Pentoxifylline
Small molecule targets TLR4, TNF via inhibition
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | TRENTAL | — | 1984-08-30 | fda.gov ↗ |
Trials 121 · started per year
Also used as a comparator or background therapy in 58 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT05590117 Comparator | Oct 2022 → Oct 2023 | colorectal cancer, mucositis, peripheral neuropathy | Tanta University | Unknown | No outcome recorded |
| Phase 11 trial | ||||||
| Phase 1 | NCT03836222 Comparator | Feb → Jun 2018 | — | Processa Pharmaceuticals | Completed | No outcome recorded |
| Phase 1/23 trials | ||||||
| Phase 1/2 | NCT06332612 Comparator | Aug → Dec 2024 | oral submucous fibrosis | Ziauddin University | Completed | No outcome recorded |
| Phase 1/2 | NCT05073640 Comparator | Apr 2019 → Apr 2022 | schizophrenia | Mazra Mental Health Center | Unknown | No outcome recorded |
| Phase 1/2 | NCT00243789 Comparator | Sep 2005 → Dec 2007 | Duchenne muscular dystrophy | Cooperative International Neuromuscular Research Group | Completed | No outcome recorded |
| Phase 214 trials | ||||||
| Phase 2 | NCT07349472 Comparator | Jan 2026 → Jan 2027 expected | inflammatory bowel disease | Ihab Elsayed Hassan | Recruiting | No outcome recorded |
| Phase 2 | NCT06998628 Comparator | Jun 2025 → May 2026 overdue | rheumatoid arthritis | Tanta University | Recruiting | No outcome recorded |
| Phase 2 | NCT07137793 Comparator | May 2025 → May 2026 overdue | breast cancer, doxorubicin induced cardiomyopathy | Tanta University | Recruiting | No outcome recorded |
| Phase 2 | NCT06186700 Comparator | Dec 2023 → Dec 2024 | chemotherapy-induced neuropathy, female breast carcinoma | Mansoura University | Completed | No outcome recorded |
| Phase 2 | NCT06176339 Comparator | Dec 2023 → Aug 2024 | female breast carcinoma | Mansoura University | Unknown | No outcome recorded |
| Phase 2 | NCT05962957 Comparator | Aug 2023 → Sep 2024 | Parkinson disease | Mostafa Bahaa | Completed | No outcome recorded |
| Phase 2 | NCT05575505 Comparator | Feb 2023 → Feb 2026 overdue | inflammatory bowel disease | Tanta University | Recruiting | No outcome recorded |
| Phase 2 | NCT05637086 Comparator | Dec 2022 → Dec 2026 expected | epilepsy | Mostafa Bahaa | Recruiting | No outcome recorded |
| Phase 2 | NCT05558761 Comparator | Oct 2022 → Apr 2024 | inflammatory bowel disease | Tanta University | Completed | No outcome recorded |
| Phase 2 | NCT03916068 Comparator | Jul 2019 → Oct 2023 | breast cancer | Legacy Health System | Terminated | No outcome recorded |
| Phase 2 | NCT03342950 Comparator | Feb 2019 → Oct 2021 | peripheral neuropathy | Terence J. Coderre | Terminated | No outcome recorded |
| Phase 2 | NCT02776059 Comparator | Jan 2017 → Mar 2020 | alcoholic hepatitis | Timothy Morgan, MD | Completed | No outcome recorded |
| Phase 2 | NCT02530697 Background | Aug 2015 → Aug 2025 overdue | leishmaniasis | University of Brasilia | Active not recruiting | No outcome recorded |
| Phase 2 | NCT01822405 Comparator | Jul 2010 → Jul 2013 | — | Hospital Universitario de Canarias | Unknown | No outcome recorded |
| Phase 2/34 trials | ||||||
| Phase 2/3 | NCT05897034 Comparator | Jun 2023 → Jun 2024 overdue | bacterial sexually transmitted disease | Tanta University | Not yet recruiting | No outcome recorded |
| Phase 2/3 | NCT05387187 Comparator | May 2022 | chronic kidney disease | Taipei Medical University Hospital | Unknown | No outcome recorded |
| Phase 2/3 | NCT04367935 Comparator | Jan 2021 → Apr 2022 | acute coronary syndrome | Ain Shams University | Completed | No outcome recorded |
| Phase 2/3 | NCT00663949 Comparator | Feb 2006 → Dec 2007 | diabetic kidney disease | Shiraz University of Medical Sciences | Completed | No outcome recorded |
| Phase 311 trials | ||||||
| Phase 3 | NCT06421870 Comparator | Mar 2024 → May 2025 | chronic kidney disease | Ain Shams University | Unknown | No outcome recorded |
| Phase 3 | NCT06422000 Comparator | Jun 2022 → Nov 2023 | necrotizing enterocolitis | Tanta University | Completed | No outcome recorded |
| Phase 3 | NCT02898376 Background | Dec 2018 → Jul 2020 | breast carcinoma | Institut de Cancérologie de Lorraine | Unknown | No outcome recorded |
| Phase 3 | NCT03406169 Comparator | Feb 2017 → Dec 2021 | erectile dysfunction, prostate cancer | Brooke Army Medical Center | Unknown | No outcome recorded |
| Phase 3 | NCT02687841 Comparator | Jan 2016 → Dec 2017 | acute kidney injury | National Taiwan University Hospital | Unknown | No outcome recorded |
| Phase 3 | NCT02485106 Comparator | Jul 2015 → Dec 2016 | alcoholic hepatitis | Saint Vincent's Hospital, Korea | Unknown | No outcome recorded |
| Phase 3 | NCT02163174 Comparator | May 2011 → Feb 2013 | neonatal sepsis | Abd Elazeez Attala Shabaan | Completed | No outcome recorded |
| Phase 3 | NCT01214226 Comparator | Dec 2007 → Dec 2010 | alcoholic hepatitis | University Hospital, Lille | Completed | No outcome recorded |
| Phase 3 | NCT00162552 Comparator | Aug 2004 → Dec 2007 | cirrhosis of liver, liver failure | Assistance Publique - Hôpitaux de Paris | Completed | No outcome recorded |
| Phase 3 | NCT00632697 Comparator | Oct 2001 → Dec 2006 | endometriosis | Hospital Clinic of Barcelona | Completed | No outcome recorded |
| Phase 3 | NCT01263925 Comparator | Apr 2001 → Apr 2011 | intermittent vascular claudication, peripheral arterial occlusive disease 1 | UCB Pharma | Completed | No outcome recorded |
| Phase 411 trials | ||||||
| Phase 4 | NCT06115174 Comparator | Nov 2023 → Nov 2024 | colorectal carcinoma | Tanta University | Unknown | No outcome recorded |
| Phase 4 | NCT04977661 Comparator | Feb → May 2020 | metabolic dysfunction-associated steatohepatitis | Kafrelsheikh University | Completed | No outcome recorded |
| Phase 4 | NCT03664414 Comparator | Mar 2018 → Jul 2019 | chronic kidney disease, type 2 diabetes mellitus | Maria Eugenia Galván Plata | Unknown | No outcome recorded |
| Phase 4 | NCT03006952 Comparator | Apr → Sep 2015 | diabetic kidney disease | Tehran University of Medical Sciences | Completed | No outcome recorded |
| Phase 4 | NCT02971306 Background | Jul 2014 → Dec 2017 | alcoholic hepatitis | Post Graduate Institute of Medical Education and Research, Chandigarh | Unknown | No outcome recorded |
| Phase 4 | NCT02051075 Comparator | Mar 2014 → May 2015 | infertility disorder | Rambam Health Care Campus | Withdrawn | No outcome recorded |
| Phase 4 | NCT01542268 Comparator | Mar 2012 → Jan 2013 | irritable bowel syndrome | Hospital Universitario de Canarias | Unknown | No outcome recorded |
| Phase 4 | NCT01382303 Comparator | Oct 2010 → Dec 2013 | type 2 diabetes mellitus | Ajou University School of Medicine | Completed | No outcome recorded |
| Phase 4 | NCT01377285 Comparator | Jun 2010 → Dec 2018 | chronic renal failure syndrome | National Taiwan University Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT01006499 Comparator | Aug 2009 → Oct 2010 | neonatal sepsis | Zekai Tahir Burak Women's Health Research and Education Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT01718288 Background | Nov 2006 → Mar 2011 | peripheral arterial disease | Fadoi Foundation, Italy | Completed | No outcome recorded |
| Phase not applicable12 trials | ||||||
| — | NCT07626788 Comparator | Jun 2026 → Mar 2027 expected | psoriasis | Wasuchon Chaichan | Not yet recruiting | No outcome recorded |
| — | NCT07088328 Comparator | Jul 2025 → Jan 2026 overdue | brain hypoxia - ischemia | Alexandria University | Not yet recruiting | No outcome recorded |
| — | NCT06319768 Comparator | Jan → Jun 2024 | skin atrophy | Sohag University | Unknown | No outcome recorded |
| — | NCT06458465 Comparator | Oct 2023 → Sep 2024 | chronic kidney disease | Alexandria University | Completed | No outcome recorded |
| — | NCT05640817 Comparator | Jan 2023 → Jan 2026 | cisplatin toxicity | Tanta University | Completed | No outcome recorded |
| — | NCT06562998 Comparator | Jul 2022 → Apr 2024 | chemotherapy-induced neuropathy | Beni-Suef University | Completed | No outcome recorded |
| — | NCT05329116 Comparator | May → Oct 2022 | osteoarthritis, knee | Necmettin Yildiz | Unknown | No outcome recorded |
| — | NCT04739345 Comparator | Dec 2020 → Jun 2021 | COVID-19, cytokine release syndrome | Ain Shams University | Completed | No outcome recorded |
| — | NCT02231333 Comparator | Jul 2013 → Jul 2015 | metabolic dysfunction-associated steatohepatitis | Institute of Liver and Biliary Sciences, India | Completed | No outcome recorded |
| — | NCT01676597 Background | Sep 2012 → Sep 2014 | hepatopulmonary syndrome | Institute of Liver and Biliary Sciences, India | Unknown | No outcome recorded |
| — | NCT01893450 Comparator | Jun 2008 → Jun 2013 | disease of orbital part of eye adnexa | National Institute of Medical Sciences and Nutrition Salvador Zubiran | Terminated | No outcome recorded |
| — | NCT00681733 Comparator | Jan 2007 → Dec 2008 | — | Govind Ballabh Pant Hospital | Unknown | No outcome recorded |
| Phase not stated1 trial | ||||||
| — | NCT01049633 Background | — | type 1 diabetes mellitus | National Institute of Allergy and Infectious Diseases (NIAID) | No longer available | No outcome recorded |
Evidence & citations 18 cited values
Every value below carries the sentence it was read from. 191 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Pentoxifylline | “A Phase I, Single Centre, Open-Label, Non-Randomised Study to Evaluate the PK of Single and Optional Multiple Dosing Regimens of MR Formulations of PCS499 Compared to Trental®...” NCT03836222 ↗168“23 patients will receive the intervention drug Pentoxifylline (Trental 400 milligram(MG) Extended Release Oral Tablet) twice daily in addition their usual dose of...” NCT03800433 ↗ “standard heparin / low molecular weight heparin, hemorheological / vasodilators such as pentoxifylline / buflomedil, propionyl-L-carnitine, Defibrotide) but not prostanoids” NCT01718288 ↗ “Topical Solution of Clonidine (0.01%) + Pentoxifylline (5%) in anhydrous ethanol (6.5%), polyethylene glycol 400 (20%), propylene glycol (53.5%), and oleyl alcohol (20%)” NCT03342950 ↗ “the active substance pentoxifylline has been available as tablets for decades and is used to increase peripheral blood flow in patients with circulation problems.” NCT06986031 ↗ “In this study, we investigated if pentoxifylline (PTX) and ethosuximide could potentially alleviate abdominal pain in patients with IBS treated with mebeverine.” PMID 35221706 ↗ Feb 2022 “Gel PKB171 contains pentoxifylline, which is used in assisted reproduction to treat sperm samples because of its ability to improve progressive sperm mobility” NCT07669584 ↗ “The appetite stimulating arm will include a medication known as "pentoxifylline" (also known as Trental™) and the dose will be 400 mg daily or its placebo.” NCT00561093 ↗ “Trental (pentoxifylline) 400 milligrams three times a day in combination with vitamin E, 400 international units orally twice daily for six months.” NCT01082003 ↗ “Standard of care treatment will be with either prednisolone 40 mg/day for 28 days or pentoxifylline 400 mg TID for 28 days.” NCT02776059 ↗ “800 mg pentoxifylline (400 mg morning and night)” NCT06055257 ↗ “1.5 ml of 30 mg of pentoxifylline” NCT05329116 ↗ “Pentoxifylline (control)” NCT02971306 ↗ “Drug: Pentoxifylline” NCT06041932 ↗ |
| Known as | Oxopurin | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05073640 ↗ |
| Known as | oxpentifylline | “Pentoxifylline (also known as oxpentifylline) is a methylxanthine derivative with strong hemorrheologic effects.” NCT06998628 ↗2“Pentoxifylline (also known as oxpentifylline)” NCT07085806 ↗ “Pentoxifylline (also known as oxpentifylline)” NCT00315679 ↗ |
| Known as | Pentoxifylline, generic | “Pentoxifylline, generic” NCT01809132 ↗ |
| Known as | Pentoxiphyllin | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01279434 ↗ |
| Known as | pentoxiphylline | “Drug: pentoxiphylline” NCT01144091 ↗ |
| Known as | Pentoxyphylline | “Fertilizations With Immotile Sperm: Pentoxyphylline Activation Alone, or With Chemical Oocyte Activation” NCT02051075 ↗ |
| Known as | POF | “Pentoxifylline (POF), a xanthine derivative used for many years in the treatment of peripheral vascular disease” NCT00001877 ↗ |
| Known as | PTF | “The purpose of the investigators study is to assess the impact of therapy with Pentoxifylline (PTF), a nonspecific phosphodiesterase inhibitor, on kidney function in patients...” NCT00285298 ↗2“Pentoxifylline (PTF) is a synthetic dimethylxanthine derivative that modulates the rheological properties of blood and has both anti-oxidant and anti-inflammatory properties.” NCT06421870 ↗ “Pentoxifylline (PTF) appears to improve circulation through its ability to alter erythrocyte deformability and enhances capillary microcirculation.” NCT05284656 ↗ |
| Known as | PTX | “This randomized, double-blind, placebo-controlled clinical trial aimed to prospectively examine the effect of pentoxifylline (PTX) on hypoxia-inducible factor-2 alpha (HIF-2α)...” PMID 39499142 ↗ Nov 202438“We aimed to clinically investigate the extra-therapeutic effect of adding therapeutic doses of pentoxifylline (PTX) and/or folic acid (FA) for CKD patients to the standard care...” PMID 40826392 ↗ Aug 2025 “This study aimed to evaluate the efficacy of oral pentoxifylline (PTX), combined with standard antibiotic and supportive therapies, for treating hospitalized children with...” PMID 42086944 ↗ May 2026 “Our preliminary in vitro and in vivo research suggests that pentoxifylline (PTX) reduces vascular inflammation and improves endothelial function in HIV-infected persons not...” PMID 23593327 ↗ Apr 2013 “This study aimed to evaluate the therapeutic benefits of pentoxifylline (PTX) in treatment of adult patients with MDD as it has anti-inflammatory and phosphodiastrase...” NCT03554447 ↗ “Pentoxifylline (PTX), a methylxanthine derivative and non-selective phosphodiesterase inhibitor, has been extensively studied for its anti-inflammatory and immunomodulatory actions.” NCT07349472 ↗ “Pentoxifylline (PTX) is a methylxanthine with promising immunomodulatory properties, which can be used as an additional therapy next to antibiotics in preterm infants.” PMID 34794420 ↗ Nov 2021 “Pentoxifylline (PTX) is a methylxanthine derivative that inhibits pro-inflammatory cytokines and also has shown anti-fibrotic effects in serum of patients with PBC.” NCT01249092 ↗ “The primary aim of this study was to compare the effects of pentoxifylline (PTX) versus placebo on the histological features of nonalcoholic steatohepatitis (NASH).” PMID 21748765 ↗ Aug 2011 “Pentoxifylline (PTX), a nonspecific phosphodiesterase inhibitor, was first considered in the treatment of peripheral vascular diseases (Nasiri-Toosi et al., 2013).” NCT05640817 ↗ “Pentoxifylline (PTX) has demonstrated potential in alleviating several adverse effects induced by chemotherapy in preclinical and limited clinical investigations.” PMID 41164763 ↗ Oct 2025 “In this study, we investigated if pentoxifylline (PTX) and ethosuximide could potentially alleviate abdominal pain in patients with IBS treated with mebeverine.” PMID 35221706 ↗ Feb 2022 “Pentoxifylline (PTX), a synthetic methylxanthine derivative, has shown promise in preclinical studies when combined with conventional anticancer drugs.” NCT06176339 ↗ “Pentoxifylline (PTX) has a well validated immune modulatory and anti-inflammatory efficacy via suppression of the TLR4/NF-κB network signaling pathway.” NCT05962957 ↗ “The non-specific phosphodiesterase inhibitor pentoxifylline (PTX) was approved by the FDA in 1984 for the treatment of peripheral vascular disease.” NCT03625648 ↗ “AIMS: To investigate the efficacy and safety of tadalafil (TAD) versus pentoxifylline (PTX) in the management of diabetic kidney disease (DKD).” PMID 38915115 ↗ Jun 2024 “Pentoxifylline (PTX) is a phosphodiesterase inhibitor that is widely used for the treatment of peripheral vascular occlusive disorders.” NCT00154661 ↗ “Pentoxifylline (PTX) is a methylxanthine derivative that is a nonselective inhibitor of cyclic nucleotide phosphodiesterase (PDE).” NCT03859570 ↗ “phosphodiesterase inhibitor pentoxifylline (PTX) is a potent anti-inflammatory, anti-proliferative, and anti-fibrotic agent” NCT02951299 ↗ “Pentoxifylline (PTX) is a methyl-xanthine derivative that possesses antioxidant and anti-inflammatory characteristics.” NCT05558761 ↗ “Pentoxifylline (PTX) is a methyl-xanthine derivative that possesses antioxidant and anti-inflammatory characteristics” NCT05575505 ↗ “Pentoxiphylline (PTX), an anti-TNF-alpha agent, has been reported to reduce hepatic inflammation and fibrosis.” PMID 33772456 ↗ Mar 2021 “Pentoxifylline (PTX) is a methylxanthine derivative that is commercially available in the name of Trental.” NCT06115174 ↗ “Pentoxifylline (PTX) is a non-specific phosphodiesterase inhibitor belonging to the methylxanthine family.” NCT05490953 ↗ “43 patients were randomized to pentoxifylline (PTX) 400 mg thrice daily (n = 22) or placebo (n = 21).” PMID 38817362 ↗ May 2024 “Pentoxifylline (PTX), a medicine with anti-inflammatory and phosphodiesterase inhibitory properties” NCT05271084 ↗ “Pentoxifylline (PTX) is a methylxanthine derivative, which acts as a phosphodiesterase inhibitor” NCT06087796 ↗ “Pilot studies suggest that pentoxifylline (PTX) can reduce liver injury in patients with NASH.” PMID 21677329 ↗ Jul 2011 “Pentoxifylline (PTX) has a well validated immune modulatory and anti-inflammatory efficacy” NCT05637086 ↗ “Pentoxifylline (PTX) is a methylated xanthine derivative and a PDE inhibitor” NCT04094207 ↗ “33 patients received pentoxifylline (PTX) 400 mg three times daily” PMID 25945012 ↗ Apr 2015 “400mg pentoxifylline (PTX) and 400IU tocopherol twice-daily PO” NCT03040778 ↗ “Pentoxifylline (PTX), a synthetic dimethylxanthine derivative” NCT07315139 ↗ “400 mg oral Pentoxifylline (PTX) three times per day” NCT07561801 ↗ “topical pentoxifylline (PTX)” NCT04186559 ↗ “Drug: Pentoxifylline (PTX)” NCT02163174 ↗ “pentoxyphylline (PTX)” NCT02687841 ↗ “pentoxiphylline (PTX)” NCT02231333 ↗ “pentoxifylline (PTX)” NCT05231980 ↗ |
| Known as | PXN | “Treatment is usually based on inducing motility with pentoxyphylline (PXN) followed by ICSI.” NCT02051075 ↗ |
| Known as | Trental | “23 patients will receive the intervention drug Pentoxifylline (Trental 400 milligram(MG) Extended Release Oral Tablet) twice daily in addition their usual dose of...” NCT03800433 ↗7“The appetite stimulating arm will include a medication known as "pentoxifylline" (also known as Trental™) and the dose will be 400 mg daily or its placebo.” NCT00561093 ↗ “Pentoxifylline (Trental) as a Modulator of Tumor Necrosis Factor and of HIV Replication in Patients With AIDS” NCT00000646 ↗ “Pentoxifylline (PTX) is a methylxanthine derivative that is commercially available in the name of Trental.” NCT06115174 ↗ |
| Known as | Trental SR | “25 patients will receive pentoxifylline (Trental SR®) 400 mg three times daily with their standard therapy for 6 months.” NCT05284448 ↗ |
| Known as | trentoximal | “They will be given pentoxifylline as reno-protective drug (trentoximal, Egypharma ; E.D.A Reg.No.: 25276/2007) was administered intravenously to Neonates with perinatal hypoxia...” NCT07088328 ↗ |
| Action | Inhibit | “Pentoxifylline decreases tumor necrosis factor (TNF)” NCT00000646 ↗ |
| Modality | Small molecule | “Pentoxifylline (POF), a xanthine derivative” NCT00001877 ↗ |
| Route | Oral | “400 mg po TID” NCT00001437 ↗ |
| Target | TNF | “Pentoxifylline decreases tumor necrosis factor (TNF)” NCT00000646 ↗ |