NDAORALCAPSULE
Approved
Sep 1996
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
5
Data completeness
4/8 — Partial
Drug data last refreshed 10h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ELMIRON (pentosan polysulfate sodium) is an oral small-molecule drug approved in 1996 for interstitial cystitis/bladder pain syndrome. The mechanism of action involves glycosaminoglycan layer protection and anti-inflammatory effects on bladder mucosa. It represents one of the few oral options for chronic bladder pain management.
$55MPart D
LOE ApproachingDeclining
Product faces imminent loss of exclusivity with modest Part D spend of $55M; commercial team size likely contracting as generic entry approaches.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (5)
A Study to Investigate the Treatment Effect of Subcutaneous Injections of Pentosan Polysulfate Sodium Compared With Placebo in Adult Participants With Knee Osteoarthritis Pain.
Started May 2025
466 enrolled
Osteoarthritis, Knee
Treatment and Duration Effect of Pentosan Polysulfate Sodium (PPS) in Participants With Knee Osteoarthritis Pain
Started Jun 2023
133 enrolled
Osteoarthritis, Knee
A Study of Pentosan Polysulfate Sodium and the Development of Pigmentary Maculopathy and Pigmentary Retinopathy
Started Oct 2021
2 enrolled
Pigmentary MaculopathyPigmentary RetinopathyInterstitial Cystitis
Treatment Effects of Subcutaneous Injections of Pentosan Polysulfate Sodium vs Placebo in Participants With Knee OA Pain
Started Oct 2021
602 enrolled
Osteoarthritis, Knee
Effectiveness and Safety Study of Pentosan Polysulfate Sodium for the Treatment of Interstitial Cystitis
Started Sep 2003
369 enrolled
Interstitial Cystitis
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.