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相关临床试验
69
3 进行中
药物批准
0
批准总数
监管机构
监管机构数
成立时间
2003
已完成
55
79.7%
尚未招募
3
4.3%
招募中
11
15.9%
暂无批准数据
- A Phase 2/3 clinical trial in Japan demonstrated that PEDMARK significantly reduced cisplatin-induced hearing loss in pediatric cancer patients, with only 16-24% experiencing ototoxicity compared to 56-63% in historical controls. - The study confirmed PEDMARK's safety profile with no interference in cisplatin's antitumor activity, achieving a 95% tumor response rate while protecting hearing function. - These positive results support Fennec Pharmaceuticals' plans to pursue regulatory approval in Japan and explore licensing partnerships for the first FDA-approved ototoxicity prevention therapy.
