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pentoxifylline (PTX)
pentoxifylline (PTX) is a Methylxanthine derivative; hemorheological agent Small molecule drug developed by Case Western Reserve University. It is currently in Phase 3 development for Intermittent claudication due to chronic occlusive arterial disease, Diabetic angiopathies, Trophic disorders and ischemic ulcers. Also known as: Trental (brand name), trental.
Pentoxifylline improves blood flow and reduces blood viscosity by increasing red blood cell flexibility and decreasing platelet aggregation.
Pentoxifylline is a small molecule that acts as an antagonist of the adenosine A2 receptor. It has been studied in clinical trials for various conditions, including epilepsy, chronic kidney diseases, kidney failure, and male infertility, often in combination with other medications such as phenytoin and celecoxib.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Cardiovascular Phase 3 risk
-2.0pp
Modern cardiovascular outcome trials are large + long; many fail to beat aggressive standard-of-care.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | pentoxifylline (PTX) |
|---|---|
| Also known as | Trental (brand name), trental |
| Sponsor | Case Western Reserve University |
| Drug class | Methylxanthine derivative; hemorheological agent |
| Target | Phosphodiesterase (non-selective); adenosine receptors |
| Modality | Small molecule |
| Therapeutic area | Cardiovascular; Hematology |
| Phase | Phase 3 |
Mechanism of action
Pentoxifylline is a methylxanthine derivative that acts as a non-selective phosphodiesterase inhibitor, increasing cAMP levels in blood cells. This leads to improved erythrocyte deformability, reduced blood viscosity, and decreased platelet and leukocyte aggregation, enhancing microcirculation and tissue oxygenation. It also has anti-inflammatory properties through TNF-alpha reduction.
Approved indications
- Intermittent claudication due to chronic occlusive arterial disease
- Diabetic angiopathies
- Trophic disorders and ischemic ulcers
Common side effects
- Nausea
- Dizziness
- Headache
- Tremor
- Palpitations
- Gastrointestinal upset
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 |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- pentoxifylline (PTX) CI brief — competitive landscape report
- pentoxifylline (PTX) updates RSS · CI watch RSS
- Case Western Reserve University portfolio CI
Frequently asked questions about pentoxifylline (PTX)
What is pentoxifylline (PTX)?
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What is pentoxifylline (PTX) used for?
Who makes pentoxifylline (PTX)?
Is pentoxifylline (PTX) also known as anything else?
What drug class is pentoxifylline (PTX) in?
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What does pentoxifylline (PTX) target?
Related
- Drug class: All Methylxanthine derivative; hemorheological agent drugs
- Target: All drugs targeting Phosphodiesterase (non-selective); adenosine receptors
- Manufacturer: Case Western Reserve University — full pipeline
- Therapeutic area: All drugs in Cardiovascular; Hematology
- Indication: Drugs for Intermittent claudication due to chronic occlusive arterial disease
- Indication: Drugs for Diabetic angiopathies
- Indication: Drugs for Trophic disorders and ischemic ulcers
- Also known as: Trental (brand name), trental
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing