Pentosan Polysulfate Sodium

Relieves bladder pain or discomfort associated with interstitial cystitis. Sold as Elmiron. Every FDA application for this active ingredient.

As of Nov 15, 2026, FDA lists 1 application for Pentosan Polysulfate Sodium (sold as Elmiron), first approved Sep 26, 1996, with 0 new uses approved and 0 published complete response letters.

First approved: Sep 26, 1996
Applications: 1
New uses approved: 0
Complete response letters: 0
Medicare spending, 2025: $51.4M
First approved in the EU: Jun 2, 2017

Medicare Spending

CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name

Product	Part	Spending, 2025	Change	Beneficiaries
Elmiron	Part D	$51.4M	-1%	8,596

What Pharmacies Pay

Median price per unit across package codes in CMS's weekly NADAC survey, Nov 11, 2026, before rebates; see every drug's price change

ELMIRON 100 MG CAPSULE: $12.09 per unitBrand · +5% in a year

Orphan Designations (FDA)

5 designations, 1 approved for the designated use; see all orphan designations

Treatment of mucopolysaccharidosis type 1Paradigm Biopharmaceuticals Ltd. · designated Apr 28, 2020
Treatment of mucopolysaccharidosis (MPS) type VIParadigm Biopharmaceuticals Ltd. · designated Jan 5, 2015
Treatment of sickle cell disease.Vanguard Therapeutics, Inc. · designated Sep 16, 2011
Treatment of sickle cell disease.TRF Pharma, Inc. · designated Nov 21, 2008
Treatment of interstitial cystitis.Alza Corporation · designated Aug 7, 1985 · approved Sep 26, 1996

Approvals in the EU (EMA)

First approved in the EU 248 months after the US. Centrally authorised medicines, matched by ingredient; see all EU approvals

Elmiron, new substancebene-Arzneimittel GmbH · Jun 2, 2017

Clinical Trials

4 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all


Evaluate the Efficacy and Safety of U101 Oral Capsules in the Prevention of Uncomplicated rUTIs in WomenRecurrent Urinary Tract Infections in Women · TCM Biotech International Corp.	Phase 3	Recruiting	Sep 22, 2025
A Study to Investigate the Treatment Effect of Subcutaneous Injections of Pentosan Polysulfate Sodium Compared With Placebo in Adult Participants With Knee Osteoarthritis Pain.Osteoarthritis, Knee · Paradigm Biopharmaceuticals Ltd.	Phase 3	Active, not recruiting	Apr 8, 2025
Radiation Cystitis Treated With Pentosan Polysulfate Sodium TrialRadiation Cystitis · National Taiwan University Hospital	Phase 2 / Phase 3	Recruiting	Feb 18, 2022
Treatment Effects of Subcutaneous Injections of Pentosan Polysulfate Sodium vs Placebo in Participants With Knee OA PainOsteoarthritis, Knee · Paradigm Biopharmaceuticals USA (INC)	Phase 2 / Phase 3	Active, not recruiting	Mar 22, 2021

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history

Approved	Application	Sponsor	Supplements	Marketing
Sep 26, 1996	ElmironNDA 20193 · New molecular entity	Janssen Pharms	7	Marketed

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA