A Phase 1, Two Part, Randomized, Single and Multiple Dose Crossover Study to Assess the Relative Bioavailability Between Tavapadon Clinical and Commercial Tablets

This study will assess the relative bioavailability of two different Oral formulations of tavapadon in healthy adult participants.

开始日期2025-03-26

申办/合作机构

AbbVie, Inc.

NCT05610189

/ Completed临床1期

A Phase 1, Randomized, Multiple-dose, Crossover Trial in Participants With Parkinson's Disease to Evaluate the Clinical Bioequivalence Between Tavapadon Tablets

The primary purpose of the study is to evaluate the bioequivalence (BE) of tavapadon 15 milligram (mg) tablet to 3x5 mg tablets in participants with Parkinson's disease.

开始日期2022-12-15

申办/合作机构

Cerevel Therapeutics LLC

NCT05581823

/ Completed临床1期

A Phase 1, Open-label, Fixed-sequence, Crossover Trial to Evaluate the Effects of Cytochrome P450 (CYP) 3A4 Induction by Carbamazepine on the Steady-state Pharmacokinetics of Tavapadon in Healthy Adult Participants

The primary purpose of this study is to evaluate the effect of carbamazepine, a strong CYP3A4 inducer, on the steady-state pharmacokinetics (PK) of tavapadon in healthy adult participants.

开始日期2022-10-19

申办/合作机构

Cerevel Therapeutics LLC

100 项与塔瓦帕东相关的临床结果

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100 项与塔瓦帕东相关的转化医学

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100 项与塔瓦帕东相关的专利（医药）

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项与塔瓦帕东相关的文献（医药）

2026-09-01·NEUROLOGICAL SCIENCES

“Efficacy, safety and certainty of evidence for selective D1/D5 dopamine receptor partial agonists in Parkinson’s disease: a systematic review, meta-analysis and GRADE assessment”

Review

作者: Mohammad, Anas ; Nadeem, Abdullah ; Hamad, Maaz ; Rashid, Ahmad Akhtar ; Rashid, Akhtar ; Naz, Sabiha ; Malik, Umamah

BACKGROUND:

Selective D1/D5 dopamine receptor partial agonists are proposed to provide motor benefit without the impulse control disorders and somnolence associated with D2/D3 dopamine agonists. With tavapadon under regulatory review, no quantitative synthesis of this drug class exists.

METHODS:

Embase, MEDLINE, PubMed, Scopus and ClinicalTrials.gov were searched from inception to 31 May 2026 for randomised, double-blind, placebo-controlled trials of selective D1/D5 partial agonists in Parkinson's disease (PROSPERO CRD420261347585). Random-effects models (REML) were used. Risk of bias was assessed with RoB 2 and certainty of evidence with GRADE.

RESULTS:

Seven trials (1,540 participants) were included; five entered quantitative synthesis. In early-stage monotherapy, tavapadon improved the combined MDS-UPDRS Parts II and III score by 10.55 points versus placebo (95% CI - 13.11 to - 7.99; two trials). In levodopa-treated patients with motor fluctuations, good ON-time increased by 1.09 h per day (0.57 to 1.61; two trials). Adverse events (RR 1.36, 1.09 to 1.71), nausea (6.38, 3.23 to 12.59), dizziness (3.03, 2.15 to 4.27) and discontinuation due to adverse events (2.72, 1.07 to 6.96) were more frequent with tavapadon. Serious adverse events were not increased (Peto OR 1.13, 0.69 to 1.85). Impulse control disorder (RR 2.02, 0.51 to 8.00; nine events, one trial) and somnolence (1.20, 0.37 to 3.92) were rated at very low certainty. No outcome reached high certainty.

CONCLUSION:

Selective D1/D5 partial agonism improves motor function in early-stage and levodopa-treated Parkinson's disease, at moderate certainty. Its proposed neuropsychiatric advantage over D2/D3 agonists remains untested: no trial used an active comparator or exceeded 27 weeks.

2026-08-01·DRUGS

Recent Developments in the Drug Treatment of Parkinson’s Disease

Review

作者: Leiter, Simon ; Mahlknecht, Philipp ; Poewe, Werner

Parkinson's disease (PD) is a common neurodegenerative disorder caused by a spread of misfolded α-synuclein and ascending neuronal degeneration mainly in dopaminergic neurons, leading to progressive nigrostriatal dysfunction and disruption of other pathways. It is clinically defined by its cardinal motor features of bradykinesia, rest tremor and rigidity, which are usually accompanied by a variety of non-motor symptoms. Here we provide a review on recent developments in the pharmacological treatment of PD with a focus on recently approved drugs, new modes of delivery and agents that are in advanced stages of clinical development. Pharmacological dopamine substitution remains the mainstay of symptomatic treatment approaches to control PD motor symptoms. While levodopa is still considered the gold-standard of symptomatic efficacy, its chronic use is associated with the development of response oscillations and drug-induced dyskinesias in a majority of patients. Thus, much effort has been put into developing more continuous ways of levodopa delivery. Novel formulations and modes of application include extended-release (ER) oral levodopa (IPX203), levodopa powder for inhalation, and levodopa infusion therapies through subcutaneous (foslevodopa/foscarbidopa, ND0612) or intrajejunal pumps (levodopa [entacapone] carbidopa intestinal gel). Additionally, different preparations for subcutaneous and sublingual administration of apomorphine, a dopamine agonist with equivalent efficacy to levodopa, are available for the treatment of PD motor fluctuations. Novel dopamine agonists have been developed and tavapadon, a selective dopamine D1/D5 receptor partial agonist, was shown to be efficacious as monotherapy in early PD and adjunct to levodopa in patients with motor fluctuations. In addition, new data on the early use of the COMT-inhibitor opicapone have emerged. This expanding drug armamentarium is complemented by an increasing number of drugs targeting non-dopaminergic pathways with increasing evidence for amantadine's symptomatic efficacy in treating levodopa-induced dyskinesia and motor fluctuations. Beyond the approval of different botulinum toxin preparations for the treatment of sialorrhea, efforts to address the plethora of non-motor symptoms of the disease have not translated to novel PD-specific approvals over the last few years. PD symptoms can usually be satisfactorily controlled in the early to mid-stages, but the progressive course of the disease inevitably leads to increasing functional disability underlining the yet unmet need for disease-modifying therapies. While there is currently no conclusive evidence for disease-modifying efficacy on any of the numerous efforts, we summarize recent late-stage clinical trial evidence focusing on glucagon-like peptide 1 (GLP1) agonists, approaches targeting the glucocerebrosidase (GBA) pathway and inhibition of the leucine-rich repeat kinase 2 (LRRK2), as well as α-synuclein based treatments.

2026-08-01·LANCET NEUROLOGY

Safety, tolerability, and efficacy of flexible-dose tavapadon for Parkinson's disease (TEMPO-2): a phase 3, randomised, placebo-controlled, double-blind trial

Article

作者: Peckham, Elizabeth ; Boiser, Joey ; Leoni, Matthew ; Fernandez, Hubert H ; Fietzek, Urban M ; Bhatia, Perminder ; Cloud, Leslie ; Combs, Cari ; Tringali, Stacey ; Chang, Ih ; Sanchez, Raymond ; Zadikoff, Cindy ; Molho, Eric ; Tarakad, Arjun ; Matarazzo, Michele

BACKGROUND:

Current dopaminergic therapies for Parkinson's disease carry significant limitations: levodopa can cause long-term motor complications, while D2/D3 receptor-targeting dopamine agonists can produce non-motor adverse effects. Tavapadon is an oral, once-daily, selective D1/D5 agonist that might improve Parkinson's disease motor symptoms. We aimed to evaluate the safety, tolerability and efficacy of flexible-dose tavapadon in people with early-stage Parkinson's disease.

METHODS:

TEMPO-2 was a phase 3, randomised, double-blind, placebo-controlled trial conducted at 75 clinical sites (both hospital or academic and community settings) across 13 countries. Adults aged 40-80 years with early-stage Parkinson's disease (<3 years' disease duration) who were treatment-naive or had less than 3 months of previous dopaminergic treatment were eligible. Participants were randomly assigned 1:1 to flexible-dose tavapadon (5-15 mg) or placebo orally once daily for 27 weeks. The primary endpoint was change from baseline to week 26 in the combined score of the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts II and III (reflecting activities of daily living and motor performance). Safety endpoints included adverse events, clinical laboratory values, vital signs, and electrocardiograms. The primary endpoint was assessed in the modified intent-to-treat population (participants who received one dose or more of study drug and had both a baseline and one or more post-baseline MDS-UPDRS assessments) and safety was assessed in the safety analysis set (all participants who received one dose or more of tavapadon or placebo). This study is registered with ClinicalTrials.gov (NCT04223193) and is now complete.

FINDINGS:

Between Jan 6, 2020, and Feb 22, 2024, 473 individuals were screened and 304 were randomly assigned to receive tavapadon 5-15 mg (n=151) or placebo (n=153). The majority of participants were male (169 [56%] of 304 male; 135 [44%] of 304 female), the mean age was 62·9 (SD 9·2) years, and the mean disease duration was 0·86 (0·79) years. 80 (26%) of 304 participants discontinued from the trial (57 [38%] of 151 on tavapadon and 23 [15%] of 153 on placebo), most commonly due to adverse events (42 [14%] of 304; 36 [24%] of 151 on tavapadon and six [4%] of 153 on placebo). The primary endpoint of change from baseline to week 26 in the MDS-UPDRS Parts II and III combined score was significantly improved with tavapadon versus placebo (least squares mean [LSM] decrease of 10·3 [95% CI -12·2 to -8·3] points vs 1·2 [-2·9 to 0·6] points; LSM treatment difference -9·1 [95% CI -11·7 to -6·5]; p<0·0001). Most adverse events were non-serious and mild to moderate in severity. More adverse events were observed with tavapadon than with placebo (115 [76%] of 151 participants vs 84 [55%] of 153 participants). The incidence of adverse events in the tavapadon group was higher during the titration phase (92 [61%] of 151) than during the dose adjustment (44 [37%] of 151) and maintenance (47 [43%] of 151) phases. The most commonly reported adverse events with tavapadon versus placebo (>10% of participants) were nausea (45 [30%] of 151] vs five [3%] of 153), headache (25 [17%] vs eight [5%]), and dizziness (24 [16%] vs five [3%]).

INTERPRETATION:

Tavapadon showed significant and clinically meaningful improvements in Parkinson's disease motor symptoms, with low incidence of somnolence and impulse control disorders. However, the short observation period limits conclusions about long-term tolerability. An ongoing extension study aims to confirm its long-term safety and efficacy.

FUNDING:

AbbVie.

273

项与塔瓦帕东相关的新闻（医药）

2026-09-30

·今日头条

FDA今年批了11款CNS新药四分之一名额透露什么信号

截至9月底，FDA CDER今年批准的44款新药里，有11款直接和中枢神经系统挂钩——神经系统罕见病、CNS精准诊断都算在内。四分之一。这个比例搁在五年前，大概率会被当成统计口径出了问题。“CNS无新药”的说法在行业里流传了快二十年，失败率高、安慰剂效应跨不过去、机制说不清楚，大药企一度成批砍掉神经科学管线。所以今年这批名单值得单独拿出来看。经典靶点还在，但打法明显变了 2月获批的Bysanti（milsaperidone）用于精神分裂症和双相I型障碍急性发作。它的身份有点绕：本质上是已上市药物Fanapt（伊潘立酮）的活性代谢物，两者在体内快速互变。 FDA批它靠的是生物等效性数据，不是全新临床试验。与其说是新药，不如说是一次基于代谢物化学特性的生命周期延伸。 7月的Simtriyo（centanafadine）走的是另一条路。它是首个同时抑制去甲肾上腺素、多巴胺和5-羟色胺再摄取的ADHD药物。兴奋剂和单一机制非兴奋剂主导这个领域很多年了，三重再摄取提供的是第三种药理学路径。三期数据里，成人患者用药后ADHD评分改善约10分，安慰剂组约7分，效应量落在0.4上下。大冢制药在新闻稿里把它定位为“first-in-class的NDSRI”。 9月底的Juvmo（tavapadon）则是帕金森病领域一次受体层面的精细化操作。它是首个选择性靶向多巴胺D1/D5受体亚型的部分激动剂，不像传统药物那样笼统刺激多巴胺系统。 TEMPO三期项目里，15mg剂量组26周时将患者日常活动评分改善约10分，安慰剂组反而恶化了。三款药都踩在经典神经递质系统上，做法完全不同：代谢物再开发、三重机制叠加、受体亚型精准靶向。粗放式的“找到新靶点”不够用了，药物设计的颗粒度在变细。 “补回缺失的东西”，机制型药物开始集中落地 8月5日，Takeda的Orzeyful（oveporexton）获批用于1型发作性睡病。这款药的特殊之处在于治疗逻辑换了方向：发作性睡病1型的核心病理是食欲素神经元丢失导致信号不足，oveporexton作为口服食欲素受体2激动剂，直接补充缺失的信号。过去的治疗是用兴奋剂对抗白天嗜睡、用抗抑郁药压制猝倒，都在“控制症状”。这款药试图替代缺失的生物学功能。《The Pharma Letter》的报道把它描述为“首个针对导致疾病的食欲素信号丢失直接起效的药物”。 9月3日获批的Zanvastro（zilganersen）逻辑类似。Alexander病由GFAP基因突变导致异常蛋白在星形胶质细胞中积累，zilganersen是一款反义寡核苷酸，在异常蛋白生成之前就抑制其产生。 FDA的批准基于49名患者的随机对照研究和一项小规模开放标签子研究，主要终点是61周时的步速变化。这是Alexander病的首款获批治疗。患者太少、做不了大样本试验、用自然史数据或小规模研究支撑审批——罕见神经病领域的典型证据困境，FDA这次选择了接受。诊断正在变成治疗的前置条件只看治疗性药物，会漏掉今年CNS领域另一个变化。 8月获批的Tauklarify（florquinitau F18）是一款Tau蛋白PET显像剂，用于阿尔茨海默病评估中的认知障碍患者，识别脑内Tau神经原纤维缠结。 9月获批的Pixclara（floretyrosine F18）用于胶质瘤患者的PET显像，帮助区分肿瘤复发和治疗相关改变，是FDA批准的首个FET-PET显像药物。这两款诊断产品的意义不在技术本身，而在于它们和药物开发的关系正在收紧。阿尔茨海默病的疾病修饰治疗只对携带特定病理的患者有效，认知障碍不等于同一种脑病理。 Tau PET提供的病理层面证据，直接决定患者能不能进入治疗窗口。胶质瘤同理——MRI上的异常信号可能是肿瘤进展，也可能是放疗后的改变，处理方向完全不同。诊断不再只是“辅助”，它正在成为治疗体系里跳不过去的一环。四条线同时在推把这11款产品按干预深度排一下，大致是四层：最底下是经典递质系统的药理学优化，往上是直接靶向疾病生物学节点的机制型药物，再往上是拿罕见病当验证环境的递送和平台技术，最顶上决定“谁该用药”的诊断工具。四层不是替代关系。Bysanti和Simtriyo说明经典靶点还有迭代空间，Orzeyful和Zanvastro证明机制型干预能在特定疾病里走通，Tau PET和Pixclara则提示诊断能力正在变成CNS药物体系的组成部分。 2026年这批获批产品没给出“CNS研发全面复苏”这种简单结论。但它们确实在展示另一种可能性：当药物设计、递送技术、生物标志物和诊断工具开始咬合运转，CNS领域的开发逻辑会从“押注单一靶点”转向“搭建可验证的系统”。本文仅医药健康行业知识交流，不构成投资、用药指导或生产操作建议。 [1] Vanda Pharmaceuticals. FDA Approves Bysanti for Treatment of Bipolar 1 Disorder and Schizophrenia[EB/OL]. Psychiatric Times, 2026-02-20. [2] Otsuka Pharmaceutical. Otsuka Receives FDA Approval for First-in-Class SIMTRIYO® (centanafadine) for the Treatment of Attention-Deficit Hyperactivity Disorder (ADHD) in Adults and Pediatric Patients Aged 6 Years and Older[EB/OL]. Otsuka News Release, 2026-07-27. [3] AbbVie. U.S. FDA Approves AbbVie‘s JUVMO™ (tavapadon) for Parkinson’s Disease[EB/OL]. AbbVie News Center, 2026-09-28. [4] U.S. Food and Drug Administration. FDA Approves First Drug to Treat the Full Range of Narcolepsy Type 1 Symptoms[EB/OL]. FDA News Release, 2026-08-04. [5] Ionis Pharmaceuticals. ZANVASTRO™ (zilganersen) approved by the FDA as the first and only disease modifying treatment for Alexander disease (AxD) in pediatric and adult patients[EB/OL]. Ionis Press Releases, 2026-09-03. [6] Telix Pharmaceuticals. FDA Approves Telix’s Brain Cancer Imaging Drug Pixclara[EB/OL]. Telix News, 2026-09-14. #CNS药物研发 #FDA新药审批 #神经科学

