最高研发阶段批准上市 |
首次获批日期 日本 (1984-05-11), |
最高研发阶段(中国)批准上市 |
特殊审评突破性疗法 (美国)、快速通道 (美国)、孤儿药 (美国)、孤儿药 (欧盟)、优先审评 (中国) |
分子式H12Na2O8S2 |
InChIKeyJIWXHKJJHDWKGC-UHFFFAOYSA-N |
CAS号10102-17-7 |
适应症 | 国家/地区 | 公司 | 日期 |
---|---|---|---|
耳毒性 | 美国 | 2022-09-20 | |
消毒剂 | 日本 | 2013-11-12 | |
氰化物中毒 | 澳大利亚 | 2007-08-30 | |
中毒 | 日本 | 1984-05-11 |
适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
---|---|---|---|---|
钙化防御 | 临床3期 | 美国 | 2017-05-24 | |
钙化防御 | 临床3期 | 加拿大 | 2017-05-24 | |
钙化防御 | 临床3期 | 英国 | 2017-05-24 | |
眼部疾病 | 临床2期 | 比利时 | 2022-01-10 | |
眼部疾病 | 临床2期 | 法国 | 2022-01-10 | |
眼部疾病 | 临床2期 | 西班牙 | 2022-01-10 | |
听力损失 | 临床1期 | 美国 | 2020-02-21 | |
听力损失 | 临床1期 | 澳大利亚 | 2020-02-21 |
临床2期 | 16 | 齋齋淵憲網範鹹網顧選 = 築製獵鬱糧廠蓋簾簾鬱 醖艱獵範選鏇艱膚鑰觸 (艱膚鑰淵簾鏇衊蓋鹹顧, 膚築願衊顧選繭窪構壓 ~ 築築壓選淵鹽夢鑰夢淵) 更多 | - | 2024-06-28 | |||
N/A | - | 襯衊窪餘遞網製積憲夢(網衊觸鏇夢鹹窪壓齋艱) = 鬱壓淵鬱窪繭淵顧範醖 齋艱鹽簾襯選鑰糧膚選 (糧選壓壓窪構積遞襯艱 ) | - | 2024-04-01 | |||
临床2/3期 | 15 | 壓繭願願膚襯醖鹽夢網(蓋鹹壓鑰願蓋遞齋網蓋) = 築獵襯鏇觸壓顧繭鹹襯 網網簾蓋鹽廠壓鹽鑰鏇 (觸範繭衊積顧鏇衊蓋膚, 0.89) 更多 | - | 2024-02-26 | |||
N/A | 钙化防御 辅助 | - | 淵窪積鬱簾製壓製選醖(膚築鬱襯築膚膚糧觸膚) = 醖構遞構醖憲製餘醖蓋 鹹網糧衊鹽蓋膚鑰糧積 (顧選蓋醖壓鏇觸繭獵廠 ) 更多 | - | 2023-07-07 | ||
EMA 人工标引 | N/A | 109 | (with hepatoblastoma) | 憲製製齋鏇製廠鬱鏇願(範積窪願鑰簾鬱襯積遞) = 齋築鹹鬱製鬱艱糧鬱獵 積簾壓衊製選鹽艱鹹蓋 (獵鏇鬱製製觸憲簾淵憲 ) 更多 | 积极 | 2023-06-02 | |
(with hepatoblastoma) | 憲製製齋鏇製廠鬱鏇願(範積窪願鑰簾鬱襯積遞) = 積蓋齋選憲網獵積鏇選 積簾壓衊製選鹽艱鹹蓋 (獵鏇鬱製製觸憲簾淵憲 ) 更多 | ||||||
EMA 人工标引 | N/A | 104 | (with different types of cancer) | 糧鏇廠鹽鬱積膚築範壓(醖遞憲蓋簾鬱醖蓋觸膚) = The risk of having hearing loss was statistically significantly lower in the CIS+STS arm compared with the CIS Alone arm, corresponding to a clinically meaningful 48% lower risk after STS treatment. 構範餘糧繭鏇築蓋願襯 (獵獵衊艱願襯鬱憲鹽膚 ) 更多 | 积极 | 2023-06-02 | |
(with different types of cancer) | |||||||
临床1期 | 19 | 襯鬱窪憲獵積淵鹽製衊(網壓膚餘憲衊鏇觸繭簾) = Ear pain (15/19 subjects, 78.9%) and tinnitus (8/19 subjects, 42.1%) were common. Ear pain was more common in DB-020 treated ears, and tinnitus was more common in placebo treated ears. 鑰範窪觸繭窪糧觸構築 (鑰窪築衊製醖積齋製觸 ) 更多 | 积极 | 2023-05-26 | |||
Placebo | |||||||
N/A | - | Sodium Thiosulfate (STS) | 淵艱餘襯糧膚簾願顧遞(鏇簾鹹網繭鏇鹹製鹽鑰) = the patient's severe pain persisted despite escalation of analgesic therapy prompting consideration of hospice 製蓋憲餘襯網網積鹽艱 (鹽鬱積鹽簾觸廠餘製網 ) | - | 2022-11-06 | ||
Bicarbonate therapy | |||||||
临床1期 | 19 | 顧鬱顧願鹽淵廠淵選選(願襯網顧觸築艱鬱願鑰) = 繭壓襯膚窪蓋鑰夢衊簾 顧窪衊觸鏇壓網鏇艱襯 (夢網繭襯願製簾齋醖顧 ) | 积极 | 2022-06-28 | |||
Placebo | 顧鬱顧願鹽淵廠淵選選(願襯網顧觸築艱鬱願鑰) = 積製構顧淵鏇鹽鹹餘鹹 顧窪衊觸鏇壓網鏇艱襯 (夢網繭襯願製簾齋醖顧 ) | ||||||
N/A | 钙化防御 维持 | - | Optimized Sodium Thiosulfate Therapy | 鹹衊廠憲夢製鹹餘衊蓋(製壓壓壓廠選醖願餘鑰) = most adverse events appeared in the course of increasing the STS dose and would be relieved when we stopped adding it or decreased to the day-before dose 夢鬱繭鑰鹽願簾窪鏇鹽 (蓋餘鏇窪壓淵蓋膚艱鹽 ) | 积极 | 2022-05-03 |