{"id":"belinostat-injection","safety":{"commonSideEffects":[{"rate":"40-50","effect":"Nausea"},{"rate":"35-45","effect":"Fatigue"},{"rate":"25-35","effect":"Vomiting"},{"rate":"20-30","effect":"Diarrhea"},{"rate":"20-25","effect":"Anemia"},{"rate":"15-20","effect":"Thrombocytopenia"},{"rate":"15-20","effect":"Infection"}]},"_chembl":{"chemblId":"CHEMBL408513","moleculeType":"Small molecule","molecularWeight":"318.35"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"By inhibiting histone deacetylases, belinostat increases acetylation of histone proteins, which opens chromatin structure and allows transcription of genes involved in cell cycle arrest and apoptosis. This mechanism is particularly effective in hematologic malignancies where epigenetic dysregulation drives tumor growth. The drug induces differentiation and death of cancer cells while sparing many normal cells.","oneSentence":"Belinostat is a histone deacetylase (HDAC) inhibitor that blocks HDAC enzymes to promote histone acetylation, leading to altered gene expression and cancer cell death.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T01:03:55.187Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Peripheral T-cell lymphoma (PTCL)"},{"name":"Cutaneous T-cell lymphoma"}]},"trialDetails":[{"nctId":"NCT06072131","phase":"PHASE3","title":"To Evaluate Efficacy of Belinostat or Pralatrexate in Combination Against CHOP Alone in PTCL","status":"RECRUITING","sponsor":"Acrotech Biopharma Inc.","startDate":"2023-10-04","conditions":"Peripheral T Cell Lymphoma","enrollment":504},{"nctId":"NCT03432741","phase":"PHASE1","title":"Direct Tumor Microinjection and FDG-PET in Testing Drug Sensitivity in Patients With Relapsed or Refractory Non-Hodgkin Lymphoma, Hodgkin Lymphoma, or Stage IV Breast Cancer","status":"TERMINATED","sponsor":"Mayo Clinic","startDate":"2018-03-27","conditions":"Breast Adenocarcinoma, Metastatic Breast Carcinoma, Recurrent Breast Carcinoma","enrollment":17},{"nctId":"NCT01100944","phase":"PHASE1, PHASE2","title":"A Phase 1/2 Study of PXD101 (Belinostat) in Combination With Cisplatin, Doxorubicin and Cyclophosphamide in the First Line Treatment of Advanced or Recurrent Thymic, Malignancies","status":"TERMINATED","sponsor":"National Cancer Institute (NCI)","startDate":"2010-03-04","conditions":"Thymoma, Thymic Carcinoma","enrollment":26},{"nctId":"NCT01317927","phase":"PHASE1","title":"A Study of Belinostat in Combination With Warfarin in Patients With Solid Tumors or Hematological Malignancies","status":"COMPLETED","sponsor":"Spectrum Pharmaceuticals, Inc","startDate":"2010-12","conditions":"Solid Tumor, Hematological Malignancy","enrollment":27}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":2,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Beleodaq®","PXD101"],"phase":"phase_3","status":"active","brandName":"Belinostat Injection","genericName":"Belinostat Injection","companyName":"Acrotech Biopharma Inc.","companyId":"acrotech-biopharma-inc","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Belinostat is a histone deacetylase (HDAC) inhibitor that blocks HDAC enzymes to promote histone acetylation, leading to altered gene expression and cancer cell death. Used for Peripheral T-cell lymphoma (PTCL), Cutaneous T-cell lymphoma.","enrichmentLevel":3,"visitCount":1,"regulatoryByCountry":[{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"2014-07-03T00:00:00.000Z","mah":"ACROTECH BIOPHARMA","brand_name_local":"BELEODAQ","application_number":"NDA206256"}],"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}