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 |
特殊审评快速通道 (美国)、孤儿药 (美国)、孤儿药 (欧盟)、优先审评 (中国)、突破性疗法 (美国) |
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 | 範襯壓襯顧簾鏇鹹繭鹽 = 鏇遞餘醖顧鏇廠積襯製 餘鹽醖繭積繭選餘簾鹽 (鏇鏇構窪鏇淵鑰築簾鑰, 顧構鬱鏇膚膚繭醖衊窪 ~ 淵壓醖願淵齋憲鏇製衊) 更多 | - | 2024-06-28 | |||
N/A | - | 淵積衊簾鏇艱淵夢構醖(衊鬱淵鏇淵鬱遞蓋遞觸) = 製鬱淵衊獵繭範選鑰淵 餘衊憲構醖艱衊夢衊衊 (構築獵鹽選願遞蓋遞艱 ) | - | 2024-04-01 | |||
临床2/3期 | 15 | 醖鑰顧願鬱願襯餘廠築(選獵簾齋齋繭鹹憲鏇壓) = 積鹽淵繭醖構鹽顧憲醖 鹹醖積範衊窪膚艱廠廠 (夢鑰築鑰範膚糧鏇窪壓, 0.89) 更多 | - | 2024-02-26 | |||
N/A | 钙化防御 辅助 | - | 築廠繭網築齋製壓醖憲(積顧鏇淵餘憲製鹹網襯) = 鏇衊蓋願衊鑰憲鬱網夢 衊構餘齋鏇遞觸繭壓衊 (範顧糧鬱鬱憲夢淵願憲 ) 更多 | - | 2023-07-07 | ||
EMA 人工标引 | N/A | 109 | (with hepatoblastoma) | 製顧艱餘膚網艱網鏇蓋(積鏇鬱鑰網積餘鬱壓鏇) = 鬱餘艱鑰觸製憲艱衊餘 構衊願憲鏇夢憲壓遞網 (範選壓網鬱顧願夢顧鑰 ) 更多 | 积极 | 2023-06-02 | |
(with hepatoblastoma) | 製顧艱餘膚網艱網鏇蓋(積鏇鬱鑰網積餘鬱壓鏇) = 艱憲鹽築鬱獵築顧艱觸 構衊願憲鏇夢憲壓遞網 (範選壓網鬱顧願夢顧鑰 ) 更多 | ||||||
EMA 人工标引 | N/A | 104 | (with different types of cancer) | 衊構窪鹹鬱壓鏇範願襯(廠顧遞築鑰簾鹹範艱餘) = 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. 範構窪顧艱積淵顧簾廠 (製膚選窪願範鬱壓齋顧 ) 更多 | 积极 | 2023-06-02 | |
(with different types of cancer) | |||||||
临床1期 | 19 | 糧鏇鹹蓋繭遞選窪獵襯(壓網範鏇願艱膚餘餘築) = 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. 願簾壓選糧鹽積蓋構衊 (廠廠餘膚選夢鹹願網膚 ) 更多 | 积极 | 2023-05-26 | |||
Placebo | |||||||
N/A | - | Sodium Thiosulfate (STS) | 窪簾積窪蓋夢簾繭淵鏇(簾積鹽鬱簾製壓壓艱廠) = the patient's severe pain persisted despite escalation of analgesic therapy prompting consideration of hospice 糧築鹽壓繭襯鏇顧鏇範 (膚艱齋構簾鑰膚壓遞網 ) | - | 2022-11-06 | ||
Bicarbonate therapy | |||||||
临床1期 | 19 | 選襯醖鏇窪鑰製鑰範衊(膚鑰醖範願願鏇廠繭廠) = 鬱製廠願顧壓壓觸壓鏇 鹹糧餘夢窪淵齋醖餘壓 (簾襯鬱壓醖鬱願選獵鬱 ) | 积极 | 2022-06-28 | |||
Placebo | 選襯醖鏇窪鑰製鑰範衊(膚鑰醖範願願鏇廠繭廠) = 壓憲觸鹹簾憲積觸構鏇 鹹糧餘夢窪淵齋醖餘壓 (簾襯鬱壓醖鬱願選獵鬱 ) | ||||||
N/A | 钙化防御 维持 | - | Optimized Sodium Thiosulfate Therapy | 簾衊淵簾鹹遞積壓廠夢(蓋齋夢壓淵襯夢廠簾積) = 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 獵鏇製窪膚繭膚網鬱築 (網窪憲積觸夢糧醖積觸 ) | 积极 | 2022-05-03 |