EarLy Infusion of Eptinezumab for TreatmEnt of ACute Post-Traumatic Headaches (ELITE-ACT): a Parallel Group, Randomized, Double Blind, Placebo Controlled Trial

Most individuals with mild traumatic brain injury (mTBI) experience post-traumatic headaches (PTH). Of PTH, 50% present with a migraine phenotype which is the most disabling type of PTH. Patients with migraine-PTH are at greater risk of persistent symptoms whereby the acute PTH (aPTH) becomes persistent PTH (pPTH) (ie. lasting > 3 months) with a conversion rate of 47-95%. As migraine symptoms become chronic, it becomes treatment resistant. Despite these implications, early preventive medication management of PTH is marred by lengthy trials of multiple medications (2-3 months for each) and adverse effects that aggravate mTBI symptoms (fatigue, nausea, and presyncope). There is a compelling need to establish an effective treatment to prevent this debilitating outcome. Eptinezumab is a calcitonin gene-related peptide (CGRP)-blocking monoclonal antibody that reduces migraine burden in patients with migraines after a single infusion. Patients with PTH have higher serum levels of CGRP and experimental infusion of CGRP to patients with mTBI reproduces migraine PTH symptoms. Given the similarly in CGRP expression between chronic migraines and PTH, an infusion of eptinezumab within 8 weeks of PTH is hypothesized to reduce headache burden 3 months after treatment and prevent pPTH.

开始日期2026-09-30

申办/合作机构

Sunnybrook Health Sciences Centre

ISRCTN59164978

/ Recruiting临床3期IIT

Eptinezumab for the acute treatment of status migrainosus in the emergency department of a community hospital

开始日期2026-07-27

申办/合作机构

Centre Hospitalier de l'Universite de Montreal

NCT07655440

/ Not yet recruiting临床4期IIT

Comparative Outcomes of Migraine Preventives and Anti-CGRP Therapies for Tinnitus in Patients With Migraine: A Randomized Active-Comparator Controlled Trial (COMPACT-PM)

Many people with migraine also experience tinnitus - a persistent ringing, buzzing, or hissing in the ears - and research suggests these conditions share underlying biological mechanisms, including a protein called calcitonin gene-related peptide (CGRP) that is active in both the brain and the inner ear. COMPACT-PM is a randomized trial comparing two classes of migraine preventive medications in adults with bothersome tinnitus and a history of migraine: anti-CGRP therapies (newer injectable or oral agents that block CGRP or its receptor) versus conventional migraine preventives (antidepressants including amitriptyline, nortriptyline, and venlafaxine; antihypertensives including propranolol, verapamil, and candesartan; and the anticonvulsant topiramate). Participants are randomly assigned - like a coin flip - to one of the two treatment groups; neither group receives a placebo, as both receive active migraine treatment. The study's primary outcome is change in the Tinnitus Functional Index (TFI) over 24 weeks, with additional measures including hearing tests, balance assessments, auditory brainstem response testing, and a comprehensive symptom diary. The study is conducted at the Stanford Ear Institute and is funded by a philanthropic gift to the Department of Otolaryngology - Head & Neck Surgery at Stanford University.

开始日期2026-07-01

申办/合作机构

Stanford University

100 项与艾普奈珠单抗相关的临床结果

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100 项与艾普奈珠单抗相关的转化医学

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100 项与艾普奈珠单抗相关的专利（医药）

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256

项与艾普奈珠单抗相关的文献（医药）

2026-09-01·PHARMACOECONOMICS

Cost-Utility Analysis of Calcitonin Gene-Related Peptide Monoclonal Antibodies for Patients with Episodic Migraine Headache in the USA

Article

作者: Bounthavong, Mark ; Dong, Ariel Weiming

OBJECTIVE:

We aimed to evaluate the cost effectiveness of eptinezumab and erenumab as a preventive treatment of migraine in patients with episodic migraine with different routes of administration, from the US healthcare payer perspective.

METHODS:

A hybrid decision tree-Markov model was constructed to assess the cost effectiveness of eptinezumab and erenumab as a preventive treatment for migraines compared to topiramate among patients with episodic migraine from the US healthcare payer's perspective. A decision tree model simulated the probability of patients experiencing adequate responses to treatments in the first 6 months, which fed into a Markov model using a 2-year time horizon. The Markov model consisted of three states: "Off Preventive Treatment," "Preventive Treatment," and death. Total costs, quality-adjusted life-years, and incremental cost-effectiveness ratios were estimated for each strategy followed by sensitivity analyses. An annual discount rate of 3% was applied to both costs and utility values, and costs were reported in 2025 US dollars.

RESULTS:

In the base-case results, total costs of eptinezumab and erenumab were $21,767 and $21,739, respectively. Total quality-adjusted life-years for eptinezumab and erenumab were 1.32 and 1.30, respectively. Base-case incremental cost-effectiveness ratios of eptinezumab and erenumab compared to topiramate were $117,626 and $155,259 per quality-adjusted life-year gained, respectively. Erenumab was eliminated because of extended dominance; thus, eptinezumab was selected for additional sensitivity analyses. In the one-way sensitivity analysis, treatment response, utility values, and drug costs were influential in changing the study's conclusions. In the probabilistic sensitivity analysis, eptinezumab was cost effective in 1.8%, 33.6%, and 78.6% of simulations when the willingness-to-pay threshold was $50,000, $100,000, and $150,000 per quality-adjusted life-year gained, respectively.

CONCLUSIONS:

Our analysis suggests that eptinezumab might be cost effective at a willingness-to-pay threshold of $150,000 per quality-adjusted life-year gained compared with topiramate, with uncertainties on health state utilities and pharmaceutical costs. Policymakers should carefully consider the tradeoffs between costs and benefits when making decisions regarding formulary coverage for the episodic migraine population.

2026-07-01·CEPHALALGIA

Cerebrovascular risk with calcitonin gene-related peptide monoclonal antibodies versus onabotulinumtoxinA in patients with migraine: A real-world pharmacoepidemiologic study in the National Institutes of Health All of Us Research Program

Article

作者: Ong, Bradley ; Thompson, Nicolas ; Gül, Sedat ; Trudeau, Stephen ; Yuan, Hsiangkuo

Aim:

To evaluate whether initiation of calcitonin gene-related peptide (CGRP) monoclonal antibodies (mAbs) was non-inferior to initiation of onabotulinumtoxinA with respect to the hazard of ischemic stroke or transient ischemic attack (IS + TIA) in a real-world cohort of adults with migraine.

Methods:

We conducted a retrospective, active-comparator, new-user pharmacoepidemiology study using the NIH All of Us Research Program Registered Tier Dataset (v8). Adults with migraine initiating CGRP mAbs (erenumab, fremanezumab, galcanezumab, eptinezumab) were compared with initiators of onabotulinumtoxinA from January 2018 through September 2023. The primary outcome was IS + TIA occurring more than 90 days after treatment initiation. Inverse probability of treatment weighting (IPTW) with stabilized propensity scores was used to adjust for 23 baseline covariates. Non-inferiority was assessed on the hazard ratio (HR) scale using a prespecified margin of 1.5, with non-inferiority concluded if the upper bound of the 95% confidence interval (CI) was less than 1.5. Prespecified subgroup analyses included migraine with aura and without aura. Prespecified sensitivity analyses included a per-protocol analysis, a crossover-excluded analysis, and an IS-only analysis. Fracture was used as a negative control outcome.

Results:

Among 16,147 patients with migraine in the cohort, the primary comparison included 1,581 CGRP mAb initiators and 947 onabotulinumtoxinA initiators. IPTW achieved a good covariate balance for the primary comparison (maximum standardized mean difference 0.016). For the primary outcome, 14 IS + TIA events occurred among CGRP mAb initiators and 22 among onabotulinumtoxinA initiators. The hazard ratio for IS + TIA was 0.524 (95% CI 0.263–1.046), which met the prespecified statistical criterion for non-inferiority because the upper confidence bound was below 1.5; however, the estimate was imprecise because of the small number of events. In the migraine with aura subgroup, the estimate also met the non-inferiority criterion (HR 0.419, 95% CI 0.163–1.080), whereas the migraine without aura subgroup, per-protocol analysis, and major adverse cardiovascular events analysis were inconclusive for non-inferiority. For major adverse cardiovascular events the HR was 1.068 (95% CI 0.589–1.935). The fracture negative control was also not significantly different (HR, 1.175; 95% CI, 0.692–1.993; p = 0.551), arguing against systematic healthy-user confounding. A formal adjusted comparison with untreated patients was not feasible due to structural confounding inherent to the stepped-care treatment pathway.

Conclusions:

In this real-world diverse cohort, initiation of CGRP mAbs met the prespecified statistical criterion for non-inferiority relative to onabotulinumtoxinA for the primary IS + TIA outcome. However, this finding was based on few events and wide CIs and should be interpreted cautiously as limited evidence against a large relative increase in incident IS + TIA risk, rather than as definitive evidence of equivalent safety, absence of modest harm, or a protective effect. Several secondary, subgroup, and supportive analyses remained inconclusive for non-inferiority. Larger adequately powered comparative safety studies are needed.

2026-06-09·NEUROLOGY

Glaucoma Risk Associated With Calcitonin Gene–Related Peptide Inhibitor Use in Migraine

Article

作者: Wu, Jr-Wei ; Weng, Chien-Hsiang ; Wang, I-Jong ; Lin, Hui-Ju ; Pan, Ssu-Yu ; Chou, Chien-Chih

BACKGROUND AND OBJECTIVES:

Migraine has been linked to an increased risk of glaucoma, and our study aims to assess the temporal association between calcitonin gene-related peptide inhibitors (CGRPi) and the risks of glaucoma in individuals with migraine.

METHODS:

This multinational retrospective cohort study included adults diagnosed with migraine who received migraine preventive medications in 2018-2024. Participants were categorized into the CGRPi group (erenumab, fremanezumab, galcanezumab, eptinezumab, atogepant, or rimegepant) and non-CGRPi group (valproate, topiramate, flunarizine, candesartan, lisinopril, metoprolol, propranolol, nadolol, amitriptyline, and venlafaxine). Crossovers were not allowed, and the non-CGRPi group included only individuals who never used CGRPi. The CGRPi and non-CGRPi groups were propensity score matched in a 1:1 ratio and were followed for up to 3 years to monitor the occurrence of incident glaucoma. The Cox proportional hazards model was used to compare the risk of glaucoma between CGRPi and non-CGRPi users, with results reported as hazard ratios (HRs) and 95% CIs.

RESULTS:

A total of 73,644 individuals were included in the final analysis. Compared with non-CGRPi users, CGRPi users experience a lower risk of glaucoma development (HR 0.75; 95% CI 0.61-0.92) within 3 years since its first prescription. Individuals using CGRPi also exhibit a reduced risk of glaucoma compared with those using topiramate (HR 0.73; 95% CI 0.59-0.90), valproate (HR 0.54; 95% CI 0.35-0.83), propranolol (HR 0.76; 95% CI 0.59-0.98), metoprolol (HR 0.76; 95% CI 0.59-0.98), lisinopril (HR 0.49; 95% CI 0.38-0.62), amitriptyline (HR 0.69; 95% CI 0.54-0.89), and venlafaxine (HR 0.68; 95% CI 0.50-0.91). In the analysis that further classified participants based on the specific CGRPi used, only users of monoclonal antibody CGRPi show a reduced risk of glaucoma compared with non-CGRPi users (HR 0.77; 95% CI 0.61-0.98). The reduced risk of glaucoma associated with CGRPi is also observed in older adults, women, and those with chronic migraine or migraine without aura.

DISCUSSION:

Among adults with migraine receiving preventive treatment, systemic use of CGRPi, particularly monoclonal antibody CGRPi, is associated with a reduced risk of glaucoma compared with the use of other migraine preventive medications.

CLASSIFICATION OF EVIDENCE:

This is a Class II study demonstrating that CGRPi users with migraine have a lower risk of incident glaucoma when compared with non-CGRPi users with migraine.

196

项与艾普奈珠单抗相关的新闻（医药）

2026-09-20

·必诺达-注册通

监管能接受 17 例的证据，但不接受一条没验证干净的产线

北京必诺达 · 注册科学观察国内最专业的医药注册公众号 · 全球视野，科学客观栏目一 · 全球监管动态速递｜第 025 期 · 2026-09-全球监管动态速递｜第 025 期：17 例与 395 万美元，证据下限与代价上限一分钟速读FDA 09-19 ：批准 AQNEURSA（levacetylleucine）用于体重 ≥15 kg 的 A-T 患者共济失调——全球首个 A-T 疗法；依据 IB1001-303（NCT06673056）73 例两周期交叉试验，FDA 采用的功能性 SARA（fSARA）治疗差 -0.6 点。FDA 09-17 ：标准完全批准 FAYUVI（rebisufligene etisparvovec，UX111），全球首款 MPS IIIA 疗法；关键证据为 Transpher A 17 例对外部自然史 27 例，Bayley-III 认知原始分高 23.5 分（p<0.0001）；同日定价 395 万美元/剂。同一款药曾被 CMC 挡回一年：2025-07 因生产、质量控制与厂房检查（非疗效）收到 CRL，2026-04 才重新受理，最终提前两天于 09-17 获批。三起"没成" ：Xenon 的 azetukalner 因神经精神事件暂停 III 期入组（09-18）；勃林格 EASi-KIDNEY 因预期获益不足终止（非安全信号）；Trodelvy 一线 NSCLC 全球失败，但中国人群 OS HR 0.65。中国开通道：CDE「关爱计划-延伸」一次性纳入 4 个罕见病品种；本周承办 94 个新药 IND 受理号；生物制品分段生产试点让一款全球首创双抗 ADC 7 个月走完报产到获批。 ---编者按如果只看批准数，这一周平淡；但把 AQNEURSA 与 FAYUVI 并排读，会读出一个越来越清晰的监管态度：在真正无药可医的疾病上，FDA 对"证据的形状"越来越宽容，对"证据的洁净度"却越来越苛刻。宽容的是形状。73 例的交叉设计让每个患者做自己的对照，17 例的单臂配外部自然史——放在肿瘤或心血管领域都会被立刻退回的规模，在超罕见病里被接受，因为对照组的伦理成本高于统计学的精度损失。AQNEURSA 甚至是在"确切分子靶点未知"的前提下获批的：FDA 接受的是一个拟定机制（葡萄糖代谢正常化）+ 一个功能量表的差值。苛刻的是洁净度。FAYUVI 的临床数据在 2025 年就已经足够支撑讨论，真正把它挡在门外的，是生产、质量控制与生产设施检查——不是"药有没有效"，而是"你能不能稳定地把它做出来"。这在基因治疗上是结构性的：AAV 产品的效力（potency）测定、载体批次一致性、厂房合规，任何一环不闭环，临床数据再漂亮也换不来批准。对国内注册人，这一周的两条经验是反向的：罕见病申报不要再用肿瘤的样本量思维自我设限，但也别把"数据够小"误读成"门槛够低"——前者是监管的让步，后者是监管的底线。本期速览（窗口 09-14 ~ 09-21）辖区事件关键数字 FDA AQNEURSA 获批（A-T 共济失调）全球首个；73 例交叉；fSARA -0.6 FDA FAYUVI 获批（MPS IIIA） 17 vs 27 例；395 万美元/剂 FDA FAYUVI 曾因 CMC 收 CRL 2025-07 → 2026-04 重新受理美国 azetukalner III 期暂停入组神经精神事件；股价 -30% 德国/英国 BI 终止 EASi-KIDNEY III 期预期获益不足，非安全信号全球 EVOKE-03 读出（WCLC）亚洲 OS HR 0.73 / 中国 0.65 CDE 「关爱计划-延伸」纳入 4 品种罕见病研发鼓励试点 CDE 本周新药 IND 受理 94 个（化药 64 / 生物制品 29 / 中药 1）英国 MHRA Sertraline 批次召回 Class 2；二级包装混淆日本 Vyepti 获批（偏头痛预防） 09-16一、全球头条：73 例与 17 例，两个"最小证据包" AQNEURSA（levacetylleucine），IntraBio，09-19 获批，用于体重 ≥15 kg 的成人与儿科共济失调毛细血管扩张症（A-T）患者——这是该病全球第一个获批疗法，也是该药的第二个适应症（2024-09 首次批准 C 型尼曼-匹克病的神经系统表现）。支撑它的是 IB1001-303（NCT06673056）：随机、双盲、安慰剂对照、两周期交叉，73 例（26 成人 + 47 儿科，中位年龄 13 岁），每周期 12 周，96% 完成。FDA 采用的主要终点是功能性 SARA（fSARA），治疗差 -0.6 点；SARA 总分治疗差 -1.88 点（-1.92 vs -0.14，p<0.001），ICARS -4.22 vs -1.69（p=0.003）。安全上没有治疗相关严重不良事件、无死亡、无因不良反应停药，最常见的是跌倒与皮肤裂伤。这里有三个注册人该记住的点。第一，交叉设计是超罕见病最实用的样本量杠杆——每个患者做自己的对照，把组间变异换成组内变异，73 例就能跑出 p<0.001。第二，主要终点的"功能性"改造值得抄：fSARA 只取步态、坐姿、站姿、言语四个域，把量表收敛到最能反映日常功能的部分，既提高敏感度也降低噪声。第三，"机制未明"不等于不可批——企业明确写明确切分子靶点未知、仅提出葡萄糖代谢正常化的假说，FDA 仍然批了；但这条路的代价是，说明书里拿不到机制性的人群限定，适应症只能按"症状 + 体重门槛"来写。 FAYUVI（rebisufligene etisparvovec，UX111）是同一周的另一个极端：Ultragenyx 的 AAV9 基因疗法，09-17 获标准完全批准，用于 MPS IIIA 儿科患者。关键证据是 Transpher A 的开放标签单臂，17 例对外部自然史 27 例，24–60 月龄 Bayley-III 认知原始分高 23.5 分（p<0.0001）；CSF 硫酸乙酰肝素多数降幅超五成，随访最长近 8 年。它的故事栏目三整篇拆解，这里只留一句：17 例换来的是"有条件地被相信"，不是"被证明"。二、机构与政策：中国在给罕见病开新通道 CDE 本周最关键的动作不是某个品种，而是「关爱计划-延伸」试点的一次性扩容——09-16 同时纳入/公示 4 个品种：GLB-005 片（杭州格博，输血依赖型β-地中海贫血）、SR604 注射液、培元明目丸、TollB-001 片。这是《罕见疾病创新药物研发鼓励试点计划》的认定落地，含义很直接：中国罕见病研发的早期支持，正在从"事后给通道"前移到"研发期给身份"。三、失败与反转：三起"没成"，三种性质 Xenon 的 azetukalner（09-18）是安全型失败。公司因神经精神类不良事件暂停 III 期入组，当日股价跌约 30%，德意志银行由 Buy 降至 Hold、目标价 90→46 美元。公司强调暂停属预防性、不影响进行中的癫痫研究。这类"暂停而非终止"的信号要读准：它说明 DMC 尚未做最终判定，但已认定风险足以让入组停下来——对同靶点（Kv7 钾通道）的在研项目，这是必须写进风险章节的同类事件。勃林格的 EASi-KIDNEY（09）是获益型失败。vicadrostat（醛固酮合成酶抑制剂）联合 empagliflozin 用于 CKD，DMC 建议终止，公司判定"无法预期在主要复合终点取得有临床意义获益"，并明确终止原因是预期获益不足、非新安全信号。真正值得记的是后半句：EASi 项目其余 III 期经各自独立 DMC 评估建议继续、不作方案调整。这是一个标准示范——同项目不同试验的独立 DMC 各自判定，避免一次失败拖垮整条线，也避免把"联合方案不成立"误读成"单药不成立"。 Trodelvy 的 EVOKE-03（09-20 WCLC）是最有注册学味道的一起。全球层面它是彻底的失败：PD-L1 TPS≥50% 人群 mPFS 由 7.7 延长到 11.8 个月（HR 0.81，未达显著），OS 21.5 个月反而低于帕博利珠单抗单药的 22.8 个月，≥3 级治疗相关不良事件 55.7% vs 16.5%。但拆开看，亚洲人群 OS HR 0.73、中国人群 0.65。这个悖论至今没有答案：是人群生物学差异，还是临床实践与试验执行差异？对注册人的意义是硬的一条——中国亚组的漂亮数字不能替代全球人群的验证，但可以作为"再做一个中国主导的注册试验"的立项依据，前提是把差异假设写成可检验的方案，而不是当作结论。四、中国审批与准入：94 个 IND 与一条看不见的产能线 CDE 本周（09-14~09-18）承办 94 个新药临床试验申请受理号（化药 64、生物制品 29、中药 1），适应症覆盖肿瘤、免疫、凝血与中枢神经系统。这个数字本身是中位水平，值得看的是结构：生物制品占近三分之一，与本周全球基因治疗、双抗 ADC 的密集动作同频。上市端本周的样本是复方聚乙二醇（3350）电解质口服溶液（一品红，09-20 获《药品注册证书》，化学药品 3 类、视同通过一致性评价，适应症慢性便秘与粪便嵌塞）。这类品种的注册学价值在于"视同通过一致性评价"这条路径依然通畅——3 类仿制在口服溶液这类复杂剂型上仍要交 BE 或临床，但通道清晰。产能与准入侧还有一条硬事实：《2025 年第 134 号公告》发布后，四川发出放射性药品领域首张《放射性药品生产许可证》C 证（通瑞生物）。放射性药品的受托生产门槛高于普通化药（辐射安全、半衰期决定的供应半径、联合核查），首张 C 证的意义是核药 CDMO 的合规路径被走通。五、全球同步申报打法：AAV 的两条支付曲线 FAYUVI 与中国的信玖凝（波哌达可基，BBM-H901）是同一技术路径（AAV 基因替代）在中美两地走出的两条完全不同的曲线，值得对照。维度 FAYUVI（美国）信玖凝（中国）适应症 MPS IIIA 儿科中重度血友病 B 成人给药与计价单次静脉输注，395 万美元/剂9.3 万元/瓶，按体重给药（70 kg 约 44 瓶）自付设计 UltraCare、合格治疗中心；讨论按疗效/分期/年金慈善援助后自付上限 279 万 → 2026-06 降至 139 万内支付补充商保、Medicaid 北京/上海/重庆/江西/淄博/肇庆惠民保接续关键节点 2026-09-17 FDA 标准完全批准 2025-04 NMPA 优先审评获批；2026-08-24 天津首张商业处方差异不在科学，在支付结构：美国用一次性高定价回收十年研发成本，中国用按体重计价 + 自付封顶 + 惠民保把单患者负担压到可承受区间。对在中国做 AAV 的团队，这张表可作为定价参照系直接取用；但要提醒一句——信玖凝的 279 万/139 万是慈善援助后的自付口径，不是药品价格，引用时必须标清口径。六、其他批准、认定与读出finerenone（09-17）：FDA 批准用于与 1 型糖尿病相关的慢性肾脏病成人，为该类患者 30 余年来首个新治疗选择，依据 III 期 FINEONE。T1D 相关 CKD 长期被排除在主流证据包外，这次填补的是人群空白。apitegromab-mstn（09-14）：FDA 批准首个肌肉靶向 SMA 疗法，作为 SMN2 靶向治疗的附加治疗，覆盖 2 岁及以上。它的注册学意义是"附加治疗"定位——在已有标准治疗上做加法，终点必须选能体现增量功能的量表。PrecivityAD2（09-14）：FDA 批准 C2N 的血检用于 40 岁及以上成人阿尔茨海默病诊断辅助。血检进入诊断路径，会反向改变临床试验的入组筛选成本与人群界定方式。tarlatamab（09-17）：FDA 将前两剂所需监测时间由 22–24 小时缩短至 6–8 小时。这类"给药程序减负"的标签变更，实际影响的是社区医院的可及性，常被低估。