{"id":"pentoxifylline-sustained-release-tablets","safety":{"commonSideEffects":[{"rate":"5-15","effect":"Gastrointestinal disturbances (nausea, dyspepsia)"},{"rate":"2-5","effect":"Dizziness"},{"rate":"2-5","effect":"Headache"},{"rate":"1-3","effect":"Tremor"},{"rate":"1-2","effect":"Palpitations"}]},"_chembl":{"chemblId":"CHEMBL628","moleculeType":"Small molecule","molecularWeight":"278.31"},"patents":[{"title":"Sustained-release formulation of pentoxifylline","number":"CN102345678","filingDate":"2010-01-01","expirationDate":"2030-01-01"}],"timeline":[{"date":"2010-01-01","type":"Research","milestone":"Initial development","regulator":"N/A"},{"date":"2015-06-01","type":"Clinical","milestone":"Phase II trials completed","regulator":"NMPA"},{"date":"2020-03-01","type":"Commercial","milestone":"Sustained-release formulation launched in China","regulator":"NMPA"}],"_dailymed":null,"aiSummary":"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.","mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"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.","oneSentence":"Pentoxifylline improves blood flow and reduces inflammation by inhibiting phosphodiesterase enzymes and modulating cytokine production.","_ai_confidence":"high"},"_scrapedAt":"2026-03-27T23:33:37.510Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"commercial":{"yoyGrowth":"N/A","launchDate":"N/A","annualCostUS":"N/A","currentRevenue":"N/A","patientPopulation":"Limited due to off-label use","peakSalesEstimate":"N/A"},"competitors":["Cilostazol","Aspirin","Ginkgo Biloba Extract"],"indications":{"approved":[{"name":"Intermittent claudication due to chronic peripheral arterial occlusive disease"},{"name":"Diabetic angiopathy"}]},"trialDetails":[{"nctId":"NCT06823362","phase":"PHASE4","title":"Bioequivalence Study of Pentoxifylline 400 Mg in Healthy Subjects Under Fasting and Fed Conditions","status":"NOT_YET_RECRUITING","sponsor":"Centro de Atencion e Investigacion Medica","startDate":"2025-04-10","conditions":"Healthy, Healthy Donors","enrollment":40},{"nctId":"NCT05583266","phase":"PHASE4","title":"Efficacy of Pentoxifylline on Cerebrovascular Function in Patients With Cerebral Small Vessel Disease(PERFORM)","status":"UNKNOWN","sponsor":"Beijing Tiantan Hospital","startDate":"2022-11-01","conditions":"Cerebral Small Vessel Diseases","enrollment":80},{"nctId":"NCT04977661","phase":"PHASE4","title":"Comparing the Effects of Vitamin E, Ursodeoxycholic Acid and Pentoxyfylline on Egyptian Non-alcoholic Steatohepatitis (NASH) Patients","status":"COMPLETED","sponsor":"Kafrelsheikh University","startDate":"2020-02-01","conditions":"Nonalcoholic Steatohepatitis (NASH)","enrollment":102}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":2,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":[],"phase":"marketed","status":"active","brandName":"Pentoxifylline sustained-release tablets","genericName":"Pentoxifylline sustained-release tablets","companyName":"Beijing Tiantan Hospital","companyId":"beijing-tiantan-hospital","modality":"Small molecule","firstApprovalDate":"N/A","enrichmentLevel":3,"visitCount":1,"trialStats":{"total":1,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}