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

Pentoxifylline In Pediatric Acute Lymphoblastic Leukemia During Induction

Phase 2
Conditions
Acute Lymphoblastic Leukemia
Interventions
Drug: Placebo Plus Chemotherapy
First Posted Date
2015-05-22
Last Posted Date
2018-05-09
Lead Sponsor
Ramón Óscar González-Ramella, Ph.D
Target Recruit Count
44
Registration Number
NCT02451774
Locations
🇲🇽

Hospital Civil de Guadalajara "Dr. Juan I. Menchaca", Guadalajara, Jalisco, Mexico

The Impact of Pentoxifylline and Vitamin E on Radiotherapy-induced Toxicity in Head & Neck Cancer Patients

Phase 2
Completed
Conditions
Head and Neck Neoplasms
Interventions
First Posted Date
2015-03-25
Last Posted Date
2019-11-26
Lead Sponsor
Ain Shams University
Target Recruit Count
60
Registration Number
NCT02397486
Locations
🇪🇬

Ain Shams University Hospitals, Cairo, Egypt

Management of Mandibular ORN: PENTO as Medical Treatment

Phase 4
Completed
Conditions
Osteoradionecrosis
Interventions
First Posted Date
2015-02-23
Last Posted Date
2018-03-22
Lead Sponsor
Hospital Vall d'Hebron
Target Recruit Count
24
Registration Number
NCT02368457
Locations
🇪🇸

Vall d'Hebrón Hospital, Barcelona, Spain

The Effect of Pentoxifylline on Liver Function Tests in Fatty Liver Disease

Phase 2
Completed
Conditions
Fatty Liver
Interventions
Behavioral: Lifestyle modification
First Posted Date
2014-11-05
Last Posted Date
2014-11-06
Lead Sponsor
Tehran University of Medical Sciences
Target Recruit Count
120
Registration Number
NCT02283710
Locations
🇮🇷

Gastroenterology clinic, Sina Hospital, Tehran, Iran, Islamic Republic of

PPALM-Palm Oil and Pentoxifylline Against Late Morbidity

Phase 2
Completed
Conditions
Long-term Adverse Effects of Radiotherapy for Pelvic Cancer
Interventions
First Posted Date
2014-09-03
Last Posted Date
2019-12-23
Lead Sponsor
Royal Marsden NHS Foundation Trust
Target Recruit Count
62
Registration Number
NCT02230800
Locations
🇬🇧

The Royal Marsden NHS Foundation Trust, London, United Kingdom

Pentoxifylline and Late Onset Sepsis in Preterm Infants

Phase 3
Completed
Conditions
Neonatal Late Onset Sepsis
Interventions
First Posted Date
2014-06-13
Last Posted Date
2014-06-16
Lead Sponsor
Abd Elazeez Attala Shabaan
Target Recruit Count
120
Registration Number
NCT02163174
Locations
🇪🇬

Mansoura University Children Hospital, Mansoura, Eldakahlia, Egypt

Metadoxine as a Therapy for Severe Alcoholic Hepatitis

Phase 4
Completed
Conditions
Severe Alcoholic Hepatitis
Interventions
First Posted Date
2014-06-12
Last Posted Date
2014-11-11
Lead Sponsor
Hospital General de Mexico
Target Recruit Count
135
Registration Number
NCT02161653
Locations
🇲🇽

Hospital General de Mexico, Mexico City, D.f., Mexico

Efficacy of PTX+IFN Alpha+ RBV on Hepatitis C Virus Coinfected HIV Patients

Phase 4
Conditions
Hepacivirus
HIV Infections
Interventions
First Posted Date
2013-12-11
Last Posted Date
2013-12-11
Lead Sponsor
Centro Universitario de Ciencias de la Salud, Mexico
Target Recruit Count
60
Registration Number
NCT02008214
Locations
🇲🇽

Hospital Civil de Guadalajara, Guadalajara, Jalisco, Mexico

Bromocriptine and Pentoxifylline in Ophthalmopathy Autoimmune Treatment

Not Applicable
Terminated
Conditions
Graves Ophthalmopathy
Interventions
First Posted Date
2013-07-09
Last Posted Date
2013-07-09
Lead Sponsor
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Target Recruit Count
31
Registration Number
NCT01893450
Locations
🇲🇽

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran, Mexico City, Distrito Federal, Mexico

Safety of Pentoxifylline and Vitamin E With Stereotactic Ablative Radiotherapy (SABR) in Non-small Cell Lung Cancers

Phase 2
Recruiting
Conditions
Non-small Cell Lung Cancers
Interventions
Radiation: stereotactic ablative radiotherapy (SABR)
First Posted Date
2013-06-06
Last Posted Date
2024-02-07
Lead Sponsor
University of Louisville
Target Recruit Count
59
Registration Number
NCT01871454
Locations
🇺🇸

James Graham Brown Cancer Center, U of Louisville, Louisville, Kentucky, United States

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