Is Pentosan polysulfate registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 0 valid registrations of Pentosan polysulfate.

Is Pentosan polysulfate approved by the US FDA?

Drugs@FDA lists 1 application product line for Pentosan polysulfate, including ELMIRON (Prescription).

Is Pentosan polysulfate authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Pentosan polysulfate: Elmiron.

Are there safety signals or safety updates for Pentosan polysulfate?

US FDA: 1 entry (latest 2021-03-12).

Active substance

Pentosan polysulfate

SFDA 1
US FDA 1
EMA 1
Health Canada 1
US price lines 1
NHS prices 1
Safety 1

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
HEMOCLAR CREAM 0.5GM-100GM	0.5 %	Cream · Topical	1 Tube	SAR 6.00	NCE · Prescription	sanofi-aventis	Invalid · Not Marketed

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
ELMIRON	100MG	capsule · oral	JANSSEN PHARMS	Prescription	26 Sep 1996

EMA European Union — centrally authorised medicines

Elmiron bene-Arzneimittel GmbH · Authorised · authorised 2 Jun 2017 · ATC G04BX15

Therapeutic indication (EMA)

Elmiron is indicated for the treatment of bladder pain syndrome characterized by either glomerulations or Hunner’s lesions in adults with moderate to severe pain, urgency and frequency of micturition.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
ELMIRON	02029448	100 MG	CAPSULE · ORAL	JANSSEN INC

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	ELMIRON 100 MG CAPSULE	$12.09644	per EA	23 Sep 2026
NHS Drug Tariff	Pentosan polysulfate sodium 100mg capsules	£450.00	90 capsule	1 Oct 2026

NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.

Safety signals and safety-related labeling changes

US FDA 12 Mar 2021 ELMIRON — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for pentosan polysulfate →

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.