CLINICAL TRIALS PROFILE FOR PENTOXIL

All Clinical Trials for PENTOXIL

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT02487225 ↗	Pentoxifylline Treatment in Acute Pancreatitis (AP)	Completed	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	Phase 3	2015-05-01	The purpose of this study was to determine the effects (good and bad) of giving a drug called pentoxifylline to patients with acute pancreatitis.
NCT02487225 ↗	Pentoxifylline Treatment in Acute Pancreatitis (AP)	Completed	Mayo Clinic	Phase 3	2015-05-01	The purpose of this study was to determine the effects (good and bad) of giving a drug called pentoxifylline to patients with acute pancreatitis.
NCT01625845 ↗	Anti-INFLammatory to Address Mood and Endothelial Dysfunction (INFLAMED)	Completed	National Institute of Mental Health (NIMH)	Phase 2	2012-06-01	The objective of this clinical trial is to evaluate whether an anti-inflammatory medication, pentoxifylline, reduces depressive symptoms and improves artery function. Participants in this trial will be older primary care patients (60 years and up) who are depressed but do not have a history of cardiovascular disease. Half of these patients will receive pentoxifylline, and half will receive placebo. In addition, participants in both arms will receive an evidence-based psychological treatment called Beating the Blues®, which is a computerized, cognitive behavioral treatment program for depression. The investigators will use questionnaires to assess change in depressive symptoms and an ultrasound test to measure change in artery function from pre- to post-treatment. It is hypothesized that patients who receive pentoxifylline will show greater improvements in both depression and artery function than patients who receive placebo.
NCT01625845 ↗	Anti-INFLammatory to Address Mood and Endothelial Dysfunction (INFLAMED)	Completed	Indiana University	Phase 2	2012-06-01	The objective of this clinical trial is to evaluate whether an anti-inflammatory medication, pentoxifylline, reduces depressive symptoms and improves artery function. Participants in this trial will be older primary care patients (60 years and up) who are depressed but do not have a history of cardiovascular disease. Half of these patients will receive pentoxifylline, and half will receive placebo. In addition, participants in both arms will receive an evidence-based psychological treatment called Beating the Blues®, which is a computerized, cognitive behavioral treatment program for depression. The investigators will use questionnaires to assess change in depressive symptoms and an ultrasound test to measure change in artery function from pre- to post-treatment. It is hypothesized that patients who receive pentoxifylline will show greater improvements in both depression and artery function than patients who receive placebo.

Clinical Trial Conditions for PENTOXIL

Condition Name

Condition Name for PENTOXIL
Intervention	Trials
Idiopathic (Unknown) Acute Pancreatitis	1
Acute Pancreatitis (AP)	1
Major Depressive Disorder	1
Alcoholic Pancreatitis	1

Condition MeSH

Condition MeSH for PENTOXIL
Intervention	Trials
Depressive Disorder, Major	1
Pancreatitis, Alcoholic	1
Depressive Disorder	1
Pancreatitis	1

Clinical Trial Locations for PENTOXIL

Trials by Country

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Trials by Country for PENTOXIL
Location	Trials
United States	2

Trials by US State

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−

Trials by US State for PENTOXIL
Location	Trials
Minnesota	1
Indiana	1

Clinical Trial Progress for PENTOXIL

Clinical Trial Phase

Clinical Trial Phase for PENTOXIL
Clinical Trial Phase	Trials
Phase 3	1
Phase 2	1

Clinical Trial Status

Clinical Trial Status for PENTOXIL
Clinical Trial Phase	Trials
Completed	2

Clinical Trial Sponsors for PENTOXIL

Sponsor Name

Sponsor Name for PENTOXIL
Sponsor	Trials
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	1
Mayo Clinic	1
National Institute of Mental Health (NIMH)	1

Sponsor Type

Sponsor Type for PENTOXIL
Sponsor	Trials
Other	2
NIH	2

Pentoxifylline: Clinical Trials Update, Market Analysis, and Projections

Introduction

Pentoxifylline, a xanthine derivative, has been used for various medical conditions due to its anti-inflammatory, immunomodulatory, and hemorheologic properties. Here, we will delve into the current clinical trials, market analysis, and future projections for this drug.

Clinical Trials Update

COVID-19 and Cytokine Storm Syndrome

A recent randomized clinical trial investigated the effects of pentoxifylline on hospitalized COVID-19 patients with cytokine storm syndrome. The study found no significant improvements in clinical outcomes, such as clinical improvement rates, length of hospital stay, or mortality rates, between the treatment and control groups. However, there were notable changes in some laboratory parameters, including a reduction in IL-6 levels and an increase in lymphocyte counts in both groups after treatment[1].

Preterm Infants with Late-Onset Sepsis or Necrotizing Enterocolitis

The PROTECT study is an ongoing clinical trial evaluating the effect of pentoxifylline on preterm babies with late-onset sepsis or necrotizing enterocolitis. This study aims to determine if pentoxifylline improves survival without disability in these infants. The trial involves intravenous administration of pentoxifylline versus a placebo in infants born at less than 29 weeks gestation and is currently recruiting participants[4].

Market Analysis

Global Market Size and Growth

The global pentoxifylline market was valued at a significant amount in 2018 and is projected to expand at a moderate Compound Annual Growth Rate (CAGR) from 2019 to 2025. The market growth is driven by increasing demand for treatments that address various inflammatory and vascular conditions[5].

Key Market Drivers

• Therapeutic Versatility: Pentoxifylline's broad therapeutic applications, including the treatment of intermittent claudication, cerebrovascular diseases, and inflammatory conditions, contribute to its market growth.
• Research and Development: Ongoing clinical trials and research into new indications, such as COVID-19 and neonatal conditions, are expected to boost market interest and expansion.

Market Segmentation

The market can be segmented based on application, distribution channel, and geography. The therapeutic applications include cardiovascular diseases, respiratory diseases, and neurological conditions, among others. Distribution channels include hospitals, clinics, and retail pharmacies.

Market Projections

Forecasted Growth

The global pentoxifylline market is expected to grow steadily over the forecast period. This growth is anticipated due to the increasing prevalence of chronic diseases, the expanding elderly population, and advancements in healthcare infrastructure[5].

Regional Market Insights

• North America and Europe: These regions are expected to maintain significant market shares due to well-established healthcare systems and high awareness of the drug's benefits.
• Asia-Pacific: This region is projected to experience rapid growth, driven by increasing healthcare spending and a rising incidence of chronic diseases.

Challenges and Opportunities

Challenges

• Generic Competition: The availability of generic versions of pentoxifylline can reduce the market share of branded products.
• Regulatory Hurdles: Strict regulatory requirements and the need for extensive clinical trials can slow down market entry and expansion.

Opportunities

• Emerging Markets: Expanding into emerging markets, particularly in Asia-Pacific, offers significant growth opportunities.
• New Indications: Successful outcomes from ongoing clinical trials, such as the PROTECT study, could open up new therapeutic areas and boost market demand.

Key Takeaways

• Pentoxifylline's clinical trials are ongoing for various indications, including COVID-19 and neonatal conditions.
• The global market is expected to grow at a moderate CAGR driven by therapeutic versatility and ongoing research.
• Regional growth varies, with Asia-Pacific showing the most promising potential.
• Generic competition and regulatory hurdles are key challenges, while emerging markets and new indications offer significant opportunities.

FAQs

What is the current status of pentoxifylline in treating COVID-19 patients with cytokine storm syndrome?

Pentoxifylline did not show significant improvements in clinical outcomes for COVID-19 patients with cytokine storm syndrome in a recent clinical trial, although some laboratory parameters improved[1].

What is the PROTECT study, and what does it aim to achieve?

The PROTECT study is evaluating the effect of pentoxifylline on preterm babies with late-onset sepsis or necrotizing enterocolitis to see if it improves survival without disability in these infants[4].

What are the key drivers of the pentoxifylline market growth?

The market growth is driven by the drug's therapeutic versatility, ongoing research and development, and increasing demand for treatments addressing inflammatory and vascular conditions[5].

How is the pentoxifylline market expected to grow in the Asia-Pacific region?

The Asia-Pacific region is expected to experience rapid growth due to increasing healthcare spending and a rising incidence of chronic diseases[5].

What are the main challenges facing the pentoxifylline market?

The main challenges include generic competition and regulatory hurdles, which can reduce market share and slow down market entry and expansion[5].

Sources

1. Pentoxifylline Effects on Hospitalized COVID-19 Patients with Cytokine Storm Syndrome: A Randomized Clinical Trial - MDPI
2. NSCLC MARKET - Global Drug Forecast & Market Analysis to 2025 - GlobalData
3. United States PENTHROX (Methoxyflurane) Emerging Drug Insight and Market Forecast - 2032 - GlobeNewswire
4. Pentoxifylline to Protect the Preterm Brain (PROTECT) - University of Sydney
5. Pentoxifylline Market Size, Share, Trend and Forecast to 2025 - Prof Research