CLINICAL TRIALS PROFILE FOR PENTOXIFYLLINE

505(b)(2) Clinical Trials for PENTOXIFYLLINE

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
OTC	NCT06016452 ↗	A Study of Chlorophyllin for the Management of Brain Radio-necrosis in Patients With Diffuse Glioma	Recruiting	Bhabha Atomic Research Centre (BARC)	Phase 2	2023-11-13	Diffuse gliomas are common tumors involving the brain. They are usually treated by surgery followed by radiation and chemotherapy. Radiotherapy is used for the treatment of brain tumors which causes damage to the tumor cells. However, radiotherapy can also affect the surrounding healthy cells in the brain, causing inflammation and swelling in the region, which is known as radio necrosis (RN). This is considered a late side effect of radiation and is seen in 10-25% of patients treated with radiation for brain tumors. Sometimes, radionecrosis can be detected on routine imaging during follow-up without new symptoms (asymptomaticRN). At the same time, in some patients, it can give rise to new symptoms like headaches, weakness, seizures,etc (symptomatic RN). The standard treatment of RN includes steroid medicines called dexamethasone, which is helpful in a proportion of patients. This is a prospective phase 2 study. This study is being conducted to investigate the ability of the drug Chlorophyllin in the treatment of radionecrosis. Chlorophyllin is a water-soluble compound obtained from the green plant pigment called chlorophyll. It has been shown to have anti-cancer, anti-bacterial, anti-viral, anti-inflammatory, and antioxidant properties. It is also used as an oral formulation and is an over-the-counter drug in various countries, and also as a food colouring agent. This is the first time chlorophyllin will be used in the setting of brain radionecrosis. Our primary aim of the study is to assess whether CHL will improve the clinical-radiological response rates. This study will be conducted on a population of 118 patients for a duration of 3 months. The total study duration is 2 years. The study is funded by Bhabha Atomic Research Centre (BARC).
OTC	NCT06016452 ↗	A Study of Chlorophyllin for the Management of Brain Radio-necrosis in Patients With Diffuse Glioma	Recruiting	Tata Memorial Centre	Phase 2	2023-11-13	Diffuse gliomas are common tumors involving the brain. They are usually treated by surgery followed by radiation and chemotherapy. Radiotherapy is used for the treatment of brain tumors which causes damage to the tumor cells. However, radiotherapy can also affect the surrounding healthy cells in the brain, causing inflammation and swelling in the region, which is known as radio necrosis (RN). This is considered a late side effect of radiation and is seen in 10-25% of patients treated with radiation for brain tumors. Sometimes, radionecrosis can be detected on routine imaging during follow-up without new symptoms (asymptomaticRN). At the same time, in some patients, it can give rise to new symptoms like headaches, weakness, seizures,etc (symptomatic RN). The standard treatment of RN includes steroid medicines called dexamethasone, which is helpful in a proportion of patients. This is a prospective phase 2 study. This study is being conducted to investigate the ability of the drug Chlorophyllin in the treatment of radionecrosis. Chlorophyllin is a water-soluble compound obtained from the green plant pigment called chlorophyll. It has been shown to have anti-cancer, anti-bacterial, anti-viral, anti-inflammatory, and antioxidant properties. It is also used as an oral formulation and is an over-the-counter drug in various countries, and also as a food colouring agent. This is the first time chlorophyllin will be used in the setting of brain radionecrosis. Our primary aim of the study is to assess whether CHL will improve the clinical-radiological response rates. This study will be conducted on a population of 118 patients for a duration of 3 months. The total study duration is 2 years. The study is funded by Bhabha Atomic Research Centre (BARC).
New Indication	NCT05387187 ↗	Evaluate the Effect and Safety of Pu Yang Wan Wu Tang and Western Medicine on Chronic Kidney Disease	Not yet recruiting	Taipei Medical University Hospital	Phase 2/Phase 3	2022-06-01	The indication of Pu Yang Wan Wu Tang is stroke sequelae, such as half body paralysis, aphasia and muscle weakness. Pu Yang Wan Wu Tang is proved to have the effect of protecting nerve and blood vessel, anti-inflammation, anti-coagulation, dilating peripheral vessel, promot-ing micro circulation, improving hemodynamics, and activating central nerve system. Huangqi could attenuate podocyte injury by regulating the expression and distribu-tion of nephrin and podocin. Huangqi and Danggui are associated with fewer infiltra-tion of macrophages and limitation of renal intrinsic cell activation, which may lead to earlier and persistent reduction of proteinuria. This research will use the compound Chinese medicine, Pu Yang Wan Wu Tang. Those treatments combined Western medicine to assess the efficacy and drug safety on the CKD cases. Series of blood and urine were collected regularly during study to prove the role of Chinese medicine in the treatment of CKD, and to assess their drug safety. The final goal of the plan is to establish the new indication of Pu Yang Wan Wu Tang and enhance the interaction and cooperation between Chinese and Western medicine.

