2026年4月24日 13:19 UTC / 路透社
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2026年4月18日，美国总统唐纳德·特朗普在华盛顿白宫椭圆形办公室签署行政令，鼓励对伊波加因开展更多研究，身旁站着美国卫生与公众服务部（HHS）部长小罗伯特·F·肯尼迪、乔·罗根以及美国伊波加因组织首席执行官W·布莱恩·哈伯德。路透社/内森…… 阅读更多
4月24日（路透社）——美国食品药品监督管理局（FDA）周五表示，在上周总统唐纳德·特朗普签署一项行政令后，该局正采取措施加快治疗抑郁症等严重精神疾病的新型疗法的研发。
该行政令要求FDA向带有“突破性疗法”标识的 psychedelic 药物发放专员国家级优先审评券，此举有望将审评时间从常规的6至10个月缩短至1至2个月。
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根据美国全国精神疾病联盟的数据，2024年约有23.4%的美国成年人曾罹患精神疾病，2023年这一比例在退伍军人中达到17.6%。
美国卫生监管机构表示，将向三家研发 psychedelic 疗法的公司发放国家级优先审评券。
在这三家公司中，两家正在研究裸盖菇素用于治疗难治性抑郁症和重度抑郁症，另一家正在研究甲烯二氧吡咯戊酮（methylone）用于创伤后应激障碍。
FDA局长马蒂·马卡里在一份声明中表示：“这些药物有潜力应对美国的心理健康危机，包括难治性抑郁症、酒精成瘾以及其他严重精神健康和药物滥用病症。”
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尽管FDA未披露这三家公司的名称，但Compass Pathways公司正在开发合成形式的裸盖菇素用于治疗难治性抑郁症，Usona研究所正在研究裸盖菇素治疗重度抑郁症，Transcend Therapeutics公司则正在开发甲烯二氧吡咯戊酮作为创伤后应激障碍的潜在治疗方案。
Compass、Usona和Transcend均未立即回复路透社的置评请求。
伊波加因是行政令中唯一提及的 psychedelic 物质，尽管 LSD、MDMA 和裸盖菇素也正在美国开展针对各类精神健康病症的大型临床试验。
根据美国药品 Enforcement 管理局的数据，裸盖菇素和伊波加因均被列为第一类管制药品，这意味着它们目前没有公认的医疗用途，且具有较高的滥用潜力。
FDA还为美国首个伊波加因衍生物诺里波加因的人体试验扫清了障碍。伊波加因源自一种非洲本土灌木。
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US FDA moves to fast-track psychedelic drugs after Trump order
April 24, 2026 1:19 PM UTC / Reuters
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U.S. President Donald Trump signs an executive order encouraging more research into ibogaine, next to U.S. Health and Human Services (HHS) Secretary Robert F.Kennedy Jr., Joe Rogan, and Americans for Ibogaine CEO W. Bryan Hubbard, in the Oval Office of the White House in Washington, D.C., April 18, 2026. REUTERS/Nathan… Read more
April 24 (Reuters) – The U.S. Food and Drug Administration said on Friday it is taking steps to speed up the development of new treatments for serious mental illness such as depression, following an executive order signed by President Donald Trump last week.
The executive order directed the FDA to give commissioner’s national priority vouchers to psychedelic drugs that have the “breakthrough therapy” tag, potentially cutting the review time to one to two months from the usual six to 10 months.
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About 23.4% of U.S. adults experienced mental illness in 2024, while 17.6% of U.S. veterans did so in 2023, according to the National Alliance on Mental Illness.
The health regulator said it would issue national priority vouchers to three companies developing psychedelic treatments.
Of the three companies, two are studying psilocybin for treatment-resistant depression and major depressive disorder, and another is studying methylone for post-traumatic stress disorder.
“These medications have the potential to address the nation’s mental health crisis, including conditions like treatment-resistant depression, alcoholism and other serious mental health and substance abuse conditions,” FDA Commissioner Marty Makary said in a statement.
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While the FDA did not disclose the names of the companies, Compass Pathways is developing a synthetic form of psilocybin for treatment-resistant depression, Usona Institute is studying psilocybin for major depressive disorder and Transcend Therapeutics is developing methylone as a potential treatment for PTSD.
Compass, Usona and Transcend did not immediately reply to Reuters’ requests for comment.
Ibogaine is the only psychedelic mentioned in the executive order, though LSD, MDMA and psilocybin are also being studied in large U.S. trials for various mental health conditions.
Both psilocybin and ibogaine are listed as Schedule I drugs, meaning they currently have no accepted medical use and a high potential for abuse, according to the Drug Enforcement Administration.
The FDA also cleared the way for the first human trial in the United States of noribogaine, a derivative of ibogaine. Ibogaine is derived from a shrub native to Africa.
Reporting by Kamal Choudhury in Bengaluru; Editing by Shilpi Majumdar
Our Standards: The Thomson Reuters Trust Principles.
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