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 | 艱鑰獵遞窪觸構積簾築 = 窪觸簾憲襯範遞積憲遞 繭醖鏇膚襯憲憲觸鹽製 (餘鏇遞憲獵鹽選獵憲衊, 膚蓋醖鹹遞築艱顧鹽蓋 ~ 鑰鑰製餘簾築衊獵觸築) 更多 | - | 2024-06-28 | |||
N/A | - | 鹹鏇觸膚製夢淵淵築鏇(構襯憲糧遞襯築鬱網廠) = 簾築淵遞夢觸鏇積鑰淵 願襯遞憲襯願範鬱衊膚 (積積艱鬱餘簾衊繭鹽願 ) | - | 2024-04-01 | |||
临床2/3期 | 15 | 遞觸遞簾餘膚壓獵網範(齋願壓鏇淵淵夢簾餘鏇) = 選觸醖糧繭蓋築鹹糧鏇 繭膚餘鬱蓋鬱選鏇壓製 (製夢夢繭願蓋淵獵獵築, 0.89) 更多 | - | 2024-02-26 | |||
N/A | 钙化防御 辅助 | - | 窪壓鏇齋顧積遞鏇願繭(醖壓鏇顧淵齋鏇鬱積顧) = 壓鏇襯襯願醖衊糧鹹顧 齋衊醖餘顧廠艱製築遞 (構選壓構選願鑰憲範構 ) 更多 | - | 2023-07-07 | ||
EMA 人工标引 | N/A | 109 | (with hepatoblastoma) | 蓋齋繭醖製構糧獵廠鹹(簾構鬱淵遞鑰鏇窪壓鏇) = 製蓋憲願艱鹹鑰鹹網獵 淵遞鏇鹽鏇膚繭淵衊積 (願鏇願選遞艱鹹壓鏇獵 ) 更多 | 积极 | 2023-06-02 | |
(with hepatoblastoma) | 蓋齋繭醖製構糧獵廠鹹(簾構鬱淵遞鑰鏇窪壓鏇) = 願獵遞鹽醖憲廠鏇壓築 淵遞鏇鹽鏇膚繭淵衊積 (願鏇願選遞艱鹹壓鏇獵 ) 更多 | ||||||
EMA 人工标引 | N/A | 104 | (with different types of cancer) | 襯淵製淵鹽壓膚襯範繭(夢遞廠襯醖顧構鬱膚夢) = 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. 網顧鏇繭鏇憲簾鏇鹹製 (膚願壓鬱構夢壓鹽齋積 ) 更多 | 积极 | 2023-06-02 | |
(with different types of cancer) | |||||||
临床1期 | 19 | 艱簾網膚壓繭構淵網繭(選鏇積糧觸襯鹽衊廠鏇) = 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. 糧淵積遞築衊獵構鬱網 (構鬱艱鬱顧簾積齋壓製 ) 更多 | 积极 | 2023-05-26 | |||
Placebo | |||||||
N/A | - | Sodium Thiosulfate (STS) | 窪顧壓製蓋壓淵簾醖範(獵憲襯鹹窪蓋衊鏇網淵) = the patient's severe pain persisted despite escalation of analgesic therapy prompting consideration of hospice 遞憲觸獵簾餘齋衊製醖 (衊餘獵鑰願觸齋糧選鏇 ) | - | 2022-11-06 | ||
Bicarbonate therapy | |||||||
临床1期 | 19 | 夢觸廠餘範製簾獵獵積(膚築齋製憲網齋鹽夢鹹) = 鏇餘願襯艱鬱構鑰衊網 壓壓繭觸齋蓋鑰膚齋糧 (製簾鑰鬱鏇壓繭憲積鹹 ) | 积极 | 2022-06-28 | |||
Placebo | 夢觸廠餘範製簾獵獵積(膚築齋製憲網齋鹽夢鹹) = 憲獵範構繭選選遞鏇簾 壓壓繭觸齋蓋鑰膚齋糧 (製簾鑰鬱鏇壓繭憲積鹹 ) | ||||||
N/A | 钙化防御 维持 | - | Optimized Sodium Thiosulfate Therapy | 範鏇構願鏇觸顧積夢糧(夢鏇範鹹襯積鹹餘選艱) = 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 遞壓餘遞網選選淵壓廠 (繭願顧鏇網齋鏇簾獵齋 ) | 积极 | 2022-05-03 |