Pediatric attention deficit hyperactivity disorder (ADHD) affects up to 10% of children in the U.S. and more than 90% are prescribed stimulant medications according to clinical guidelines. The standard of care for pharmacological treatment of ADHD is a "trial-and-error" approach that requires frequent dose adjustments, side effects management, and communication among doctors, parents, and school personnel over weeks, months, and years. In the first year following prescription of stimulant medications, >50% of doctors are not able to conduct the recommended follow-up with their patients. Many patients stop taking medications or keep taking medications that do not work well, as a result.
This investigation will use a non-invasive brain imaging technique called EEG to look for activity in the brain that can predict which children with ADHD will respond well to two commonly prescribed stimulant medication groups, methylphenidate and amphetamines. Based on a previous study, it is expected that EEG signals can differentiate among children whose ADHD symptoms will get better on methylphenidate, and those whose ADHD symptoms will get better on amphetamines.
220 participants ages 7-11 with ADHD will be enrolled. Participants will not have autism or intellectual disabiltiy. They will not currently be taking psychiatric medications. Participants will not have not taken stimulant medications before or have tried stimulant medications >6 months or experienced an improvement in their ADHD symptoms by taking a stimulant medication before.
Study Participation Includes:
1. Participant and caregiver complete a 3-hour visit at the Arnett Laboratory at 2 Brookline Place. During this visit, participants complete a brief IQ test and an EEG while their caregiver completes questionnaires and a clinical interview. The caregiver will give permission to request survey responses from the participant's teacher.
2. The next day, the participant and caregiver will come back to the laboratory for a 1-hour visit. The participant will do another EEG while the caregiver fills out more surveys. The doctor will take the participant's vital signs and prescribe the medication.
3. The participant will be randomly assigned to take either methylphenidate HCl or amphetamines every morning for 3 weeks. At the end of each week, the caregiver and teacher will fill out a questionnaire about the participant's behaviors and symptoms, including side effects.
4. For one week, the participant will not take medications. They will come back into the lab for another EEG at the end of that week.
5. The participant will then take the other medication every morning for 3 weeks. At the end of each week, the caregiver and teacher will fill out a questionnaire about the participant's behaviors and symptoms, including side effects.
6. It will take participants about 7 weeks to complete this study. During this time, they will complete 3 in-person and 6 virtual study visits.
7. The research funds will cover cost associated with the study. The participant's health insurer will not be billed for the medications or treatment. Medications will be provided through the research pharmacy.
8. Participants will be given a report at the end of the study with details about the medication trials, symptom response, and any other findings. They will receive up to $270 for the completion of the study. Some travel-related costs will be covered by the study.

开始日期2026-09-15

申办/合作机构

The Children's Hospital Corp.

[+2]

TCTR20250909006

/ Not yet recruiting临床1/2期IIT

The Effect of Motivational Interviewing with Family Support and Line Application-Based Program on Amphetamine Consumption of Adult with Amphetamine Use Disorder

开始日期2025-12-01

申办/合作机构-

CTIS2023-509874-48-00

/ Not yet recruiting临床1期

An open label, balanced, randomized, two-treatment, two-period, two-sequence, single-dose, crossover, bioequivalence study comparing Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets (Mixed Salts of Single Entity Amphetamine Product) 30 mg, manufactured by Frontida Biopharm. Inc., Philadelphia, USA with Attent 30 mg (Mixed Amphetamine Salts tablets) manufactured by Teva Israel Ltd., in healthy adult, human subjects under fasting condition.

开始日期2025-01-09

申办/合作机构

Sun Pharmaceutical Industries Ltd.

100 项与苯丙胺相关的临床结果

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100 项与苯丙胺相关的转化医学

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100 项与苯丙胺相关的专利（医药）

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21,233

项与苯丙胺相关的文献（医药）

2026-12-01·JOURNAL OF AFFECTIVE DISORDERS

Pooled analysis assessing the efficacy and safety of amphetamine derivative adjunctive therapy for bipolar depression

Article

作者: Nunez, Nicolas ; Mori, Nicole ; Ozerdem, Aysegul ; Georgiev, Georgi ; Singh, Balwinder ; Biernacka, Joanna M ; Pazdernik, Vanessa K ; Frye, Mark A ; Cuellar-Barboza, Alfredo B ; Veldic, Marin ; Ali, Dina N ; Lindstrom, Karin ; Sanchez-Ruiz, Jorge A ; McElroy, Susan L

OBJECTIVE:

The bipolar pharmacopoeia targeting depression is significantly underdeveloped. Despite high rates of attention deficit symptoms, there has been inadequate investigation of stimulants as a treatment intervention for adults with bipolar depression.

METHODS:

Data were pooled from two, 8-week, randomized, placebo-controlled trials of adjunctive mixed d-amphetamine/l-amphetamine salt (MAS) and lisdexamfetamine (LDX). The primary outcome measure was baseline-to-endpoint change in the Montgomery-Asberg Depression Rating Scale (MADRS). Secondary outcomes included treatment response and remission (50%MADRS reduction, MADRS < 10), and improvement as measured by the Clinical Global Impression for Bipolar Disorder (CGI-BP). The primary safety assessment was the Young Mania Rating Scale (YMRS).

RESULTS:

Fifty-seven bipolar [BD-I: n = 23 (40.4%); BD-II: n = 34 (59.6%); male: n = 17 (29.8%); female: n = 40 (70.2%); mean age = 40.1 ± 11.3 years] depressed participants were randomized. There were no significant group differences in baseline demographics (all p ≥ 0.14). In age-adjusted analysis, participants receiving adjunctive LDX/MAS (n = 26) in comparison to placebo (n = 31) showed greater improvement in MADRS (mean % reduction: 54.6% vs. 25.6%; 95% CI: 9.1, 48.9; p = 0.005), with higher response (65.7% vs. 16.7%; p < 0.001), remission (48.8 vs. 15.3%; p = 0.007) and CGI-BP improvement rates (65.0% vs. 23.5%; p = 0.001). There was no between-group difference in YMRS scores at baseline or endpoint (p ≥ 0.36).

CONCLUSIONS:

In this pooled controlled analysis, 8-week adjunctive amphetamine was associated with reduction in depressive symptoms in carefully selected patients with bipolar depression, with no increased risk of treatment-emergent mania/hypomania. Further studies are encouraged to identify clinical correlates of treatment response guiding clinicians when to consider this potentially effective treatment.

2026-11-01·BRAIN BEHAVIOR AND IMMUNITY

A longitudinal examination of gut microbiota dysbiosis and neuro-behavioral phenotypes of poly(I:C)-maternal immune activation in a preclinical model of autism and schizophrenia

Article

作者: García-Mena, Jaime ; González-Franco, Diego A ; Corona-Cervantes, Karina ; Diaz-Miranda, Sofia Y ; Bello-Medina, Paola C ; Pacheco-López, Gustavo ; Pérez-Morales, Marcel

Maternal immune activation (MIA) induced by polyinosinic/cytidylic acid [poly(I:C)] is a widely used approach to study how gestational inflammation affects neurodevelopment. For this reason, we aimed to describe the changes in gut microbiota and neurobehavioral phenotypes across the lifespan of the MIA offspring. We administered poly(I:C) on gestational day 12 to induce MIA in pregnant C57 mice. Subsequently, we conducted behavioral phenotyping, a neuropharmacological sensitivity test, a morphological analysis of dendritic branches and spines, and a gut microbiota assessment in male offspring. Here, we performed a longitudinal analysis of gut microbiota maturation across development in poly(I:C)-MIA offspring and integrated these findings with behavioral and neuronal morphology assessments relevant to ASD and schizophrenia. Our results show that MIA treatment induces an increase in the marble burying test, which assesses repetitive and persevering behavior related to obsessive-compulsive disorder, as well as decreased social interaction, anhedonia, sensitivity to the psychotomimetic drug amphetamine, and a reduction of dendritic branches and spines in the pyramidal neurons of layers II/III of the prefrontal cortex. We also observed infant gut dysbiosis on postnatal day (PD) 30. This condition is unrelated to maternal vertical transferences and persisted until early adulthood (PD57) and adulthood (PD100). Our results show that MIA is a consistent and robust preclinical model of ASD/SCZ that allows identifying symptoms and signs of these disorders, which agrees with epidemiological human evidence. Additionally, the gut dysbiosis induced by MIA could be permanent, and since it is not induced by vertical transference, it could be supported by the brain-gut-microbiota axis effects. Additional neuroimmune and microbiological studies, such as microbiota transplantation or antibiotic interference, are necessary to better interpret the effects observed in this study.

2026-10-01·FOOD AND CHEMICAL TOXICOLOGY

Integrated whole-transcriptome analysis reveals ceRNA network dysregulation underlying methcathinone-induced synaptic damage and cognitive impairment

Article

作者: Chen, Zhe ; Xu, Chunming ; Lv, Jieping ; Zhou, Rukui ; Wei, Zhiwen ; Yun, Keming

Methcathinone (MCAT), a synthetic cathinone structurally analogous to amphetamine, poses substantial public health concerns due to its high addictive liability and pronounced neurotoxicity. In the present study, rat models of MCAT-induced neurotoxicity were established using low (0.5 mg/kg), medium (5 mg/kg), and high (20 mg/kg) doses. Cognitive function was assessed using the Morris water maze, while hippocampal synaptic morphology and ultrastructure were examined via Golgi staining and transmission electron microscopy. To elucidate the underlying molecular mechanisms, whole-transcriptome sequencing was performed to profile mRNAs, miRNAs, circRNAs, and lncRNAs in the hippocampus across exposure groups relative to controls. Differential expression analysis identified extensive transcriptional alterations, including 1646, 1539, and 1477 DEmRNAs; 32, 28, and 23 DEmiRNAs; 749, 728, and 753 DEcircRNAs; and 391, 369, and 371 DElncRNAs in the low-, medium-, and high-dose groups, respectively. Functional enrichment analyses consistently implicated synapse-related processes and neurodegeneration-associated pathways. Notably, activity-dependent immediate-early genes (c-Fos, Nr4a1, Arc, Egr1, Egr2, and Npas4) were uniformly downregulated across all exposure levels, indicating impaired neuronal activity-dependent transcriptional responses. Integration of multi-layered transcriptomic data enabled the construction of circRNA-miRNA-mRNA and lncRNA-miRNA-mRNA competing endogenous RNA (ceRNA) networks, revealing extensive post-transcriptional regulatory interactions. A core ceRNA network was identified, comprising 6 hub mRNAs, 9 miRNAs, 95 lncRNAs, and 146 circRNAs. Quantitative RT-PCR validation demonstrated high concordance with RNA-seq results, supporting the robustness of the dataset. These findings demonstrate that MCAT induces cognitive deficits and synaptic structural impairments by disrupting activity-dependent gene expression and neurotrophic signaling through complex ceRNA-mediated regulatory networks. This study provides novel mechanistic insights into MCAT-induced neurotoxicity and identifies potential molecular targets for therapeutic intervention in psychostimulant-related cognitive dysfunction.

122

项与苯丙胺相关的新闻（医药）

2026-09-09

·国际糖尿病idiabetes

绝经期肥胖症的阶梯化综合治疗策略：生活方式、药物、手术与HRT的个体化应用

点击“蓝字”关注我们绝经期女性肥胖症的患病率和死亡率均明显上升，前瞻性研究显示BMI≥35.0 kg/m2死亡率明显增加[1]。这主要与肥胖症相关心血管和代谢性疾病如2型糖尿病（T2DM）、心血管疾病和高脂血症等有关。因此针对肥胖症的治疗对于改善临床结局尤为重要。此外，绝经期女性因为体内激素水平变化造成一系列症状和心理变化，往往可能服用抗抑郁药治疗，这些药物都存在促进体重作用，因此在治疗过程中须平衡利弊。目前绝经期肥胖症的治疗重点是生活方式干预和饮食控制，但其长期有效性仍存在巨大的挑战，越来越多的绝经期女性开始选择药物和减重手术治疗。一、饮食和运动管理绝经期女性快速且持久的体重下降5%~10%即可有明显的健康获益。选择更健康的饮食和适量的运动可适度减轻体重，改善人体成分，而这足以使患者向代谢正常性肥胖症转变，代谢异常和不良健康结局风险明显减少。因此绝经期女性往往可以通过饮食和运动控制达到代谢健康这一目标，而不一定需要达到体重完全正常。 1 饮食结构调整 + + 饮食控制是体重管理的重要组成部分。食物量的控制和对所吃食物的充分认识对于维持健康饮食很重要。为实现体重减轻，总能量摄入需根据500~750 kcal/d能量亏损来估算每日能量需求。充足的蛋白质摄入对于维持肌肉质量和力量、预防肌少症和维持骨量正常非常重要。目前推荐蛋白质摄入量为0.8 g/kg。蛋白质来源方面，建议多食用动物蛋白，优于豆类和豆制品，建议每周至少两次食用鱼和瘦肉。碳水化合物除了作为重要的能量来源外，还可提供丰富的膳食纤维、维生素和矿物质。碳水化合物每日推荐摄入量为130 g，作为总能量摄入的45%~65%。绝经期女性应适当限制膳食脂肪的摄入。脂肪供能比应该控制在30%以下。除了应当注意脂肪的总摄入量外，还应注重不同脂肪酸的摄入比例。饱和脂肪酸的供能比控制在10%以下有助于改善血脂异常。单不饱和脂肪酸、多不饱和脂肪酸ω-3和多不饱和脂肪酸ω-6推荐1∶1∶1。部分植物油氢化后可产生反式脂肪酸，反式脂肪酸能增加胆固醇、低密度脂蛋白并降低高密度脂蛋白，在日常饮食中要尽量避免摄入。膳食纤维每日推荐量为20~30 g。营养学家建议女性减少食盐和富盐食物的摄入。食盐摄入量应限制为每日5 g[2]。 2 运动管理 + + 有氧和抗阻运动对于维持体重极为必要。成年人每周应该进行150~300分钟中等强度运动，或70~150分钟高强度有氧运动（或同等组合）以及1周2天以上全肌肉强化活动。推荐肥胖症患者进行更高强度的运动以达到代谢和心血管获益，且伴随着能量消耗，瘦体重衰减效应会消失。对于围绝经期女性进行有氧运动，以自我感觉疲劳程度来衡量运动强度更为合理，自我感觉稍累为适宜的运动强度。锻炼应当从小强度开始，随着身体适应性的增加提升运动强度和运动时间。对于中老年女性，抗阻运动以低强度到中等强度为宜，且一定遵循循序渐进的原则，每2~4周增加1次运动量，每次增加2.5%~5%。合并高血压的女性在进行抗阻运动时要尽量避免屏气动作。二、药物治疗生活方式改变是所有减重计划的基础，但几乎所有行为治疗研究均表明，仅仅生活方式改变只能够达到体重3%~10%的持久性减重效果，大多数人在12个月后反弹[3]。减重药物仅在患者服用时才起作用，因此需要长期使用。对于生活方式干预和运动控制难以达到减重目的和维持减重效果时，药物治疗有很好的辅助作用。BMI≥30.0kg/m2或BMI≥27.0kg/m2伴有T2DM、高血压和高脂血症等疾病时推荐使用药物减重。目前FDA批准四类长期减重药，包括苯丙胺类药物及其衍生物、特异性胃肠道脂肪酶抑制剂、纳曲酮/安非他酮合剂、GLP-1受体激动剂。2021年FDA推荐司美格鲁肽2.4mg每周皮下注射可用于减重。利拉鲁肽和司美格鲁肽均为GLP-1受体激动剂，GLP-1受体激动剂可刺激胰岛素的释放，促进饱腹感，延缓胃排空，减少能量摄入，从而维持葡萄糖稳态和促进体重减轻。绝经期女性往往存在骨骼和心血管疾病等方面问题，而GLP-1受体激动剂在这些方面均有积极作用，因此对于绝经期女性尤为推荐应用。奥利司他是临床上常用的减重药，通过抑制膳食脂肪的吸收来减少热量的吸收。奥利司他除了减重外，还可有效改善血糖和血脂。但值得注意的是，奥利司他会减少脂溶性维生素，尤其是维生素D的吸收。研究显示，奥利司他治疗两年后，维生素D水平明显下降（虽然仍在正常范围内）。故绝经后肥胖症女性如使用奥利司他控制体重，需特别注意补充钙和维生素D，以防止骨量减少，减少骨质疏松的发生[4]。此外，绝经期女性由于年龄偏大，各项身体功能减退等因素，临床上医生和患者往往很少首选药物治疗，因为这部分人群往往更需考虑减重药物的副作用。但对于控制不佳的肥胖症，尤其是心血管和代谢性疾病高风险时，仍需考虑药物减重。三、外科手术减重手术是治疗重度肥胖症及肥胖症相关代谢性疾病（以T2DM为代表）的高效、长效干预手段，也是生活方式干预、药物治疗效果不佳后的核心进阶治疗方案。相较于饮食、运动及药物治疗易出现的体重反弹、疗效有限等问题，减重手术能够从根源上调控进食与代谢机制，实现长期稳定减重，大幅改善肥胖症合并症，降低远期死亡风险。目前大量前瞻性、回顾性临床研究均证实，减重手术对各年龄段肥胖症人群均有显著获益，可有效降低肥胖症相关死亡率，持续减轻体重，逆转或缓解T2DM、高脂血症、高血压等代谢并发症，对于机体机能特殊的绝经期女性同样适用。临床针对不同术式的对比研究显示，患者人群适配性存在明显差异：与育龄期女性相比，绝经期女性因激素衰退、代谢速率下降、肌肉量减少等生理特点，可调节胃束带术的减重效果相对有限、疗效稳定性较差；而经典的Roux-en-Y胃旁路术受年龄、激素水平影响较小，在绝经期与育龄期女性中的治疗效果无显著差异，是适配绝经期肥胖症女性的优选术式。