This study will examine the effect of a single high dose of psilocybin therapy (30 mg) versus a very low dose (1 mg) as an adjunctive therapy to individuals undergoing standard-of-care buprenorphine treatment for Opioid use disorder (OUD). Effects of adjunctive psilocybin will be determined for longitudinal outcomes of opioid abstinence, compliance with buprenorphine maintenance, quality of life, and mood.

开始日期2027-04-01

申办/合作机构

The Johns Hopkins University

NCT06801041

/ Not yet recruiting临床2期IIT

TRIPS - Treatment to Improve Depression and/or Anxiety Using Psilocybin-assisted Psychotherapy in Cancer Survivors

This clinical research study is to learn about the feasibility, safety, and effects of psilocybin-assisted psychotherapy for cancer survivors with depression and/or anxiety.

开始日期2025-06-01

申办/合作机构

The University of Texas MD Anderson Cancer Center

ACTRN12624000816550

/ Not yet recruiting临床2期IIT

Feasibility Study of the Effect of Psilocybin in Response to Brief Psychological Input with Psychological Flexibility as a Mediating Factor on adults with Mild to Moderate Depression or Anxiety.

开始日期2025-05-01

申办/合作机构

University of Otago

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100 项与裸盖菇素相关的专利（医药）

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2,426

项与裸盖菇素相关的文献（医药）

2025-12-01·Current Pain and Headache Reports

Pain and Perception: Exploring Psychedelics as Novel Therapeutic Agents in Chronic Pain Management

Review

作者: Strand, Natalie H ; Gomez, Diego ; Leathem, James ; Viswanath, Omar ; Whitney, Madeline ; Johnson, Brooks ; Attanti, Sumedha ; Maloney, Jillian ; Misra, Lopa ; Dunn, Tyler ; Emami, Eric

PURPOSE OF REVIEW:

Chronic pain affects approximately 1.5 billion people worldwide, representing the leading cause of disability and a significant financial burden on healthcare systems. Conventional treatments, such as opioids and non-steroidal anti-inflammatory drugs, are frequently linked to adverse effects, including dependency and gastrointestinal issues, and often offer limited long-term relief. This review explores the potential of psychedelics, including psilocybin, LSD, and ketamine, as alternative therapeutic agents in chronic pain management.

RECENT FINDINGS:

These substances modulate pain perception through actions on serotonergic and glutamatergic systems and may promote neuroplasticity, offering novel pathways for pain relief. Specifically, the review details the pharmacologic actions of psychedelics, their effects on chronic pain syndromes such as cancer pain, migraines, and neuropathic pain, and their clinical implications. The safety profiles, patient responses, and analgesic properties of these compounds are examined, highlighting the need for further research to validate their efficacy and optimize their therapeutic use in pain management.

2025-12-01·Current Pain and Headache Reports

Exploring the Potential of Psychedelics in the Treatment of Headache Disorders: Clinical Considerations and Exploratory Insights

Review

作者: Henderson, Isabella ; Duarte, Robert A ; Vadhan, Nehal P ; Chan, Gabriel ; Elsaadany, Ronnie ; Goodman, Sadie ; Duarte, Diana ; Grunstein, Michael ; Bajaj, Vikram

PURPOSE OF REVIEW:

Exploration of the potential of serotonergic psychedelic drugs, such as psilocybin and LSD, as potential treatments for headache disorders. This review addresses the need for well-informed physician guidelines and discusses mechanisms, safety, and efficacy of these treatments. Further research, including the consideration of combination with psychotherapy, is needed.

RECENT FINDINGS:

Psychedelics demonstrate promising outcomes as treatments for headache disorders. Recent findings indicated that some patients who underwent brief periods of treatment with psychedelics experienced a reduction in headache attack frequency, severity, or duration. When prescription medications are ineffective at treating headache disorders, or are habit-forming, patients often turn to alternative options. There is anecdotal evidence that psychedelic drugs like LSD and psilocybin can effectively treat and prevent pain in patients with headache disorders, such as migraine or cluster headache. It is vital that physicians treating patients who self-treat with psychedelics be well-informed about the mechanisms and their effects to best advise their patients and coordinate their care well. This is a review assessing the literature on the mechanisms, safety, and efficacy of psychedelic drugs as a headache management intervention. We believe there is evidence that may support further investigation into the clinical use of psychedelic medications to treat cluster headache and migraine, including the consideration of use in conjunction with other interventions like cognitive behavioral therapy or acceptance and commitment training.

2025-03-01·EUROPEAN JOURNAL OF PHARMACOLOGY

Mice lacking the serotonin transporter do not respond to the behavioural effects of psilocybin

Article

作者: Wilson, Carey ; Gattuso, James J ; Hannan, Anthony J ; Renoir, Thibault ; Li, Shanshan

BACKGROUND AND PURPOSE:

Psilocybin is a serotonergic psychedelic with therapeutic potential for several neuropsychiatric disorders, including depression and anxiety disorders. Serotonin transporter (5-HTT) knockout mice (KO) are a well-validated mouse model of anxiety/depression and are relevant to both chronic treatment with serotonin transporter reuptake inhibitors (SSRIs) and polymorphisms in the serotonin transporter-linked polymorphic region (5-HTTLPR) associated with depression/anxiety and resistance to classic antidepressant treatments. However, there is yet to be a study assessing the effect of psilocybin in 5-HTT KO mice.

EXPERIMENTAL APPROACH:

We investigated the effects of a single dose of psilocybin (1 mg/kg) on locomotor activity and the head-twitch response as well as anxiety- and depressive-like behaviour in KO versus wild-type (WT) mice using the light-dark box and Porsolt swim test respectively.

KEY RESULTS:

We found that both the psilocybin-induced head-twitch and hyperlocomotor responses observed in WT mice were completely absent in KO animals. In female WT mice only, psilocybin was also able to block the weight loss observed one day after intraperitoneal injection. While psilocybin did not alter anxiety- and depression-like behaviours for both genotypes, we revealed a genotype-specific trend for a main effect of treatment for WT females (p = 0.054) in the Porsolt swim test. Finally, we found that only female KO mice exhibit anhedonia-like behaviour in the saccharin-preference test.

CONCLUSION AND IMPLICATIONS:

Our findings highlight the complexity of psilocybin's effects and suggest that functional integrity of 5-HTT is essential for psilocybin's acute behavioural effects. This could also have implications for pharmacogenetics, including individuals with polymorphisms or mutations in 5-HTT.

1,016

项与裸盖菇素相关的新闻（医药）

2025-02-03

·BioPharmaDive

Shares of psychedelics biotech nearly double on depression data

In a little more than a weeks time, a drug developed by a small psychedelics company was able to significantly curb hard-to-treat depression in a mid-stage clinical trial.Thats according to high-level results announced Monday. The trial recruited 81 people with treatment-resistant depression and evaluated them via a widely used, 60-point scale where larger scores mean more severe depressive symptoms. The drug, from Ireland-based GH Research, hit the studys main goal by showing that participants taking it had their scores drop 15.5 points more than those who were given a placebo.GH Research said its drug was well-tolerated. No serious adverse events had been reported as of Jan. 22. All treatment-emergent adverse events were mild or moderate, and investigators found no evidence the drug led to flashbacks, suicidal thoughts or behavior, or changes in heart activity. Almost all participants were discharge-ready within an hour of getting their last doses.Additionally, GH Research called the drug ultra-rapid, providing relief just eight days into treatment. By that time, 58% of patients in the drug arm were in remission, compared with 0% in the placebo group. Among 54 patients who then completed an extension portion of the study in which everyone knowingly got the drug the remission rate was 78% at the six-month mark.A novel treatment with such a large and rapid effect, particularly one that may require only infrequent, short 1-3 hours clinic visits, has the potential to be a practice changing treatment, Michael Thase, a psychiatry professor at University of Pennsylvania and a GH Research scientific adviser, said in a statement from the company.The drug is an inhalable form of mebufotenin, one member in a diverse family of molecules that also includes serotonin, melatonin and a psychedelic chemical found in some mushrooms. GH Research studied it in bipolar II disorder as well, and has a different, injectable version of it that went through a small trial of healthy volunteers.The newly released results look highly compelling and the best-in-class for a psychedelic targeting treatment-resistant depression, according to Paul Matteis, an analyst at the investment bank Stifel. While the experiment was not large, and the lack of any signal in the placebo group could be from patients deciphering what arm they were assigned to, Matteis still thinks the study was well run and had no oddities or red flags.Overall, the data look remarkably consistent and are essentially a best-case scenario for GH Research, he wrote in a note to clients.Shares of GH Research nearly doubled on the news. By late Monday morning they were up 81%, trading at over $19 apiece.Biotechnology investors have viewed psychedelics, much like the broader neuroscience field, as a high-risk, high-reward area of medical research. Theres mounting evidence these drugs can be valuable therapies for common conditions like depression, anxiety and addiction.Last year, psychedelics developers Lykos Therapeutics and Reunion Neuroscience each closed fundraising rounds worth more than $100 million.The hope is that these investments lead to products like Johnson & Johnsons Spravato, a form of ketamine used in treatment-resistant depression as well as certain cases of major depression. Sales from Spravato last year totaled almost $1.1 billion. (Matteis, notably, said his team was struck that GH Researchs drug looks much better than Spravato monotherapy in treatment-resistant depression, where the latter therapy showed a roughly 7-point decline in depressive symptoms after 28 days.)Still, the journey to market remains perilous. Psychedelics trials are exceedingly difficult, in part because the mind-altering effects of these drugs can tip off participants to the therapy theyve received, possibly skewing results.This was a key issue for the Food and Drug Administration when it reviewed a request from Lykos to approve MDMA better known to some as the party drug ecstasy for the treatment of post-traumatic stress disorder.The FDA went on to reject Lykos application, leading the company to lay off about three quarters of its employees. '

临床结果临床研究

2025-01-26

·药渡

强生千亿并购案的背后，艾伯维、BI相继折戟——CNS赛道的冰与火之歌

来源：药渡撰文：哥哈骎编辑：维他命 1 艾伯维、BI相继折戟精神分裂症 “蜀道难，多歧路，今安在”，历经磨难的中枢神经系统疾病疗法开发在2025年开篇就放了一记“蔫炮”。勃林格殷格翰开发的精神分裂症认知功能受损 (CIAS) 潜在首创新药iclepertin，其三项III期临床研究因为未达到终点而宣告失败。作为一个群体，精神分裂症患者的智商低于一般人群。这个患者群体的整体认知能力明显受损，平均比健康对照组低约两个标准差。目前，几乎所有批准的精神分裂症治疗药物都是通过拮抗多巴胺D2受体发挥作用的，但这些药物对精神分裂症的认知障碍几乎没有影响，或许是因为精神分裂症认知障碍与个体不同的病理过程有关。全球约有2400万人患有精神分裂症，估计其中80%的人患有与精神分裂症相关的认知障碍 (CIAS)。 BI的候选药Iclepertin是一种甘氨酸转运蛋白1 (GlyT1) 抑制剂，可以调节NMDA （N-甲基-D-天门冬氨酸受体）受体的活性，后者的功能障碍与精神分裂症及其认知症状有关。但BI于今年1月16日宣布，Iclepertin的临床研究未能达到主要终点，即通过MATRICS认知评估工具（MATRICS Consensus Cognitive Battery，MCCB）对患者的整体复合T评分（T-score）与基线的变化。不仅如此，Iclepertin也没有达到其次要终点。 Iclepertin的临床项目在41个国家招募了1840名患者，目前已结束。BI已经宣布放弃长期的延长试验CONNEX-X。BI的管线中只剩下为数不多的中枢神经系统疾病资产，意兴阑珊的BI已经开始将研究重点转移到肿瘤学领域。不过BI并没有完全放弃对精神分裂症以及CIAS疗法的追求，他们在去年3月以6.7亿欧元从Sosei Heptares（现为Nxera）获得了GPR52（一种GPCR类受体）激动剂组合（核心资产HTL0048149）的许可，针对精神分裂症的积极、消极和认知症状进行开发。在BI失败之前，AbbVie也经历精神分裂症药物emraclidine的两项II期研究失败。 Emraclidine是艾伯维2024年斥87亿美元巨资收购Cerevel Therapeutics而获得的资产，Cerevel Therapeutics最初是由辉瑞分拆产生的。过去几年中，Cerevel开展了两项研究，评估emraclidine能否快速缓解精神分裂症的症状。艾伯维非常看好emraclidine的前景，但在收购之后却遭到了两项II期研究失败。消息一经公布，艾伯维的股价立即暴跌12%，公司瞬间蒸发400亿美元市值。虽然BI和艾伯维针对精神分裂症相关适应症的开发均遭失败，但百时美施贵宝的Cobenfy在去年9月份获得了FDA的批准，创造了该疗法开发的里程碑事件。因为Cobenfy不同于之前的多巴胺D2受体拮抗剂，它是首款胆碱能受体（胆碱能受体中的毒蕈碱受体）激动剂。有分析师预测，其2030年销售额能够超过30亿美元，更有人预测，如果Cobenfy的适应症能扩展到阿尔茨海默病和双相情感障碍，其峰值销售有望超过100亿美元。预计精神分裂症今年将迎来众多读数，其总结见表1。读数的候选药中包括Atai的 RL-007，这是一种调节胆碱能、谷氨酸能和GABA-B受体的口服药物。与BI的Iclepertin一样，RL-007也正在针对精神分裂症认知功能受损 (CIAS) 进行专门研究，预计不久将公布其IIb期研究的结果。表1. 2025年将产生读数的精神分裂症临床研究 2 EMA开放态度对待“迷幻疗法” EMA神经和精神疾病治疗办公室主任Pavel Balabanov最近表示，欧洲估计有120万人患有精神疾病，但由于这些疾病的“病理复杂”，开发新疗法具有挑战性。与此同时，Balabanov也对迷幻类药物（psychedelic medicines）保持了更加开放的态度。 Balabanov在日前的新闻发布会上表示，由于开发能够有效穿过血脑屏障的药物存在挑战，以及设计这些药物的临床试验的复杂性，精神疾病治疗的失败率很高。作为监管者，EMA正在尝试刺激和支持创新，其中包括已经在美国加大开发力度的“迷幻药物”。图1. Psilocybin和MDMA化学结构式迷幻疗法，例如所谓的神奇蘑菇中含有的裸盖菇素（Psilocybin），以及所谓的“派对药物” MDMA（3,4-Methylenedioxymethamphetamine, 3,4-亚甲二氧甲基苯丙胺，摇头丸的成分之一），已开始成为美国精神疾病的潜在治疗方法（图1）。Balabanov强调，迷幻药研究领域产生了令人振奋的变化，并表示EMA不仅欢迎来自世界各地的监管机构，也欢迎患者、科学家共同努力，寻找“迷幻疗法”研究中最紧迫问题的解决方案。 3 146亿美元，CNS领域的开年大单虽然中枢神经系统疾病疗法开发已经被众多壮志难酬的项目证明“道阻且长”，但有志于此的开发者仍然前仆后继。新年伊始，强生146亿美元收购Intra-Cellular的意向为2025年的医药界领域并购交易开了一个“高调”，交易背后的核心资产就是治疗精神分裂症和双相抑郁症（双相情感障碍的一种表现形式）的药物Caplyta (lumateperone)。 Caplyta是一种每日一次口服药物，选择性并同时调节血清素、多巴胺和谷氨酸，于2019年获批用于治疗精神分裂症。目前正在针对重度抑郁症 (MDD) 进行开发。强生对这款药物的前景颇为看好，预测其峰值销售额将超过50亿美元。Caplyta 2023年的销售额为4.62亿美元，预计2024年将实现6.65亿至6.85亿美元的销售业绩。强生也对于Caplyta标签扩展的前景信誓旦旦，如果Caplyta能够攻克重度抑郁症的话，其商业版图将得到非常显著的扩张。强生表示，如果获得批准用于治疗重度抑郁症，Caplyta将成为15年来第一个同时用于治疗重度抑郁症和双相抑郁症的药物。Intra-Cellular目前正在进行SNDA申请，已向FDA递交了Caplyta针对重度抑郁症辅助治疗申请。这项申请的PDUFA时间为2025年10月。除此之外，Caplyta针对双相躁郁症（双相情感障碍中的另一种表现形式）目前也处于III期临床试验阶段，并且已产生了用于预防精神分裂症复发的III期疗效数据。强生认为，Caplyta有可能成为“最常见抑郁症”的治疗标准。除了以上市的Caplyta之外，强生收购Intra-Cellular的交易中还包括众多的中枢神经系统疾病管线资产，包括II期候选药ITI-1284，这款药物正针对广泛性焦虑症以及与阿尔茨海默病相关的精神病和躁动进行研究，可作为单一疗法或辅助疗法。强生斥巨资收购Caplyta的金额是146亿美元，几乎是2024年医药并购交易纪录的三倍，即Vertex以49亿美元收购Alpine Immune的那笔（不包括诺和控股收购Catalent的交易）。这笔交易比Intra-Cellular 1月10日的收盘价溢价39%。巧合的是，上一笔同级别的收购交易，即BMS 2023年12月140亿美元收购Karuna的那笔，背后的推动力量也是神经科学资产。Karuna的Cobenfy于2024年9月取得正果，被FDA批准用于精神分裂症治疗，以最新的机制开创了精神分裂症疗法的里程碑，将为BMS的投入带来丰厚的回报。Cobenfy还在针对包括阿尔茨海默病在内的一系列新适应症进行开发。有意思的是，Caplyta正是BMS在2005年授权给Intra-Cellular的，兜兜转转却成为强生对抗自己收购资产Cobenfy的竞争对手。也就是说，BMS将一个潜在重磅炸弹卖给了对手，而又斥巨资收购了另一个潜在重磅炸弹，而这两个重磅炸弹目前至少在精神分裂症领域直接短兵相接，未来还可能在众多其它领域龙争虎斗。医药领域似乎永远不缺乏“失之东隅，收之桑榆”以及“塞翁失马”的主题剧。即便前有艾伯维87亿美元收购Cerevel造成35亿潜在损失的前车之鉴，但强生收购Caplyta的交易核心是一款已经上市的产品，因此风险-利益评估更为精准，风险控制更加有效。更为重要的是，Captlyta与强生现有的神经科学产品组合契合完美，符合公司长远发展规划。虽然Caplyta的关键专利在美国将于2034年到期，但Intra-Cellular于1月10日宣布与Sandoz达成专利和解协议，有可能为其延长市场独占期。该协议允许Sandoz于2040年7月1日将仿制药推向市场。但为了巩固延长的专利保护，还需要与另外六家ANDA申请人达成协议（Alkem、Aurobindo、Dr. Reddy's、MSN Laboratories、Hetero Drugs和Zydus）。未雨绸缪的提前量如此之长，足以证明开发商对于这款药物前景的看好。 4 一半是海水一半是火焰新技术下CNS领域前景光明中枢神经系统疾病疗法开发，在当今医药领域表现出与众不同的独特属性。一方面，这个领域存在巨大未满足需求的现状，而且患者群体以及适应症也在变化之中；另一方面，临床研究的特殊性导致了疗法开发速度远远不能满足患者群体的需求，不断出现壮志难酬的失败案例。尽管如此，中枢神经系统疾病疗法的开发仍然处在枕戈待旦的蓄势阶段，随着Cobenfy等新机制疗法的获批上市，其对整个CNS疗法的带动效应将逐渐显现。随着科学技术的进步，尤其是在基因组学、神经科学和精准医学方面的突破，CNS疾病疗法的开发前景越来越光明。近年来，创新药物和治疗方式，如靶向疗法、基因疗法、干细胞疗法以及神经调控技术，正在为治疗阿尔茨海默病、帕金森病、抑郁症、精神分裂症等疾病提供新的希望。此外，神经炎症、神经保护和神经再生的研究也逐渐成为热点，为开发更有效的疗法提供了新的方向。尽管目前仍存在诸多挑战，如药物穿越血脑屏障的难题和治疗效果的个体差异，但随着对中枢神经系统复杂机制的深入理解，以及技术平台的不断创新，未来CNS疾病的治疗将更加精准、个性化，带来更大的临床疗效和患者福祉。希望CNS疗法开发能够最终进入到“自是不归归便得，五湖烟景有谁争”的恬静阶段。参考文献： 1.McCutcheon, R. A. et al. Cognitive impairment in schizophrenia: aetiology, pathophysiology, and treatment. Molecular Psychiatry volume 28, pages1902–1918 (2023) 2.Boehringer Ingelheim and Sosei Heptares join forces to develop first-in-class treatments targeting all symptoms of schizophrenia. BI Press Release. 11. 03. 2024. 3.Bell, J. AbbVie’s $9B bet collapses as closely watched schizophrenia drug fails studies. Biopharma dive. 11. 11. 2024. 4.Feuerstein, A. FDA approves schizophrenia drug that could alter how disorder is treated. STAT. 26. 09. 2024. 5.McConaghie, A. Boehringer’s Three Shots At Schizophrenia Miss The Target. Scrip. 17. 01. 2025. 6.Slawther, E. EMA Pushes For Industry Collaboration On Psychiatric And Psychedelic Drug Innovations. Pink Sheet. 17. 01. 2025. 7.Haas, J. J&J To Buy Intra-Cellular, Psychiatric Drug Caplyta For $14.6bn. Scrip. 13. 01. 2025. 8.Intra-Cellular Therapies, Inc. Receives Exclusive License for Central Nervous System Compounds from Bristol-Myers Squibb Company. Intra-Cellular Press Release. 01. 06. 2005. 专栏作者哥哈骎南开大学本科、硕士，德国比勒菲尔德大学博士。多肽化学、多肽API GMP生产专家、欧洲制药公司首席科学家；拥有Lean Six Sigma黑带认证；著有专著《Side Reactions in Peptide Synthesis》。 *声明：本文仅是介绍医药疾病领域研究进展或简述研究概况或分享医药相关讯息，并非也不会进行治疗或诊断方案推荐，也不对相关投资构成任何建议。内容如有疏漏，欢迎沟通指出！科伦博泰PD-L1单抗「塔戈利单抗」新适应症获批日本生物制药迎来复苏？中国医药的“春天”还远吗？ 2024医药交易「风云榜」：年终深度复盘与未来趋势展望

并购临床2期临床3期临床结果临床失败

2025-01-22

·Pharmaceutical Technology

J&J’s Spravato receives FDA label expansion for depression monotherapy

Major depressive disorder (MDD) is characterised by characterised by depression and inability to feel pleasure. Credit: Justin Paget via Getty Images. Johnson & Johnson’s (J&J) nasal spray Spravato (esketamine) has received a label expansion, now approved as a monotherapy treatment for major depressive disorder (MDD) in adults who do not respond to two oral antidepressants. The US Food and Drug Administration’s (FDA’s) decision makes Spravato the first-ever standalone treatment for adults with treatment-resistant depression. Initially approved in 2019 for use alongside oral antidepressants, this label expansion follows a priority review from the FDA. The approval was based on data from the Phase IV TRD4005 study (NCT04599855), which demonstrated a significant reduction in the Montgomery-Asberg Depression Rating Scale (MADRS) total score within 24 hours after the initial dose, with effects sustained for at least four weeks. Spravato’s safety profile aligns with existing data for oral antidepressants, with no new safety concerns detected. The standard-of-care for MDD typically involves selective serotonin reuptake inhibitors (SSRIs) or serotonin-norepinephrine reuptake inhibitors (SNRIs) as first-line treatments, often in combination with psychotherapy. However, these therapies can take weeks to exert an effect, and many patients do not respond adequately, leading to a need for innovative alternatives. Spravato targets the brain’s N-methyl-D-aspartate (NMDA) receptor. Unlike traditional MDD therapies that usually take weeks to work, J&J says this drug delivers rapid action. MDD is a severe, chronic mood disorder characterised by depression, inability to feel pleasure, guilt, low energy, and impairments in essential functioning. The global MDD market, valued at $8.8bn in 2019, is expected to grow to $16.2bn in 2029, according to a GlobalData report. GlobalData is the parent company of Pharmaceutical Technology. GlobalData notes that growth will be driven by the rising patient share of newly approved drugs, including J&J’s Spravato. Generating $689m in 2023 – nearly double its 2022 revenue of $374m – the drug’s sales are projected to reach $2.6bn by 2030. Another key contributor to this growth is Axsome Therapeutics’ Auvelity (dextromethorphan and bupropion). The company submitted a new drug application for Auvelity to the FDA for the treatment of MDD, which was accepted under priority review in April 2021. The FDA then approved Auvelity extended-release tablets in August 2022. Axsome’s drug is forecast to generate $1.9bn by 2030. With researchers looking for alternative treatments for mental health conditions, psychedelics have gained investor attention in recent years after demonstrating success in clinical trials. Psilocybin, a psychedelic prodrug compound found in more than 200 species of fungi, is currently in a Phase III programme for treatment-resistant depression with Compass Pathways .

临床3期临床结果上市批准优先审批临床2期

100 项与裸盖菇素相关的药物交易

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KEGG	Wiki	ATC	Drug Bank
-	裸盖菇素	-	DB11664

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适应症	最高研发状态	国家/地区	公司	日期
重度抑郁症	临床3期	美国	Usona Institute	2024-03-05
难治性抑郁症	临床3期	美国	Compass Pathways Plc	2023-01-19
兴奋剂滥用	临床2期	-	Filament Health Corp.	2025-01-01
阿片滥用	临床2期	-	Filament Health Corp.	2024-12-01
肠易激综合征	临床2期	美国	Tryp Therapeutics, Inc.	2024-01-17
边缘性人格障碍	临床2期	美国	Usona Institute	2023-11-01
烟草依赖	临床2期	美国	The University of Alabama at Birmingham	2023-11-01
纤维肌痛	临床2期	美国	Tryp Therapeutics, Inc.	2023-09-27
纤维肌痛	临床2期	美国	University of Michigan	2023-09-27
肿瘤	临床2期	美国	Sunstone Medical LLC	2023-07-07

