Disease × agent evidence record

Pentoxifylline for Peripheral Artery Disease (PAD): evidence, trials and status

Pentoxifylline has both completed registered trials and synthesis-level publications linked to Peripheral Artery Disease (PAD). That is the strongest profile in this database, but the summaries here do not extract effect sizes, so read the linked reviews for direction and magnitude of benefit.

4 registered trials 0 recruiting 14 publications Evidence tier A · Strong Score 64.0
Research Tracker › Pairs › Peripheral Artery Disease (PAD) › Pentoxifylline
Research map, not treatment advice. This page aggregates registry and literature records. It does not evaluate efficacy, dosing or safety for any individual. Discuss any treatment decision with a qualified clinician.

Summary

Pentoxifylline has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Peripheral Artery Disease (PAD) would be drug repurposing rather than first-in-human development. This does not mean it is approved for Peripheral Artery Disease (PAD). ClinicalTrials.gov lists 4 registered trials linking Pentoxifylline to Peripheral Artery Disease (PAD): 4 have completed. The most advanced is Phase 4 (NCT01718288). The largest enrolment is 10398 participants (NCT05635370). Registration activity spans 2001 to 2022. The literature layer holds 14 publications for this pair: 5 Cochrane reviews, 1 meta-analysis, 3 randomised controlled trial publications and 5 clinical trial publications. Publication years run from 1990 to 2021. Because at least one synthesis-level source exists (systematic review, meta-analysis or Cochrane review), this pair has been assessed beyond single studies, although the synthesis may concern a different indication.

The RepurpOS disease-intelligence file for Peripheral Arterial Disease ranks 292 candidate therapeutics from Open Targets, ChEMBL, DGIdb and PubMed; only a minority carry direct clinical evidence, and this page covers one of those. Spontaneous remission context recorded for the condition: Progressive disease; spontaneous improvement rare; limb ischaemia worsens in 25-30% over 5 years; major adverse limb events (MALE) in 10-15%/year in advanced PAD; major amputation in 5-10% at 5 years without revascularisation.

Open in Repurposing ExplorerAgent page: PentoxifyllinePeripheral Artery Disease (PAD) hubPeripheral Artery Disease (PAD) biomarkers & interventions

Evidence table

Evidence tierA · Strong
Evidence score64.0 (trials 14.0, literature 30.0, tier 15, approved bonus 5.0)
Registered trials4 total: 0 recruiting, 0 active / not yet recruiting, 4 completed, 0 other
Linked publications14 (5 Cochrane reviews, 5 clinical trial publications, 3 randomised controlled trial publications, 1 meta-analysis)
Agent typeDrug (Small molecule)
Development stage (any indication)Approved
Mechanism / classinhibitor
Data sourcesDGIdb
Linked via biomarker / targetADORA2A
How the evidence score is calculated
  • Each registered trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5). The trial component is capped at 30.
  • Each literature item scores by design (Cochrane review 5, meta-analysis 4, systematic review 3, RCT 3, clinical trial publication 2, curated reference 1.5, other PubMed record 1). The literature component is capped at 30.
  • The existing evidence tier adds 15 (A / Strong), 10 (B / Moderate), 5 (C / Preliminary) or 0 (D / Anecdotal).
  • Agents approved for any indication (max clinical phase 4) add 5, because an approved agent has an established safety profile that lowers the barrier to repurposing trials.
  • The score ranks what has been studied, not what works. It does not read effect sizes or directions of effect.

Registered clinical trials

NCT IDTitleStatusPhaseEnrolment
NCT01718288Optimization of Treatment in Patients With Severe Peripheral Ischemia (Fontaine Stage IIb)
2006
completedPhase 4150
NCT01263925Prostaglandin E1 in Outpatients With Intermittent Claudication
2001
completedPhase 3561
NCT05635370Data Analysis for Drug Repurposing for Effective Alzheimer's Medicines (DREAM)- Pentoxifylline Versus Cilostazol
2022
completedNot applicable10,398
NCT01378260Comparative Effectiveness Research Study of Peripheral Arterial Disease (PAD)
2011
completedNot applicable323

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Published literature

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Mechanism and notes

Recorded mechanism or class: inhibitor.

OSMF's existing evidence tier for this pair is A (Strong), derived from the strength of the disease association recorded in DGIdb, in this case via the biomarker or target ADORA2A. The tier describes how well the drug-disease link is documented, not how well the drug works.

Frequently asked questions

Is Pentoxifylline approved for Peripheral Artery Disease (PAD)?

Pentoxifylline has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Peripheral Artery Disease (PAD) would be drug repurposing rather than first-in-human development. This does not mean it is approved for Peripheral Artery Disease (PAD). Approval status for the specific indication should always be confirmed with the relevant regulator and prescribing information.

Is Pentoxifylline in clinical trials for Peripheral Artery Disease (PAD)?

ClinicalTrials.gov lists 4 registered trials linking Pentoxifylline to Peripheral Artery Disease (PAD): 4 have completed. The most advanced is Phase 4 (NCT01718288). The largest enrolment is 10398 participants (NCT05635370). Registration activity spans 2001 to 2022.

What does the evidence show for Pentoxifylline in Peripheral Artery Disease (PAD)?

Pentoxifylline has both completed registered trials and synthesis-level publications linked to Peripheral Artery Disease (PAD). That is the strongest profile in this database, but the summaries here do not extract effect sizes, so read the linked reviews for direction and magnitude of benefit. OSMF's existing evidence tier for this pair is A (Strong), derived from the strength of the disease association recorded in DGIdb, in this case via the biomarker or target ADORA2A. The tier describes how well the drug-disease link is documented, not how well the drug works.

Cite this page

Open Source Medicine Foundation. Pentoxifylline for Peripheral Artery Disease (PAD): evidence, trials and status. OSMF Research Tracker. Updated 2026-07-05. https://research.opensourcemed.info/pairs/peripheral-arterial-disease/pentoxifylline.html

Data: ClinicalTrials.gov, PubMed, Open Targets, ChEMBL, DGIdb and the OSMF therapeutic agent database. Last updated 2026-07-05. Page built 2026-10-07.

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This is a research map, not treatment advice. Evidence tiers and scores summarise what has been studied, not whether a treatment works or is safe for you.