常规减重手术可帮助患者实现50%~60%的大幅体重下降，减重获益明确且持久，但该手术存在一定安全风险，整体严重手术并发症发生率约为1%，临床术前需严格评估患者身体基础条件。针对绝经期女性的专项研究证实，Roux-en-Y胃旁路术的减重效果更为突出，可使患者体重降幅高达70%，且疗效能够稳定维持12~24个月，同时可显著改善绝经后女性高发的代谢紊乱问题。结合绝经期肥胖症女性的诊疗特点，对于经长期生活方式干预、药物治疗仍无法有效控制体重，且合并高危心血管、代谢疾病的重度肥胖症患者，在严格把控手术禁忌症、完善术前评估与术后管理的前提下，可积极开展减重手术，以实现长效减重，降低远期不良预后风险。四、激素替代治疗（hormone replacement therapy，HRT）女性HRT是缓解卵巢功能减退所致相关症状最有效的治疗方法，绝经早期使用还可在一定程度上预防老年慢性病的发生。一项荟萃分析评估了HRT对绝经后女性代谢综合征的影响，其结果提示HRT可改善非糖尿病女性的中心性肥胖症，降低胰岛素抵抗，减少新发糖尿病，降低血脂、血压、黏附分子和促凝血因子，亦可以降低糖尿病女性的胰岛素抵抗和空腹血糖水平[5]。动物实验也证实雌激素可以减轻主动脉周围和腹内脂肪的重量以及甘油三酯和总胆固醇水平等，改善绝经后代谢综合征[6]。HRT还可改善心血管疾病风险，降低总胆固醇和LDL水平，降低血压等。但HRT也存在一定的风险，包括乳腺癌、深静脉血栓形成等。此外HRT需注意“时间窗”治疗这一概念，即治疗宜针对绝经10年内或<60岁有症状的女性；在“时间窗”外进行HRT时心脑血管疾病的风险大于获益，需慎重使用。因此更年期HRT需权衡利弊后决定是否治疗。为了改善肥胖症，建议更年期HRT应尽可能予以最低有效治疗剂量和短疗程治疗。五、结语综上所述，绝经期肥胖症是激素波动、代谢衰退、生活方式及药物因素共同诱发的特殊病理状态，可显著升高心血管、代谢疾病风险及全因死亡率，需引起临床高度重视。绝经期肥胖症治疗遵循阶梯化、个体化原则，以饮食与运动干预为基础，通过科学膳食配比与循序渐进的运动方案，优先实现代谢健康、改善身体成分，无需过度追求体重完全正常。针对生活方式干预效果不佳、体重反弹或合并代谢并发症的患者，可针对性选用GLP-1受体激动剂、奥利司他等减重药物，同时兼顾绝经期骨骼健康，及时补充营养素。对于重度肥胖症高危人群，规范开展Roux-en-Y胃旁路术等减重手术可实现长效减重。此外，在严格把握时间窗与利弊原则下，个体化HRT治疗可改善绝经后代谢紊乱。临床需综合患者年龄、基础疾病、激素水平及用药情况，权衡利弊制定综合方案，在安全前提下有效控制体重，降低远期不良临床结局风险。参考文献：（上下滑动可查看） [1] Bea JW, Thomson CA, Wertheim BC, et al. Risk of Mortality According to Body Mass Index and Body Composition Among Postmenopausal Women. Am J Epidemiol. 2015;182(7):585-596. [2] Ko SH, Kim HS. Menopause-Associated Lipid Metabolic Disorders and Foods Beneficial for Postmenopausal Women. Nutrients. 2020;12(1):202. [3] Pedersen SD, Manjoo P, Dash S, Jain A, Pearce N, Poddar M. Pharmacotherapy for obesity management in adults: 2025 clinical practice guideline update. CMAJ. 2025;197(27):E797-E809. [4] Bansal AB, Patel P, Al Khalili Y. Orlistat. [Updated 2024 Feb 14]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. [5] Salpeter SR, Walsh JM, Ormiston TM, Greyber E, Buckley NS, Salpeter EE. Meta-analysis: effect of hormone-replacement therapy on components of the metabolic syndrome in postmenopausal women. Diabetes Obes Metab. 2006;8(5):538-554. [6] Zhu J, Zhang L, Ji M, Jin B, Shu J. Elevated adipose differentiation-related protein level in ovariectomized mice correlates with tissue-specific regulation of estrogen. J Obstet Gynaecol Res. 2023; 49(4): 1173–1179. 声明：本文仅供医疗卫生专业人士了解最新医药资讯参考使用，不代表本平台观点。该等信息不能以任何方式取代专业的医疗指导，也不应被视为诊疗建议，如果该信息被用于资讯以外的目的，本站及作者不承担相关责任。最新《国际糖尿病》读者专属微信交流群建好了，快快加入吧！扫描左边《国际糖尿病》小助手二维码（微信号：guojitnb），回复“国际糖尿病读者”，ta会尽快拉您入群滴！（来源：《减重时讯》编辑部）

2026-09-03

·华大智造MGI

一座“会思考”的运动医学实验室，如何终结反兴奋剂百年“猫鼠游戏”？

在香港浸会大学运动科学与医学研究中心（Centre for Exercise Science and Medicine, 以下简称“CESAME”），一个在体育赛场上持续了百年的“猫鼠游戏”，正在被推向终局。在反兴奋剂领域，有一个公开的秘密：有些违禁物质，停药后在人体内很难查到“痕迹”，但作用却能持续很久。以EPO（erythropoietin）为例。它的中文全称是促红细胞生成素，是人体肾脏自然分泌的一种激素蛋白质，主要功能是刺激骨髓制造红细胞。红细胞负责把氧气送到全身，红细胞多了，人的耐力自然更强。临床上，人工合成的EPO制剂可用于治疗肾性贫血等疾病；但在体育竞技中，额外使用外源性EPO来提升成绩，则属于兴奋剂违规。问题就出在这里。运动员如果注射人工合成的EPO，就能让身体在短时间内产生过量红细胞，获得持续数周的不公平耐力优势。但传统反兴奋剂检测追踪血液或尿液中的外源EPO的时限较短（例如48小时）——超过该时间后，这种外源物质查不到了，但它引发的身体变化还在，这为反兴奋剂工作带来了重要挑战。香港浸会大学运动科学与医学研究中心（CESAME）如今，CESAME的科学家们，试图用一种全新的方法终结它：不再“找药”，而是“读痕”。一场竞逐了一百多年的“猫鼠游戏” 1904年圣路易斯奥运会，马拉松选手托马斯·希克斯靠服用士的宁混合白兰地冲过终点后倒地，成为奥运史上第一起有据可查的兴奋剂事件。此后一百余年间，从苯丙胺到合成类固醇，从血液回输到EPO，作弊手段不断翻新，检测技术也在追赶中迭代。但所有传统方法都困于同一逻辑：在身体里找药物——药物会代谢、痕迹会消失，让“找药”越来越像一场滞后的追捕。 CESAME主任Yannis Pitsiladis教授 CESAME主任Yannis Pitsiladis教授直言：“对于运动员体内存在的违禁药物，现在的检测技术已经非常完善。问题在于那些已经排出体外的药物——药物虽然离开了，但它留下的痕迹，以及它带来的运动表现优势，却依然存在。” 从“找药”到“读痕”：检测范式的跃迁如果传统检测像是在一个已经清空现场的房间里寻找凶器，那么转录组学则是在读取房间墙上留下的指纹。每一次干预——兴奋剂、血液回输、极限训练、高原暴露——都会在基因表达层面留下独特的“分子指纹”。借助高通量测序与AI，科学家可同时读取成千上万个基因表达信号，捕捉药物离开后仍残留的生物学“记忆”。这意味着血液兴奋剂检测窗口有望从约48小时延长至数周甚至数月，也让"自然适应还是人为增强"的判断从经验走向数据——CESAME团队此前已鉴定出一组*rHuEPO（重组人促红细胞生成素）响应候选基因，其中约50个与运动、高原暴露的标志物无重叠；目前正通过超1000例样本的大规模测序项目，验证这些标志物能否稳定区分rHuEPO暴露与生理性适应。范式已经改变，但要让它从论文走向实战，需要一座能把样本、测序、AI分析全部闭环运转的实验室。 CESAME实验室建一座“会思考”的实验室华大智造与Yannis Pitsiladis教授团队的合作，早在CESAME揭幕之前就已经埋下种子。 2021年，团队发表了一项开创性研究，横向比较了当时所有主流测序平台。在50个顶级样本的实测结果中，华大智造综合表现突出——这成为双方后续深度合作的技术起点。 2024年巴黎奥运会期间，E25、G99与AlphaTool智能移液工作站走进OLY House（运动员活动中心），向全球运动员展示前沿检测方案；同年，Pitsiladis教授联合华大智造及国际研究者，在Translational Exercise Biomedicine发表前瞻性文章，勾勒出血液兴奋剂转录组检测的清晰路径。 2026年4月17日，CESAME正式揭幕——作为中国香港首个获国际运动医学联会（FIMS）认可、聚焦运动科学与基因组学交叉融合的“运动医学合作中心”，它不只是一座实验室，更是一个将精准医学、人体运动表现与运动科学整合在一起的完整生态系统。 