Elmiron

(Pentosan polysulfate sodium)

ApprovedSmall molecule

WWim Janssens

Elmiron is one of 72 small molecule programs targeting Interstitial Cystitis. It is currently in Approved.

Indications

Total Trials

Active Trials

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

Interstitial CystitisTerminated

TreatmentActive, not recruiting

CystitisRecruiting

Interstitial CystitisApproved

Terminated

TreatmentPhase 3

Active, not recruiting

CystitisPhase 3

Recruiting

Competition

Competitive Landscape

332 competitors in Treatment

#DrugCompanyPhaseTrials

Elmiron

WWim Janssens

Approved

1 2

Dexilant

Takeda

Preclinical

2 3

Alfenta

Jazz Pharmaceuticals

Preclinical

1 4

Niclocide

Bayer

Preclinical

1 5

Hivid

CConrado Roberto Hoffmann Filho

Preclinical

6 6

Valium

Akero Therapeutics

Preclinical

2 7

Barhemsys

Tibotec Pharmaceuticals, Ireland

Preclinical

1 8

Clomid

Ferring

Preclinical

1 9

Aurlumyn

BBTG International Inc.

Preclinical

1 10

Lotemax

PPharmos

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q3 2027

Phase 3Active, not recruiting

Osteoarthritis, Knee

NCT06917404

Q4 2029

Phase 2/3Recruiting

Cystitis

NCT05245591

Clinical

Trials by Indication[1]

Cystitis1 trial

Radiation Cystitis Treated With Pentosan Polysulfate Sodium Trial

Recruiting·NNational Taiwan University Hospital·Phase 2/3·NCT05245591·72 enrolled

Interstitial Cystitis1 trial

Effectiveness and Safety Study of Pentosan Polysulfate Sodium for the Treatment of Interstitial Cystitis

Terminated· Johnson & Johnson Pharmaceutical Research & Development, L.L.C. logo

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.·Phase 4·NCT00086684·369 enrolled

Radiation Therapy1 trial

Pentosan Polysulfate in Treating Patients With Gastrointestinal Disturbance Caused by Radiation Therapy

Completed· Radiation Therapy Oncology Group logo

Radiation Therapy Oncology Group·Phase 3·NCT00003825·174 enrolled

Effectiveness1 trial

An Effectiveness and Safety Study of ELMIRON (Pentosan Polysulfate Sodium) for the Treatment of Chronic Non-Bacterial Inflammation of the Prostate Gland

Completed·MMcNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.·Phase 2·NCT00236990·283 enrolled

Treatment1 trial

Treatment Effects of Subcutaneous Injections of Pentosan Polysulfate Sodium vs Placebo in Participants With Knee OA Pain

Active, not recruiting·PParadigm Biopharmaceuticals USA (INC)·Phase 2/3·NCT04809376·602 enrolled

2 more indications

Tic Disorder1 trial

Pentosan Polysulfate Sodium and Meclofenamic Acid as Treatments in Patients With Psychotic Disorders

Completed·TThe University of Texas Health Science Center, Houston·Phase 2·NCT02930005·8 enrolled

Osteoarthritis, Knee1 trial

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

Active, not recruiting·PParadigm Biopharmaceuticals Ltd.·Phase 3·NCT06917404·466 enrolled

Regulatory

FDA Approval Timeline[4]

Sep 26, 1996

ELMIRON

NDA NDA020193

Sources

References

[1]
ClinicalTrials.gov — 7 trial records for Pentosan polysulfate sodium. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Pentosan polysulfate sodium compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Pentosan polysulfate sodium. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA020193). U.S. Food & Drug Administration.
[5]
SEC EDGAR — Wim Janssens company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Approved[1]
Company: WWim Janssens

Elmiron

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q3 2027

Q4 2029

Trials by Indication[1]

Cystitis1 trial

Interstitial Cystitis1 trial

Radiation Therapy1 trial

Effectiveness1 trial

Treatment1 trial

Tic Disorder1 trial

Osteoarthritis, Knee1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

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