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.
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.

Clinical Trial Conditions for pentoxifylline

Condition Name

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

Condition MeSH

Condition MeSH for pentoxifylline
Intervention	Trials
Kidney Diseases	14
Hepatitis, Alcoholic	12
Renal Insufficiency, Chronic	12
Syndrome	11

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 Heart, Lung, and Blood Institute (NHLBI)	5

Sponsor Type

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

Last updated: July 28, 2026

Pentoxifylline Clinical Trials Update, Market Analysis, and Revenue Projection (2026-2036)

Pentoxifylline is an immunomodulatory xanthine derivative with limited global late-stage development visibility and no widely adopted, blockbuster-grade commercial footprint. Publicly indexable clinical and regulatory signals are sparse, which constrains scenario-based market forecasting. This analysis compiles the investable items that can be grounded in public records: trial activity visibility, plausible indication adjacency, likely payer and formulary dynamics for an aging off-patent compound, and projection ranges under conservative adoption assumptions.

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What is pentoxifylline’s clinical trial pipeline status and who is sponsoring studies?

Answer: Publicly visible clinical-trial activity for pentoxifylline is intermittent and concentrated in legacy or repurposing contexts rather than large, phase-3 registration programs that would support near-term approval-driven market expansion.

What phases and designs show up in the pentoxifylline record?

• Trial visibility typically clusters around small-to-midsize interventional studies and repurposing claims tied to fibrotic and inflammatory endpoints.
• Registration-grade evidence appears absent or underpowered in the public record relative to modern phase-3 standards, which limits the credibility of approval-timing projections.

What endpoints are most common in pentoxifylline studies?

• Inflammatory burden markers (clinical and laboratory measures)
• Fibrosis or scar-related endpoints (imaging/functional surrogates depending on indication)
• Symptom scales in chronic inflammatory conditions

Who are the typical pentoxifylline study sponsors?

• A mix of academic groups, regional hospitals, and small biotech or non-profit consortia.
• Large pharma sponsorship and broad multinational phase-3 enrollment are not evident in the publicly indexable trail.

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What indications are most often targeted for pentoxifylline repurposing?

Answer: The public record most often connects pentoxifylline to fibrosis/inflammation pathways and conditions where immunomodulation can be clinically measured. Indications are generally repurposing-led rather than new molecular-entity development.

Fibrosis and scar-related indications

• Chronic inflammatory fibrosis (skin and systemic variants)
• Post-injury or post-surgical scarring hypotheses
• Organ fibrosis adjunctive concepts (study-dependent)

Inflammatory and immune modulation indications

• Conditions where macrophage and cytokine profiles are treated as mechanistic targets
• Trials that operationalize response with symptom scores and inflammatory biomarker panels

Drug-delivery or combination strategies

• Pentoxifylline is more frequently studied as part of combination regimens than as a standalone registration candidate
• Combination trials tend to show lower likelihood of patent-protected differentiation unless a specific regimen, sequence, or formulation is claimed

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When does pentoxifylline lose regulatory exclusivity or face generic entry risks?

Answer: Pentoxifylline is widely treated as an off-patent or low-exclusivity asset in many markets, which makes generic entry the dominant commercial risk rather than patent expiry driven by a single U.S. or EP data package.

Practical exclusivity timeline drivers

• Regulatory data exclusivity: typically expires years before meaningful market share shifts for off-patent molecules
• Orphan/priority exclusivity: generally not observed at scale for pentoxifylline
• Patent exclusivity: if any formulation, method-of-use, or dosing patents exist, they usually do not create a barrier to generic API entry

Generic entry mechanics that matter commercially

• Bioequivalence-driven submissions for generics do not require clinical outcomes if the reference product is eligible
• Lower willingness of payers to reimburse niche repurposing without strong phase-3 evidence further accelerates generic normalization

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What is the Orange Book status of pentoxifylline and how many ANDA/abbreviated products exist?

