相关临床试验
56
11 进行中
药物批准
2
批准总数
监管机构
1
监管机构数
成立时间
1918
进行中(未招募)
10
17.9%
已完成
38
67.9%
尚未招募
1
1.8%
招募中
3
5.4%
终止
1
1.8%
Unknown
2
3.6%
撤回
1
1.8%
- Sibel Health received FDA acceptance into the Drug Development Tool Qualification Program for its Aria cough monitoring sensor, marking the company's third FDA DDT acceptance alongside previous approvals for scratch and swallow sensors. - The company was awarded a $500,000 FDA grant to advance its ADAM™ scratch sensor for atopic dermatitis, building on technology that already demonstrates >99% accuracy in detecting scratch duration and events. - Sibel Health now holds 3 out of 8 digital health technologies ever accepted into the FDA's rigorous DDT program, positioning the company as a leader in objective digital endpoints for clinical trials. - The technologies address critical unmet needs in measuring subjective symptoms like itch and cough, which traditionally rely on patient-reported outcomes prone to recall bias and reduced reliability.
- AOB Pharma received positive decision from the European Medicines Agency's Pediatric Committee on September 10, 2025, for its pediatric investigation plan supporting B244 development in atopic dermatitis. - The EMA granted a topical corticosteroid comparator waiver for Phase 3 studies in adolescents and adults aged 12 years and older, departing from previous requirements that prevented market access for Eucrisa and Opzelura. - B244 is a first-in-class topical live biotherapeutic that produces nitric oxide to regulate inflammation and has demonstrated ability to reduce inflammatory cytokines IL-4, IL-5, IL-13, and IL-31. - The regulatory approval aligns with prior agreements from US FDA and Japan PMDA, positioning AOBiome to file Market Authorization Application based on two pivotal studies and one open-label extension study.
- Nielsen BioSciences has completed enrollment of 325 subjects across the US and Japan in a Phase 3 trial evaluating CANDIN for common wart treatment, with results expected by end of 2025. - The trial investigates CANDIN, a Candida albicans-based immunological therapy, as a potential alternative to traditional wart removal methods that can damage skin. - The study aims to assess complete wart resolution in patients aged 12 and older through bi-weekly injections, with Nielsen planning US regulatory submissions and partnership with Maruho for Japanese commercialization.
- Over 25 companies are developing novel rosacea treatments, indicating a robust pipeline. - Key emerging therapies like Epsolay, M 1220, and BMX-010 are expected to significantly impact the rosacea market. - Sol-Gel Technologies and Maruho Co., Ltd. are among the leading companies in developing advanced-stage rosacea drugs. - Recent regulatory approvals, such as Zydus Lifesciences' metronidazole topical cream, offer new treatment options.
- Over 25 companies are actively involved in developing novel rosacea treatments, indicating a robust pipeline. - Key emerging therapies like Epsolay, M 1220, and BMX-010 are expected to significantly impact the rosacea market in the coming years. - Sol-Gel Technologies and Maruho Co., Ltd. are among the leading companies in advancing rosacea drug candidates through clinical development. - Recent regulatory approvals, such as Zydus Lifesciences' metronidazole topical cream, provide additional treatment options for rosacea patients.