MedPath

Pentoxifylline

Generic Name
Pentoxifylline
Drug Type
Small Molecule
Chemical Formula
C13H18N4O3
CAS Number
6493-05-6
Unique Ingredient Identifier
SD6QCT3TSU
Background

Pentoxifylline (PTX) is a synthetic dimethylxanthine derivative that modulates the rheological properties of blood and also has both anti-oxidant and anti-inflammatory properties. Although originally developed to treat intermittent claudication, a form of exertion-induced leg pain common in patients with peripheral arterial disease, PTX has been investigated for its possible use in diverse conditions, including osteoradionecrosis, diabetic kidney disease, and generally any condition associated with fibrosis. More recently, PTX has been suggested as a possible treatment for COVID-19-induced pulmonary complications due to its ability to regulate the production of inflammatory cytokines.

Pentoxifylline has been marketed in Europe since 1972; PTX extended-release tablets sold under the trade name TRENTAL by US Pharm Holdings were first approved by the FDA on Aug 30, 1984, but have since been discontinued. A branded product, PENTOXIL, marketed by Upsher-Smith Laboratories, and generic forms marketed by Valeant Pharmaceuticals and APOTEX have been available since the late 1990s.

Indication

Pentoxifylline is indicated for the treatment of intermittent claudication in patients with chronic occlusive arterial disease. Pentoxifylline may improve limb function and reduce symptoms but cannot replace other therapies such as surgical bypass or removal of vascular obstructions.

Associated Conditions
Intermittent Claudication, Venous Leg Ulcer (VLU), Severe alcoholic liver disease

Evaluation of Efficacy, Safety and Molecular Mechanism of Pentoxifylline Supplementation in Patients With Hepatic and Obstructive Jaundice

Phase 3
Completed
Conditions
Hepatobiliary Disorders
Interventions
First Posted Date
2025-04-25
Last Posted Date
2025-04-30
Lead Sponsor
Tanta University
Target Recruit Count
43
Registration Number
NCT06944704
Locations
🇪🇬

Faculty of Pharmacy, Tanta University, Tanta, Egypt

Reversing External-beam Radiotherapy-associated Fibrosis Syndrome: an Interventional Bayesian Adaptive Randomized-controlled Orphan Drug Platform Trial for Orodental Sequelae (Reverse-fibrose)

Phase 2
Not yet recruiting
Conditions
Fibrosis Syndrome
Lymphedema
Head &Amp; Neck Cancer
Fibrosis
Interventions
First Posted Date
2025-04-06
Last Posted Date
2025-04-06
Lead Sponsor
M.D. Anderson Cancer Center
Target Recruit Count
250
Registration Number
NCT06912763
Locations
🇺🇸

MD Anderson Cancer Center, Houston, Texas, United States

Pentoxifylline for Vascular Calcification in Kidney Disease

Phase 1
Not yet recruiting
Conditions
Chronic Kidney Disease
Vascular Calcification
Kidney Failure, Chronic
Interventions
Other: Conventional Medications for Chronic Kidney Disease
First Posted Date
2025-04-01
Last Posted Date
2025-04-01
Lead Sponsor
Mansoura University
Target Recruit Count
80
Registration Number
NCT06903689

Bioequivalence Study of Pentoxifylline 400 Mg in Healthy Subjects Under Fasting and Fed Conditions

Phase 4
Not yet recruiting
Conditions
Healthy
Healthy Donors
Interventions
First Posted Date
2025-03-25
Last Posted Date
2025-03-25
Lead Sponsor
Centro de Atencion e Investigacion Medica
Target Recruit Count
40
Registration Number
NCT06823362

Pneumonitis Prevention Protocol Using Pentoxifylline and α-tocopherol In Stage III Non-Small Cell Lung Cancer Patients Undergoing Chemoradiation

Phase 2
Not yet recruiting
Conditions
Non-Small Cell Lung Cancer
Radiation Induced Lung Injury (RILI)
Interventions
Other: Placebo
Other: α-Tocopherol
First Posted Date
2024-10-09
Last Posted Date
2025-04-09
Lead Sponsor
University Health Network, Toronto
Target Recruit Count
150
Registration Number
NCT06634056
Locations
🇨🇦

University Health Network - Princess Margaret Cancer Centre, Toronto, Ontario, Canada

Pentoxifylline Role Against Chemotherapy-induced Neuropathy

Not Applicable
Completed
Conditions
Chemotherapy-induced Peripheral Neuropathy
Interventions
First Posted Date
2024-08-20
Last Posted Date
2024-08-20
Lead Sponsor
Beni-Suef University
Target Recruit Count
72
Registration Number
NCT06562998
Locations
🇪🇬

University Hospital, Banī Suwayf, Beni-Suef, Egypt

Systemic Therapy of Open-label Prophylactic Pravastatin or Pentoxifylline/Tocopherol Prevention of Lymphedema Advancing to Eventual Fibrosis: an Interventional Registry-embedded Bayesian Randomized Trial for Radiation Sequelae (STOP4-LATE-FIBROSE)

Phase 2
Not yet recruiting
Conditions
Lymphedema
Fibrosis
Interventions
First Posted Date
2024-07-10
Last Posted Date
2025-01-24
Lead Sponsor
M.D. Anderson Cancer Center
Target Recruit Count
295
Registration Number
NCT06494111
Locations
🇺🇸

MD Anderson Cancer Center, Houston, Texas, United States

Impact of Curcumin and Pentoxiphylline on Chronic Kidney Disease Patients

Not Applicable
Recruiting
Conditions
Chronic Kidney Disease
Interventions
Dietary Supplement: Curcumin
First Posted Date
2024-06-13
Last Posted Date
2024-06-13
Lead Sponsor
Alexandria University
Target Recruit Count
60
Registration Number
NCT06458465
Locations
🇪🇬

Nada Mustafa Kamel, Alexandria, Egypt

Effect of Pentoxifylline Versus Probiotic on Preterm Neonates With Necrotizing Enterocolitis

Phase 3
Completed
Conditions
Necrotizing Enterocolitis
Interventions
Drug: Probiotic Formula
First Posted Date
2024-05-20
Last Posted Date
2024-05-20
Lead Sponsor
Tanta University
Target Recruit Count
75
Registration Number
NCT06422000
Locations
🇪🇬

Tanta University, Tanta, El Gharbia, Egypt

Renoprotective Effects of Dapagliflozin Versus Pentoxiphylline in Chronic Kidney Disease Patients

Phase 3
Recruiting
Conditions
Chronic Kidney Diseases
Interventions
First Posted Date
2024-05-20
Last Posted Date
2024-05-20
Lead Sponsor
Ain Shams University
Target Recruit Count
210
Registration Number
NCT06421870
Locations
🇪🇬

Ain Shams University, Cairo, Egypt

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