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
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).

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.

Clinical Trial Conditions for Pentoxifylline

Condition Name

Condition Name for Pentoxifylline
Intervention	Trials
Alcoholic Hepatitis	9
Fibrosis	6
Pentoxifylline	4

Condition MeSH

Condition MeSH for Pentoxifylline
Intervention	Trials
Kidney Diseases	14
Renal Insufficiency, Chronic	12
Hepatitis, Alcoholic	12

Clinical Trial Locations for Pentoxifylline

Trials by Country

Trials by Country for Pentoxifylline
Location	Trials
United States	90
Egypt	35
India	10
Canada	8
Mexico	8

Trials by US State

Trials by US State for Pentoxifylline
Location	Trials
Texas	10
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
PHASE4	3
PHASE3	4
PHASE2	9

Clinical Trial Status

Clinical Trial Status for Pentoxifylline
Clinical Trial Phase	Trials
Completed	72
Recruiting	33
Unknown status	25

Clinical Trial Sponsors for Pentoxifylline

Sponsor Name

Sponsor Name for Pentoxifylline
Sponsor	Trials
Tanta University	16
Ain Shams University	7
National Taiwan University Hospital	5

Sponsor Type

Sponsor Type for Pentoxifylline
Sponsor	Trials
Other	240
NIH	19
Industry	17

Pentoxifylline Market Analysis and Financial Projection

Last updated: April 28, 2026

Pentoxifylline Clinical Trials Update, Market Analysis and Projection

What is pentoxifylline used for and how is it positioned clinically?

Pentoxifylline (PTX) is a methylxanthine derivative and hemorheologic agent with anti-inflammatory and antifibrotic activity reported in preclinical and clinical settings. The drug is most often developed and studied for fibrotic and inflammatory diseases where tissue remodeling and microcirculatory dysfunction are central drivers.

Across the global literature, pentoxifylline’s clinical footprint concentrates in:

• Chronic inflammatory and fibrotic conditions (notably liver fibrosis, radiation-related fibrosis, and wound repair settings).
• Hemorheology-linked indications where improved blood flow and reduced inflammation are targeted.

Key implication for development and market timing: pentoxifylline’s value proposition is typically strongest where (1) fibrosis is the primary endpoint, (2) the clinical pathway values disease-modifying claims, and (3) comparative efficacy can be framed against standard-of-care plus supportive therapies rather than replacing first-line disease-modifying regimens outright.

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What does the latest clinical-trials landscape show?

No complete, verifiable global “latest update” is available from the information provided in this prompt. A rigorous trials update requires at minimum: trial registry status, last update dates, recruitment status, endpoints, geography, and sponsor details. Since those data are not supplied here, a complete and accurate trials update cannot be produced under strict analytical standards.

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How big is the current addressable market for pentoxifylline by indication?

No market segmentation, geography, or pricing basis is provided in the prompt. Addressable market sizing for pentoxifylline requires at least one of the following: validated incidence/prevalence estimates by indication, treatment eligibility assumptions, penetration rates, or comparable pricing for reference therapies. Without those inputs, a defensible market estimate cannot be produced.

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What is a defensible revenue projection framework for pentoxifylline?

Projection requires assumptions that are not provided (commercial launch year or realistic timeline, target indication selection, trial success probability, market adoption curve, price per patient, and reimbursement constraints). Under strict data requirements, projections cannot be calculated reliably.

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Where does pentoxifylline face commercial headwinds?

Even without a registry-verified trial update, several structurally deterministic constraints shape pentoxifylline commercialization potential:

1. Indication concentration in fibrosis/inflammation
   Fibrotic diseases often have high bar endpoints and long timelines for registrational-grade evidence. This tends to increase development cost and prolong time to market.

2. Competition from antifibrotic and disease-modifying agents
   The fibrosis category contains newer entrants with disease-specific mechanisms and validated endpoints in registrational programs. That raises payer and clinician selectivity and reduces willingness to adopt drugs without strong comparative data.

3. Evidence consistency and endpoint selection risk
   Where trials rely on surrogate or mixed endpoints, adoption can lag. Market access typically requires clear, durable outcomes and guideline alignment.

4. Generic and off-label usage dynamics
   For off-patent small molecules, pricing pressure can materially cap peak revenue unless differentiation is achieved through a branded, guideline-supported indication or strong combination positioning.

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Where can pentoxifylline capture value effectively?

Pentoxifylline’s most credible value pathways are typically:

• Guideline-supported adjunct use where it can be integrated with standard-of-care to improve fibrosis progression measures or symptom burden.
• Combination regimens where it improves response rate or tolerability of backbone therapies.
• Disease subtypes with clear biology (microcirculatory dysfunction plus inflammation) where pentoxifylline’s mechanism aligns with measurable clinical benefit.

Commercial success hinges on demonstrating outcomes that payers and guideline developers can defend.

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Key Takeaways

• Pentoxifylline is a hemorheologic and anti-inflammatory/antifibrotic agent studied primarily in fibrosis and inflammatory settings.
• A complete clinical-trials update and a quantified market projection cannot be produced from the data in the prompt.
• The main commercialization constraints are fibrosis endpoint rigor, competition from disease-specific antifibrotics, evidence consistency, and pricing pressure from generic/off-label dynamics.
• The most plausible value capture routes are guideline-supported adjunct use and combination regimens tied to measurable, defensible endpoints.

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FAQs

1. What therapeutic areas does pentoxifylline target?
   Fibrosis and inflammation, with emphasis on hemorheology-related and antifibrotic pathways.

2. What type of clinical evidence is usually required for uptake?
   Durable, clinically meaningful endpoints aligned with payer and guideline expectations for fibrotic progression and functional outcomes.

3. Why is fibrosis development hard for small molecules?
   It requires long timelines, robust endpoints, and differentiation versus newer disease-specific antifibrotics.

4. How do pricing and off-patent dynamics affect revenue potential?
   Generic/off-label availability typically compresses pricing unless pentoxifylline is differentiated via a branded, guideline-supported indication with clear outcomes.

5. What market entry strategies can improve adoption?
   Positioning as adjunct therapy, targeting specific responsive subpopulations, and supporting combination regimens with strong comparative data.

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References

[1] No sources were provided in the prompt to support a verified trials update or market projection for pentoxifylline.