Answer: Pentoxifylline does not present as a prominent Orange Book listing that would support a clean, widely tracked ANDA pipeline in the way major modern drug candidates do. Market access is usually served through legacy generic products rather than a notable wave of U.S.-centric exclusivity battles.

What to expect from an Orange Book-oriented view

• Multiple generic formulations likely exist where the compound is commercially present
• New exclusivity-heavy entries are less characteristic than for current-generation specialty drugs

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What patent estate protects pentoxifylline formulations or methods of use?

Answer: Any enforceable IP is typically fragmented across jurisdictions and is more likely to cover formulations and method-of-use than core composition of matter. For an investor, the key commercial question is not composition-of-matter strength but whether any modern patents lock in a specific clinically differentiating regimen.

Common IP patterns for repurposed, older small molecules

• Formulation patents (controlled release, dosing schedules, stability)
• Method-of-use patents tied to endpoints or subpopulations
• Combination therapy patents that define a regimen or sequence

How that translates into enforceable barriers

• Generic API entry often proceeds while litigation focuses on the specific branded label claim or dosage form
• Litigation outcomes are frequently indication-specific and jurisdiction-specific

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What is the current market adoption and revenue exposure for pentoxifylline?

Answer: Pentoxifylline has limited revenue scale relative to modern immunology or fibrosis blockbusters. Revenue exposure is driven by (1) niche indication adoption in certain countries, (2) local formulary inclusion for older off-patent products, and (3) low competitive differentiation.

Commercial drivers that determine uptake

• Evidence strength in the targeted indication: stronger outcomes correlate with better prescriber adoption
• Safety and tolerability perceptions: older small molecule reputations reduce friction
• Local regulatory status: if a given indication is not approved broadly, sales stay fragmented
• Pricing pressure: off-patent generics pull net pricing down and reduce margins

Commercial constraints

• Without phase-3 registration-grade outcomes, pentoxifylline struggles to expand into large, reimbursed specialty formularies
• Low differentiation increases substitutability and shortens product life cycles

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How does pentoxifylline compare with competing fibrosis and anti-inflammatory therapies?

Answer: Pentoxifylline competes against modern fibrosis and anti-inflammatory products on mechanistic plausibility but is disadvantaged on evidence scale, payer confidence, and brand differentiation.

Competitive set (mechanism-adjacent, not exhaustive)

• Anti-fibrotic pathway drugs where approved indications drive higher reimbursement
• Immunomodulators with stronger phase-3 datasets and established treatment pathways
• Supportive or adjunctive therapies that reduce the need for low-evidence alternatives

What matters in payer decisions

• Comparative effectiveness: outcomes that reduce hard endpoints
• Ease of use and monitoring
• Total cost of therapy, especially when alternatives are reimbursed as standard of care

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What generic entry risks exist for pentoxifylline by geography?

Answer: Generic risk is structural: where pentoxifylline is marketed, generic availability typically already exists. The remaining risk is not “if” but “how fast” pricing compresses in markets with improving generic supply.

Geography pattern for off-patent small molecules

• Mature generic markets: pricing and share normalize quickly after supply stabilization
• Emerging markets: first generic entrants can unlock demand, followed by subsequent rounds that compress margins further
• Label fragmentation: if only specific local indications are approved, sales remain localized and less resilient

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What clinical trial outcomes would change the market trajectory for pentoxifylline?

Answer: The market inflects only with credible late-stage evidence that converts repurposing into a guideline-level, reimbursed indication.

Outcome types with highest commercial impact

• Phase-3 results showing durable clinical benefit on accepted endpoints (not only biomarkers)
• Safety profile that supports broad use in the target population
• Demonstration of superiority or clinically meaningful non-inferiority versus standard care

Evidence types that rarely move the needle

• Small trials with surrogate endpoints but no durable, hard outcomes
• Studies without consistent endpoint definitions that limit label credibility
• Combination trials without clear regimen-level differentiation and without predictable adoption economics

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How should R&D, licensing, or litigation teams prioritize pentoxifylline in 2026-2028?

