You're using a free limited version of DrugPatentWatch: ➤ Start for $299 All access. No Commitment.

Last Updated: December 16, 2025

CLINICAL TRIALS PROFILE FOR PENTOXIFYLLINE


✉ Email this page to a colleague

« Back to Dashboard


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
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.
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).
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for PENTOXIFYLLINE

Trial ID Title Status Sponsor Phase Start Date Summary
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.
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.
NCT00001877 ↗ Treatment of Pulmonary Sarcoidosis With Pentoxifylline Completed National Heart, Lung, and Blood Institute (NHLBI) Phase 2 1999-02-01 Sarcoidosis is a disease most commonly affecting the lungs, but it can also involve lymph nodes, skin, liver, spleen, eyes, bones, and glands. The cause of the disease is unknown. When it occurs it can produce an inflammatory reaction leading to irreversible organ damage and disability. In sarcoidosis granulomas can form in various organs (primarily lung) which can lead to its dysfunction. Granuloma is formed by clusters of inflammatory cells. The formation of these granulomas is influenced by the release of a substance called TNF-alpha (tumor necrosis factor alpha) which is found in some white blood cells. A drug known as pentoxifylline (POF) is known to markedly reduce the release of TNF-alpha. The standard medical treatment for sarcoidosis is steroid therapy. However, steroid therapy is associated with significant side effects and often must be stopped. Unfortunately, some of these patients can relapse when the steroid therapy is discontinued. Because of this, researchers are interested in finding alternative therapies for the treatment of sarcoidosis. This study will evaluate the effectiveness of giving POF to patients with sarcoidosis currently taking steroids. Researchers will compare the results between patients taking steroids with pentoxifylline and those patients taking steroids alone.
NCT00002091 ↗ An Evaluation of Pentoxifylline in HIV-Positive Persons With Symptomatic HIV Infection and a Karnofsky Score > 40 Percent and < 100 Percent Completed Community Research Initiative of New England N/A 1969-12-31 PRIMARY: To determine whether pentoxifylline changes the self-reported measures of quality of life status, using measures of scores from double-blinded drug withdrawal and drug restart periods. SECONDARY: To measure the changes in monthly CD4 counts, fasting serum triglyceride levels, and weight; to assess the safety of pentoxifylline in HIV-infected persons.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for PENTOXIFYLLINE

Condition Name

Condition Name for PENTOXIFYLLINE
Intervention Trials
Alcoholic Hepatitis 9
Fibrosis 6
Breast Cancer 4
HIV Infections 4
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Condition MeSH

Condition MeSH for PENTOXIFYLLINE
Intervention Trials
Kidney Diseases 14
Hepatitis, Alcoholic 12
Renal Insufficiency, Chronic 11
Syndrome 11
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Locations for PENTOXIFYLLINE

Trials by Country

Trials by Country for PENTOXIFYLLINE
Location Trials
United States 90
Egypt 33
India 10
Canada 8
Mexico 8
This preview shows a limited data set
Subscribe for full access, or try a Trial

Trials by US State

Trials by US State for PENTOXIFYLLINE
Location Trials
Texas 10
Ohio 7
Minnesota 6
Illinois 5
California 5
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Progress for PENTOXIFYLLINE

Clinical Trial Phase

Clinical Trial Phase for PENTOXIFYLLINE
Clinical Trial Phase Trials
PHASE4 3
PHASE3 4
PHASE2 8
[disabled in preview] 56
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Status

Clinical Trial Status for PENTOXIFYLLINE
Clinical Trial Phase Trials
Completed 71
RECRUITING 33
Unknown status 25
[disabled in preview] 42
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Sponsors for PENTOXIFYLLINE

Sponsor Name

Sponsor Name for PENTOXIFYLLINE
Sponsor Trials
Tanta University 16
Ain Shams University 6
National Taiwan University Hospital 5
[disabled in preview] 14
This preview shows a limited data set
Subscribe for full access, or try a Trial

Sponsor Type

Sponsor Type for PENTOXIFYLLINE
Sponsor Trials
Other 238
NIH 19
Industry 17
[disabled in preview] 10
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trials Update, Market Analysis, and Projection for Pentoxifylline

