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Pentoxifylline sustained-release tablets
Pentoxifylline improves blood flow and reduces inflammation by inhibiting phosphodiesterase enzymes and modulating cytokine production.
Pentoxifylline sustained-release tablets, manufactured by Beijing Tiantan Hospital, are not approved by the FDA. The drug is primarily used to improve blood flow and reduce inflammation, making it potentially useful for conditions like intermittent claudication. However, due to the lack of FDA approval, its use is limited and primarily off-label. The drug has a moderate safety profile but lacks comprehensive clinical trial data in the US. It competes with other vasodilators and anti-inflammatory agents in the market, though its commercial impact is limited without FDA approval.
At a glance
| Generic name | Pentoxifylline sustained-release tablets |
|---|---|
| Sponsor | Beijing Tiantan Hospital |
| Drug class | Methylxanthine derivative; phosphodiesterase inhibitor |
| Target | Phosphodiesterase |
| Modality | Small molecule |
| Therapeutic area | Cardiovascular |
| Phase | FDA-approved |
Mechanism of action
As a methylxanthine derivative, pentoxifylline inhibits phosphodiesterase, leading to increased cyclic adenosine monophosphate (cAMP) levels that enhance red blood cell deformability and reduce blood viscosity. It also suppresses the production of pro-inflammatory cytokines and improves microcirculation, thereby reducing tissue hypoxia and inflammation in peripheral vascular disease.
Approved indications
- Intermittent claudication due to chronic peripheral arterial occlusive disease
- Diabetic angiopathy
Common side effects
- Gastrointestinal disturbances (nausea, dyspepsia)
- Dizziness
- Headache
- Tremor
- Palpitations
Key clinical trials
- Bioequivalence Study of Pentoxifylline 400 Mg in Healthy Subjects Under Fasting and Fed Conditions (PHASE4)
- Efficacy of Pentoxifylline on Cerebrovascular Function in Patients With Cerebral Small Vessel Disease(PERFORM) (PHASE4)
- Comparing the Effects of Vitamin E, Ursodeoxycholic Acid and Pentoxyfylline on Egyptian Non-alcoholic Steatohepatitis (NASH) Patients (PHASE4)
Patents
| Patent | Expiry | Type |
|---|---|---|
| CN102345678 |
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 |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
Competitive intelligence
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