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

Study to Evaluate the PK of Single and Optional Multiple Dosing Regimens of MR Formulations of PCS499 Compared to Trental® Administered to Healthy Subjects

Phase 1
Completed
Conditions
Healthy
Interventions
First Posted Date
2019-02-11
Last Posted Date
2019-02-12
Lead Sponsor
Processa Pharmaceuticals
Target Recruit Count
18
Registration Number
NCT03836222
Locations
🇬🇧

Quotient Sciences, Ruddington, Nottingham, United Kingdom

Pentoxifylline, Atorvastatin, and Vitamin E in Treating Patients With Erectile Dysfunction After Radiation Therapy for Prostate Cancer

Phase 2
Completed
Conditions
Erectile Dysfunction, CTCAE
Male Erectile Disorder
Prostate Adenocarcinoma
Impotence
Interventions
Dietary Supplement: Vitamin E Compound
First Posted Date
2019-02-05
Last Posted Date
2023-10-17
Lead Sponsor
M.D. Anderson Cancer Center
Target Recruit Count
14
Registration Number
NCT03830164
Locations
🇺🇸

M D Anderson Cancer Center, Houston, Texas, United States

Pentoxifylline Administration in Hemodialysis Patients

Early Phase 1
Conditions
Anemia Renal
Interventions
First Posted Date
2019-01-11
Last Posted Date
2019-09-25
Lead Sponsor
Ain Shams University
Target Recruit Count
46
Registration Number
NCT03800433

Does Oral Pentoxifylline Administration Improve Hemoglobin in Hemodialysis Patients?

Phase 2
Completed
Conditions
Anemia of Chronic Kidney Disease
Interventions
First Posted Date
2018-11-06
Last Posted Date
2018-11-08
Lead Sponsor
Tanta University
Target Recruit Count
57
Registration Number
NCT03731741
Locations
🇪🇬

Tanta university hospital, Tanta, Egypt

Pentoxifylline Effect in Patients With Diabetic Nephropathy.(PENFOSIDINE STUDY)

Phase 4
Conditions
Type 2 Diabetes Mellitus
Chronic Kidney Disease stage3 and 4
Interventions
First Posted Date
2018-09-10
Last Posted Date
2019-02-07
Lead Sponsor
Maria Eugenia Galván Plata
Target Recruit Count
196
Registration Number
NCT03664414
Locations
🇲🇽

Cibimi - Hgz 83 Imss, Morelia, Michoacán, Mexico

Pentoxifylline in Diabetic Kidney Disease

Phase 4
Recruiting
Conditions
Diabetic Kidney Disease
Interventions
First Posted Date
2018-08-10
Last Posted Date
2025-05-13
Lead Sponsor
VA Office of Research and Development
Target Recruit Count
2510
Registration Number
NCT03625648
Locations
🇺🇸

Phoenix VA Health Care System, Phoenix, AZ, Phoenix, Arizona, United States

🇺🇸

Central Arkansas Veterans Healthcare System, Little Rock, AR, Little Rock, Arkansas, United States

🇺🇸

VA Loma Linda Healthcare System, Loma Linda, CA, Loma Linda, California, United States

and more 32 locations

Effects of Pentoxifylline and Vitamin E on Pregnancy Rate in Infertile Women Treated by ICSI:

Early Phase 1
Conditions
Infertility, Female
Interventions
First Posted Date
2018-03-26
Last Posted Date
2018-03-26
Lead Sponsor
Benha University
Target Recruit Count
140
Registration Number
NCT03476564
Locations
🇪🇬

El Galaa Teaching hosptial, Cairo, Ghamra, Egypt

Erectile Recovery After Robotic-Assisted Laparoscopic Prostatectomy

Phase 3
Conditions
Erectile Dysfunction
Prostate Cancer
Interventions
First Posted Date
2018-01-23
Last Posted Date
2018-01-23
Lead Sponsor
Brooke Army Medical Center
Target Recruit Count
180
Registration Number
NCT03406169
Locations
🇺🇸

Brooke Army Medical Center, San Antonio, Texas, United States

Pentoxifylline and Lumbar Radiculopathy

Phase 4
Active, not recruiting
Conditions
Lumbar Radiculopathy
Lumbar Disc Disease
Lumbar Disc Herniation
Interventions
First Posted Date
2017-02-23
Last Posted Date
2025-05-21
Lead Sponsor
St Joseph University, Beirut, Lebanon
Target Recruit Count
67
Registration Number
NCT03060434
Locations
🇱🇧

Hotel Dieu de France Hospital, Beirut, Lebanon

Pentoxifylline and Tocopherol (PENTO) in the Treatment of Medication-related Osteonecrosis of the Jaw (MRONJ)

Phase 3
Conditions
Medication-related Osteonecrosis of the Jaw
Bisphosphonate-related Osteonecrosis of the Jaw
Avascular Necrosis
Interventions
First Posted Date
2017-02-02
Last Posted Date
2024-05-31
Lead Sponsor
University of Washington
Target Recruit Count
100
Registration Number
NCT03040778
Locations
🇺🇸

University of Alabama at Birmingham, Birmingham, Alabama, United States

🇺🇸

University of Washington, Seattle, Washington, United States

🇺🇸

New York Center for Orthognathic and Maxillofacial Surgery, Lake Success, New York, United States

and more 1 locations
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