Treats intermittent claudication on the basis of chronic occlusive arterial disease of…. Sold as Trental. Every FDA application for this active ingredient: 1 branded and 10 generic.
As of Nov 13, 2026, FDA lists 11 applications for Pentoxifylline (sold as Trental), first approved Aug 30, 1984, with 0 new uses approved and 0 published complete response letters.
| Product | Part | Spending, 2025 | Change | Beneficiaries |
|---|---|---|---|---|
| Pentoxifylline | Part D | $13.1M | +6% | 87,391 |
| Study | Phase | Status | Posted |
|---|---|---|---|
| Pentoxifylline Add-On Therapy for Mild-to-Moderate Plaque PsoriasisPsoriasis · Wasuchon Chaichan | Not applicable | Not yet recruiting | Jun 4, 2026 |
| Effect of Pentoxyfilline on Endometrial Thickness and Frozen Embryo Transfer OutcomesEmbryo Transfer, IVF · Beni-Suef University | Phase 3 | Recruiting | Mar 30, 2026 |
| Pentoxifylline in Patients With Ulcerative ColitisInflammatory Bowel Diseases · Ihab Elsayed Hassan | Phase 2 | Recruiting | Jan 16, 2026 |
| Effect of Pentoxifylline + CoQ10 vs CoQ10 Alone on Sperm Motility in Subfertile Men With AsthenozoospermiaAsthenozoospermia · Mst.Sumyara Khatun | Not applicable | Recruiting | Nov 26, 2025 |
| Nephroprotection Following Perinatal Asphyxia: Randomized Controlled TrialHypoxic-Ischemic Encephalopathy, Neonatal Encephalopathy · Alexandria University | Not applicable | Not yet recruiting | Jul 28, 2025 |
| Cocaine and Pentoxifylline (BED IN 47)Cocaine Use Disorder · William Stoops | Early phase 1 | Recruiting | Jul 25, 2025 |
| To Study Effect of Injection Pentoxifylline on Liver Growth After Major Liver SurgeryLiver Regeneration · Institute of Liver and Biliary Sciences, India | Not applicable | Recruiting | Jul 25, 2025 |
| Comparison of the Efficacy of Mesotherapy and Extracorporeal Shock Wave Therapy in Patients With Lateral EpicondylitisLateral Epicondylitis, Tennis Elbow · Haydarpasa Numune Training and Research Hospital | Not applicable | Recruiting | Jun 29, 2025 |
| Approved | Application | Sponsor | Supplements | Marketing |
|---|---|---|---|---|
| Aug 30, 1984 | TrentalNDA 18631 · New molecular entity | Validus Pharms | 32 | Marketed |
| Jul 8, 1997 | PentoxifyllineANDA 74425 | Rising | 16 | Marketed |
| Jul 8, 1997 | PentoxifyllineANDA 74877 | Heritage | 5 | Discontinued |
| Jul 9, 1997 | PentoxifyllineANDA 74878 | Ani Pharms | 10 | Marketed |
| Jul 20, 1998 | PentoxifyllineANDA 75028 | Bausch | 10 | Discontinued |
| Sep 4, 1998 | PentoxifyllineANDA 75107 | Ani Pharms | 4 | Discontinued |
| Mar 31, 1999 | PentoxilANDA 74962 | Upsher Smith Labs | 5 | Discontinued |
| May 25, 1999 | PentoxifyllineANDA 74874 | Pliva | 8 | Discontinued |
| Jun 9, 1999 | PentoxifyllineANDA 75191 | Apotex | 11 | Marketed |
| Aug 10, 1999 | PentoxifyllineANDA 75093 | Impax Labs | 2 | Discontinued |
| Sep 3, 1999 | PentoxifyllineANDA 75199 | Ani Pharms | 1 | Discontinued |
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA