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Home/Compounds/Pentosan Polysulfate Sodium
HealingFDA approvedRx required

Pentosan Polysulfate Sodium

Also known as: Elmiron · PPS
Brands: Elmiron

Semi-synthetic sulfated polysaccharide approved for interstitial cystitis; not technically a peptide but often discussed in peptide/regenerative contexts.

A
Grade A
Multiple human RCTs
Human studies22
PubMed citations28
Routeoral
Regulatory (US)FDA approved · Rx
Last verified2 days ago

Mechanism of action

Believed to restore the glycosaminoglycan (GAG) layer of the bladder epithelium, reducing irritation by urinary solutes.

Evidence summary

22
Human studies
28
PubMed citations
11
Clinical trials
A
Evidence grade

Evidence summary in progress. See the citations section below for the underlying research papers.

Dosing protocols

Educational information only. Consult a licensed provider before using any peptide.
Administration routes
oral

Side effects & safety

From the FDA label
Source
abdominal painarthralgiaconstipationdehydrationdiarrheadizzinessdyspepsiaheadacheinsomnianauseapruritusrashurticariavomiting

Terms pulled directly from the referenced source. We don't fabricate frequencies — when a label doesn't publish a percentage, we don't either.

Interactions

No documented drug interactions on file.

Regulatory status

United States
FDA approved

FDA approved for bladder pain/discomfort associated with interstitial cystitis (Elmiron). Boxed warning for pigmentary maculopathy.

Compounding
Not permitted

Not available via 503A/503B compounding pharmacies.

Regulatory data last verified 4/19/2026

Clinical trials

NCT06917404A 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 PainRecruiting · Phase 3 · Osteoarthritis, Knee · n=466NCT07184827A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of U101 Oral Capsules in the Prevention of Uncomplicated Recurrent Urinary Tract Infections (rUTIs) in WomenRecruiting · Phase 3 · Recurrent Urinary Tract Infections in Women · n=348NCT04814719An Observational Follow-up Study to Investigate the Duration of Treatment Effect With Subcutaneous Injections of Pentosan Polysulfate Sodium Compared With Placebo in Adult Participants With Knee Osteoarthritis PainCompleted · Osteoarthritis, Knee · n=133NCT05179460Post-authorization Safety Study and Real-world Evaluation of the Use of Pentosan Polysulfate Sodium and the Development of Pigmentary Maculopathy and Pigmentary RetinopathyCompleted · Pigmentary Maculopathy · n=2NCT04809376A 2-stage, Adaptive, Randomised, Double-blind, Placebo-controlled, Multicentre Study to Evaluate Dose and Treatment Effect of Pentosan Polysulfate Sodium Compared With Placebo in Participants With Knee Osteoarthritis PainActive Not Recruiting · Phase 2 · Osteoarthritis, Knee · n=602NCT05245591A Randomized, Controlled, Phase II/III Trial to Evaluate the Efficacy and Safety of U101 Oral Capsules in Radiation-induced CystitisRecruiting · Phase 2 · Radiation Cystitis · n=72NCT01895153The Efficacy of Pentosan Polysulfate Sodium,Hydrodistension and Combination Therapy in Patients With Bladder Pain SyndromeCompleted · Bladder Pain Syndrome · n=91NCT00003825Phase III Study of Pentosanpolysulfate (PPS) in Treatment of GI Tract Sequelae of RadiotherapyCompleted · Phase 3 · Diarrhea · n=174NCT02930005A Pilot Open-label Trial of Pentosan Polysulfate Sodium and Meclofenamic Acid As Adjunctive Treatments in Patients With Psychotic DisordersCompleted · Phase 2 · Psychotic Disorders · n=8NCT00086684Randomized, Double-Blind, Placebo-Controlled, Parallel Group Evaluation of the Efficacy and Tolerability of Two Different Doses of ELMIRON for the Treatment of Interstitial CystitisTerminated · Phase 4 · Interstitial Cystitis · n=369NCT00236990A Double-Blind, Randomized, Placebo-Controlled Trial of ELMIRON (Pentosan Polysulfate Sodium) for the Treatment of Chronic Non-Bacterial ProstatitisCompleted · Phase 2 · Prostatitis · n=283

Citations

PMID 37567725Lenhart D, Tischhöfer MT et al. · Chemical and biological differences between original and mimetic pentosan polysulfates.Carbohydrate polymers (2026)HumanPMID 39877031Wu M, Fulgenzi CAM et al. · Second-line treatment patterns and outcomes in advanced HCC after progression on atezolizumab/bevacizumab.JHEP reports : innovation in hepatology (2025)HumanPMID 40792210Jung EH, Zheng W et al. · Colopathy associated with pentosan polysulfate use.Frontiers in pharmacology (2025)PMID 37066211Jung EH, Zheng W et al. · Colopathy Associated with Pentosan Polysulfate Use.medRxiv : the preprint server for health sciences (2025)PMID 39731248Andreeva NA, Sheremet NL · [Peripapillary pachychoroid syndrome].Vestnik oftalmologii (2024)HumanPMID 38590442Srinivasan S, Chen L et al. · Initial Insights into the Genetic Variation Associated with Metformin Treatment Failure in Youth with Type 2 Diabetes.Pediatric diabetes (2024)HumanPMID 38255888Nicze M, Borówka M et al. · The Current and Promising Oral Delivery Methods for Protein- and Peptide-Based Drugs.International journal of molecular sciences (2024)HumanPMID 38104331Evans RJ, Xu R · Re: Pentosan polysulfate and a pigmentary maculopathy: causation versus correlation?The Canadian journal of urology (2023)HumanPMID 34296258Blackorby BL, Banda H et al. · Macular Findings of Patients on Pentosan Polysulfate Sodium.Military medicine (2023)HumanPMID 35385434Somisetty S, Santina A et al. · RAPID PENTOSAN POLYSULFATE SODIUM MACULOPATHY PROGRESSION.Retinal cases & brief reports (2023)HumanPMID 36845136Krishnan R, Stapledon CJM et al. · Anti-inflammatory actions of Pentosan polysulfate sodium in a mouse model of influenza virus A/PR8/34-induced pulmonary inflammation.Frontiers in immunology (2023)HumanPMID 37101838Fu QT, Zhong XQ et al. · Luteolin-Loaded Nanoparticles for the Treatment of Melanoma.International journal of nanomedicine (2023)HumanPMID 35120847Mehr J, Santarelli S et al. · Emerging Roles of Penile Traction Therapy and Vacuum Erectile Devices.Sexual medicine reviews (2022)HumanPMID 34000253Lindeke-Myers A, Hanif AM et al. · Pentosan polysulfate maculopathy.Survey of ophthalmology (2022)HumanPMID 34298229Jain N, Liao A et al. · Expanded Clinical Spectrum of Pentosan Polysulfate Maculopathy: A Macula Society Collaborative Study.Ophthalmology. Retina (2022)HumanPMID 35277990Bae SS, Sodhi M et al. · Risk of maculopathy with pentosan polysulfate sodium use.British journal of clinical pharmacology (2022)HumanPMID 35447258Yue F, Xu J et al. · Structural features and anticancer mechanisms of pectic polysaccharides: A review.International journal of biological macromolecules (2022)PMID 34175012Samaan A, Escalon MX · Joint and Back Pain: Medications and Role of Injection Therapy for Destructive Joint.Physical medicine and rehabilitation clinics of North America (2021)HumanPMID 33999854Gergely R, Ecsedy M et al. · [Pachychoroid diseases].Orvosi hetilap (2021)HumanPMID 33231621Lyons RJ, Brower J et al. · Visual Function in Pentosan Polysulfate Sodium Maculopathy.Investigative ophthalmology & visual science (2021)Human

Showing 20 of 28 papers. View all on PubMed →