CESAME研究人员处理实验样本在这里，一份生物样本从采集、运动测试、分子分析、测序到AI分析，全程在同一设施内完成；中心拥有多组学与遗传学、生物力学与运动表现实验室及低氧舱，已积累超过3,000份样本。而让这些空间真正“会思考”的，是华大智造与子公司涌生智能共同打造的“AI+数字孪生”体系。 CESAME实验室AI+数字孪生系统在硬件层，STP-7000分杯系统与SP-NE384全自动核酸提取纯化仪完成高通量样本前处理，智能调度系统统一协同全自动建库设备，αLab™ Robot机器人实现样本跨平台无人化转运，T7高通量测序仪24小时内可完成60例人类全基因组30X测序，数据同步传输至αCube BioXpert生信AI推理一体机完成分析——从样本到报告几乎全流程自动化，单日可处理数百份样本。在环境层，温湿度、气压等关键参数24小时实时监测并映射至数字空间，同一份样本在任何时间复测，环境条件均可控可复现——而结果的可复现性，正是反兴奋剂证据达到法庭级可靠性的基石。 Yannis Pitsiladis教授指导研究人员 Yannis Pitsiladis教授评价道：“华大智造带来的先进技术与设备，让我们能够把样本到数据的链路做到极致。从采集到分析，几乎所有环节都可以自动化完成，这不仅加速了研究进程，也让我们对结果的可靠性更有信心。最令我兴奋的是，从样本输入到结果输出，我们几乎不需要任何人为干预——因为相比机器，人类更容易犯错。” 从赛场到病房这场博弈的终点是全人类健康 CESAME要回答的问题，远远超出“谁使用了兴奋剂”这个单点问题。依托这套智能实验室平台，中心重点开展四大方向的前沿研究：运动员基因组学，以遗传与表观遗传标记评估运动潜能、定制个性化训练；新一代反兴奋剂检测，以转录组生物标志物实现微量检出，将检测窗口延长至数周甚至数月；航天医学研究，解析太空环境对肌肉记忆与生理机能的影响；性别公平研究，以多基因标记分析为全球体育公平议题提供循证支撑。更具行业意义的是，当自动化与人工智能把检测效率推向极致，曾经只属于顶尖实验室的组学能力，有望进入更广泛的医疗机构与公共卫生体系——反兴奋剂检测将变得更加公平可及，精准医学正从概念走向日常；当测序、自动化、数字孪生与AI在同一空间内闭环运转，生命科学研究便从“作坊式”迈向“工程化”，这种“环境可控、流程自动、运转高效、结果可靠”的实验室范式，或将成为未来精准医疗的新基础设施。从血液里的分子印记到每一个人的健康未来，这场持续了百年的“猫鼠游戏”，将在CESAME迎来终局。在这里，体育不只是胜负的竞技，更是理解人类潜能、推动精准健康的前沿阵地。 *rHuEPO为重组人促红细胞生成素（recombinant human erythropoietin），可刺激红细胞生成、提升血液携氧能力，是WADA禁用的促红细胞生成类物质，常被耐力项目运动员滥用。其直接检测窗口短，但生理效应持续时间长，因此需要转录组学等新技术来辅助识别。关于CESAME 香港浸会大学运动科学与医学研究中心(CESAME)是一个跨学科研究与转化平台，致力于推进人体运动表现、运动医学、精准健康及公共福祉的全面发展。通过整合生理学、基因组学、生物力学、临床研究、可穿戴技术与数据科学，CESAME将前沿科学发现转化为可量化的成果，惠及精英运动员、患者以及社会大众。 CESAME是连接精英体育与公共健康之间的重要桥梁。中心是香港首个获国际运动医学联会(FIMS)认可的运动医学合作中心(CCSM)，亦是中国第三个、全球仅31个获此认证的中心之一。这一权威认证确立了香港在运动医学、运动健康研究及体育诚信科学领域的重要国际地位。中心的转化研究涵盖运动员健康与运动表现、运动医学及人类健康等多元领域。其具有国际影响力的反兴奋剂与体育诚信研究项目，致力于研发先进的生物与分子策略，以加强运动员保护并捍卫公平竞技。通过整合生物标志物科学、真实世界监测与人工智能分析，CESAME产出可指导实践、影响政策制定并支持负责任技术发展的科学依据。 · ·

