Summary

KEY INSIGHTS
ZILOSUL, also known as pentosan polysulfate sodium (PPS), is a semi-synthetic medication derived from the wood chips of European beech trees. The extraction process yields glucurono-xylans, which are then sulfated to create a negatively charged substance that resembles glycosaminoglycans (GAGs). GAGs are complex carbohydrates that interact with proteins involved in inflammatory processes, thereby regulating various bodily functions.
PPS is known for its anti-inflammatory and tissue regenerative properties, along with a mild anti-thrombotic effect. Given its multiple mechanisms of action, Paradigm is investigating the potential of PPS to treat a range of conditions that originate from and are maintained by inflammation, such as osteoarthritis. This approach is particularly relevant given the increased prevalence of osteoarthritis and the demand for effective osteoarthritis treatments.
The drug is developed by Paradigm Biopharmaceuticals Limited, an Australian biopharmaceutical company dedicated to developing innovative therapies aimed at addressing unmet medical needs. The company’s focus is on the late-stage development of treatments derived from pentosan polysulfate sodium (PPS), a semi-synthetic compound with potential applications in a wide range of diseases. Paradigm’s current research pipeline includes the development of PPS-based therapies targeting inflammatory conditions, particularly respiratory disorders such as allergic rhinitis, allergic asthma, and chronic obstructive pulmonary disease.
MARKET POTENTIAL AND POSITIONING
ZILOSUL is a semi-synthetic drug formulated with pentosan polysulfate sodium (PPS), sourced from xylans of European beech trees. It is specifically designed to treat osteoarthritis by targeting the underlying disease mechanisms rather than simply alleviating symptoms. ZILOSUL supports the health of cartilage and joint tissues, which may lead to enhanced joint function and reduced pain for patients.
Administered through subcutaneous injection, the drug is currently in Phase III clinical trials to determine its efficacy and safety in individuals with osteoarthritis. Its distinctive mechanism of action presents ZILOSUL as a promising new treatment option in the evolving field of osteoarthritis management.
In March 2023, Paradigm Biopharmaceuticals announced it had obtained parallel regulatory and ethics approvals for the pivotal PARA_OA_002 clinical trial across Belgium, Poland, and the Czech Republic. The Phase III PARA_OA_002 trial is a randomized, double-blind, placebo-controlled, multicenter study (spanning the US, Australia, the UK, the EU, and Canada) designed to assess the dosage and therapeutic effect of injectable pentosan polysulfate sodium (iPPS) in participants suffering from knee osteoarthritis pain. The application for the PARA_OA_002 trial was submitted through Europe’s newly established Clinical Trials Information System (CTIS) for evaluation in three European nations.
REGIONAL ANALYSIS
Inkwood Research offers an analysis of seven key markets:
• United States
• Germany
• France
• United Kingdom
o The UK Government has allocated approximately £69 million (~ $86 million) for research into musculoskeletal (MSK) conditions, including osteoarthritis. However, this amount is considered insufficient to adequately address the growing needs of patients suffering from these debilitating conditions.
o Organizations like Versus Arthritis have called on the government to increase funding for MSK research to develop more effective treatments and interventions. They argue that more substantial investment is necessary to keep pace with the rising prevalence of osteoarthritis and other related disorders, improve patient outcomes, and reduce the long-term healthcare costs associated with these conditions.
o Moreover, the UK’s healthcare system, the NHS, is focusing on improving patient access to cutting-edge treatments and rehabilitation programs. This holistic approach, supported by ongoing investments, aims to reduce the overall burden of osteoarthritis on the healthcare system, improve patient outcomes, and enhance the quality of life for those affected.
• Italy
• Spain
• Japan

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Table of Contents

TABLE OF CONTENTS
1. INTRODUCTION TO THE REPORT
2. ZILOSUL OVERVIEW
2.1. PRODUCT DETAIL
2.2. CLINICAL DEVELOPMENT
2.2.1. CLINICAL STUDIES
2.2.2. CLINICAL TRIALS INFORMATION
2.3. OTHER DEVELOPMENTAL ACTIVITIES
2.4. PRODUCT PROFILE
3. COMPETITIVE LANDSCAPE
3.1. MARKETED THERAPIES
3.2. LATE-STAGE EMERGING THERAPIES
4. ZILOSUL MARKET ASSESSMENT
4.1. MARKET OUTLOOK OF ZILOSUL IN OSTEOARTHRITIS
5. 7 MAJOR MARKET’S ANALYSIS
5.1. MARKET SIZE OF ZILOSUL IN THE 7 MAJOR MARKETS FOR OSTEOARTHRITIS
5.2. 7 COUNTRY ANALYSIS
5.2.1. MARKET SIZE OF ZILOSUL IN UNITED STATES FOR OSTEOARTHRITIS
5.2.2. MARKET SIZE OF ZILOSUL IN GERMANY FOR OSTEOARTHRITIS
5.2.3. MARKET SIZE OF ZILOSUL IN FRANCE FOR OSTEOARTHRITIS
5.2.4. MARKET SIZE OF ZILOSUL IN ITALY FOR OSTEOARTHRITIS
5.2.5. MARKET SIZE OF ZILOSUL IN SPAIN FOR OSTEOARTHRITIS
5.2.6. MARKET SIZE OF ZILOSUL IN UNITED KINGDOM FOR OSTEOARTHRITIS
5.2.7. MARKET SIZE OF ZILOSUL IN JAPAN FOR OSTEOARTHRITIS
6. SWOT ANALYSIS
7. ANALYST PERSPECTIVE