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PENTOXIFYLLINE
Pentoxifylline is a marketed drug primarily indicated for the treatment of intermittent claudication. Its key composition patent is set to expire in 2028, providing a period of exclusivity that supports current market position. The primary risk is the potential increase in competition following patent expiry in 2028.
At a glance
| Generic name | PENTOXIFYLLINE |
|---|---|
| Drug class | Blood Viscosity Reducer [EPC] |
| Modality | Small molecule |
| Phase | FDA-approved |
| First approval | 1984 |
Approved indications
- Intermittent Claudication
Common side effects
- Discontinued for Side Effect
- Angina/Chest Pain
- Belching/Flatus/Bloating
- Dyspepsia
- Nausea
- Vomiting
- Dizziness
- Headache
- Tremor
- Discontinued for Side Effect
- Angina/Chest Pain
- Arrhythmia/Palpitation
Drug interactions
- NSAIDs, anticoagulants, or platelet aggregation inhibitors
- vitamin K antagonists
- theophylline-containing drugs
- strong CYP1A2 inhibitors (e.g., ciprofloxacin, fluvoxamine)
- antihypertensive drugs, beta blockers, digitalis, diuretics, and antiarrhythmics
- nifedipine or captopril
- cimetidine
Key clinical trials
- Pneumonitis Prevention Protocol Using Pentoxifylline and α-tocopherol In Stage III Non-Small Cell Lung Cancer Patients Undergoing Chemoradiation (PHASE2)
- PentoxIfylline and Tocopherol for the Treatment of Post-radiotherapy Fibrosis in Head and Neck Cancer Patients (PHASE1)
- RECLAIM: Recovering From COVID-19 Lingering Symptoms Adaptive Integrative Medicine (PHASE2, PHASE3)
- Comparison of the Efficacy of Mesotherapy and Extracorporeal Shock Wave Therapy in Patients With Lateral Epicondylitis (NA)
- 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) (PHASE2)
- Nephroprotective Effect of Pentoxifylline Against Cisplatin in Patients With Head and Neck Cancer (NA)
- Reversing External-beam Radiotherapy-associated Fibrosis Syndrome: an Interventional Bayesian Adaptive Randomized-controlled Orphan Drug Platform Trial for Orodental Sequelae (Reverse-fibrose) (PHASE2)
- Pentoxifylline in Patients With Ulcerative Colitis (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |