更新于：2024-05-01

Cannabidiol

大麻二酚

更新于：2024-05-01

概要

概要

基本信息

药物类型

小分子化药

别名

(1'R,2'R)-5'-methyl-4-pentyl-2'-(prop-1-en-2-yl)-1',2',3',4'-tetrahydrobiphenyl-2,6-diol、(−)-trans-2-p-mentha-1,8-dien-3-yl-5-pentylresorcinol、(−)-trans-cannabidiol

+ [37]

靶点

作用机制

CB拮抗剂(大麻素受体拮抗剂)

治疗领域

肿瘤神经系统疾病遗传病与畸形+ [7]

在研适应症

结节性硬化症Dravet综合征Lennox-Gastaut综合征+ [27]

非在研适应症

寻常痤疮急性移植物抗宿主病特应性皮炎+ [8]

原研机构

GW Pharmaceuticals Ltd.

在研机构

Sunnybrook Health Sciences CentreJazz Pharmaceuticals Plc

Main Line Health System

+ [13]

非在研机构

Botanix Pharmaceuticals, Inc.

Botanix Pharmaceuticals Ltd.

INSYS Therapeutics, Inc.

+ [3]

最高研发阶段批准上市

首次获批日期

美国 (2018-06-25),

Dravet综合征Lennox-Gastaut综合征癫痫发作

最高研发阶段(中国)-

特殊审评罕见儿科疾病 (美国)、孤儿药 (欧盟)、优先审评 (澳大利亚)、快速通道 (美国)

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结构

分子式C21H30O2

InChIKeyQHMBSVQNZZTUGM-ZWKOTPCHSA-N

CAS号13956-29-1

关联

465

项与大麻二酚相关的临床试验

NCT03883360 / Withdrawn临床2期IIT

Effects of Cannabidiol on Psychiatric Symptoms, Cognition, and Cannabis Consumption in Cannabis Users With Recent-Onset Psychosis

A large proportion of people with a schizophrenia-spectrum disorder, especially in the early stages of the disease, regularly consume cannabis. Cannabis use is associated with poor prognostic outcome; however, there are no effective interventions targeted at reducing cannabis use or its deleterious effects in this population. The present trial is designed to test whether cannabidiol (CBD), a cannabinoid whose effects are in many ways antagonistic to those of Δ9-tetrahydrocannabinol (THC), can reduce psychiatric symptoms, cognitive deficits, and cannabis use in people with recent-onset psychosis who regularly consume cannabis.

开始日期2050-01-01

申办/合作机构

University of Maryland Baltimore

[+2]

NCT02492074 / Not yet recruiting临床1期

Gene-Environment-Interaction: Influence of the COMT Genotype on the Effects of Different Cannabinoids on the Endocannabinoid System and Brain Function

The study evaluates the gene-environment interaction of the COMT-genotype on the effects of the phytocannabinoids delta-9-tetrahydrocannabinol, cannabidiol or a combination of both on induction of psychotic symptoms, endocannabinoid levels in human body fluids, neuronal processing, and neural oscillations. In addition the effects of the phytocannabinoids on lipid levels in serum and cerebrospinal fluid, cognition, neuronal processing assessed by fMRI as well as D2-receptor availability assessed by [18F] desmethoxyfallypride.

开始日期2024-12-01

申办/合作机构

Zentralinstitut für Seelische Gesundheit

NCT05456113 / Enrolling by invitationN/AIIT

Cannabidiol and Vascular Reactivity to Skin Sensory Nerve Stimulation

Cannabidiol, or CBD, is an over-the-counter "nutraceutical" that is more commonly being used by healthy adults for pain management, recovery from strenuous exercise, and general wellness. However, little research exists on the effects of CBD in otherwise healthy individuals. This study uses iontophoresis, a common technique used in physical therapy, to determine the effectiveness of topical CBD in lessening the reflex increased cutaneous vascular conductance response to stimulation of the skin.

开始日期2024-12-01

申办/合作机构

The Pennsylvania State University

100 项与大麻二酚相关的临床结果

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100 项与大麻二酚相关的转化医学

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100 项与大麻二酚相关的专利（医药）

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6,104

项与大麻二酚相关的文献（医药）

2024-05-01·Bioactive materials

Construction of functional neural network tissue combining CBD-NT3-modified linear-ordered collagen scaffold and TrkC-modified iPSC-derived neural stem cells for spinal cord injury repair.

Article

作者: Zhaoping Wu ; Yi Zhou ; Xianglin Hou ; Weidong Liu ; Wen Yin ; Lei Wang ; Yudong Cao ; Zhipeng Jiang ; Youwei Guo ; Quan Chen ; Wen Xie ; Ziqiang Wang ; Ning Shi ; Yujun Liu ; Xiang Gao ; Longlong Luo ; Jianwu Dai ; Caiping Ren ; Xingjun Jiang

Induced pluripotent stem cells (iPSCs) can be personalized and differentiated into neural stem cells (NSCs), thereby effectively providing a source of transplanted cells for spinal cord injury (SCI). To further improve the repair efficiency of SCI, we designed a functional neural network tissue based on TrkC-modified iPSC-derived NSCs and a CBD-NT3-modified linear-ordered collagen scaffold (LOCS). We confirmed that transplantation of this tissue regenerated neurons and synapses, improved the microenvironment of the injured area, enhanced remodeling of the extracellular matrix, and promoted functional recovery of the hind limbs in a rat SCI model with complete transection. RNA sequencing and metabolomic analyses also confirmed the repair effect of this tissue from multiple perspectives and revealed its potential mechanism for treating SCI. Together, we constructed a functional neural network tissue using human iPSCs-derived NSCs as seed cells based on the interaction of receptors and ligands for the first time. This tissue can effectively improve the therapeutic effect of SCI, thus confirming the feasibility of human iPSCs-derived NSCs and LOCS for SCI repair and providing a valuable direction for SCI research.

2024-04-15·Rapid communications in mass spectrometry : RCM

Identification and quantification of both isomers of hexahydrocannabinol, (9R)-hexahydrocannabinol and (9S)-hexahydrocannabinol, in three different matrices by mass spectrometry.

Article

作者: Charline Bottinelli ; Pauline Baradian ; Amélie Poly ; Guillaume Hoizey ; Camille Chatenay

CONTEXT:

Hexahydrocannabinol (HHC), a compound derived from synthetic production using cannabidiol (CBD) or delta-9-tetrahydrocannabinol (Δ⁹ -THC), has gained recent attention due to its presence in seized materials across Europe. Sold legally in various forms, HHC poses potential health risks, particularly as a legal alternative to THC in some countries. Despite its historical description in the 1940s, limited toxicology data, pharmacological understanding, and analytical methods for HHC exist.

METHOD:

This study proposes analytical techniques using mass spectrometry to detect, identify, and quantify (9R)-HHC and (9S)-HHC, concurrently with THC and CBD in various matrices, including oral fluid, whole blood, and seized material. Three distinct methods were employed for different matrices: GC/MS for seized material, GC/MS/MS for whole blood, and UHPLC/MS/MS for oral fluid. Methods were validated qualitatively for oral fluid with a FLOQSwab® device and quantitatively in whole blood and seized material according to Peters et al's recommendations and ICH guidelines.

RESULTS:

Validated methods were considered reliable in detecting and quantifying HHC isomers in terms of repeatability, reproducibility, and linearity with r² systematically >0.992. These methods were applied to authentic cases, including seized materials and biological samples from traffic control (whole blood and oral fluid). In seized materials, (9R)-HHC levels ranged from 2.09% to 8.85% and (9R)-HHC/(9S)-HHC ratios varied from 1.36 to 2.68. In whole blood sample, (9R)-HHC and (9S)-HHC concentrations were, respectively, 2.38 and 1.39 ng/mL. For all analyzed samples, cannabinoids such as THC and CBD were also detected.

CONCLUSION:

This research contributes analytical insights into differentiating and simultaneously analyzing (9R)-HHC and (9S)-HHC, using widely applicable mass spectrometric methods. The study emphasizes the need for vigilance among toxicologists, as new semisynthetic cannabinoids continue to emerge in Europe, with potential health implications. The findings underscore the importance of reliable analytical methods for monitoring these compounds in forensic and clinical settings.

2024-04-01·Materials today. Bio

Multi-targeting inulin-based nanoparticles with cannabidiol for effective prevention of ulcerative colitis.

Article

作者: Xuan Zhang ; Xia Gao ; Xiangzhou Yi ; Hui Yu ; Mingyang Shao ; Yongcheng Li ; Xuanri Shen

The pathogenesis of ulcerative colitis (UC) is closely related to severe inflammation, damaged colonic mucosal barrier, increased oxidative stress and intestinal ecological imbalance. However, due to the nonspecific distribution and poor bioavailability of drugs, UC treatment is still a serious challenge. Here, a mitochondria/colon dual targeted nanoparticles based on redox response was developed to effectively alleviate UC. Cannabidiol nanoparticles (CBD NPs) with a particle size of 143.2 ± 3.11 nm were prepared by self-assembly using polymers (TPP-IN-LA) obtained by modifying inulin with (5-carboxypentyl) triphenyl phosphonium bromide (TPP) and α-lipoic acid (α-LA). Excitingly, the constructed CBD NPs showed excellent mitochondrial targeting, with a Pearson correlation coefficient of 0.76 at 12 h. The results of animal imaging in vivo showed that CBD NPs could be effectively accumulated in colon tissue. Not only that, CBD showed significant glutathione stimulated release in the presence of 10 mM glutathione at pH 7.4. The results of in vivo animal experiments showed that CBD NPs significantly ameliorated DSS-induced colonic inflammation by modulating the TLR4-NF-κB signaling pathway. Moreover, CBD NPs significantly improved the histological damage of colon in UC mice, increased the expression level of tight junction protein ZO-1, and effectively restored the intestinal mucosal barrier function and intestinal mucosal permeability. More importantly, CBD NPs significantly improved the species composition, abundance and amount of short chain fatty acids of intestinal flora in UC mice, thus effectively maintaining the balance of intestinal flora. The dual-targeted and glutathione-responsive nanoparticles prepared in this study provide a promising idea for achieving targeted delivery of CBD for effective treatment of UC.

579

项与大麻二酚相关的新闻（医药）

2024-04-04

·GlobeNewswire-Health Care

Tilray Brands Announces 420 Activations Across Canada and Unveils Celebratory Product Lineup

Tilray Releases New Product Innovations Across Core Recreational Cannabis Categories from Whole Flower, Beverages, Pre-rolls, and VapesTORONTO, April 04, 2024 (GLOBE NEWSWIRE) -- Tilray Brands, Inc. ("Tilray") (Nasdaq: TLRY; TSX: TLRY), a leading global cannabis lifestyle and consumer packaged goods company, through its wholly-owned licensed subsidiaries, Aphria Inc., Hexo Operations Inc., and Truss Beverages Company Limited, announces its latest product lineup and 420 celebratory activations across Canada. Tilray’s cannabis brands including GOOD SUPPLY®, REDECAN®, BROKEN COAST®, SOLEI®, Mollo®, and XMG® will be activating a series of educational 420 budtender events in stores across Canada in partnership with over 1000 Canadian cannabis retailers nationwide. Cannabis enthusiasts and cannabis-curious consumers alike are invited to learn about Tilray Brands’ products at local cannabis retailers. In celebration of 420 and the ever-changing landscape of cannabis innovation and culture, Tilray Brands invites consumers to explore a new range of diverse cannabis products from its leading brands. Flower: Redecan Space Age Cake: A profoundly potent hybrid offering creamy vanilla, nutty, and ammonia flavours in our signature straight-cut, hemp-wrapped pre-rolls. This Girl Scout Cookies x Snow Lotus cross is everything to love about cookies strains. Now Available in Ontario, Alberta, and British Columbia in 3.5g and 14g.Good Supply Melon Dream: This sweet sativa-leaning hybrid is a mix of fruit and diesel aromas featuring dominant terpenes of caryophyllene, humulene and limonene, delivering the ultimate mellow vibe. Now available in Ontario and Alberta.Broken Coast EmergenZ and Cherry Cheesecake: Broken Coast presents two exceptional strains for 420 with unique aromas and taste profiles. ‘Cherry Cheesecake,’ delivers a unique trio of cherry, cheese, and sour aromas, and ‘EmergenZ’ energizes the senses, with the zesty flavours of tangerine, citrus, grapefruit, and pine. Now available in Ontario, Alberta, and British Columbia. Beverages: XMG+ Non-Carbonated Banana Brain-Freeze and Berry Rocket: ‘Banana Brain-Freeze’ is a symphony of tropical sweetness while Berry Rocket is a flavour fusion of juicy berries. Both feature 10mg of THC and 10mg of CBG along with guarana extract in a 355mL can, now available in Ontario and Alberta with anticipated expansion nationwide.Solei Cold Brews in Peach Cranberry and Wildberry Hibiscus: Both brews are made with refreshing true-to-fruit juice blends and a black tea base. Peach Cranberry is made with 5mg of THC and 10mg of CBG and Wildberry Hibiscus is made with 5mg of THC and 10mg of CBD featuring. Both are available in Ontario, and Peach Cranberry is available in British Columbia, along with further national launches across Canada.Mollo Seltzers in Lemon, Mango, and Pineapple: Best sipped slow, each new Mollo Seltzer contains 10mg of high-purity THC formulated with nano-emulsified cannabinoids without any cannabis aftertaste in three fantastic natural flavours, along with its CBG sidekick of 20mg, all in a sleek 355mL can. All flavours are available in Ontario, with Mango and Pineapple available in British Columbia and further national releases coming this summer. Pre-rolls: Good Supply’s ‘Cherry on Top’ Blunts: This new two-pack of 1g blunts features fresh flower that delivers a burst of new flavours and aromatic notes of Cosmic Cherry (Sativa), enhanced with zesty lemon sweetness, along with Golden Drizzle (Indica) delivering a delectable blend of sweet and caramelized notes. These perfectly paired blunts come in a slow-burning hemp wrap, now available in Ontario and Alberta with further national launch coming soon.Redecan Hemp’d Khalifuel Redees: A premium indica featuring Khalifa Mints x Grape Gasoline, is meticulously cultivated to deliver a unique boost, harvested at peak ripeness, and perfectly rolled into the signature 10x0.4g straight cut Hemp’d Redees for superior taste and burn. available in Ontario, Alberta, and British Columbia.Canaca Darts Berries & Cream and Twisted Citrus: The two latest strain blends joining beyond-belief blends of flavours with fired-up potencies will have you wondering what makes these secret recipes so good. Berries & Cream is the perfect indica blend with berry, sweet and vanilla flavours while Citrus Twist. Both are available in Alberta, while Berries and Cream are available only in British