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相关临床试验
4
0 进行中
药物批准
1
批准总数
监管机构
监管机构数
成立时间
2016
已完成
3
75.0%
Unknown
25.0%
CANADA
Health Canada
- Shionogi and Torii Pharmaceutical obtained Japanese manufacturing and marketing approval for VTAMA Cream 0.5% (tapinarof) for atopic dermatitis in pediatric patients under 12 years of age. - The approval was based on a domestic Phase 3 trial in children aged 2 to under 12 in which the drug met its primary efficacy endpoint versus vehicle cream. - Pooled Phase 3 ADORING data showed consistent vIGA-AD and EASI75 improvements across pediatric age groups, with responses observed as early as week 2. - Tapinarof is a first-in-class nonsteroidal topical aryl hydrocarbon receptor agonist, offering a steroid-free option for a disease that frequently develops in childhood.