2026-08-31

·BioSpace

Ensysce Biosciences Completes Final Phase of PF614-MPAR-102 Clinical Study

~ ~ The Second Study Fully Enrolled for Breakthrough Therapy-Designated, First-in-Class Opioid Designed to Protect Against Oral Overdose ~ ~ SAN DIEGO, CA / ACCESS Newswire / August 31, 2026 / Ensysce Biosciences, Inc. (NASDAQ:ENSC) ("Ensysce" or the "Company"), a biotechnology company developing novel neuroplastogenic therapies beyond mood disorders, with an initial focus on complex pain, and advancing next-generation pain and central nervous system therapeutics designed to reduce abuse and overdose risk, today announced completion of enrollment in the final stage of the PF614-MPAR-102 clinical study. The study evaluated its novel MPAR ® (Multi-Pill Abuse Resistance) overdose-protection technology. Unlike traditional abuse-deterrent technologies, PF614-MPAR is engineered to actively protect against oral overdose, addressing one of the most persistent risks in opioid therapy. Its proprietary chemical-control mechanism provides therapeutic opioid exposure when used as prescribed and automatically limits additional release when excessive doses are taken. This built-in "safety switch" establishes a new therapeutic paradigm: opioids designed not only for efficacy, but also for controlled exposure under misuse conditions. Part 3 of this second PF614-MPAR study, supported by the National Institute on Drug Abuse (NIDA) 1 , was designed to further characterize the drug's protective pro a full range of dosing scenarios. Clinical data published to date demonstrates PF614-MPAR maintains consistent therapeutic plasma levels at normal doses while significantly blunting exposure increases at supratherapeutic levels. Dr. Lynn Kirkpatrick, Chief Executive Officer of Ensysce, stated, "Completing enrollment in this second PF614-MPAR study marks an important milestone for Ensysce as we advance a Breakthrough Therapy-designated program targeting one of the most urgent challenges in prescription opioid therapy: overdose risk. PF614-MPAR is designed to deliver therapeutic opioid exposure when used as prescribed while limiting additional release at excessive doses, a differentiated approach we believe could redefine prescription opioid safety. With nearly 80,000 people in the U.S. still dying each year from opioid overdose, prescription opioids remain a significant part of this crisis 2 . By embedding overdose protection directly into the molecule, MPAR ® represents a potentially new class of chemically engineered opioids and an important step toward a safer standard of care for pain management." Beyond pain management, Ensysce is leveraging its TAAP and MPAR ® technologies to expand its pipeline across additional high-need therapeutic categories. The Company has identified lead TAAP analogues for amphetamine and methadone, supporting a broader strategy to develop safer treatment options for pain, attention-deficit/hyperactivity disorder (ADHD), and opioid use disorder, in addition to its newly acquired psychedelic program for Complex Regional Pain Syndrome. 1 Research supporting this program was funded by the National Institute on Drug Abuse of the National Institutes of Health under Award Number DA047682. 2 About Ensysce Biosciences Ensysce Biosciences is a clinical-stage biotechnology company developing novel neuroplastogenic therapies using psychedelics that go beyond mood disorders and address the root cause of chronic pain through central nervous system modulation. The company is also developing a new class of highly novel opioids for the treatment of severe pain while minimizing the risk of both drug abuse and overdose. For more information, please visit . Forward-Looking Statements Statements contained in this press release that are not purely historical may be deemed to be forward-looking statements for the purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995 and other federal securities laws. Without limiting the foregoing, the use of words such as "may," "intends," "can," "might," "will," "expect," "plan," "possible," "believe" and other similar expressions are intended to identify forward-looking statements. The product candidates discussed are in clinic and not approved and there can be no assurance that the clinical programs will be successful in demonstrating safety and/or efficacy, that Ensysce will not encounter problems or delays in clinical development, or that any product candidate will ever receive regulatory approval or be successfully commercialized. All forward-looking statements are based on estimates and assumptions by Ensysce's management that, although Ensysce believes to be reasonable, are inherently uncertain. All forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those that Ensysce expected. In addition, Ensysce's business is subject to additional risks and uncertainties, including among others, possible NASDAQ delisting, the initiation and conduct of preclinical studies and clinical trials; the timing and availability of data from preclinical studies and clinical trials; expectations for regulatory submissions and approvals; potential safety concerns related to, or efficacy of, Ensysce's product candidates; the availability or commercial potential of product candidates; continuation of government funding; the ability of Ensysce to fund its continued operations, including its planned clinical trials; the dilutive effect of stock issuances from our fundraising; and Ensysce's and its partners' ability to perform under their license, collaboration and manufacturing arrangements. These statements are also subject to a number of material risks and uncertainties that are described in Ensysce's most recent quarterly report on Form 10-Q and current reports on Form 8-K, available free of charge at the SEC's website at . Any forward-looking statement speaks only as of the date on which it was made. Ensysce undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required under applicable law. Ensysce Biosciences Company Contact: Lynn Kirkpatrick, Ph.D. Chief Executive Officer (858) 263-4196 Ensysce Biosciences Investor Relations Contact: Shannon Devine MZ North America Main: 203-741-8811 ENSC@mzgroup.us SOURCE: Ensysce Biosciences View the original press release on ACCESS Newswire

突破性疗法快速通道

100 项与苯丙胺相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D07445	苯丙胺	N06BA01	DB00182

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
注意缺陷障碍伴多动	美国	Neos Therapeutics LP	2016-01-27
注意缺陷障碍伴多动	美国	Neos Therapeutics, Inc.	2016-01-27

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
精神障碍	药物发现	美国	The Howard Hughes Medical Institute	2001-12-18

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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