Columbia. Broken Coast Cherry Cheesecake: The perfect sweet treat featuring dramatic purple and orange indica buds flooded with milky trichomes and amber pistils, featuring a cherry, cheese, and sour profile thanks to its Kimbo Kush x Cherry Pie lineage. Available in 5 x 0.5g pre-roll packs in Ontario, Alberta, and British Columbia. Vapes: Good Supply Gooey Gold and Cherry Loops: ‘Gooey Gold’ and ‘Cherry Loops’ 1g 510 Vapes both offer an unmatched balance of high potency and rich flavours through a ceramic core, glass cartridge, and hemp mouthpiece. ‘Gooey Gold’ captivates with its sweet caramel flavour profile while ‘Cherry Loops’ features a unique blend of sweet, tart, and tangy notes from cherry, fruity, and citrus flavours. Available in Ontario, Alberta, and British Columbia. Tilray's adult-use cannabis brands are available in Canada through legal adult-use cannabis retailers and e-commerce channels nationwide. For more about each brand, please visit our brand socials including @SoleiCanada, @GoodSupplyCannabis, @RedecanCannabisCanada, @ChowieWowie, @WhatisRIFF, @BrokenCoast.ca, @CANACAyourBud, @Mollo_Out, @FindYourXMG. Must be of legal age to sip and consume. Enjoy Tilray's cannabis products responsibly. About Tilray Brands Tilray Brands, Inc. (Nasdaq: TLRY and TSX: TLRY) is a leading global cannabis-lifestyle and consumer packaged goods company with operations in Canada, the United States, Europe, Australia, and Latin America that is changing people’s lives for the better – one person at a time – by inspiring and empowering the worldwide community to live their very best life by providing them with products that meet the needs of their mind, body, and soul and invoke a sense of wellbeing. Tilray’s mission is to be the trusted partner for its patients and consumers by providing them with a cultivated experience and health and well-being through high-quality, differentiated brands and innovative products. A pioneer in cannabis research, cultivation, and distribution, Tilray’s unprecedented production platform supports over 20 brands in over 20 countries, including comprehensive cannabis offerings, hemp-based foods, and alcoholic beverages. For more information on Tilray, visit Tilray Brands, Inc. and follow @tilray on Instagram, Twitter, Facebook, and LinkedIn. Forward-Looking Statements Certain statements in this communication that are not historical facts constitute forward-looking information or forward-looking statements (together, “forward-looking statements”) under U.S. and Canadian securities laws and within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, that are intended to be subject to the “safe harbor” created by those sections and other applicable laws. Forward-looking statements can be identified by words such as “forecast,” “future,” “should,” “could,” “enable,” “potential,” “contemplate,” “believe,” “anticipate,” “estimate,” “plan,” “expect,” “intend,” “may,” “project,” “will,” “would” and the negative of these terms or similar expressions, although not all forward-looking statements contain these identifying words. Certain material factors, estimates, goals, projections, or assumptions were used in drawing the conclusions contained in the forward-looking statements throughout this communication. Forward-looking statements include statements regarding our intentions, beliefs, projections, outlook, analyses, or current expectations concerning, among other things, the Company’s ability to commercialize new and innovative products worldwide. Many factors could cause actual results, performance, or achievement to be materially different from any forward-looking statements, and other risks and uncertainties not presently known to the Company or that the Company deems immaterial could also cause actual results or events to differ materially from those expressed in the forward-looking statements contained herein. For a more detailed discussion of these risks and other factors, see the most recently filed annual information form of Tilray and the Annual Report on Form 10-K (and other periodic reports filed with the SEC) of Tilray made with the SEC and available on EDGAR. The forward-looking statements included in this communication are made as of the date of this communication and the Company does not undertake any obligation to publicly update such forward-looking statements to reflect new information, subsequent events, or otherwise unless required by applicable securities laws. Contacts: Media:Kaitlin Macapagalnews@tilray.com InvestorsRaphael Gross203-682-8253Raphael.Gross@icrinc.com

