相关临床试验
6
1 进行中
药物批准
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已完成
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66.7%
Enrolling By Invitation
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16.7%
招募中
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16.7%
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- Otsuka Pharmaceutical agreed to acquire Transcend Therapeutics for $700 million upfront plus up to $525 million in milestone payments, securing TSND-201, a rapid-acting PTSD treatment. - TSND-201 demonstrated statistically significant improvements in PTSD severity scores from day 10 onward in a Phase II trial, with results published in JAMA Psychiatry. - The FDA granted TSND-201 Breakthrough Therapy designation in July 2025, marking the first new PTSD treatment approach in 25 years for over 13 million affected Americans. - TSND-201 works through a novel mechanism targeting monoamine transporters without hallucinogenic effects, distinguishing it from psychedelic compounds in development.
- The FDA has granted Breakthrough Therapy designation to TSND-201 (methylone) for PTSD treatment, potentially expediting its development and review process. - Phase 2 trial results showed TSND-201 achieved rapid and durable PTSD symptom improvements, with significant placebo-adjusted CAPS-5 improvements by day 10. - The designation addresses an urgent unmet need, as only two FDA-approved PTSD medications exist with modest efficacy for 13 million affected Americans. - Transcend Therapeutics plans to initiate Phase 3 trials for this rapid-acting neuroplastogen that works on monoamine transporters without hallucinogenic effects.