All Clinical Trials for PENTOXIFYLLINE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00001437 ↗	Trial of Pentoxifylline in Patients With Functional Disability Caused by Radiation-Induced Advanced Regional Fibrosis	Completed	National Cancer Institute (NCI)	Phase 2	1995-06-01	After initial assessment of their condition by specified clinical and laboratory parameters, each of the patients will be treated for 8 weeks at the standard pentoxifylline dose (400 mg po TID). Objective and subjective response parameters will be re-assessed at the end of the treatment and 8 weeks later for possible decay of response.
NCT00000579 ↗	Acute Respiratory Distress Syndrome Clinical Network (ARDSNet)	Completed	National Heart, Lung, and Blood Institute (NHLBI)	Phase 3	1994-09-01	The purposes of this study are to assess rapidly innovative treatment methods in patients with adult respiratory distress syndrome (ARDS) as well as those at risk of developing ARDS and to create a network of interactive Critical Care Treatment Groups (CCTGs) to establish and maintain the required infrastructure to perform multiple therapeutic trials that may involve investigational drugs, approved agents not currently used for treatment of ARDS, or treatments currently used but whose efficacy has not been well documented.
NCT00000646 ↗	Pentoxifylline (Trental) as a Modulator of Tumor Necrosis Factor and of HIV Replication in Patients With AIDS	Completed	Hoechst Marion Roussel	Phase 1	1969-12-31	To determine whether pentoxifylline lowers tumor necrosis factor (TNF) levels in AIDS patients. Pentoxifylline decreases tumor necrosis factor (TNF), and therefore should decrease such TNF-intensified events as cachexia, enhanced HIV expression, and inhibition of zidovudine (AZT) activity.
NCT00000646 ↗	Pentoxifylline (Trental) as a Modulator of Tumor Necrosis Factor and of HIV Replication in Patients With AIDS	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 1	1969-12-31	To determine whether pentoxifylline lowers tumor necrosis factor (TNF) levels in AIDS patients. Pentoxifylline decreases tumor necrosis factor (TNF), and therefore should decrease such TNF-intensified events as cachexia, enhanced HIV expression, and inhibition of zidovudine (AZT) activity.

Clinical Trial Conditions for PENTOXIFYLLINE

Condition Name

Condition Name for PENTOXIFYLLINE
Intervention	Trials
Alcoholic Hepatitis	7
Fibrosis	4
HIV Infections	4
Breast Cancer Female	3

Condition MeSH

Condition MeSH for PENTOXIFYLLINE
Intervention	Trials
Kidney Diseases	14
Syndrome	11
Hepatitis, Alcoholic	10
Hepatitis A	10

Clinical Trial Locations for PENTOXIFYLLINE

Trials by Country

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−

Trials by Country for PENTOXIFYLLINE
Location	Trials
United States	87
Egypt	23
India	8
Mexico	8
Canada	7

Trials by US State

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−

Trials by US State for PENTOXIFYLLINE
Location	Trials
Texas	8
Ohio	7
Minnesota	6
Illinois	5
California	5

Clinical Trial Progress for PENTOXIFYLLINE

Clinical Trial Phase

Clinical Trial Phase for PENTOXIFYLLINE
Clinical Trial Phase	Trials
Phase 4	25
Phase 3	27
Phase 2/Phase 3	12

Clinical Trial Status

Clinical Trial Status for PENTOXIFYLLINE
Clinical Trial Phase	Trials
Completed	63
Unknown status	25
Recruiting	25

Clinical Trial Sponsors for PENTOXIFYLLINE

Sponsor Name

Sponsor Name for PENTOXIFYLLINE
Sponsor	Trials
Tanta University	10
Ain Shams University	5
National Taiwan University Hospital	5

Sponsor Type

Sponsor Type for PENTOXIFYLLINE
Sponsor	Trials
Other	212
NIH	18
Industry	13

Pentoxifylline: Clinical Trials, Market Analysis, and Projections

Introduction

Pentoxifylline, a xanthine derivative, has been widely used in the management of peripheral vascular disease and other conditions due to its anti-inflammatory, anti-fibrotic, and hemorheological properties. This article provides an update on the clinical trials, market analysis, and projections for pentoxifylline.

Clinical Trials and Efficacy

Peripheral Vascular Disease

Pentoxifylline is primarily used to treat symptoms of intermittent claudication due to peripheral vascular disease. It improves blood flow by reducing viscosity and enhancing red blood cell flexibility, thereby alleviating symptoms such as pain and cramping in the legs[1].

Venous Ulcers

Clinical studies, including a Cochrane review, have shown that pentoxifylline is effective in treating venous ulcers, both with and without compression therapy, compared to placebo or no treatment[1].

Severe Alcoholic Hepatitis

Pentoxifylline has been found to be beneficial in treating severe alcoholic hepatitis, particularly when contraindications to corticosteroids exist. It acts as a tumor necrosis factor-α (TNF-α) inhibitor, reducing the risk of fatal hepatorenal syndrome[1].

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 that pentoxifylline reduced inflammatory markers such as IL-6 and improved clinical outcomes, although the differences in hospital stay and mortality were not statistically significant[4].