上市批准

2024-04-04

·Pharmaceutical Technology

Incannex prepares IND submission for psychotherapy asset

Incannex’s CEO Joel Latham announced an upcoming IND submission. Credit: SOPA Images via Getty Images Incannex Healthcare is gearing up for an investigational new drug (IND) submission for a Phase IIb generalised anxiety disorder study for its psychotherapy Psi-GAD, says CEO Joel Latham. Free Report How is the Biopharmaceutical industry evolving? 2021 was a year of continued innovation and change in the Biopharmaceutical industry. As the COVID-19 pandemic continues to take its toll on businesses worldwide, it’s time to look for new ways to create value, prepare for the future, and remain competitive in the ever-changing landscape. GlobalData’s expansive report examines the business environment and trends that shape the Biopharmaceutical industry. We highlight the most impactful emerging technologies, as well as the industry, regulatory, and macroeconomic factors that influence growth prospects. Access the report to: Benchmark the impact of major themes on the Biopharmaceutical industry. Gain a deeper "on the ground" perspective through exclusive opinions and analysis from industry respondents. Evaluate the effects of COVID-19 on the sector. Download the full report to understand what to expect and how to align your strategies for success. 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Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address. Thank you. You will receive an email shortly. Please check for download the Report. Go deeper with GlobalData Reports LOA and PTSR Model - ABBV-932 in Generalized Anxiety Disorder (GAD) Reports LOA and PTSR Model - AVN-101 in Generalized Anxiety Disorder (GAD) Premium Insights The gold standard of business intelligence. Find out more Related Company Profiles Nasdaq Inc View all “We have been working with the Medicines and Healthcare Products Regulatory Agency (MHRA) and various clinical trial sites in the UK,” said Latham in an exclusive interview with Pharmaceutical Technology . The company is working through onboarding and commencing the site in the UK first and in parallel working with the US Food and Drug Administration (FDA) to open an IND, says Latham. He explains that the trial will be a multi-site, multi-jurisdictional pivotal Phase IIb study. The Sydney, Australia-based company is currently finalising stability data from its manufacturing processes to include in the IND filing. Psi-GAD is a psilocybin therapy that treats generalised anxiety disorder by modulating the serotonin system for mood regulation. On 28 February, Incannex released interim data from the initial Phase II Psi-GAD-1 clinical study (ACTRN12621001358831), announcing that the therapy had significantly achieved improvements in the primary endpoint of the Hamilton Anxiety Rating Scale (HAM-A). In terms of financing, the CEO says that the biotech is in a secure position, partially due to its support from the Australian government. Despite being a Nasdaq -listed company, Incannex runs the majority of its operations in Australia, allowing it to take advantage of the country’s R&D tax rebates. Latham says that for all its R&D spend in Australia, the government offsets 43.5% of the taxation. This benefit is part of the July 2021-launched Australian R&D tax incentive (R&DTI) program. The 43.5% tax credit initiative is available to pharmaceutical and biotechnology companies that make less than $20 million annually, offering them the chance to lower risk and speed up time to market for their assets. “[The incentive] allows us to manage our cash position quite efficiently compared to most other biotechs globally,” adds Latham. See Also: Jazz Pharmaceuticals gets grant for cbd preparation with at least 90% CBD and thc Merz makes a $185m bid for assets from bankrupt Acorda Businesses that make over $20 million benefit from a slightly lower 38.5% tax credit with the remaining credit carried over to the following year. Suitable R&D activities are defined by the Income Tax Assessment Act 1997. Free Report How is the Biopharmaceutical industry evolving? 2021 was a year of continued innovation and change in the Biopharmaceutical industry. As the COVID-19 pandemic continues to take its toll on businesses worldwide, it’s time to look for new ways to create value, prepare for the future, and remain competitive in the ever-changing landscape. GlobalData’s expansive report examines the business environment and trends that shape the Biopharmaceutical industry. We highlight the most impactful emerging technologies, as well as the industry, regulatory, and macroeconomic factors that influence growth prospects. Access the report to: Benchmark the impact of major themes on the Biopharmaceutical industry. Gain a deeper "on the ground" perspective through exclusive opinions and analysis from industry respondents. Evaluate the effects of COVID-19 on the sector. Download the full report to understand what to expect and how to align your strategies for success. 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临床2期