2026-09-30

·药物清除率

每日生物医药速递 — 2026年9月30日（星期三）

今日焦点：国产创新药出海"双响"——恒瑞医药每周一次口服GLP-1/GIP双靶点激动剂以最高26亿美元授权诺和诺德；阿斯利康以20亿美元战略入股康方生物海外伙伴Summit Therapeutics。1.【新药审批】事件：9月29日，默沙东宣布其PD-1（程序性死亡受体1，Programmed Death-1，PD-1）抑制剂帕博利珠单抗（可瑞达）皮下注射剂型获中国国家药品监督管理局（NMPA）批准，覆盖19项实体瘤适应症，系中国境内获批的皮下注射剂型PD-1抑制剂，批准基于MK-3475A-D77研究数据。关注原因：PD-1抑制剂长期依赖静脉输注，皮下剂型可明显缩短给药时间、降低输注相关资源占用，给药场景有望向门诊与基层延伸，将影响国内PD-1/PD-L1市场的竞争维度。2.【新药审批】事件：9月28日，美国食品药品监督管理局（FDA）批准艾伯维（AbbVie）tavapadon（商品名Juvmo）上市，用于成人帕金森病，为首个获批的选择性D1/D5受体部分激动剂。该批准基于Ⅲ期TEMPO项目；TEMPO-3中，tavapadon联合左旋多巴使每日"开期"增加1.7小时（对照组0.6小时）、"关期"减少1.9小时（对照组0.9小时）。关注原因：现有口服多巴胺能药物多作用于D2/D3受体，选择性D1/D5机制有望减少非运动类不良反应；该批准也是艾伯维2024年收购Cerevel（87亿美元）后的管线兑现。3.【临床进展】事件：9月30日，礼来公布Ⅲ期TRIUMPH-2研究详细结果，并同期发表于《柳叶刀》（The Lancet）。研究评估retatrutide（首个进入研发阶段的GIP（抑胃肽，Gastric inhibitory polypeptide）/GLP-1（胰高血糖素样肽-1，Glucagon-like peptide-1）/胰高血糖素三受体激动剂）在合并2型糖尿病的肥胖或超重成人中的疗效与安全性；治疗80周时，所有剂量组（4 mg、9 mg、12 mg）均实现显著体重下降与糖化血红蛋白（HbA1c）降低。结果在第62届欧洲糖尿病研究协会（EASD）年会公布，礼来计划2027年第一季度向FDA提交生物制品许可申请（BLA）。关注原因：三受体激动剂是减重赛道的下一代方向，本次数据将直接影响礼来与诺和诺德在代谢领域的产品梯队竞争，具体减重幅度与胃肠道耐受性数值值得跟踪。4.【临床进展】事件：9月29日，百济神州（BeOne Medicines）宣布Ⅲ期MANGROVE研究达到主要终点：泽布替尼（百悦泽）联合利妥昔单抗对比苯达莫司汀联合利妥昔单抗，用于未经治疗的套细胞淋巴瘤（Mantle Cell Lymphoma，MCL），经独立评审委员会评估的无进展生存期（Progression-Free Survival，PFS）显著改善，疾病进展或死亡风险降低43%（HR=0.57，95%CI 0.43–0.76，p<0.0001）；总生存期（Overall Survival，OS）数据尚未成熟。公司计划于2026年下半年提交全球注册申请。关注原因：这是首个在MCL一线头对头对比化疗免疫方案、且不含化疗的Ⅲ期研究，若获批有望改变该病种长期依赖化疗的一线治疗范式。5.【企业动态】事件：9月29日，恒瑞医药宣布与诺和诺德达成许可协议，将自主研发的HRS-1596（有望实现每周一次口服的GLP-1/GIP双受体激动剂，目前处于Ⅰ期临床就绪阶段）在中国大陆、香港特别行政区、澳门特别行政区及台湾地区以外的全球开发、生产与商业化权益授予诺和诺德。交易潜在总额最高26亿美元，含3亿美元首付款及最高23亿美元里程碑付款，另有销售提成。关注原因：已上市的口服GLP-1药物（司美格鲁肽片、orforglipron）均为每日一次，每周一次口服是明确的差异化方向；这也是国产代谢类早研资产首次交由全球减重巨头完成全球化开发。6.【企业动态】事件：9月29日，康方生物披露其海外合作伙伴Summit Therapeutics与阿斯利康达成战略合作。阿斯利康将出资20亿美元认购Summit新发行的可转换优先股（对应约12%已发行普通股），并主导推进依沃西（ivonescimab，PD-1/VEGF双特异性抗体）联合阿斯利康CLDN18.2（紧密连接蛋白18.2，Claudin-18.2）抗体偶联药物（Antibody-Drug Conjugate，ADC）**Sonesitatug Vedotin（Sone-Ve）**用于多种胃肠道肿瘤的临床研究；双方另签署谅解备忘录，拟探索依沃西与阿斯利康系列ADC的联合疗法。关注原因：交易不涉及权益转让，本质是"ADC+下一代免疫疗法"的组合卡位；对依沃西而言，在美国上市申请（目标审评日期2026年11月14日）的关键阶段，获得了跨国药企的资金与产业背书。7.【政策法规】事件：9月28日，国家药品监督管理局药品审评中心（CDE）发布《推进新方法（New Approach Methodologies，NAMs）研究和应用试点计划（"先锋计划"）》（2026年第46号通告）。该计划面向药物非临床研究与评价领域，推动类器官、器官芯片等不依赖传统动物试验的新方法的研究、验证与应用，以减少/优化/替代动物试验（3R原则），提升非临床研究结果向临床外推的准确性。关注原因：NAMs由此从"行业趋势"进入"监管试点"阶段，将直接影响体外评价方法（如体外ADME、毒理）的合规路径与数据采信标准，对具备类器官/器官芯片能力的CRO与药企是明确的政策窗口。8.【政策法规】事件：9月28日，国家医保局召开口腔种植体、正畸托槽集采成果发布会，并启动接续采购。首轮集采落地三年，单颗常规种植牙治疗费用由15000元降至6000—7000元，全国公立医疗机构累计实际采购种植体系统347万套，种植牙手术服务量由2022年21.4万例增至2025年89.2万例（年均增长71%）；正畸托槽16个联盟省份采购完成率达118%。接续采购由四川、陕西两省牵头，坚持"稳临床、保质量、反内卷、防非标"原则。关注原因：口腔耗材是集采常态化的代表性品类，接续采购的规则调整（如将有共识的新型材质种植体纳入采购范围）将影响耗材企业的报价与供应策略，也为其他品类的接续采购提供范式参考。9.【学术前沿】事件：9月29日，《细胞》（Cell）在线发表中国医学科学院肿瘤医院张媛媛、刘明洋等团队的研究，综合单细胞与空间转录组分析，描绘胰腺癌恶病质微环境的演化图谱，鉴定出由SEMA4A⁺肿瘤细胞、AQP9⁺巨噬细胞与LOXL2⁺癌相关成纤维细胞构成的促恶病质三细胞生态位，并阐明其通过闭环信号网络放大致病效应的机制；该生态位在恶病质前期即可出现，相关分子特征可在尚未发生恶病质的患者中预测术后新发恶病质风险。关注原因：胰腺癌恶病质发生率超过80%，且长期缺乏可靠的早期识别靶点；该研究把干预窗口从"恶病质确诊"前移至"恶病质前期"，为风险分层与亚型特异性干预提供了候选靶点。10.【学术前沿】事件：9月29日，拜耳旗下Vividion Therapeutics在《自然·医学》（Nature Medicine）发表VVD-214（首个进入临床的共价Werner解旋酶（Werner helicase，WRN）抑制剂）Ⅰ期结果：88例经多线治疗的MSI-high（高度微卫星不稳定，Microsatellite Instability-high）/dMMR晚期实体瘤患者中，66例可评估疗效，疾病控制率（Disease Control Rate，DCR）74.2%，确认部分缓解7例（10.6%），中位PFS 6.7个月；结直肠癌亚组DCR达80.5%，中位PFS7.3个月。关注原因：WRN抑制是针对MSI-high肿瘤的"合成致死"策略，本次是该机制首个经同行评议的人体数据；公司同步开展与贝伐珠单抗、帕博利珠单抗的联合研究，将决定该靶点能否由后线走向前线。

2026-09-30

·药通社

全球首创，又一款重磅口服新药获批上市

当地时间，2026年9月25日，FDA网站最新显示，美国FDA批准艾伯维的tavapadon（商品名：Juvmo）上市。 Tavapadon是全球首款选择性靶向多巴胺D1/D5受体亚型的部分激动剂，用于治疗成人帕金森病，为每日一次口服的片剂。帕金森病一直是一种常见且挑战多多的神经退行性疾病，其发病机制主要源于中脑黑质多巴胺能神经元的持续丢失，导致大脑内多巴胺水平的骤降，引发震颤、僵硬等症状。尽管左旋多巴作为经典疗法长期被应用，但其存在的“剂末现象”和可能诱发的异动症仍是患者和医生面临的难题。根据新闻稿，Tavapadon作为一种首创的选择性多巴胺D1/D5受体部分激动剂，具备每日口服一次的特点。Tavapadon凭借其独特的“选择性”和“部分激动剂”特性，有望在治疗帕金森病中发挥重大作用。 Tavapadon旨在选择性地激活D1/D5受体，从而为患者提供运动控制、安全性和耐受性的适当平衡。通过选择性地激活黑质纹状体通路上的D1/D5多巴胺受体，tavapadon有可能提供适当的多巴胺信号平衡以改善运动控制，同时避免D2/D3过度刺激，这被认为是当前多巴胺激动剂许多副作用的原因。此外，作为一种半衰期为24小时的部分激动剂，tavapadon可以每日服用一次，从而避免多巴胺受体的过度激活所造成的运动障碍。 Tavapadon最初由辉瑞研发，由于辉瑞公司采用了战略调整，将其在2018年剥离给Cerevel Therapeutics。2023年12月，艾伯维以87亿美元收购了Cerevel，从而获得了对Tavapadon的掌控权。本次批准基于艾伯维三期临床项目TEMPO的数据。其中TEMPO-1和TEMPO-2评估tavapadon在早期帕金森病患者中的单药疗效，两项研究均达到主要终点；TEMPO-2中，治疗组第26周MDS-UPDRS第二部分与第三部分合计评分较安慰剂多下降9.1分（P<0.0001），超过公认的最小临床重要差值阈值。TEMPO-3则评估其联合左旋多巴用于已出现运动波动的患者：与安慰剂相比，每日"良好开期"（无痛性异动）延长1.1小时，"关期"缩短0.94小时。同时，其安全性数据表明，Tavapadon的耐受性良好，常见副作用为轻至中度。帕金森病是仅次于阿尔茨海默病的第二大神经退行性疾病。其典型表现是静止性震颤、肌强直、动作迟缓、姿势平衡障碍，还常伴睡眠障碍、嗅觉减退、便秘、抑郁等非运动症状。帕金森病的核心是大脑里产生多巴胺的神经元逐渐丢失，出现运动症状时通常已经丢了六到八成。现有的口服多巴胺激动剂，比如普拉克索、罗匹尼罗，主要作用在D2/D3受体上，这一路径和嗜睡、冲动控制障碍、幻觉等副作用相关。 Tavapadon的不同在于靶点。它能够选择性作用于与运动调控相关的D1和D5受体，相较于其他多巴胺激动剂，Tavapadon可能更具精准性，减少不必要的副作用。另外，其“双向调节”的机制设定在模拟生理多巴胺信号方面也具有重要意义。与此前长期主导临床的普拉克索、罗匹尼罗、罗替高汀等主要作用于D2/D3受体的激动剂走了完全不同的通路。外媒称，它也是十余年来首个获批上市的口服多巴胺受体激动剂。参考：北京药研汇

100 项与塔瓦帕东相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D11431	塔瓦帕东	-	DB14899

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
帕金森病	美国	AbbVie, Inc.	2026-09-25

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
精神运动障碍	临床3期	美国	AbbVie, Inc.	2020-09-23
精神运动障碍	临床3期	澳大利亚	AbbVie, Inc.	2020-09-23
精神运动障碍	临床3期	保加利亚	AbbVie, Inc.	2020-09-23
精神运动障碍	临床3期	加拿大	AbbVie, Inc.	2020-09-23
精神运动障碍	临床3期	捷克	AbbVie, Inc.	2020-09-23
精神运动障碍	临床3期	法国	AbbVie, Inc.	2020-09-23
精神运动障碍	临床3期	德国	AbbVie, Inc.	2020-09-23
精神运动障碍	临床3期	匈牙利	AbbVie, Inc.	2020-09-23
精神运动障碍	临床3期	以色列	AbbVie, Inc.	2020-09-23
精神运动障碍	临床3期	意大利	AbbVie, Inc.	2020-09-23

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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


NCT04542499 (Pubmed \| JAMA Neurol)	临床3期	帕金森病	507	Tavapadon	鹽願繭觸鹹網艱糧膚壓(鹹觸鹽窪鹽襯廠窪窪糧) = 構膚選鑰蓋齋築顧餘膚構範築鹽積衊襯齋積餘 (鏇窪鹽齋餘衊遞鏇餘窪 ) 更多	积极	2026-05-01
				Placebo	鹽願繭觸鹹網艱糧膚壓(選糧蓋選鏇製襯衊憲衊) = 艱願網觸築鹹遞獵觸夢鏇夢鏇鏇築範艱齋願製 (餘顧鑰簾鑰艱鑰廠淵衊 ) 更多
NCT04201093 (TEMPO-1, AAN2026)	临床3期	帕金森病	833	Tavapadon	繭構糧窪襯膚簾鑰顧獵(構憲獵窪夢鏇繭窪餘簾) = 淵鑰構構鏇艱願鹹餘膚鏇顧選憲餘襯醖憲醖蓋 (遞壓餘顧艱製願繭餘製 ) 更多	积极	2026-04-25
				Placebo	繭構糧窪襯膚簾鑰顧獵(構憲獵窪夢鏇繭窪餘簾) = 蓋獵構窪選艱繭獵顧蓋鏇顧選憲餘襯醖憲醖蓋 (遞壓餘顧艱製願繭餘製 ) 更多
NCT04760769 (TEMPO-4, AAN2026)	临床3期	帕金森病	337	Tavapadon	憲襯憲繭築鏇鑰構壓壓(選鏇簾顧構憲蓋鹽鏇艱) = 廠繭鬱艱觸艱衊簾遞憲鬱襯簾憲鹹觸遞膚蓋艱 (襯鏇築鏇築鏇積齋窪糧 )	积极	2026-04-25
				Tavapadon+Levodopa	憲襯憲繭築鏇鑰構壓壓(選鏇簾顧構憲蓋鹽鏇艱) = 獵膚襯壓願繭衊膚憲簾鬱襯簾憲鹹觸遞膚蓋艱 (襯鏇築鏇築鏇積齋窪糧 ) 更多
NCT04223193 (TEMPO-2, CTgov)	临床3期	帕金森病	304	Placebo (Placebo)	餘襯窪積襯壓鬱齋憲窪(簾構鏇衊鏇選獵鑰簾窪) = 願顧網窪顧鬱夢願鑰蓋鬱蓋簾壓淵選膚繭醖餘 (顧餘選窪廠夢糧憲憲艱, 0.89) 更多	-	2025-11-21
				Tavapadon (Tavapadon)	餘襯窪積襯壓鬱齋憲窪(簾構鏇衊鏇選獵鑰簾窪) = 選淵鹽艱構繭齋夢糧壓鬱蓋簾壓淵選膚繭醖餘 (顧餘選窪廠夢糧憲憲艱, 0.99) 更多
NCT04201093 (TEMPO-1, CTgov)	临床3期	帕金森病	529	Placebo (Placebo)	鑰網願觸壓蓋糧鏇鑰鑰(顧廠夢艱網願顧顧繭鑰) = 繭繭蓋願艱鏇選膚鬱製蓋醖簾簾繭繭繭鹽餘簾 (築淵範鹹餘鬱構蓋鏇選, 0.82) 更多	-	2025-07-28
				Tavapadon (Tavapadon 5 mg)	鑰網願觸壓蓋糧鏇鑰鑰(顧廠夢艱網願顧顧繭鑰) = 鬱齋窪夢積艱鑰鑰醖艱蓋醖簾簾繭繭繭鹽餘簾 (築淵範鹹餘鬱構蓋鏇選, 0.86) 更多
NCT04542499 (TEMPO-3, CTgov)	临床3期	精神运动障碍 \| 帕金森病	507	Placebo (Placebo)	遞製窪淵壓選膚網糧蓋(簾壓築鬱鹽顧觸願窪繭) = 製醖醖艱齋網簾顧淵範鏇願憲衊築鏇築構鬱醖 (遞築艱積遞遞醖願衊鑰, 0.188) 更多	-	2025-03-25
				Tavapadon (Tavapadon)	遞製窪淵壓選膚網糧蓋(簾壓築鬱鹽顧觸願窪繭) = 鏇鏇蓋鹹製廠襯憲醖窪鏇願憲衊築鏇築構鬱醖 (遞築艱積遞遞醖願衊鑰, 0.207) 更多
NCT04223193 (TEMPO-2, Company_Website) 人工标引	临床3期	帕金森病	304	Tavapadon	築艱鬱襯鬱膚構夢窪築(遞願衊觸糧構築遞獵蓋) = 衊鏇醖簾艱構願夢遞糧築醖網衊廠製繭鬱遞範 (淵淵襯壓窪壓淵衊襯構 ) 达到	积极	2024-12-09
				Placebo	築艱鬱襯鬱膚構夢窪築(遞願衊觸糧構築遞獵蓋) = 構顧繭鹽繭艱鬱衊製淵築醖網衊廠製繭鬱遞範 (淵淵襯壓窪壓淵衊襯構 ) 达到
NCT04201093 (TEMPO-1, NEWS) 人工标引	临床3期	帕金森病	-	tavapadon (5 mg/day)	蓋遞獵顧鹽衊遞夢願夢(壓廠鑰壓憲鏇衊鑰製窪) = 繭網積夢膚齋構夢築憲鬱鑰觸繭鏇獵願淵積鹽 (願夢築糧範餘獵範鑰襯 ) 达到	积极	2024-09-27
				tavapadon (15 mg/day)	蓋遞獵顧鹽衊遞夢願夢(壓廠鑰壓憲鏇衊鑰製窪) = 願繭鏇蓋衊窪蓋積廠壓鬱鑰觸繭鏇獵願淵積鹽 (願夢築糧範餘獵範鑰襯 ) 达到
NCT04542499 (TEMPO-3, NEWS) 人工标引	临床3期	帕金森病	-	Tavapadon	淵鹽餘繭鑰蓋遞鏇鑰醖(淵網夢廠簾壓顧遞構顧) = Patients treated with tavapadon adjunctive to LD experienced a clinically meaningful increase of 1.1 hours in total “on” time without troublesome dyskinesia compared to those treated with LD and placebo. 鏇艱壓積衊襯膚願製夢 (簾顧艱簾糧鏇鑰築淵遞 ) 达到更多	积极	2024-04-18
NCT02847650 (Pubmed \| Ther Adv Neurol Disord) 人工标引	临床2期	帕金森病	57	PF-06649751	夢顧窪衊淵膚衊網構鹽(襯糧憲網蓋衊憲蓋憲膚) = 築遞網夢齋範壓網憲鏇廠夢遞膚蓋網遞廠製願 (夢鬱壓遞獵繭網鬱願鏇, 1.54)	积极	2020-03-06
				Placebo	夢顧窪衊淵膚衊網構鹽(襯糧憲網蓋衊憲蓋憲膚) = 衊鑰夢鏇齋齋夢獵齋夢廠夢遞膚蓋網遞廠製願 (夢鬱壓遞獵繭網鬱願鏇, 1.65)