相关临床试验
13
1 进行中
药物批准
0
批准总数
监管机构
0
监管机构数
成立时间
N/A
进行中（未招募）
1
7.7%
已完成
11
84.6%
终止
1
7.7%
暂无批准数据
- Bionomics' BNC210 demonstrated statistically significant improvement in PTSD symptom severity compared to placebo at Week 12, with benefits observed as early as Week 4. - The Phase 2 ATTUNE study also revealed clinically meaningful improvements in depressive symptoms and sleep quality among patients treated with BNC210. - Bionomics is advancing BNC210 to a Phase 3 trial for PTSD, slated to begin in the second half of 2025, following positive FDA feedback. - BNC210 is also under evaluation in a Phase 3 trial for social anxiety disorder (SAD), with results expected in Q3 2025.
- A Phase IIb trial of BNC210, a novel α7 nicotinic acetylcholine receptor modulator, demonstrated significant improvement in PTSD symptom severity as early as 4 weeks. - The study showed that BNC210 significantly reduced PTSD symptoms at week 12 compared to placebo, with a Cohen's d effect size of 0.40 (P = 0.048). - BNC210 was also associated with reduced depressive symptoms and improved sleep, although a higher rate of adverse events led to more discontinuations compared to placebo. - The FDA has granted BNC210 fast track designation, and a Phase III trial is planned to further evaluate its efficacy and safety in PTSD patients.
- Bionomics initiates Phase 3 trial for BNC210 in social anxiety disorder (SAD) after successful regulatory interactions and IP portfolio expansion, with data readout anticipated in Q3 2025. - The company is advancing a strategic partnership with Merck & Co. for α7 receptor PAMs targeting cognitive dysfunction in Alzheimer’s disease, expected to enter Phase 2 soon. - Bionomics is redomiciling to the U.S. and launching Neuphoria Inc., focusing on CNS pipeline development, while maintaining its Australian presence and potential tax benefits. - BNC210 holds FDA Fast Track designations for SAD and PTSD, showcasing a favorable safety profile and positive datasets across multiple anxiety and stress-related indications.