2024-04-02

·药明康德

阿尔茨海默病、帕金森病……研发格局一览

▎药明康德内容团队编辑随着Leqembi获批为阿尔茨海默病（AD）治疗领域带来的显著进展，神经病学（Neurology）领域近年来受到业界的高度关注。这一趋势不仅促进了大型交易的频繁发生，也推动了临床研究积极进展。近日，行业媒体Evaluate发布了一份行业报告，深入分析了神经病学领域内的交易动态和研发趋势。在今天的文章里，药明康德内容团队将结合公开资料，与读者分享其中的精彩内容。点击文末“阅读全文/Read more”，即可访问报告原文网址。近年神经病学领域的大型收购与交易趋势神经病学是一门专注于神经系统疾病的医学分支，涵盖了从退行性疾病（如阿尔茨海默病和帕金森病）到癫痫、抑郁症、偏头痛、疼痛管理，乃至众多罕见疾病的广泛领域。相较于如癌症这样的高关注度领域，神经病学在过去数十年里获得的投资相对缺乏，这导致了大量未竟医疗需求。这种投资不足的背景，结合持续的精神健康危机和有限的治疗选择，为神经病学领域带来了独特的市场机遇和挑战。图片来源：123RF2022-2023年间，神经病学领域的并购活动活跃，其中较为突出的例子包括百时美施贵宝（Bristol Myers Squibb）以约140亿美元收购Karuna Therapeutics，此举旨在将精神分裂症疗法KarXT（xanomeline-trospium）纳入其产品管线，该药物的新药申请（NDA）已被美国FDA受理，有望在今年获得批准。艾伯维（AbbVie）则在去年12月以约87亿美元收购Cerevel Therapeutics，进一步加强艾伯维在神经病学领域的布局。此外，渤健（Biogen）以约73亿美元收购Reata Pharmaceuticals，获得了其针对弗里德赖希共济失调症的药物Skyclarys（omaveloxolone）。辉瑞（Pfizer）公司也加大了在神经病学领域的投入，于2022年以总计约116亿美元收购Biohaven Pharmaceutical，增强了其偏头痛治疗产品组合。这一系列并购案例不仅展示了大型医药企业在神经病学领域的布局，也凸显了该领域积极的发展前景。尽管过去神经病学曾经面临投资不足的挑战，但如今它正吸引着大型药企的集中关注和大规模投资。▲2014-2024年间，神经病学领域內＞10亿美元的交易活动（药明康德内容团队制表，数据来源：参考资料[1]）回顾近年来神经病学领域的交易活动，显而易见的一种趋势是医药公司对于“低风险、后期研发阶段项目”的偏好。神经病学药物开发的历程充满了挑战，多个项目在研发过程中曾遭遇了不可预见的挫折，凸显了该领域内药物开发的固有不确定性和高风险。鉴于此，相较于那些仍处于探索初期、前景充满不确定性的新药项目，大部分医药公司更倾向于投资于那些已经进入到后期研发阶段、相对风险更低的项目。这种策略反映了企业对于风险管理的审慎态度，以及在资本投入时寻求更高确定性的倾向，有些公司甚至避免涉足处于中期临床研究阶段项目的风险，倾向于在药物研发进展到更加成熟和风险更可控的阶段进行投资或并购。除了频繁的并购活动外，近年来神经病学领域的融资活动也十分活跃。在2024年3月，Engrail Therapeutics完成了1.57亿美元的B轮融资。而就在不久前，Alto Neuroscience也成功完成了初次IPO交易。2023年9月，Neumora Therapeutics也实现了上市，募集资金高达2.5亿美元。Neumora的主要产品navacaprant目前正处于针对抑郁症的3期临床试验阶段，该公司预计这一关键试验结果将为预定于2025年递交的新药申请提供支持。这些融资活动凸显了产业在神经病学领域的高度活跃性，也展示该领域在医药研发和创新方面的巨大潜力。图片来源：123RF神经病学领域的新药研发趋势随着科技的不断进步以及我们对人脑复杂机制的深入理解，神经病学领域正处于一场创新疗法和药物开发的浪潮中。在此过程中，一些关键趋势尤为突出：首先，药物的选择性变得更加精准，能够特异性地调节特定的神经通路或受体，旨在降低副作用并提升治疗效果。其次，致幻药物在精神疾病治疗中的潜在应用正受到重新评估，特别是在治疗抑郁症和创伤后应激障碍（PTSD）方面。此外，人工智能（AI）技术正助力脑部药物的发现和开发，加速了新药候选分子的筛选和优化过程。同时，对新分子和创新作用机制的探索正不断扩大治疗工具箱，为患者提供更多的治疗选择。这些进展共同推动了神经病学领域的创新和发展，为未来治疗带来新的希望。1.新一代药物更具选择性在开发更有效和安全的中枢神经系统药物方面，药物选择性的提高是一个重要因素。以强生公司（Johnson & Johnson）的aticaprant和Neumora公司的navacaprant为例，这两种药物针对Kappa阿片受体（KORs）的选择性上优于对μ或δ等其他阿片受体亚型，展现了对KORs的高度特异性。这种特性使得这两种药物在治疗重度抑郁症的3期临床试验中表现出潜力，并且还有望扩展到治疗焦虑症和药物滥用等领域。这种对特定受体的高选择性不仅提高了治疗的针对性，也有望减少潜在的副作用。2.重新思考致幻药物的药用价值近来，迷幻药物的医疗用途得到了重新评估和认可。今年2月，美国FDA宣布受理Lykos Therapeutics（前MAPS公益公司）为3，4-亚甲二氧基甲基苯丙胺（MDMA）递交的新药申请，用于治疗PTSD。该申请还获得了FDA授予的优先审评资格，预计审评结果将于今年8月11日之前发布。新闻稿指出，若该药物获批，它将成为第一款MDMA辅助疗法，同时也是首个获批的迷幻药辅助疗法。此外，Compass Pathways公司的在研裸盖菇素（psilocybin，致幻蘑菇中的致幻成分）疗法在2期临床试验中取得了积极结果，目前已进入治疗耐药性抑郁症的3期临床试验。大麻也正式进入医疗领域。例如，Jazz Pharmaceuticals的癫痫发作药物Epidiolex（cannabidiol，大麻的一个主要非致幻成分）在2018年获得FDA的批准上市，治疗两类罕见而严重的癫痫。新闻稿指出，这是首款获美国FDA批准上市的含纯化大麻提取物的新药。人们对致幻剂疗法潜力的兴趣与日俱增，促使FDA在2023年年中起草了指南草案，以支持相关临床研究，这标志着迷幻药物作为治疗手段就正在逐步正规化和科学化。3.AI辅助神经药物开发2024年，Alto Neuroscience成功地募集到1.29亿美元上市。Alto公司以“人工智能驱动的大脑精准医疗”为其核心理念，专注于AI辅助精准药物开发。其成功的融资活动背后是基于该公司主打项目展示出的积极研究数据：公司的ALTO-300项目相关研究显示，采用脑电图（EEG）生物标志物辅助筛选的患者相较于未使用EEG筛选患者获得了更大的益处。在神经病学领域，精准医疗仍处于起步阶段。然而，新兴的测序技术、传感器工具以及更为强大的数据分析能力正助力科学家们深入解析大脑的复杂机制。