FDA Seeks Public Input to Support Ibogaine Research
正文 · 中文译文
FDA新闻发布 FDA征求公众意见以支持伊波加因研究 更多新闻公告 即时发布： 2026年10月5日 美国食品药品监督管理局（FDA）今日宣布发布一份信息征求书（RFI），其中描述了该机构正在考虑的用于伊波加因药品早期临床试验设计的方法，并就这些方法征求公众意见。该信息征求书就与伊波加因药物开发相关的具体方案要素征求意见、数据和信息，包括剂量选择与递增、治疗场所、安全性监测、入选标准、停止规则和安全性监督。这份信息征求书标志着FDA为推进特朗普总统2026年4月发布的《加速严重精神疾病的医疗治疗》行政命令所采取的最新行动，该行政命令要求各机构加快对致幻剂医学的研究。 “对于患有现有治疗无效的严重疾病的患者而言，有前景的新治疗方法理应接受严格的科学研究，”FDA药品审评与研究中心主任、医学博士（M.D.）、哲学博士（Ph.D.）迈克尔·戴维斯（Michael Davis）表示，“就伊波加因而言，既有重要的科学问题，也存在严重的安全性问题。我们正在寻求高质量的数据和意见，以便在将患者安全放在首位的同时，为临床研究提供参考。” FDA正在以下四个主要领域征求意见、数据和信息： 总体研究设计，包括适当的患者人群； 剂量选择与剂量递增，包括拟议采用小规模、逐级递增的剂量组，以及由现有数据支持且不超过10 mg/kg的起始剂量； 安全性考虑，包括对心脏及神经系统不良事件的监测，以及临床试验的其他保障措施；以及 伦理与监督考虑，包括知情同意和适当的独立安全监督。 FDA认识到寻求伊博格碱治疗的患者所面临的疾病严重性和未满足的医疗需求。通过本次信息征询收到的信息可能有助于该机构更好地了解伊博格碱药品的潜在用途、获益和风险，并为药物开发方法提供参考。 FDA一直在联邦政府各部门间协同工作，通过审慎的循证流程支持伊博格碱药品的负责任开发。2026年7月，FDA发布了最终的行业指南《迷幻类药物：临床研究考虑事项》，为开发迷幻类药物的申办方提供了总体考虑。FDA还允许去甲伊博格碱盐酸盐（伊博格碱的一种衍生物）的早期临床研究在研究性新药申请下继续进行，作为酒精使用障碍的潜在治疗方法。 作为以全政府方式推进致幻剂药物研发的一部分，美国卫生与公众服务部（HHS）正通过卫生高级研究计划局（ARPA-H）资助一个通过早期临床试验收集安全性和有效性数据的项目，同时美国国家药物滥用研究所（NIDA）正在资助关于伊博格碱用于阿片类药物使用障碍（OUD）潜在治疗的研究。基于现有数据和病情的严重性，HHS将两类初始人群列为联邦资助研究的优先对象：患有OUD的成人以及患有创伤后应激障碍（PTSD）的成人。 公众自《联邦公报》发布之日起有45天时间向案卷提交意见、数据或信息。鼓励利益相关方访问 regulations.gov 并搜索 Docket No. FDA-2026-N-10429，以电子方式提交意见。书面/纸质提交材料亦可寄送至：美国食品药品监督管理局（FDA）案卷管理办公室（Dockets Management Staff (HFA-305)），5630 Fishers Lane, Rm. 1061, Rockville, MD 20852。 意见征询期于2026年11月20日（星期五）截止。逾期提交的意见将不予考虑。 媒体： FDA 征求意见 202-690-6343 消费者： 888-INFO-FDA ### 模板文字 FDA是美国卫生与公众服务部下属的一个机构，通过确保人用和兽用药物、疫苗及其他人类生物制品和医疗器械的安全性、有效性和安全性保障来保护公众健康。该机构还负责我国食品供应、化妆品、膳食补充剂、辐射发射电子产品及烟草制品的安全保障与监管。 内容当前截至： 10/05/2026 监管产品 药物 关注FDA 在X平台关注@US_FDA 在Facebook上关注FDA 在X平台关注@FDAMedia
正文 · 英文原文
FDA News Release FDA Seeks Public Input to Support Ibogaine Research More Press Announcements For Immediate Release: October 05, 2026 The U.S. Food and Drug Administration today announced a request for information (RFI) describing approaches the agency is considering for the design of early-phase clinical trials of ibogaine drug products and seeking public input on those approaches. The RFI seeks comments, data, and information on specific protocol elements relevant to ibogaine drug development, including dose selection and escalation, care setting, safety monitoring, eligibility criteria, stopping rules and safety oversight. This RFI marks the latest FDA action to advance President Trump’s April 2026 executive order on Accelerating Medical Treatments for Serious Mental Illness, which directed agencies to accelerate research into psychedelic medicine. “Patients facing serious conditions that have not responded to existing treatments deserve rigorous scientific investigation of promising new approaches,” said Michael Davis, M.D., Ph.D., Director of the FDA Center for Drug Evaluation and Research. “With ibogaine, there are important scientific questions as well as serious safety concerns. We are seeking high-quality data and input that can help inform clinical research while putting patient safety first.” The FDA is seeking comments, data and information in four primary areas: General study design, including appropriate patient populations; Dose selection and escalation, including the proposed use of small, sequential dose-ascending groups and a starting dose justified by available data and not exceeding 10 mg/kg; Safety considerations, including monitoring for cardiac and neurologic adverse events and other safeguards for clinical trials; and Ethical and oversight considerations, including informed consent and appropriate independent safety oversight. The FDA recognizes the seriousness of the conditions and unmet needs that patients seeking ibogaine treatments face. The information received through this RFI may help the agency better understand the potential uses, benefits and risks of ibogaine drug products and inform approaches to drug development. The FDA has been working across the federal government to support the responsible development of ibogaine drug products through careful evidence-based processes. In July 2026, the FDA issued its finalized guidance for industry, Psychedelic Drugs: Considerations for Clinical Investigations, which provides general considerations for sponsors developing psychedelic drugs. The FDA has also allowed an early-phase clinical study of noribogaine hydrochloride, a derivative of ibogaine, to proceed under an Investigational New Drug application as a potential treatment for alcohol use disorder. As part of the whole-of-government approach to advance psychedelic drug development, HHS, through the Advanced Research Projects Agency for Health (ARPA-H), is funding a program to collect safety and efficacy data through early-phase clinical trials, and the National Institute on Drug Abuse (NIDA) is funding research on ibogaine for the potential treatment of opioid use disorder (OUD). Based on available data and the seriousness of the conditions, HHS is prioritizing two initial populations for federally supported research: adults with OUD and adults with post-traumatic stress disorder (PTSD). The public will have 45 days following publication in the Federal Register to submit comments, data or information to the docket. Stakeholders are encouraged to submit comments electronically at regulations.gov by searching for Docket No. FDA-2026-N-10429. Written/paper submissions may also be sent to: Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. The comment period closes Friday, November 20, 2026. Late comments will not be considered. Media: FDA Request for Comment 202-690-6343 Consumer: 888-INFO-FDA ### Boilerplate The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, radiation-emitting electronic products, and for regulating tobacco products. Content current as of: 10/05/2026 Regulated Product(s) Drugs Follow FDA Follow @US_FDA on X Follow FDA on Facebook Follow @FDAMedia on X
摘要 待译
The U.S. Food and Drug Administration today announced a request for information (RFI) describing approaches the agency is considering for the design of early-phase clinical trials of ibogaine drug products and seeking public input on those approaches.