Active Ingredient History
Pentoxil (Pentoxifylline Extended-release Tablets, USP) is indicated for the treatment of patients with intermittent claudication based on chronic occlusive arterial disease of the limbs. Pentoxil can improve function and symptoms but is not intended to replace more definitive therapy, such as surgical bypass, or removal of arterial obstructions when treating peripheral vascular disease. Pentoxifylline and its metabolites improve the flow properties of blood by decreasing its viscosity. In patients with chronic peripheral arterial disease, this increases blood flow to the affected microcirculation and enhances tissue oxygenation. The precise mode of action of pentoxifylline and the sequence of events leading to clinical improvement are still to be defined. Pentoxifylline inhibits erythrocyte phosphodiesterase, resulting in an increase in erythrocyte cAMP activity. Subsequently, the erythrocyte membrane becomes more resistant to deformity. Along with erythrocyte activity, pentoxifylline also decreases blood viscosity by reducing plasma fibrinogen concentrations and increasing fibrinolytic activity. It is also a non-selective adenosine receptor antagonist. Pentoxifylline administration has been shown to produce dose-related hemorrheologic effects, lowering blood viscosity, and improving erythrocyte flexibility. Pentoxifylline has been shown to increase leukocyte deformability and to inhibit neutrophil adhesion and activation. Tissue oxygen levels have been shown to be significantly increased by therapeutic doses of pentoxifylline in patients with peripheral arterial disease. Clinical trials were conducted using either extended-release pentoxifylline tablets for up to 60 weeks or immediate-release pentoxifylline capsules for up to 24 weeks. Dosage ranges in the tablet studies were 400 mg bid to tid and in the capsule studies, 200-400 mg tid. The incidence of adverse reactions was higher in the capsule studies (where dose related increases were seen in digestive and nervous system side effects) than in the tablet studies. Studies with the capsule include domestic experience, whereas studies with the extended-release tablets were conducted outside the U.S. NCATS
Drug Pricing (per unit)
Note: This drug pricing data is preliminary, incomplete, and may contain errors.
| Organization | Org Type | FDA approvals | Clinical Trials involvement | Org ID | Force Sort |
|---|
| Organization | Org Type | FDA approvals | Clinical Trials involvement | Org ID | Force Sort |
|---|
Intermittent Claudication (approved 1999)
Acute Coronary Syndrome (Phase 2/Phase 3)
Acute Kidney Injury (Phase 3)
Arterial Occlusive Diseases (Phase 3)
Atherosclerosis (Phase 2)
Behcet Syndrome (Phase 2)
Biliary Atresia (Phase 2)
Bipolar Disorder (Early Phase 1)
Blood Loss, Surgical (Phase 3)
Brain Neoplasms (Phase 1)
Breast Neoplasms (Phase 3)
Carcinoma, Non-Small-Cell Lung (Phase 2)
Cardiovascular Diseases (Phase 2)
Cocaine-Related Disorders (Phase 1)
Colorectal Neoplasms (Phase 2)
Conjunctivitis (Phase 3)
Coronary Artery Disease (Phase 2)
COVID-19 (Phase 1/Phase 2)
Crohn Disease (Early Phase 1)
Depression (Phase 2)
Depressive Disorder, Major (Phase 2)
Diabetes Mellitus, Type 2 (Phase 4)
Diabetic Nephropathies (Phase 4)
Disability Evaluation (Phase 3)
Ductus Arteriosus, Patent (Phase 2)
Endometriosis (Phase 3)
Enterocolitis, Necrotizing (Phase 2)
Erectile Dysfunction (Phase 3)
Fatty Liver (Phase 2)
Fibrosis (Phase 3)
Glomerulonephritis (Phase 3)
Head and Neck Neoplasms (Phase 2)
Healthy Volunteers (Phase 1)
Heart Diseases (Phase 2)
Heart Failure (Phase 4)
Hemolysis (Phase 4)
Hepacivirus (Phase 4)
Hepatitis, Alcoholic (Phase 4)
Hepatitis C, Chronic (Phase 3)
Hepatopulmonary Syndrome (Phase 1)
HIV (Phase 2)
HIV Infections (Phase 4)
Human T-lymphotropic virus 1 (Phase 3)
Hypoalbuminemia (Phase 3)
Immune System Diseases (Phase 3)
Infertility (Phase 4)
Infertility, Female (Early Phase 1)
Inflammation (Phase 4)
Intermittent Claudication (Phase 3)
Irritable Bowel Syndrome (Phase 4)
Kidney Diseases (Early Phase 1)
Kidney Failure, Chronic (Phase 4)
Leishmaniasis (Phase 2)
Leishmaniasis, Cutaneous (Phase 2/Phase 3)
Liver Cirrhosis (Phase 3)
Liver Cirrhosis, Biliary (Phase 2)
Liver Diseases (Phase 2/Phase 3)
Liver Diseases, Alcoholic (Phase 3)
Liver Failure (Phase 3)
Liver Regeneration (Phase 4)
Lumbar Vertebrae (Phase 4)
Lupus Nephritis (Phase 4)
Lymphedema (Phase 2)
Malaria, Falciparum (Phase 2)
Muscular Dystrophy, Duchenne (Phase 1/Phase 2)
Neonatal Sepsis (Phase 3)
Neoplasm Metastasis (Phase 2)
Nephrotic Syndrome (Phase 3)
Neuralgia (Phase 2)
Non-alcoholic Fatty Liver Disease (Phase 4)
Obesity (Phase 4)
Osteonecrosis (Phase 3)
Osteoradionecrosis (Phase 4)
Oxidative Stress (Phase 3)
Pancreatic Neoplasms (Phase 3)
Pancreatitis (Phase 3)
Pancreatitis, Alcoholic (Phase 3)
Paraparesis, Tropical Spastic (Phase 3)
Pentoxifylline (Phase 3)
Precursor Cell Lymphoblastic Leukemia-Lymphoma (Phase 2/Phase 3)
Prostatic Neoplasms (Phase 3)
Protein-Energy Malnutrition (Phase 3)
Radiation Injuries (Phase 2)
Radiation Oncology (Phase 3)
Radiculopathy (Phase 4)
Renal Dialysis (Phase 4)
Renal Insufficiency, Chronic (Phase 4)
Sarcoidosis, Pulmonary (Phase 2)
Schizophrenia (Phase 1/Phase 2)
Sepsis (Phase 4)
Squamous Cell Carcinoma of Head and Neck (Phase 1)
Traumatology (Phase 3)
Vascular Diseases (Phase 3)
Wounds and Injuries (Phase 2)
| Trial | Phase | Start Date | Organizations | Indications |
|---|
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