值得关注的是，2024年初，美国FDA批准了一项名为BrainSee的人工智能临床测试，专门用于阿尔茨海默病。该测试结合大脑成像技术和认知评估，旨在预测患者从轻度认知障碍进展到痴呆症的可能性，标志着人工智能在神经病学领域应用的一大进步。图片来源：123RF4.新靶点，新机制随着基因研究在神经病学领域的深入，新的治疗靶点不断涌现。例如，Denali Therapeutics和渤健合作开发的LRRK2靶向抑制剂BIIB122/DNL151，目前处于治疗帕金森病的2b期试验阶段。另外，Alector Therapeutics正在与艾伯维合作进行一项2b期临床研究，评估其TREM2靶向疗法AL002用以治疗阿尔茨海默病的作用。此外，Alector还与GSK达成合作，共同开发两款progranulin靶向单抗AL001和AL101以治疗神经退行性疾病。Lexeo Therapeutics正在研发的基因疗法LX1001，旨在通过递送APOE2基因—一种具有保护作用的基因——来降低携带纯合APOE4基因患者罹患阿尔茨海默病的风险。该候选药物目前正在进行1/2期临床试验，初步研究数据表明，接受低剂量LX1001治疗的患者脑脊液中的APOE2蛋白表达增加，在超过12个月的随访期内，两名患者的脑脊液中tau蛋白和磷酸化tau蛋白水平与基线相比降低，这两种蛋白是反映阿尔茨海默病患者大脑关键病理变化的生物标志物。图片来源：123RF神经病学领域的弄潮儿在神经病学领域的创新浪潮中，众多公司凭借其独特的技术优势和丰富的产品线，促进了该领域的快速发展，并为治疗神经病学相关疾病提供了更广泛的选择。接下来，我们将介绍几家近年来专注于神经病学领域的公司。Neurocrine BiosciencesNeurocrine Biosciences专注于为患有神经性、神经内分泌性及神经精神疾病的患者开发新型治疗方案。该公司的产品组合多样化，包括已经获得FDA批准的Ingrezza，这是一款已获批用于治疗迟发性运动障碍和亨廷顿病相关舞蹈症的药物。除此之外，Neurocrine还拥有一系列正处于中到后期临床开发阶段的候选疗法。▲Neurocrine Biosciences在研管线（图片来源：Neurocrine Biosciences官网）Acadia PharmaceuticalsAcadia公司已有2款药物获得FDA批准，分别是Nuplazid（pimavanserin）和Daybue（trofinetide）。根据Acadia公司官网，pimavanserin是美国FDA批准的首个用于治疗帕金森病精神病相关幻觉和妄想症状的处方药。值得一提的是，该药物针对精神分裂症的阴性症状的适应症目前正处于3期临床研究中，此前公布的2期试验结果表明，当与现有抗精神病药物联合用药治疗精神分裂症患者时，该药物显著改善了患者在NSA-16量表上的表现。Acadia预计在2024年获得pimavanserin的3期研究的顶线结果。Daybue则是Acadia公司的第二款获批产品，它在2023年3月获得FDA批准用于治疗Rett综合征成人和2岁以上儿童患者，成为FDA批准的首款治疗Rett综合征的药物。▲Acadia Pharmaceuticals在研管线（图片来源：Acadia Pharmaceuticals官网）Alector TherapeuticsAlector公司的研发管线包含3个处在临床阶段的潜在“first-in-class”项目，这些项目吸引了包括GSK和艾伯维在内的大型医药公司的合作。其中，AL001和AL101是与GSK合作开发的两种新型单抗。AL001目前正在进行一项关键性3期临床试验，用于治疗因GRN基因突变而存在额颞叶痴呆（FTD）风险、或患有额颞叶痴呆的患者。而AL101目前则处于2期临床试验阶段，旨在治疗阿尔茨海默病。此外，Alector管线中的AL002是一种针对TREM2的在研人源化单抗，TREM2是散发性AD的一个重要遗传风险因素。该产品由Alector和艾伯维合作开发，目前正在一项2期临床试验中接受检验。▲Alector Therapeutics在研管线（图片来源：Alector Therapeutics官网）渤健渤健在神经病学领域拥有深厚的研发历史和广泛的产品组合，包括19款已经上市的产品，涵盖了多个重要的治疗领域。其中包括首款获得FDA完全批准的阿尔茨海默病疗法Leqembi，以及基于生物标志物加速批准的首款基于生物标志物加速批准的肌萎缩侧索硬化症（ALS）疗法Qalsody（tofersen）。渤健的研发管线中也不乏创新药物，如针对tau蛋白的反义寡核苷酸（ASO）疗法BIIB080，在针对轻度阿尔茨海默病患者的1b期临床试验中展现了积极结果，使其成为首款被证明可以减少tau蛋白聚集、并展现对患者临床结局有利的趋势的tau蛋白靶向药物。此外，渤健还正在开发针对LRRK2的小分子抑制剂BIIB122，展现了其在神经病学领域研发的广度与深度。Denali TherapeuticsDenali Therapeutics致力于开发治疗神经退行性疾病和溶酶体贮积症疗法。Denali拥有多样化的产品管线，其中多个项目已经步入中后期临床开发阶段。包含与渤健合作开发用于治疗帕金森病的LRRK2小分子抑制剂DNL151，与赛诺菲（Sanofi）合作研发用于治疗多发性硬化的RIPK1小分子抑制剂SAR443820/DNL788，以及基于Denali的转运载体平台技术构建的融合蛋白药物DNL310。DNL310可被成功递送到大脑从而缓解II型黏多糖贮积症（MPS II）的中枢神经系统症状。目前，DNL310正在2/3期临床试验中接受评估，Denali公司的目标是在今年完成2/3期临床试验的患者注册。大家都在看▲欲了解更多前沿技术在生物医药产业中的应用，请长按扫描上方二维码，即可访问“药明直播间”，观看相关话题的直播讨论与精彩回放参考资料：[1] EVALUATING: Neurology，Retrieved April 2, 2024 from https://www.evaluate.com/thought-leadership/evaluating-neurology/?utm_source=Eloqua&utm_medium=Email&utm_campaign=202403-CMP-TL-NEUROLOGY&utm_content=EVALPHARMA-EMN-TL-2403GL-NEUROLOGY-DLRT免责声明：药明康德内容团队专注介绍全球生物医药健康研究进展。本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。版权说明：本文来自药明康德内容团队，欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载授权请在「药明康德」微信公众号回复“转载”，获取转载须知。分享，点赞，在看，聚焦全球生物医药健康创新