NCT03834766 (CTgov)	临床3期	注意缺陷障碍伴多动	130	AMPH+20 mg (AMPH ER Tab)	簾選選衊餘願範鑰鏇艱(遞鹹繭廠窪醖製獵觸醖) = 壓衊糧衊簾獵築繭觸網製膚積鹽製餘築艱簾顧 (壓糧繭鑰顧艱網繭選鑰, 69.40) 更多	-	2023-11-02
				AMPH ER Tab Matching Placebo 5, 10, 15 and 20 mg (Matching Placebo)	簾選選衊餘願範鑰鏇艱(遞鹹繭廠窪醖製獵觸醖) = 鏇選鏇衊觸淵願醖襯膚製膚積鹽製餘築艱簾顧 (壓糧繭鑰顧艱網繭選鑰, 77.75) 更多
NCT02058693 (CTgov)	临床4期	重度抑郁症	41	mixed salts amphetamine (Group 1(A): Placebo/MSA)	夢鑰鹽遞簾膚觸襯範選(醖積艱築鏇夢醖蓋糧簾) = 糧鹹觸窪襯夢簾積鏇鹹簾艱遞鬱遞積鬱糧憲艱 (廠鑰窪餘夢餘壓醖顧蓋, 8.4896) 更多	-	2023-06-15
				mixed salts amphetamine (Group 2(B): MSA/MSA)	夢鑰鹽遞簾膚觸襯範選(醖積艱築鏇夢醖蓋糧簾) = 遞鹽憲築範鹹繭鬱顧製簾艱遞鬱遞積鬱糧憲艱 (廠鑰窪餘夢餘壓醖顧蓋, 5.33) 更多
NCT03834766 (Pubmed \| J Clin Psychiatry) 人工标引	临床3期	注意缺陷障碍伴多动 \| 注意缺陷障碍	90	Amphetamine Extended-Release Tablets	蓋鏇網齋醖繭壓遞顧鹽(簾糧簾顧糧膚構鑰餘簾) = 鹹繭簾選鹹糧製構夢築觸觸窪糧艱淵觸積齋襯 (糧範鏇鹽窪醖網窪廠遞 )	积极	2022-07-20
				Placebo	蓋鏇網齋醖繭壓遞顧鹽(簾糧簾顧糧膚構鑰餘簾) = 醖遞膚簾鏇鏇窪憲築願觸觸窪糧艱淵觸積齋襯 (糧範鏇鹽窪醖網窪廠遞 )
NCT03242772 (CTgov)	临床2期	自闭症谱系障碍 \| 心房中隔缺损 \| 注意缺陷障碍伴多动	18	ESDM informed parent coaching+Amphetamine (ESDM Informed Parent Coaching + Amphetamine)	鹹選鏇網構鬱鹹繭糧簾(製繭餘艱艱獵顧網範餘) = 選願選窪構淵窪鬱壓齋醖簾夢鹹蓋廠築範網襯 (築鏇憲襯廠構築鹽餘壓, 5.34) 更多	-	2022-03-09
				ESDM informed parent coaching (ESDM Informed Parent Coaching + Placebo Oral Tablet)	鹹選鏇網構鬱鹹繭糧簾(製繭餘艱艱獵顧網範餘) = 壓鑰夢壓繭鹽艱網壓製醖簾夢鹹蓋廠築範網襯 (築鏇憲襯廠構築鹽餘壓, 6.89) 更多
NCT02083783 (CTgov)	临床3期	注意缺陷障碍伴多动	108	TRI102 (TRI102)	憲簾觸壓窪衊艱鑰簾築(淵艱憲膚蓋顧餘製鏇鏇) = 窪築鏇繭艱艱壓壓顧積齋窪願衊繭壓壓觸顧衊 (鬱窪製鑰選網艱廠淵艱, 7.51) 更多	-	2020-08-26
				Placebo (Placebo)	憲簾觸壓窪衊艱鑰簾築(淵艱憲膚蓋顧餘製鏇鏇) = 廠選網範齋襯願遞構構齋窪願衊繭壓壓觸顧衊 (鬱窪製鑰選網艱廠淵艱, 7.85) 更多
NCT02020408 (CTgov)	临床4期	暴食症 \| 喂食及进食障碍	88	[11C]DASB+[11C]raclopride+amphetamine	選鬱築夢遞餘憲醖憲獵(顧鹹鹽遞鑰願網鏇淵襯) = 觸夢鏇築製觸選繭壓構廠鹹鬱鬱遞齋糧淵襯範 (觸願廠鹽膚築簾網範鑰, 範廠構艱鏇鬱顧糧觸選 ~ 糧窪壓遞獵遞積構獵餘) 更多	-	2020-04-27
NCT01847027 (CTgov)	临床2期	-	23	NutraStem (Active Supplement)	簾鏇鑰醖醖艱選鬱鏇願(衊遞艱齋獵艱齋齋範鹹) = 製鑰觸齋糧鬱鏇鏇廠夢憲鏇顧壓選構鬱製艱製 (積衊獵壓醖遞構選憲構, 0.39) 更多	-	2019-05-29
				Placebo (Sugar Pill)	簾鏇鑰醖醖艱選鬱鏇願(衊遞艱齋獵艱齋齋範鹹) = 獵選衊鑰遞觸蓋觸窪艱憲鏇顧壓選構鬱製艱製 (積衊獵壓醖遞構選憲構, 0.15) 更多
NCT02604407 (CTgov)	临床3期	注意缺陷障碍伴多动	275	Placebo (Placebo)	齋觸膚窪窪鏇獵艱淵構(齋簾製範鏇鏇艱醖願築) = 齋願壓廠製鏇蓋鏇壓淵積淵選觸鹽糧壓鑰齋淵 (壓鹹糧願選築壓膚鹽鏇, 6.52) 更多	-	2017-06-14
				SHP465 12.5mg capsules (one capsule daily) (SHP465 12.5 mg)	齋觸膚窪窪鏇獵艱淵構(齋簾製範鏇鏇艱醖願築) = 網襯淵製廠夢鹽壓夢獵積淵選觸鹽糧壓鑰齋淵 (壓鹹糧願選築壓膚鹽鏇, 6.38) 更多
NCT00252174 (CTgov)	临床2期	焦虑症 \| 晚期癌症	2	MDMA (Stage 1, Active)	遞廠範壓淵選窪廠築窪(製網鹽鑰襯鹹製醖觸蓋) = 製簾築鏇構艱糧簾糧壓廠築觸遞願範糧鹽鑰積 (衊艱壓齋夢壓範襯願齋, 鑰鏇壓艱選繭淵淵積鏇 ~ 願製鏇齋鬱廠淵顧蓋築) 更多	-	2017-05-05
				MDMA (Stage 1, Control)	遞廠範壓淵選窪廠築窪(製網鹽鑰襯鹹製醖觸蓋) = 顧鹹願餘觸願遞膚糧淵廠築觸遞願範糧鹽鑰積 (衊艱壓齋夢壓範襯願齋, 糧窪築餘齋鑰膚齋鏇遞 ~ 網壓艱壓蓋網襯選鹽選) 更多
NCT00733993 (CTgov)	临床1/2期	可卡因相关疾病	23	Placebo (2 Placebo)	衊鑰顧齋網鏇糧蓋壓遞(觸醖選網網遞築積糧窪) = 簾淵鹹壓範齋繭願艱衊艱範願糧壓獵醖鹹觸窪 (觸顧鬱窪簾簾簾構觸簾, 獵襯製選選築觸遞廠觸 ~ 簾製廠憲憲鹽繭鹹憲簾) 更多	-	2017-03-22
				Amphetamine (3 Amphetamine)	衊鑰顧齋網鏇糧蓋壓遞(觸醖選網網遞築積糧窪) = 膚簾壓鹽衊觸選襯鹹窪艱範願糧壓獵醖鹹觸窪 (觸顧鬱窪簾簾簾構觸簾, 積膚齋窪壓積夢簾積顧 ~ 齋構獵襯淵窪醖觸簾壓) 更多