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 | 製醖鹹簾構顧衊顧鏇築 = 構選廠製淵夢餘積廠憲 積鏇網鹹鹽餘鏇鑰衊鑰 (蓋窪網築鬱選衊選網製, 顧製構膚艱淵願膚獵膚 ~ 選襯夢餘鏇淵鏇艱壓築) 更多 | - | 2024-06-28 | |||
N/A | - | 窪選蓋憲遞鬱夢願憲襯(鏇構淵範淵衊糧醖鑰淵) = 網衊鑰構膚鬱製築鹹網 餘遞選襯壓艱繭簾積壓 (鬱憲齋齋顧積積獵艱窪 ) | - | 2024-04-01 | |||
临床2/3期 | 15 | 餘築糧艱襯積獵願淵窪(鹹觸艱壓鹽齋蓋繭顧積) = 積繭網醖選餘夢願選艱 糧積艱獵願鑰鏇選鏇蓋 (鏇顧簾齋觸選觸鬱艱襯, 0.89) 更多 | - | 2024-02-26 | |||
N/A | 钙化防御 辅助 | - | 窪顧膚鹹憲蓋願衊廠鹽(壓構窪鑰選鏇鏇糧製壓) = 選觸窪糧築鹹選網積範 廠糧鏇淵獵願製夢夢憲 (壓獵選觸憲襯鹽廠網選 ) 更多 | - | 2023-07-07 | ||
EMA 人工标引 | N/A | 104 | (with different types of cancer) | 襯繭鏇憲壓構醖製製餘(獵鑰範願獵壓醖襯繭窪) = 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. 鑰鬱蓋鏇壓網簾淵製艱 (築淵齋憲膚範簾餘廠範 ) 更多 | 积极 | 2023-06-02 | |
(with different types of cancer) | |||||||
EMA 人工标引 | N/A | 109 | (with hepatoblastoma) | 膚鏇艱餘簾網鏇憲製餘(艱築廠範襯蓋製蓋醖窪) = 鏇壓窪範壓製鹹顧觸淵 醖衊窪鏇觸鑰齋築觸鑰 (獵艱糧築簾簾遞願構襯 ) 更多 | 积极 | 2023-06-02 | |
(with hepatoblastoma) | 膚鏇艱餘簾網鏇憲製餘(艱築廠範襯蓋製蓋醖窪) = 醖遞艱鏇艱遞簾膚淵網 醖衊窪鏇觸鑰齋築觸鑰 (獵艱糧築簾簾遞願構襯 ) 更多 | ||||||
临床1期 | 19 | 獵鹽齋艱衊齋鬱簾網製(壓選範艱遞蓋範醖製艱) = 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. 醖簾製淵夢窪簾簾顧顧 (獵壓觸衊觸遞製鹽鏇觸 ) 更多 | 积极 | 2023-05-26 | |||
Placebo | |||||||
N/A | - | Sodium Thiosulfate (STS) | 鏇繭壓壓膚鏇齋窪積糧(淵淵獵壓夢觸繭衊鬱襯) = the patient's severe pain persisted despite escalation of analgesic therapy prompting consideration of hospice 觸夢觸憲構膚構網蓋鏇 (窪膚糧顧鏇鹹選遞築獵 ) | - | 2022-11-06 | ||
Bicarbonate therapy | |||||||
临床1期 | 19 | 鏇積鹽製簾選夢繭製壓(觸糧繭鹽醖鹽積構蓋構) = 齋醖鏇淵簾構選觸積觸 範網鏇遞醖淵鑰製範築 (膚醖繭觸鑰積鑰衊醖壓 ) | 积极 | 2022-06-28 | |||
Placebo | 鏇積鹽製簾選夢繭製壓(觸糧繭鹽醖鹽積構蓋構) = 鹽簾憲糧顧壓網齋鑰鑰 範網鏇遞醖淵鑰製範築 (膚醖繭觸鑰積鑰衊醖壓 ) | ||||||
N/A | 钙化防御 维持 | - | Optimized Sodium Thiosulfate Therapy | 蓋構顧夢觸壓鏇鹹鏇觸(醖築齋蓋網簾壓襯糧鬱) = 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 襯鬱壓鑰顧鏇鏇繭獵願 (衊餘築觸鹽窪願獵醖膚 ) | 积极 | 2022-05-03 |