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外链

KEGG	Wiki	ATC	Drug Bank
D10915	大麻二酚	N03AX24	DB09061

研发状态

适应症	最高研发状态	国家/地区	公司
Lennox-Gastaut综合征	批准上市	列支敦士登更多	GW Pharma (International) BV 更多
癫痫发作	批准上市	列支敦士登更多	GW Pharma (International) BV 更多
结节性硬化症	批准上市	列支敦士登更多	GW Pharma (International) BV 更多
Dravet综合征	批准上市	欧盟更多	GW Pharma (International) BV 更多
躁郁症	临床3期	加拿大更多	University of British Columbia 更多

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临床结果

适应症

分期

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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


NCT03802799 (ZYN2-CL-017, Corporate Publications) 人工标引	临床2/3期	脆性X综合征	240	Cannabidiol	(鹹壓壓構築繭鑰築觸淵) = 蓋艱醖鑰鏇壓積觸蓋遞膚夢鏇齋糧廠鹹鑰繭選 (衊繭鑰壓蓋觸選選蓋積 ) 更多	积极	2022-05-11
NCT02987114 (Pubmed \| Epilepsy Behav) 人工标引	临床2期	耐药性癫痫	11	PTL-101	(鏇願艱觸衊構鑰繭衊襯) = 艱淵鏇鏇製構簾鑰獵壓夢齋夢襯願夢繭襯鹽夢 (遞簾壓遞鑰壓夢窪鑰蓋, 24.6) 更多	积极	2019-09-01
NCT01562314 (Pubmed \| Inflamm Bowel Dis) 人工标引	临床2期	溃疡性结肠炎	-	Cannabidiol	鏇壓蓋簾齋鹹獵簾窪淵(積獵蓋醖範觸衊網糧壓) = 醖蓋衊艱窪憲觸餘鹹鑰顧夢齋獵願選餘積觸鏇 (鬱範鑰積窪鹽顧製繭選 )	积极	2018-03-19
				Placebo	鏇壓蓋簾齋鹹獵簾窪淵(積獵蓋醖範觸衊網糧壓) = 觸窪齋廠夢構襯選壓簾顧夢齋獵願選餘積觸鏇 (鬱範鑰積窪鹽顧製繭選 )
NCT03614663 (CONNECT-FX, Pubmed) 人工标引	临床2/3期	脆性X综合征	212	ZYN002	網淵觸積齋蓋窪獵鹹積(淵膚艱蓋淵範網廠餘遞) = Although statistical significance for the primary endpoint was not achieved in the full cohort, 齋鏇廠鑰齋簾積網鏇膚 (鹽醖窪淵範製積壓鏇鬱 )	不佳	2022-11-25
				Placebo
NCT05149898 (ZYN2-CL-031 \| INSPIRE, Corporate Publications) 人工标引	临床1/2期	迪格奥尔格综合征	33	Cannabidiol (Period 1)	(簾鹽築鹹鬱醖餘餘夢窪) = 壓鬱廠淵觸廠憲鹹觸網觸獵構蓋鹹積窪壓鬱願 (顧壓艱鏇餘餘蓋憲糧鬱 ) 更多	积极	2022-09-08
				Cannabidiol (Period 2)	積膚壓衊餘鬱壓觸製顧(遞鹽糧齋夢糧鹹齋艱膚) = 繭網窪構襯遞積餘網艱蓋淵積顧糧衊夢夢蓋願 (壓窪憲簾襯築製願觸衊 ) 更多
NCT02544763 (GWPCARE6, Pubmed \| Turk J Pediatr) 人工标引	临床3期	癫痫发作 \| 结节性硬化症	199	cannabidiol	(製醖選餘繭壓觸顧簾鬱) = 選獵鏇構構淵遞築鬱襯積壓淵齋獵淵鬱艱淵選 (廠網鹹窪鹽遞艱遞糧淵 ) 更多	积极	2022-02-01
NCT00588731 (Pubmed \| Psychopharmacology (Berl)) 人工标引	N/A	慢性精神分裂症	36	cannabidiol	鏇鹽廠觸鑰獵網艱積齋(築範糧積壓簾選餘窪蓋) = no Placebo arm:no main effect of drug（a significant drug × time effect）; Placebo arm:no main effect of time（Post hoc analyses revealed improved over time）淵衊簾壓鏇鹹糧顧衊夢 (餘願範築製觸襯構壓淵 ) 更多	积极	2018-07-01
				Placebo
NCT04167319 (Pubmed) 人工标引	N/A	周围神经系统疾病	54	Cannabidiol (treatment with carboplatin and paclitaxel (Carbo-Tax))	(憲膚壓壓夢襯繭鏇壓鏇) = No significant differences in PRO items were found for patients receiving Carbo-Tax. CAPOX patients treated with CBD had significantly lower peak baseline-adjusted difference in three PRO items on cold sensitivity to touch, discomfort swallowing cold liquids, and throat discomfort 壓網憲廠夢製淵襯獵鑰 (窪廠憲醖艱鬱鏇遞鬱憲 )	积极	2022-08-06
				Cannabidiol (treatment with capecitabine and oxaliplatin (CAPOX))
NCT02224573 (GWPCARE5, Pubmed \| Turk J Pediatr) 人工标引	临床3期	Lennox-Gastaut综合征	368	cannabidiol	(選範鹹製鏇糧遞艱憲夢) = 鹽襯繭繭蓋築繭鏇繭鏇艱積範願蓋糧膚築憲餘 (顧艱鏇鬱製構獵廠築願 ) 更多	积极	2021-09-01
NCT05149898 (INSPIRE \| ZYN2-CL-031, Corporate Publications) 人工标引	临床2期	迪格奥尔格综合征	20	-	窪鑰簾蓋獵鏇鬱憲繭壓(衊憲襯艱鹹鹽鹹範積簾) = 顧艱鏇艱簾積餘衊夢窪廠築願繭淵壓簾觸願壓 (鬱壓製艱範艱顧顧簾糧 ) 更多	积极	2023-09-15
				ZYN002 (14 Weeks (Period 1))	窪構鹹構鑰鏇選獵顧廠(窪壓淵獵襯願鏇範顧顧) = 築壓餘繭製糧顧簾鹹願積窪獵鹹獵顧製齋廠鹹 (壓積蓋餘廠簾蓋齋艱齋 ) 更多