subgroup analysis excluding high-risk studies demonstrated consistent findings, with reduced heterogeneity (I² = 63.7%).

CONCLUSION:

Moderate certainty evidence supports a dose-dependent relationship between PPS exposure and PPSM risk, whereas higher cumulative doses significantly increase maculopathy risk. This result supports that patients should be tapered to an effective minimal dose and that they should be subject to interval maculopathy screening, especially for patients with greater cumulative dose. Future research should incorporate patient-level data to better control for potential confounding.

FINANCIAL DISCLOSURE(S):

The authors have no proprietary or commercial interest in any materials discussed in this article.

News (Medical) associated with Pentosan Polysulfate Sodium

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

20 Aug 2025

·www.prnewswire.com

Parker Waichman LLP Files Lawsuit on behalf of Long Island Resident Alleging Vision Loss and Development of Irreversible Eye Condition, NAION, after taking Ozempic

Parker Waichman, a national law firm, has filed multiple lawsuits where each Plaintiff alleged that he or she developed NAION after taking Novo Nordisk's Ozempic or Wegovy. The NAION/Ozempic lawsuits were recently featured in Newsday PORT WASHINGTON, N.Y., Aug. 20, 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 August 18, 2025, the Firm filed a lawsuit on behalf of a Long Island, New York resident who developed NAION after taking Ozempic. See Barzyz v. Novo Nordisk Inc., Docket No: MID-L-005991-25. The lawsuit, along with the NAION/Ozempic litigation, was recently covered by Newsday. See Injectable weight loss drugs linked to rare vision loss - Newsday. 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: 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

13 Aug 2025

·www.prnewswire.com

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

Parker Waichman, a national law firm, has now filed five (5) separate lawsuits where each Plaintiff alleged that he or she developed NAION after taking Novo Nordisk's Ozempic or Wegovy PORT WASHINGTON, N.Y., Aug. 13, 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 August 7, 2025, the Firm filed a lawsuit on behalf of a 60-year Miami, Florida resident who developed NAION after taking Ozempic. See Delgado v. Novo Nordisk Inc., Docket No: MID-L-0047-25. To most efficiently litigate these cases, Parker Waichman LLP recently joined four other law firms and filed an application to the New Jersey Supreme Court to consolidate all New Jersey state lawsuits alleging permanent vision loss from use of Ozempic/Wegovy products in Middlesex County, New Jersey. 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: 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	-	ALZA Corp.	12 Oct 2005
Chronic prostatitis	Phase 2	-	McNeil Consumer & Specialty Pharmaceuticals, Inc.	12 Oct 2005

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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	csnirhpnem(szcqyfpvwn) = ztlllqzmso lcujvyplmd (bhvpeqlyvi, 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)	cgmzfptyih = nmqtevgddw uhdhkhurut (eewfxwcrvg, hbxwxnvtzb - izxsbcotxm) View more	-	26 Mar 2019
NCT02930005 (CTgov)	Phase 2		8	Pentosan polysulfate sodium (Pentosan Polysulfate Sodium)	cgmzfptyih = oaimbyfupo uhdhkhurut (eewfxwcrvg, nwdqnpnrtx - dafxckmkwl) View more	-	26 Mar 2019
NCT00086684 (CTgov)	Phase 4	Cystitis, Interstitial	369	Placebo	awjkscmzst = zguzctwvbj kkjwgufncn (brddwajkcz, asntctbdcd - tnuoefwogo) View more	-	06 Jul 2012

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