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT04433858 (Pubmed \| J Affect Disord)	临床2期	难治性抑郁症	15	Psilocybin 25 mg	衊顧範齋醖廠窪製蓋衊(觸艱積壓鹹簾鏇齋餘淵) = 夢築鑰齋淵觸簾繭製遞齋鑰願憲齋築鑰餘廠鏇 (製積網夢願範獵餘膚廠 ) 更多	积极	2025-01-01
NCT03429075 (Psilodep-RCT, CTgov)	临床2期	重度抑郁症	59	Psilocybin + Placebo (Psilocybin)	築鑰鹹積繭壓膚鹽範壓(窪鬱顧醖鑰鏇襯鑰淵糧) = 製鹹獵齋繭餘壓築壓衊築醖願艱糧繭憲衊願窪 (範鏇鑰襯選範遞夢淵齋, 觸築築衊鬱製襯艱齋範 ~ 構鏇蓋鑰壓繭壓齋鑰築) 更多	-	2024-10-24
NCT03429075 (Psilodep-RCT, CTgov)	临床2期	重度抑郁症	59	Psilocybin + Escitalopram (Escitalopram)	築鑰鹹積繭壓膚鹽範壓(窪鬱顧醖鑰鏇襯鑰淵糧) = 鬱醖淵鏇窪艱鏇範鏇獵築醖願艱糧繭憲衊願窪 (範鏇鑰襯選範遞夢淵齋, 糧齋網廠齋淵憲齋遞遞 ~ 範範願淵鹹夢鏇憲窪簾) 更多	-	2024-10-24
NCT03429075 (Literature) 人工标引	临床2期	中度重度抑郁症	59	Psilocybin combined with psychological support	齋網醖廠積窪餘鑰網齋(繭網衊壓鏇襯鬱餘構鹽): Difference = 1.51 (95% CI, -1.35 ~ 4.38), P-Value = 0.311 更多	积极	2024-09-21
NCT03429075 (Literature) 人工标引	临床2期	中度重度抑郁症	59	Escitalopram combined with psychological support		积极	2024-09-21
NCT04661514 (Pubmed)	临床1期	神经性厌食症	10	Psilocybin	網積鬱憲築醖壓鏇廠願(鏇餘夢積蓋鹽構網襯衊) = Two participants developed asymptomatic hypoglycemia at post-treatment, which resolved within 24 h. No other clinically significant changes were observed in laboratory values. All AEs were mild and transient in nature. 鹽築蓋鹹範淵製築憲醖 (夢膚繭蓋鑰觸襯製鏇壓 )	积极	2024-07-01
NCT05434156 (GlobeNewswire) 人工标引	临床1/2期	重度抑郁症	-	ELE-101	顧糧網鏇網範鬱壓壓醖(選鹹餘鬱願齋觸蓋淵壓) = Was well-tolerated with no serious or severe adverse events (AE) reported, and an AE profile which is consistent with other compounds in this class. 鹽獵憲築壓鏇淵衊襯簾 (鹹選蓋艱醖夢窪範繭鏇 )	积极	2024-06-20
NCT05312151 (GlobeNewswire) 人工标引	临床2期	创伤后应激障碍	22	COMP360 psilocybin	築簾獵構網願築醖選製(鹹窪壓願繭廠鏇襯衊遞) = There were no treatment-emergent serious adverse events. 壓觸構築齋鹽糧糧積醖 (鏇鹹壓遞範衊憲鬱簾齋 ) 达到更多	积极	2024-05-08
NCT04593563 (Pubmed \| Cancer)	临床2期	-	-	Psilocybin-assisted therapy	餘廠構醖獵襯範範製遞(憲衊膚膚壓選簾廠築網) = e.g., nausea, headache 餘遞窪簾遞顧膚網艱範 (衊淵遞膚選窪獵醖網鹹 )	-	2024-04-01
Psi-GAD1 (NEWS) 人工标引	临床2期	广泛性焦虑障碍	72	Psilocybin	鑰醖鑰繭膚鑰繭鏇選鏇(選鏇製窪夢製鬱憲膚壓) = 觸衊鬱鹹醖鬱鑰膚壓憲艱糧壓鹽鬱蓋衊蓋醖醖 (鏇膚選淵網鹹鹽鹽遞醖 ) 达到	积极	2024-02-28
Psi-GAD1 (NEWS) 人工标引	临床2期	广泛性焦虑障碍	72	Placebo	鑰醖鑰繭膚鑰繭鏇選鏇(選鏇製窪夢製鬱憲膚壓) = 夢繭壓膚積醖壓膚壓簾艱糧壓鹽鬱蓋衊蓋醖醖 (鏇膚選淵網鹹鹽鹽遞醖 ) 达到	积极	2024-02-28
GlobeNewswire 人工标引	临床2期	创伤后应激障碍	22	COMP360 25mg	餘構壓夢壓糧糧簾憲觸(鹹壓顧積鏇觸廠糧遞網) = COMP360 was well-tolerated and the safety profile was as expected, with no treatment emergent serious adverse events recorded. 製衊觸鏇憲築齋積糧淵 (築選衊憲構淵壓範製糧 )	积极	2023-12-19
NCT04593563 (Literature) 人工标引	临床2期	重度抑郁症辅助	30	Psilocybin	範窪簾廠蓋願築膚構鹽(鏇壓憲積糧網網願餘構) = 遞衊積夢遞鹹鏇壓構鬱觸網鏇繭積夢齋齋顧製 (糧襯構製觸觸憲鏇衊觸, 22.3 ~ -16.0)	积极	2023-12-18