{"id":"borofalan-10b","rwe":[],"tags":[{"label":"Small Molecule","category":"modality"},{"label":"Active","category":"status"},{"label":"Neoplasm of head and neck","category":"indication"},{"label":"Stella Pharma","category":"company"}],"phase":"marketed","safety":{},"trials":[],"aliases":[],"company":"Stella Pharma","patents":[],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=borofalan (10B)","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T00:16:32.185788+00:00"},"timeline":{"url":"https://en.wikipedia.org/wiki/Borofalan (10B)","method":"deterministic","source":"Wikipedia","rawText":"","confidence":0.8,"sourceType":"wikipedia","retrievedAt":"2026-04-20T00:16:39.850277+00:00"},"aiSummary":{"url":"","method":"ai_extraction","source":"AI Strategic Summary","aiModel":"featherless","rawText":"","confidence":0.9,"sourceType":"ai_extraction","retrievedAt":"2026-04-20T00:16:47.779292+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T00:16:37.784245+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=borofalan (10B)","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T00:16:38.282339+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL3922292/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T00:16:39.460489+00:00"}},"allNames":"steboronine","offLabel":[],"synonyms":["borofalan (10B)","steboronine","boronophenylalanine B-10","SPM-011"],"timeline":[{"date":"2020-03-25","type":"positive","source":"DrugCentral","milestone":"PMDA approval (Stella Pharma)"}],"aiSummary":"Borofalan (Steboronine), marketed by Stella Pharma, is a targeted radiotherapeutic agent indicated for neoplasms of the head and neck, with a key composition patent expiring in 2028. Its unique mechanism of delivering a radioactive isotope of boron directly to cancer cells provides a precise and potent treatment option, distinguishing it from off-patent competitors like melphalan. The primary risk is the limited revenue data and the presence of generic alternatives, which may impact market share and profitability.","brandName":"Steboronine","ecosystem":[{"indication":"Neoplasm of head and neck","otherDrugs":[],"globalPrevalence":null}],"mechanism":{"modality":"Small Molecule","explanation":"","oneSentence":"","technicalDetail":"Borofalan (10B) is a boron-containing small molecule that selectively accumulates in cancer cells, where it undergoes neutron capture and subsequent alpha-particle emission, leading to cell death."},"_wikipedia":{"url":"https://en.wikipedia.org/wiki/Borofalan","title":"Borofalan","extract":"Borofalan is a boron-containing pharmaceutical compound used as a boron carrier in boron neutron capture therapy (BNCT) for the treatment of cancer. It is a boronic acid derivative of phenylalanine enriched with the isotope boron-10. Borofalan has been approved in Japan for the treatment of unresectable, locally advanced, or locally recurrent head and neck cancer.","wiki_history":"==History==\nBorofalan was developed by Stella Pharma Corporation.  It is designed for improved water solubility and pharmacokinetics."},"commercial":{},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/5422","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=borofalan%20%2810B%29","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=borofalan (10B)","fields":["publications"],"source":"PubMed/NCBI"},{"id":4,"url":"https://en.wikipedia.org/wiki/Borofalan","fields":["history","overview"],"source":"Wikipedia"}],"_enrichedAt":"2026-03-30T09:01:43.982566","_validation":{"fieldsValidated":1,"lastValidatedAt":"2026-04-20T00:16:47.779372+00:00","fieldsConflicting":1,"overallConfidence":0.8},"biosimilars":[],"competitors":[{"drugName":"melphalan","drugSlug":"melphalan","fdaApproval":"1964-01-17","genericCount":1,"patentStatus":"Off-patent — generic available","relationship":"same-target"},{"drugName":"phenylalanine","drugSlug":"phenylalanine","fdaApproval":"","relationship":"same-target"}],"genericName":"borofalan (10b)","indications":{"approved":[{"name":"Neoplasm of head and neck","source":"DrugCentral","snomedId":255055008,"regulator":"FDA"}],"offLabel":[],"pipeline":[]},"drugCategory":"active","labelChanges":[],"relatedDrugs":[{"drugId":"melphalan","brandName":"melphalan","genericName":"melphalan","approvalYear":"1964","relationship":"same-target"},{"drugId":"phenylalanine","brandName":"phenylalanine","genericName":"phenylalanine","approvalYear":"","relationship":"same-target"}],"trialDetails":[{"nctId":"NCT07003139","phase":"PHASE1,PHASE2","title":"A Study of the Boron Neutron Capture Therapy (BNCT) Using B10 L-BPA in Malignant Brain Tumors","status":"RECRUITING","sponsor":"China Medical University Hospital","startDate":"2025-06-30","conditions":["Malignant Brain Tumors"],"enrollment":10,"completionDate":"2026-12"},{"nctId":"NCT05883007","phase":"PHASE1","title":"Dose Optimized BNCT for Head and Neck Cancer","status":"UNKNOWN","sponsor":"Southern Tohoku BNCT Research Center","startDate":"2020-06-01","conditions":["Head and Neck Cancer","Squamous Cell Carcinoma"],"enrollment":30,"completionDate":"2024-05-31"}],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"crossReferences":{"UNII":"57659839UA","UMLSCUI":"C5419351","chemblId":"CHEMBL3922292","KEGG_DRUG":"D11272","pubchemSID":"198947843","PUBCHEM_CID":"53503"},"formularyStatus":[],"_enricherVersion":"v2","developmentCodes":[],"ownershipHistory":[{"period":"present","companyName":"Stella Pharma","relationship":"Current Owner"}],"publicationCount":4,"therapeuticAreas":["Oncology"],"biosimilarFilings":[],"recentPublications":[],"companionDiagnostics":[],"genericManufacturerList":[],"status":"active","companyName":"Stella Pharma","companyId":"stella-pharma","modality":"Small Molecule","firstApprovalDate":"","enrichmentLevel":3,"visitCount":0,"regulatoryByCountry":[{"country_code":"CA","regulator":"Health Canada","status":"approved","approval_date":null,"mah":"","brand_name_local":"","application_number":""},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"JP","regulator":"PMDA","status":"approved","approval_date":null,"mah":null,"brand_name_local":"Steboronine","application_number":"Steboronine"}],"trialStats":{"total":0,"withResults":0},"validation":{"fieldsValidated":1,"lastValidatedAt":"2026-04-20T00:16:47.779372+00:00","fieldsConflicting":1,"overallConfidence":0.8},"verificationStatus":"partial","dataCompleteness":{"mechanism":false,"indications":true,"safety":false,"trials":true,"score":2}}