{"entity":{"id":"sodium-thiosulfate","kind":"drug","name":"Sodium thiosulfate (otoprotectant)","aka":[],"tldr":"An old antidote proven in two paediatric trials to halve permanent hearing loss from cisplatin, and approved in 2022 as the first drug to prevent a chemotherapy side effect in children.","summary":"SIOPEL-6 (NEJM 2018, hepatoblastoma) and ACCL0431 (Lancet Oncol 2017) showed hearing loss reduced from ~63% to ~33% without compromising survival in localised disease (a survival signal in disseminated disease in ACCL0431 keeps use to localised tumours). Approved FDA September 2022 (ages ≥1 month), EMA 2023.","status":"approved","asOf":"2026-09-08","wikipedia":"https://en.wikipedia.org/wiki/Sodium_thiosulfate_(medical_use)","links":[{"label":"SIOPEL-6 (NEJM 2018)","url":"https://doi.org/10.1056/NEJMoa1801109"},{"label":"Label (DailyMed)","url":"https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=Pedmark"}],"tags":["gap-fill","supportive"],"related":[],"cancers":["hepatoblastoma","medulloblastoma","osteosarcoma","neuroblastoma"],"sections":[],"technologies":["platinum","survivorship-care-plan"],"targets":[],"drugs":[],"companies":["fennec-pharmaceuticals"],"institutions":[],"pathways":[],"terms":[],"trials":["nct05382338","nct00716976","nct00652132"],"people":[],"bottlenecks":[],"keyPapers":["paper-brock-n-engl-j-med"],"journals":[],"dependsOn":[],"notes":[],"brand":"Pedmark","modality":"Small-molecule chemoprotectant","supportive":true,"mechanism":"Thiol that inactivates circulating cisplatin and scavenges reactive oxygen species in the cochlea when given 6 hours after cisplatin, after tumour exposure is complete.","approvals":[{"region":"US","year":2022,"indication":"Reduce risk of ototoxicity from cisplatin in patients ≥1 month with localised, non-metastatic solid tumours"},{"region":"EU","year":2023,"indication":"Same"}],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[]},"route":"/drugs/sodium-thiosulfate/","neighbours":{"cancer":[{"id":"paediatric-germ-cell-tumours","kind":"cancer","name":"Germ cell tumours of childhood and adolescence (extracranial and CNS)","route":"/cancers/paediatric-germ-cell-tumours/"},{"id":"hepatoblastoma","kind":"cancer","name":"Hepatoblastoma","route":"/cancers/hepatoblastoma/"},{"id":"medulloblastoma","kind":"cancer","name":"Medulloblastoma","route":"/cancers/medulloblastoma/"},{"id":"neuroblastoma","kind":"cancer","name":"Neuroblastoma (paediatric)","route":"/cancers/neuroblastoma/"},{"id":"osteosarcoma","kind":"cancer","name":"Osteosarcoma","route":"/cancers/osteosarcoma/"}],"technology":[{"id":"rejuv-paed-hearing","kind":"technology","name":"Hearing after platinum and cranial radiotherapy in a developing child","route":"/technologies/rejuv-paed-hearing/"},{"id":"hearing-after-platinum-chemotherapy","kind":"technology","name":"Hearing and tinnitus after platinum chemotherapy","route":"/technologies/hearing-after-platinum-chemotherapy/"},{"id":"platinum","kind":"technology","name":"Platinum agents","route":"/technologies/platinum/"},{"id":"survivorship-care-plan","kind":"technology","name":"Survivorship care and late-effects surveillance","route":"/technologies/survivorship-care-plan/"}],"company":[{"id":"fennec-pharmaceuticals","kind":"company","name":"Fennec Pharmaceuticals","route":"/companies/fennec-pharmaceuticals/"}],"trial":[{"id":"nct05382338","kind":"trial","name":"A Study of Treatment for Medulloblastoma Using Sodium Thiosulfate to Reduce Hearing Loss","route":"/trials/nct05382338/"},{"id":"nct00652132","kind":"trial","name":"Cisplatin With or Without Sodium Thiosulfate in Treating Young Patients With Stage I, II, or III Childhood Liver Cancer","route":"/trials/nct00652132/"},{"id":"nct00716976","kind":"trial","name":"Sodium Thiosulfate in Preventing Hearing Loss in Young Patients Receiving Cisplatin for Newly Diagnosed Germ Cell Tumor, Hepatoblastoma, Medulloblastoma, Neuroblastoma, Osteosarcoma, or Other Malignancy","route":"/trials/nct00716976/"}],"paper":[{"id":"paper-brock-n-engl-j-med","kind":"paper","name":"Sodium Thiosulfate for Protection from Cisplatin-Induced Hearing Loss","route":"/key-papers/paper-brock-n-engl-j-med/"}],"term":[{"id":"peripheral-neuropathy","kind":"term","name":"Peripheral neuropathy (chemotherapy-induced)","route":"/terms/peripheral-neuropathy/"}],"roadmap":[{"id":"chemotherapy-roadmap","kind":"roadmap","name":"Chemotherapy roadmap: mustard gas → curative combinations → the warhead inside smarter drugs","route":"/roadmaps/chemotherapy-roadmap/"},{"id":"paediatric-oncology-roadmap","kind":"roadmap","name":"Paediatric oncology roadmap: cooperative-group cures → engineered immunity → drugs developed for children first","route":"/roadmaps/paediatric-oncology-roadmap/"},{"id":"survivorship-roadmap","kind":"roadmap","name":"Supportive care and survivorship roadmap: making treatment bearable → proving it extends life → caring for tens of millions afterwards","route":"/roadmaps/survivorship-roadmap/"}]}}