Other Indications

Pentoxifylline has also shown promise in reducing ischemia-reperfusion injury, drug-induced nephrotoxicity, and improving outcomes in patients undergoing cardiopulmonary bypass and those with type-2 diabetic nephropathy[1].

Mechanism of Action

Pentoxifylline's therapeutic effects are attributed to its ability to:

• Inhibit phosphodiesterase, which improves blood flow.
• Enhance leukocyte deformability and chemotaxis.
• Depress neutrophil degranulation and endothelial leukocyte adhesion.
• Lower the sensitivity of leukocytes to cytokines and inhibit the production of inflammatory cytokines[1].

Market Analysis

Global Market Size and Growth

The global pentoxifylline market was valued at USD XX million in 2022 and is expected to expand at a significant CAGR during the forecast period, reaching USD XX million by 2028. The market growth is driven by increasing demand for treatments of peripheral vascular diseases and other conditions where pentoxifylline is effective[3].

Market Segmentation

The market is segmented by type (tablets, injections, others) and by application (hospitals, medical centers, others). This segmentation helps in understanding the market dynamics and identifying potential growth areas[3].

Regional Analysis

The pentoxifylline market is analyzed across various regions including North America, Asia Pacific, Europe, Latin America, Middle East, and Africa. Each region presents different market situations and prospects, influenced by local healthcare policies, economic conditions, and the prevalence of relevant diseases[3].

Competitive Landscape

The market is competitive with several leading players. The competitive landscape includes analysis of sales, price, revenue, gross margin, and product profiles of these key players. This information is crucial for businesses to make informed decisions regarding their market strategies[3].

Market Projections

Forecast to 2029

The global and Chinese pentoxifylline markets are expected to continue growing, driven by increasing demand and advancements in manufacturing technology. The forecast includes projections on capacity, production, and production value, as well as supply and consumption trends[2].

Economic Impact

The macroeconomic environment, including global inflation and regional conflicts such as the Russia-Ukraine war, can influence the pentoxifylline market. Understanding these factors is essential for predicting market trends and making strategic business decisions[2].

Market Opportunities and Challenges

The pentoxifylline market presents several opportunities, including the growing need for effective treatments for peripheral vascular diseases and other conditions. However, challenges such as regulatory hurdles, competition from alternative treatments, and economic uncertainties must also be considered[2].

Industry Chain and Manufacturing

Industry Chain Structure

The pentoxifylline industry chain includes upstream raw materials, manufacturing processes, and downstream applications. Understanding the industry chain helps in identifying potential bottlenecks and opportunities for improvement[2].

Manufacturing Process

Advancements in manufacturing technology have improved the production efficiency and quality of pentoxifylline. The manufacturing process involves several stages, from raw material sourcing to final product formulation[2].

Key Takeaways

• Clinical Efficacy: Pentoxifylline has demonstrated efficacy in treating peripheral vascular disease, venous ulcers, severe alcoholic hepatitis, and other conditions.
• Market Growth: The global pentoxifylline market is expected to grow significantly, driven by increasing demand and advancements in manufacturing technology.
• Regional Analysis: The market varies across different regions, influenced by local healthcare policies and economic conditions.
• Competitive Landscape: The market is competitive, with several leading players, and understanding their strategies is crucial for business success.
• Economic Impact: Macroeconomic factors and regional conflicts can influence the market, and businesses must be aware of these to make informed decisions.

FAQs

What are the primary indications for pentoxifylline?

Pentoxifylline is primarily used to treat symptoms of intermittent claudication due to peripheral vascular disease. It is also effective in treating venous ulcers and severe alcoholic hepatitis.

How does pentoxifylline work?

Pentoxifylline improves blood flow by reducing viscosity and enhancing red blood cell flexibility. It also has anti-inflammatory and immunomodulatory effects by inhibiting the production of inflammatory cytokines and improving leukocyte deformability.

What is the current market size of the pentoxifylline market?

The global pentoxifylline market was valued at USD XX million in 2022 and is expected to expand significantly during the forecast period.

Which regions are key in the pentoxifylline market?

The market is analyzed across various regions including North America, Asia Pacific, Europe, Latin America, Middle East, and Africa, each presenting different market situations and prospects.

What are the potential challenges for the pentoxifylline market?

Challenges include regulatory hurdles, competition from alternative treatments, and economic uncertainties such as global inflation and regional conflicts.

Sources

1. Pentoxifylline - StatPearls - NCBI Bookshelf: This source provides detailed information on the clinical use, mechanism of action, and pharmacokinetics of pentoxifylline[1].
2. Pentoxifylline Market Size, Share, Trend and Forecast to 2025: This report offers comprehensive market analysis, including market size, growth trends, and regional analysis[2].
3. Pentoxifylline Drug Market by Industry Analysis : 2032: This report provides insights into the market driving factors, restraints, and growth opportunities for the pentoxifylline market[3].
4. Pentoxifylline Effects on Hospitalized COVID-19 Patients with Cytokine Storm Syndrome: A Randomized Clinical Trial: This study discusses the efficacy of pentoxifylline in treating COVID-19 patients with cytokine storm syndrome[4].