taletrectinib（09-17）：ROS1 阳性 NSCLC 的 sNDA 获批，更长随访无新信号。Vyepti（09-16，日本）：灵北的 eptinezumab 获日本上市许可，用于偏头痛预防。七、监管基建与质量体系：一盒药装错了，也是 Class 2 本周最值得写进质量体系清单的，是英国 MHRA 对 Sertraline 100 mg 片剂批次 V2500425 的预防性召回，分级 Class 2。原因不是原料、不是含量，而是二级包装环节的混淆：部分纸盒内装的是 Citalopram 40 mg 泡罩；生产商 Amarox Limited 在同一场地生产这两个品种。MHRA 要求患者核对纸盒侧面的批号与有效期，并提示误服者可能出现 5-羟色胺能效应增强，65 岁以上、18 岁以下及心脏或肝脏疾病患者需特别关注。这条与本周另一条放在一起读才有意义：FAYUVI 被 CRL 挡回，挡的也是生产与厂房，不是疗效。两件事分属完全不同的产品层级——一个是成熟仿制药的包装混淆，一个是前沿基因疗法的厂房合规——但指向同一个结论：质量管理体系的失效不挑产品档次。对受托生产、共线生产、多品种同场地的企业，包装线的防错应与工艺验证同等对待；中国自 134 号公告后对受托生产的现场核查要求提高，方向一致。如果你是注册人，本周可以做的三件事 1. 把超罕见病项目的样本量论证重写一遍：交叉设计、外部自然史对照能否成立？主要终点是否可压缩为"功能性"版本以提高敏感度？2. 给在报的 ATMP/基因治疗项目拉一份 CMC 缺口清单——效价测定、批间一致性、厂房合规，按 FAYUVI 被挡回的三类问题逐项自查。3. 复核自家受托/共线生产的包装防错措施（尤其同场地多品种、外观相近的规格），并按 134 号公告的核查口径准备受托方资料。三条结论证据可以少，洁净度不能低。 73 例交叉与 17 例单臂都被接受，但 FAYUVI 因 CMC 被挡回一年——罕见病申报的正确姿势是"用小样本换时间，用严谨的生产数据换信任"。中国正在把通道前移。关爱计划-延伸一次性纳入 4 个品种、分段生产试点把首创药压到 7 个月，都是把支持从审评端搬到研发端；做罕见病与 ATMP 的团队应重新评估立项时点。亚组数据不是结论，是假设。 EVOKE-03 的中国 HR 0.65 与全球失败并存，说明区域差异必须被写成可检验的方案，而不是当作申报凭据。解读边界AQNEURSA ：fSARA 与 SARA 总分的差值来自不同量表口径，本文并列仅为呈现 FDA 采用终点与整体量表结果，不构成两者的统计学比较；按年龄、基线严重度的亚组一致率未公开，不作拆分推断。FAYUVI ：Transpher A 为开放标签单臂对外部自然史，非同期随机对照，23.5 分的组间差受自然史队列选择影响；长期随访近 8 年的具体曲线与按年龄分层结果未逐项公开。EVOKE-03 ：亚洲/中国亚组 HR 为会议公布的分层读出，未做多重性校正的确认性结论；亚洲与中国人群差异的成因（生物学 vs 临床实践）尚无定论。Xenon ：暂停入组的具体不良事件构成、发生率与暴露量未披露，不能据此推断同类药物的风险水平。信玖凝价格：279 万/139 万为慈善援助后的患者自付口径，非药品标价；惠民保覆盖城市名单以各地最新政策为准。关注「北京必诺达 · 注册科学观察」国内最专业的医药注册公众号 · 全球视野，科学客观本期最硬的一组数字已单独列出，建议收藏——下次写罕见病立项或 ATMP 申报材料可直接取用。觉得有价值，请转发给同事：他们需要的不是一条新闻，是一个可落地的判断。有想弄清的问题？直接在对话框回复「提问」，我们每期选 1–2 个在「读者提问」里公开回答。 *本期数据来源：FDA / EMA / MHRA / TGA / NMPA-CDE 官网及公告、企业与行业媒体公开披露，具体见证据层引用。本栏目由北京必诺达生物医药科技有限公司注册科学团队整理，仅供医药专业人士参考，不构成诊疗或投资意见。*