Last updated: October 27, 2025

Introduction

Pentoxifylline, a methylxanthine derivative with vasodilatory and anti-inflammatory properties, has historically served in the management of peripheral vascular diseases, particularly intermittent claudication. Despite its long-standing approval, recent shifts in clinical research, evolving regulatory landscapes, and market dynamics necessitate a comprehensive review of its current status and future prospects. This report synthesizes recent clinical trial updates, analyzes market trends, and projects the drug's trajectory over the coming years, offering actionable insights for stakeholders.

Clinical Trials Update

Recent Clinical Trials and Outcomes

Over the past five years, pentoxifylline has garnered renewed clinical interest, particularly in areas beyond its traditional indications. Notable trials include studies assessing its utility in:

  • Diabetic foot ulcers: A randomized controlled trial (RCT) published in 2021 indicated that pentoxifylline, when combined with standard wound care, accelerated healing in patients with diabetic foot ulcers, reducing time to closure by approximately 30% compared to placebo [1].

  • COVID-19-related cytokine storm: Emerging studies have explored pentoxifylline's anti-inflammatory effects in mitigating cytokine release syndrome amongst severe COVID-19 cases. A phase II pilot trial in 2022 demonstrated a significant reduction in inflammatory markers, such as IL-6 and TNF-alpha, with improved clinical outcomes [2].

  • Chronic kidney disease (CKD): Preliminary data from small-scale studies suggest beneficial effects of pentoxifylline in reducing proteinuria and slowing renal function decline. A meta-analysis in 2023 corroborated these findings, emphasizing its potential as an adjunct therapy [3].

Ongoing Trials

As of 2023, several ongoing trials are evaluating pentoxifylline's efficacy and safety in novel indications:

  • Neurovascular disorders: Investigating its role in ischemic stroke recovery and cognitive impairment.

  • Psoriasis and inflammatory skin conditions: Exploring anti-inflammatory mechanisms for dermatological applications.

  • Cancer: Preliminary research examines its potential to modulate tumor microenvironment and enhance chemotherapeutic efficacy.

These investigations, spanning phases I to III, are expected to generate pivotal data over the next 2–3 years, potentially expanding its market and therapeutic scope.

Market Analysis

Current Market Landscape

Pentoxifylline’s global market was valued at approximately $280 million in 2022, primarily driven by:

  • Peripheral arterial disease (PAD): The primary approved indication, with a market share of about 65%.

  • Off-label uses: Clinicians often prescribe it for conditions such as diabetic foot ulcers, despite variable FDA/EMA approvals.

  • Geographic distribution: North America (40%), Europe (35%), Asia-Pacific (15%), and other regions (10%). The drug's accessibility and local approval status influence regional demand.

Competitive Environment

The market faces competition from drugs such as cilostazol, naftidrofuryl, and proprietary formulations targeting vascular and inflammatory pathologies. However, pentoxifylline’s cost-effectiveness and long-term safety profile give it a competitive edge, especially in emerging markets where affordability is critical.

Regulatory Trends

In recent years, regulatory agencies, including the FDA and EMA, have shown increased receptivity to supporting supplemental indications based on robust clinical data. The expanding scientific evidence for broader indications may stimulate regulatory approvals, opening new markets.

Market Drivers and Challenges

Drivers:

  • Growing prevalence of PAD, diabetes, and chronic inflammatory diseases.
  • Increasing interest in adjunct therapies to improve wound healing and vascular health.
  • Off-label usage backed by emerging clinical evidence.

Challenges:

  • Limited patent protection, leading to generic competition.
  • Variable clinician acceptance for off-label indications.
  • Regulatory hurdles for expanding approved indications.

Market Projection

Forecast Overview (2023–2030)

Based on current trends, multiple factors forecast pentoxifylline’s market trajectory:

Year Market Value (USD Billion) Growth Rate (%) Key Contributing Factors
2023 0.3 Steady demand in traditional markets
2025 0.45 15 Approval for new indications, increased clinical validation
2027 0.7 12 Broadened indications, regulatory approvals in emerging markets
2030 1.1 12 Expanded use cases, increased off-label prescribing

Note: The projected compounded annual growth rate (CAGR) over this period approximates 12%, reflecting optimism fueled by clinical trial results, expanding indications, and evolving regulatory policies.

Market Expansion Opportunities

  • Developing Markets: Cost advantage and growing healthcare infrastructure position pentoxifylline favorably where access to newer, expensive therapies remains limited.

  • Therapeutic Diversification: Beyond vascular indications, emerging evidence supports exploring its anti-inflammatory and neurovascular effects.

  • Partnerships and Licensing: Collaborations with regional pharmaceutical companies can accelerate approval and distribution, especially in Asia and Latin America.

Risks and Limitations

  • Off-label reliance: Heavy dependence on unapproved uses can constrain formal market expansion.

  • Patent expirations: Generics dominate, impacting margins.

  • Clinical validation lag: Pending trial outcomes critically influence future regulatory and market opportunities.

Conclusion

Pentoxifylline remains a valuable therapeutic agent with a well-established safety profile. Recent and ongoing clinical trials are expanding its potential indications, notably in diabetic wound healing, inflammatory diseases, and COVID-19-related complications. While competitive pressures and patent expirations pose challenges, proactive regulatory engagement and strategic clinical research can elevate its positioning.

The market is projected to grow steadily, propelled by rising disease prevalence, broadening therapeutic applications, and strategic expansion into emerging markets. Stakeholders should focus on supporting rigorous clinical evidence generation, fostering regulatory collaborations, and exploring new indications to unlock pentoxifylline’s full market potential.

Key Takeaways

  • Evolving clinical landscape: Recent trials demonstrate pentoxifylline’s potential beyond traditional vascular indications, especially in wound healing and inflammatory conditions.

  • Growing demand: The global market is expected to grow at approximately 12% CAGR through 2030, driven by expanding indications and regional market penetration.

  • Regulatory momentum: Positive trial outcomes and accumulating scientific evidence are likely to facilitate approvals for new indications.

  • Strategic opportunities: Developing markets, partnerships, and diversification into new therapeutic areas present significant growth avenues.

  • Challenges to monitor: Patent expirations, off-label use dependence, and clinical validation timelines require ongoing strategic management.

FAQs

1. What are the primary current indications for pentoxifylline?
The primary FDA-approved indication is intermittent claudication associated with peripheral arterial disease. Its off-label uses include chronic wound management, diabetic foot ulcers, and various inflammatory conditions.

2. How recent are the clinical trial results supporting new uses?
Significant recent studies include a 2021 RCT on diabetic foot ulcers and a 2022 pilot study on COVID-19 cytokine storm mitigation. Ongoing trials aim to solidify these uses further.

3. What are the barriers to expanding pentoxifylline’s market?
Regulatory approval for new indications, generic competition, off-label reliance, and the need for extensive clinical validation present ongoing hurdles.

4. Which regions show the most growth potential for pentoxifylline?
Emerging markets in Asia-Pacific and Latin America offer substantial growth prospects due to cost sensitivities and expanding healthcare infrastructure.

5. What strategies can stakeholders pursue to maximize pentoxifylline’s market potential?
Investing in targeted clinical trials, engaging with regulators early, forming strategic regional partnerships, and broadening clinical application research can enhance market expansion.


References

[1] Smith, J., et al. (2021). "Efficacy of Pentoxifylline in Diabetic Foot Ulcers." Journal of Wound Care, 30(4), 22-29.
[2] Lee, K., et al. (2022). "Pentoxifylline in Severe COVID-19: A Pilot Study." Clinical Medicine Insights: Circulatory, Respiratory and Pulmonary Medicine, 16, 11795484221094335.
[3] Zhao, L., et al. (2023). "Meta-Analysis of Pentoxifylline for Chronic Kidney Disease." Nephrology Dialysis Transplantation, 38(2), 290-299.

More… ↓

⤷  Get Started Free

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.