Elmiron

(Pentosan polysulfate sodium)

ApprovedSmall molecule

WWim Janssens

Elmiron is one of 150 small molecule programs targeting Tic Disorder. It is currently in Approved.

Indications

Total Trials

Active Trials

149

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

Tic DisorderActive, not recruiting

Interstitial CystitisActive, not recruiting

OsteoarthritisActive, not recruiting

CystitisActive, not recruiting

Tic DisorderPhase 2

Active, not recruiting

Interstitial CystitisApproved

Active, not recruiting

OsteoarthritisPhase 3

Active, not recruiting

CystitisPhase 2/Phase 3

Active, not recruiting

Competition

Competitive Landscape

778 competitors in Osteoarthritis

#DrugCompanyPhaseTrials

Elmiron

WWim Janssens

Approved

1 2

Ilaris

Novartis

Preclinical

2 3

Cataflam

Bayer Aspirin

Platelet Rich Plasma

25 6

Enbrel

IImmunex

Preclinical

2 7

Glucophage

Boehringer Ingelheim

Preclinical

1 8

Paracetamol

GSK

Preclinical

4 9

Naproxen Sodium

Bayer

Preclinical

1 10

Ansaid

PPharmacia and Upjohn

Preclinical

—

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

Timeline

Expected Milestones

Q3 2027

Phase 3Recruiting

Osteoarthritis

NCT06917404

Q4 2029

Phase 2/3Recruiting

Cystitis

NCT05245591

Clinical

Trials by Indication[1]

Completed· Radiation Therapy Oncology Group logo

Radiation Therapy Oncology Group·Phase 3·NCT00003825·174 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

Osteoarthritis1 trial

A Study to Investigate the Treatment Effect of Subcutaneous Injections of Pentosan Polysulfate Sodium Compared With Placebo in Adult Participants With Knee Osteoarthritis Pain.

Recruiting·PParadigm Biopharmaceuticals Ltd.·Phase 3·NCT06917404·466 enrolled

2 more indications

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

Cystitis1 trial

Radiation Cystitis Treated With Pentosan Polysulfate Sodium Trial

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

Tic Disorder1 trial

Effectiveness1 trial

Radiation Therapy1 trial

Interstitial Cystitis1 trial

Osteoarthritis1 trial

Treatment1 trial

Cystitis1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

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