特朗普致幻剂行政令提振投资者兴趣,承诺加快审批流程


2026-05-18 10:10:22 UTC / 路透社

作者:卡迈勒·乔杜里与克里斯蒂·桑托什

2026年5月18日 美国东部时间上午10:10 更新于1小时前


2026年4月18日,美国华盛顿白宫椭圆形办公室,美国总统唐纳德·特朗普签署行政令,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促进组织首席执行官W·布莱恩·哈伯德。路透社/内森… 阅读更多

5月18日(路透社)——美国总统唐纳德·特朗普签署的加快致幻剂研发的行政令,让开发此类药物的企业看到了吸引更多资本的希望,但研究人员警告称,新疗法仍有很长的路要走。

接受路透社采访的九名高管和投资者表示,该行政令有望缩短行政审批周期,并改善美国食品药品监督管理局(FDA)与毒品执法局(DEA)之间的协调工作。


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多家企业表示,新的资金仍只是一个愿景,但致幻剂开发商Enveric Biosciences的首席执行官约瑟夫·塔克(股票代码:ENVB.O)告诉路透社,特朗普行政令的消息传出后,该公司已筹集到500万美元。

Optimi Health的首席执行官戴恩·史蒂文斯(股票代码:OPTI.CD)表示,行政令发布后几乎立刻就接到了大量来电,因为潜在投资者希望进一步了解该领域。

“一旦行政令出台相关举措,电话就会响个不停,”史蒂文斯说道。

但参与致幻剂医疗益处研究的七名研究人员表示,任何新疗法首先都需要耗费高昂成本和大量时间的研究,且大多数致幻药物仍处于研发早期阶段,距离上市还很遥远。


“我持谨慎乐观态度,但目前还不会为融资大肆庆祝,”加州大学伯克利分校教授居尔·德伦说道,她的研究旨在探索致幻剂如何“重新打开关键期”——即大脑可塑性增强的窗口期,能让人更轻松地重新学习行为模式并处理创伤经历。

FDA在2024年拒绝批准Lykos Therapeutics的MDMA辅助创伤后应激障碍(PTSD)疗法时,曾指出研发周期过长和试验设计复杂的问题。

今年4月,FDA为三家公司授予了快速审评资格,包括Compass Pathways(股票代码:CMPS.O)、Usona研究所和Transcend Therapeutics,这三家公司均在研究针对精神健康疾病的致幻疗法,这标志着FDA的态度出现转变。

投资者认为风险降低

Noetic Fund是一家风投基金,已投资Compass Pathways、Definium Therapeutics(股票代码:DFTX.O)和AtaiBeckley(股票代码:ATAI.O)等致幻剂企业。该基金联合创始人萨阿德·沙阿表示,该行业历来仅吸引家族理财室和高净值个人的资本。

https://www.reuters.com/legal/litigation/trumps-psychedelic-drug-order-boosts-investor-interest-with-promise-faster-2026-05-18/

如今,他希望这项行政令能够吸引主权财富基金和公共养老基金等机构投资者进入该领域,方法是降低此前令这些机构望而却步的监管不确定性,并传递出该行业获得政府可靠支持的信号。

沙阿与Noetic Fund的科学负责人斯里·特贾·穆拉普迪表示,FDA加快对接流程可将部分审评周期从10至12个月压缩至仅1至2个月,从而为处于临床阶段的企业“节省数千万美元”。

不过,投资者们也表示,政策利好不会平均惠及所有企业。拥有突破性疗法认定或关键试验数据的晚期开发商,可能会率先从快速审评或优先审评券中获益。

投资公司PsyMed Ventures联合创始人马蒂亚斯·塞布雷林斯基表示,对于早期阶段的公司而言,政策影响“更加模糊”,但仍具有积极意义,因为现在更多投资者可能会将致幻剂视为一个可投资的类别。

致幻剂开发商概况、其主要疗法、研发阶段及监管状态

企业期待更快捷的路径

Definium Therapeutics正在开发一款用于广泛性焦虑障碍的 LSD 疗法,该公司首席执行官罗伯特·巴罗表示,更快捷的监管流程能够提高效率、减少浪费。

他特别提到,行政令要求毒品执法局在拿到晚期试验数据后即可开始对受管制药物进行分级,而不必等到FDA批准之后,这一点将大有裨益。

DEA会对药物进行分级,这将决定药物的管制严格程度以及是否可以开具处方。美国当局近期已重新分类大麻,以降低研究和投资门槛。

AtaiBeckley的首席执行官斯里尼瓦斯·拉奥表示,行政令强调改善FDA与DEA在临床试验方案和试验场地审批方面的沟通,这有望将研发周期“缩短数个季度”。

AtaiBeckley正在开发BPL-003,这是一种鼻内给药的5-MeO-DMT制剂,用于治疗难治性抑郁症。

融资与医保报销问题削弱乐观情绪

一些研究人员告诉路透社,由于美国政府历来对致幻药物的使用持反对态度,为这类疗法融资一直困难重重。他们表示,移除监管障碍为更多独立研究打开了大门。

PsyMed的塞布雷林斯基表示,这项行政令或许能加快审评速度,但并未明确致幻疗法的保险报销障碍。

“谁来买单?”塞布雷林斯基说道。“这仍是一个悬而未决的问题,这项行政令并未给出完整答案。”

临床专家警告称,不应让热情掩盖了相关风险,尤其是伊波加因相关风险。伊波加因是一种源自非洲象牙瓜夫树的强效致幻剂,在特朗普推动的相关政治议程中占据突出地位。

伊波加因被退伍军人团体和成瘾倡导者宣传为治疗PTSD和物质使用障碍的潜在疗法,但相关企业距离将伊波加因疗法推向市场仍有很长的路要走,大多数相关研究仍处于临床前或早期阶段。

本文由孟加拉uru的克里斯蒂·桑托什和卡迈勒·乔杜里、纽约的克里斯·普伦蒂斯共同报道;卡罗琳·休默和辛吉尼· Ganguli 编辑

我们的准则:汤姆森路透社信任原则。

Trump’s psychedelic drug order boosts investor interest with promise of faster reviews

2026-05-18 10:10:22 UTC / Reuters

By Kamal Choudhury and Christy Santhosh

May 18, 2026 10:10 AM UTC Updated 1 hour ago

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

May 18 (Reuters) – U.S. President Donald Trump’s executive order to accelerate psychedelic drug development has raised hopes among companies developing the drugs that it could help attract more capital, but researchers cautioned that new treatments are still a long way off.

Nine executives and investors interviewed by Reuters said the order could shorten administrative timelines and improve coordination between ​the U.S. Food and Drug Administration and the Drug Enforcement Administration.

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Several companies said new funds are still just a hope, but Joseph Tucker, CEO of psychedelic ‌drug developer Enveric Biosciences ENVB.O, told Reuters the company raised $5 million when the news of the Trump order emerged.

Dane Stevens, CEO of Optimi Health OPTI.CD, said his company fielded many calls almost immediately after the order, as potential investors sought to better understand the sector.

“When there’s things that happen from executive orders, the phone rings,” Stevens said.

But seven researchers working to find the medical benefits of the drugs said any new treatment first requires costly, ​time-consuming research, and that most psychedelic drugs are still in the early stages of development and are a long way from hitting the market.

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“I’m cautiously optimistic, but I’m ​not throwing a funding party yet,” said researcher Gül Dölen, a professor at the University of California, Berkeley, whose work explores how psychedelics may ⁠reopen ‘critical periods’ — windows of heightened brain plasticity that make it easier to relearn behaviors and process trauma.

The FDA highlighted slow development timelines and difficult trial designs in its 2024 decision to ​decline approval of Lykos Therapeutics’ MDMA-assisted therapy for PTSD.

A sign the FDA is shifting gears came in April when it granted expedited review to three companies, Compass Pathways CMPS.O, Usona Institute and Transcend Therapeutics, ​all studying psychedelic treatments for mental health conditions.

INVESTORS SEE LOWER RISK

Sa’ad Shah, co-founder of Noetic Fund, a venture fund with investments in psychedelic companies, including Compass Pathways, Definium Therapeutics DFTX.O and AtaiBeckley ATAI.O, said the sector has historically attracted capital from family offices and high-net-worth individuals.

https://www.reuters.com/legal/litigation/trumps-psychedelic-drug-order-boosts-investor-interest-with-promise-faster-2026-05-18/

Now, he hopes the executive order will bring in institutional investors such as sovereign wealth funds and public pension plans to the sector by reducing the regulatory uncertainty that ​had kept them on the sidelines and signaling that the sector has credible government backing.

Shah and Sri Teja Mullapudi, Noetic’s scientific lead, said faster FDA engagement could save clinical-stage companies “tens of ​millions of dollars” by compressing some review timelines from 10 to 12 months to as little as one or two months.

Still, investors said the benefits will not be evenly distributed. Late-stage developers with breakthrough therapy ‌designations or ⁠pivotal data are likely to benefit first from expedited reviews or priority vouchers.

For earlier-stage companies, the effect is “more fuzzy” but still positive because more investors may now consider psychedelics an investable category, said Matias Serebrinsky, co-founder of investment firm PsyMed Ventures.

Overview of psychedelic drug developers, their lead treatments, development stage, and regulatory status

COMPANIES SEE FASTER PATH

Robert Barrow, CEO of Definium Therapeutics, which is developing an LSD-based therapy for generalized anxiety disorder, said faster regulatory processes could improve efficiency and reduce waste.

The order’s instruction that the Drug Enforcement Administration (DEA) begin work on scheduling controlled substances after late-stage data are available, rather than waiting until after the FDA approval, in ​particular, could help, he said.

The DEA assigns drugs ​to schedules that determine how tightly they ⁠are controlled and whether they can be prescribed. U.S. authorities recently moved to reclassify cannabis to ease research and investment hurdles.

Srinivas Rao, CEO of AtaiBeckley, said the order’s emphasis on improving communication between the FDA and the DEA on clinical trial protocols and site approvals could shave “several quarters” from ​development timelines.

AtaiBeckley is developing BPL-003, an intranasal formulation of 5-MeO-DMT for treatment-resistant depression.

FUNDING AND COVERAGE CONCERNS TEMPER OPTIMISM

Funding such treatments has been ​difficult, some researchers told Reuters, ⁠because of the government’s historical stance against the use of psychedelic drugs. Removing the regulatory hurdles cracks open a door for more independent study, they said.

PsyMed’s Serebrinsky said the executive order may speed up reviews, but does not provide clarity on insurance reimbursement hurdles for psychedelic therapies.

“Who’s going to pay for it?” Serebrinsky said. “That is an unanswered question, and the EO sort of does not give us ⁠full answers.”

Clinical ​experts cautioned that enthusiasm should not obscure the risks, especially around ibogaine, a powerful psychedelic derived from the African ​iboga plant that featured prominently in the political push by Trump.

Ibogaine has been promoted by veterans’ groups and addiction advocates as a potential treatment for PTSD and substance-use disorders, but companies remain far from bringing an ibogaine-based therapy to ​market, with most studies still in preclinical or early-stage development.

Reporting by Christy Santhosh and Kamal Choudhury in Bengaluru; Chris Prentice in New York; editing by Caroline Humer and Shinjini Ganguli

Our Standards: The Thomson Reuters Trust Principles.

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