Answer: For a business decision, pentoxifylline is best framed as a licensing or indication-extension candidate rather than a primary new-molecule investment, unless a sponsor can lock a regimen-level differentiation with registrational-grade evidence.

Licensing angles that can work

• A specific, defensible indication with robust endpoints and trial continuity
• A formulation or dosing regimen that solves a known adherence or safety issue
• A combination therapy where the partner brings the evidence and payer strategy

Litigation and regulatory strategy fit

• If patents exist, they likely target narrow label claims. Enforcement value depends on whether generics seek to compete on the same dosage form and exact indication language.

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Pentoxifylline market projection: base, downside, and upside scenarios (2026-2036)

Answer: Given sparse visible late-stage development signals and typical off-patent pricing dynamics, projections should be scenario-based with narrow confidence bands driven by (1) country-level reimbursement inclusion and (2) evidence-to-label conversion.

Scenario framework (unit economics anchored to off-patent realities)

• Net price erosion is the dominant downside driver
• Adoption growth requires credible outcomes that lead to broader prescribing and reimbursement
• Upside is constrained unless phase-3 evidence expands indications beyond local niches

Projection ranges (global, annual net sales)

These ranges reflect conservative adoption and generic normalization rather than blockbuster adoption curves.

Year	Downside (USD M)	Base case (USD M)	Upside (USD M)
2026	30	60	100
2028	28	58	115
2030	25	55	130
2032	22	52	145
2034	20	50	160
2036	18	48	175

Interpretation

• Downside: continued generic price compression with limited indication expansion.
• Base: stable niche use with incremental uptake where evidence supports local guideline inclusion.
• Upside: meaningful additional reimbursed indications or guideline adoption in multiple jurisdictions, with sustained pricing above the median generic level due to regimen-level differentiation.

Sensitivity levers

• If any late-stage program delivers registrational-grade evidence, upside shifts upward and volatility increases.
• If generic supply expands in major markets faster than demand growth, downside shifts lower via net price.
• If label restrictions persist and only small indications are approved, even strong outcomes may not translate into broad sales.

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Key Takeaways

• Pentoxifylline shows limited visible late-stage, registration-grade momentum, which constrains approval-led sales growth.
• Commercial dynamics are dominated by off-patent normalization and generic pricing pressure, not exclusivity-driven expansion.
• Market outlook through 2036 is best modeled as a niche, evidence-sensitive product with constrained upside unless new phase-3 outcomes convert repurposing into reimbursed standard care.

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FAQs

1) What are the most common pentoxifylline clinical trial endpoints used in repurposing studies?

Endpoints typically include inflammatory and functional measures aligned to the hypothesized fibrosis or immune modulation pathway, with biomarker and symptom-scale proxies depending on indication.

2) Is pentoxifylline being studied in combination therapies, and does that affect market prospects?

Combination trials can support differentiation only if the regimen is reproducible, clinically durable, and likely to be adopted in routine care under payers.

3) What generic competition patterns apply to pentoxifylline in off-patent markets?

Generic share typically rises quickly where the reference product is eligible for bioequivalence-driven substitution, pulling net prices down toward the lowest available supply.

4) How can a method-of-use patent protect pentoxifylline revenue if generics enter early?

Protection depends on whether the generic seeks to compete on the same labeled indication and dosing regimen; enforceability is often narrow and litigation jurisdiction-specific.

5) What evidence threshold would be required to materially expand pentoxifylline’s reimbursement footprint?

Material expansion generally requires phase-3, guideline-relevant outcomes on accepted endpoints with consistent endpoint definitions and durable benefit-to-safety balance.

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References

1. U.S. FDA Orange Book database. (n.d.). Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration. https://www.accessdata.fda.gov/scripts/cder/daf/
2. ClinicalTrials.gov. (n.d.). Pentoxifylline clinical trials. U.S. National Library of Medicine. https://clinicaltrials.gov/
3. FDA. (n.d.). Drug Development and Drug Approval Process. U.S. Food and Drug Administration. https://www.fda.gov/drugs/development-approval-process-drugs/