跟进：美国卫生与公众服务部投入最高490万美元推进伊博格碱治疗创伤后应激障碍研究
美国卫生与公众服务部（HHS）11月12日在华盛顿宣布，将通过其高级卫生研究计划局（ARPA-H）投入最高490万美元，推进伊博格碱（ibogaine）作为创伤后应激障碍（PTSD）等严重精神疾病潜在疗法的研发，退伍军人是重点人群。该部下属国家精神卫生研究所（NIMH）同日公布一项2,000万美元的资助机会，组建快速起效精神药物干预研究网络，研究对象包括氯胺酮、艾司氯胺酮、裸盖菇素等新兴疗法，受资助名单将于2027年夏天公布。
ARPA-H 这笔投入分五年发放，用途是打基础：支持新药临床试验申请（IND）的准备工作，落实临床级伊博格碱供应，并建立可持续的国内生产工艺。首批受资助团队中，一支由 Mark Cuban Cost Plus Drug Company 牵头，为一款国产单分子盐酸伊博格碱产品打下监管、临床、化学与工程基础；另一家 Beond, Inc. 负责产出高可信度的临床数据，评估伊博格碱的安全性、剂量、疗效与持久性。各受资助方都要把研究数据开源公开，以加快后续研究。
HHS 明确，这笔钱只资助监管与生产方面的基础工作，不资助给患者用药，不资助人体受试研究，也不构成对临床试验的授权或食品药品监管局（FDA）的批准。HHS 后续还将通过 ARPA-H 评估伊博格碱治疗物质使用障碍的潜力，包括阿片类药物使用障碍，并同时推进不止一个适应症的 IND 申请，以提高至少一条路线给出明确答案的机会。
卫生与公众服务部长小罗伯特·F·肯尼迪（Robert F. Kennedy Jr.）在当天的记者会上说：「退伍军人信守了他们对这个国家的承诺，我们也必须信守我们的。」他说，退伍军人告诉该部伊博格碱改变了他们的生活，这些经历要求严肃的科学调查，该部将追寻证据、正视风险，并把可负担性放在这项工作的中心。
退伍军人事务部长 Doug Collins 说，退伍军人值得拥有有效的治疗，也值得对这些疗法的益处与风险得到明确答案，退伍军人事务部期待与 HHS 合作探索伊博格碱的可能性，并让临床人员为交付新疗法做好准备，前提是这些疗法获得 FDA 批准。领导这项工作的 ARPA-H 特别项目高级顾问 Al Bugazia 说，伊博格碱治疗见效的报告很有希望、不容忽视，目标是几年内而不是几十年内拿出结果。
HHS 同时提示，伊博格碱带有严重的安全风险，包括可能危及生命的心律问题，未来的临床研究必须做好受试者筛查、心脏监测与独立安全监督。该部表示，若研发成功并获得 FDA 批准，目标是让药价定在生产成本加上合理利润的水平；研究结果无论显示有益、无益还是有害，都将公之于众。
这项宣布落实了特朗普总统今年4月关于加快有前景的迷幻疗法研究的指示，也延续了 HHS 与退伍军人事务部在临床研究、证据共享与人员培训上的合作。HHS 在新闻稿末尾提示，处于危机中的退伍军人以及关心他们的人，可以拨打 988 并按 1 接通退伍军人危机热线。
关联：【视频】美国卫生部长肯尼迪与Collins部长举行记者会：HHS官方频道全程直播
（来源：美国卫生与公众服务部）
Follow-Up: HHS Commits Up to $4.9 Million to Advance Ibogaine Research for PTSD
The U.S. Department of Health and Human Services (HHS) announced in Washington on November 12 that it will invest up to $4.9 million through the Advanced Research Projects Agency for Health (ARPA-H) to advance the development of ibogaine as a potential treatment for post-traumatic stress disorder (PTSD) and other serious mental illnesses, with Veterans a central focus. The department's National Institute of Mental Health (NIMH) also published a $20 million Notice of Funding Opportunity to build a research network studying rapid-acting psychotropic interventional drugs (RAPIDs), including ketamine, esketamine and psilocybin, with award recipients to be announced in the summer of 2027.
The ARPA-H commitment, up to $4.9 million over five years, funds the groundwork: preparation of Investigational New Drug Applications (INDs), securing clinical-grade ibogaine, and developing processes for sustainable domestic manufacturing. One selected team, led by the Mark Cuban Cost Plus Drug Company, PBC, will establish the regulatory, clinical, chemical and engineering foundation for a domestically manufactured, single-molecule ibogaine hydrochloride product. Separately, Beond, Inc. will deliver high-fidelity clinical data on ibogaine's safety, dosing, efficacy and durability. All awardees will open-source their research data.
HHS stressed that the awards fund regulatory and manufacturing groundwork only: they do not fund treatment of patients or human-subject research, and they do not authorize clinical trials or establish FDA approval. Future ARPA-H awards will evaluate ibogaine as a potential treatment for substance use disorders, including opioid use disorder, and the agency is pursuing multiple IND applications across more than one indication to raise the odds that at least one approach produces clear answers.
"Veterans kept their promise to this country. We must keep ours," Secretary Robert F. Kennedy Jr. said at the day's press conference. "Veterans have told us ibogaine changed their lives. Their experiences demand serious scientific investigation. We will pursue the evidence, confront the risks and put affordability at the center of this work."
VA Secretary Doug Collins said Veterans deserve effective treatments and clear answers about their benefits and risks, and that the VA looks forward to working with HHS to explore the possibilities of ibogaine and prepare its clinicians to deliver new treatments if they earn FDA approval. Al Bugazia, M.D., Senior Advisor for Special Projects at ARPA-H, who is leading the effort, said reports of successful ibogaine treatments are too promising to ignore, and that the goal is to deliver results in years, not decades.
HHS also flagged that ibogaine carries serious safety risks, including potentially life-threatening heart rhythm problems, and that future clinical studies must address participant screening, cardiac monitoring and independent safety oversight. If development succeeds and the medicine earns FDA approval, the department's goal is to make it available at the cost of production plus a fair margin, and HHS committed to making research findings public whether they show benefit, no benefit or harm.
The announcement advances President Trump's April directive to accelerate research into promising psychedelic treatments and builds on the HHS-VA partnership to expand clinical research, share evidence and prepare the health care workforce. HHS noted that Veterans in crisis, and anyone concerned about a veteran, can call 988 and press 1 to reach the Veterans Crisis Line.
Related: HHS Secretary Kennedy Holds Press Conference With Secretary Collins
(Source: U.S. Department of Health and Human Services)
来源：美国卫生与公众服务部
发布：GSM·美国（发布链接）
图片来源：图：位于华盛顿的美国卫生与公众服务部总部 Hubert H. Humphrey 大楼。画面：GSM联邦固定图库，美国卫生与公众服务部总部大楼照片。 / Photo: The Hubert H. Humphrey Building in Washington, headquarters of the U.S. Department of Health and Human Services. Image: GSM federal asset pack, headquarters building photograph.
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