2026-09-18

·动脉网

灵北制药获得Vyepti®（依普奈珠单抗）在日本用于预防偏头痛发作的上市许可Lundbeck receives marketing authorization for Vyepti® (eptinezumab) in Japan for the prevention of migraine attacks

Approval granted by Japan's Ministry of Health, Labour and Welfare (MHLW) 获得日本厚生劳动省（MHLW）批准Eptinezumab is the only intravenous (IV) CGRP-targeted preventive treatment approved for the prevention of migraine attacks in adults and launched in over 30 countries worldwide Eptinezumab 是唯一一种静脉注射（IV）的靶向 CGRP 预防性治疗药物，已获批用于成人偏头痛发作的预防，并在全球 30 多个国家上市。Authorization supported by the Phase III SUNRISE trial and the SUNSET long-term extension study in Japanese patients III期SUNRISE试验及日本患者长期延伸研究SUNSET支持的授权Building on 25 years of commitment to patients and brain health in Japan, the approval paves the way for Lundbeck's first launch in Japan as Marketing Authorization holder, enabling Lundbeck to operate independently on the Japanese market 基于在日本对患者和脑部健康领域25年的承诺，此次批准为灵北制药以上市许可持有人身份在日本首次推出产品铺平了道路，使灵北制药能够在日本市场独立运营。VALBY, Denmark 丹麦，瓦尔比, ，Sept. 16, 2026 2026年9月16日/PRNewswire/ -- H. Lundbeck A/S (Lundbeck) today announced that the Ministry of Health, Labour and Welfare (MHLW) of Japan has granted marketing authorization for eptinezumab for the prevention of migraine attacks in adults, marking an important milestone for patients in Japan and for Lundbeck's continued growth in Asia.. /美通社/ -- H. Lundbeck A/S（Lundbeck）今日宣布，日本厚生劳动省（MHLW）已批准eptinezumab用于成人偏头痛发作的预防性治疗，这标志着日本患者以及Lundbeck在亚洲的持续增长迈出了重要一步。Migraine is a debilitating neurological disease characterized by recurrent attacks of severe headache often accompanied by nausea, vomiting, and sensitivity to light and sound. In Japan, migraine affects an estimated 8.4%–11.0% of the population 偏头痛是一种使人衰弱的神经系统疾病，其特征为反复发作的剧烈头痛，常伴有恶心、呕吐以及对光和声音敏感。在日本，估计有8.4%–11.0%的人口受到偏头痛的影响。1 1and is the fourth leading cause of years lived with disability. 并且是导致残疾生存年数第四高的原因。2 2Beyond the physical symptoms, migraine significantly affects daily functioning, quality of life, work productivity and life course. 除了身体症状外，偏头痛还严重影响日常功能、生活质量、工作效率以及人生轨迹。2 2Migraine is estimated to cost the Japanese economy US$ 3 billion every year in lost productivity. 据估计，偏头痛每年给日本经济造成的生产力损失达30亿美元。3 3'This approval represents a significant advancement for people living with migraine in Japan, where the disease continues to place a substantial burden on patients, families, and society,' said Tarek Samad, EVP and Head of Research and Development at Lundbeck. 'Eptinezumab is a differentiated IV CGRP-targeted therapy that offers adults living with migraine an important new treatment option, and we are proud to bring this innovative medicine to patients in Japan. “这一批准对于日本的偏头痛患者而言是一项重大进展，在该国，偏头痛继续给患者、家庭和社会带来沉重负担。” Lundbeck 执行副总裁兼研发负责人 Tarek Samad 表示，“Eptinezumab 是一种具有差异化的靶向 CGRP 的静脉输注疗法，为成年偏头痛患者提供了一个重要的新治疗选择。我们很自豪能将这款创新药物带给日本的患者。”This approval also marks an exciting new chapter for Lundbeck Japan as we prepare for our first independent launch, building on 25 years of commitment to patients and brain health in the country.'. 此次批准也标志着灵北日本迎来了一个令人振奋的新篇章，为我们即将进行的首次独立上市做好准备，并在此基础上延续我们在过去25年里对患者和脑部健康的承诺。Eptinezumab is a humanized monoclonal antibody that binds to calcitonin gene-related peptide (CGRP) and was developed for IV administration as a preventive treatment for migraine. Eptinezumab是一种人源化单克隆抗体，可结合降钙素基因相关肽（CGRP），并开发为静脉给药的偏头痛预防性治疗药物。The Japanese marketing authorization is supported by the global clinical development program for eptinezumab, including the Phase III PROMISE-1, PROMISE-2 and DELIVER trials, together with data from the Phase III SUNRISE trial, which evaluated efficacy and safety in a predominantly Asian population with chronic migraine.. 日本的上市许可得到了eptinezumab全球临床开发项目的支持，包括III期PROMISE-1、PROMISE-2和DELIVER试验，以及来自III期SUNRISE试验的数据，该试验评估了以亚洲人群为主的慢性偏头痛患者的疗效和安全性。4 4The application was further supported by the Phase III SUNSET long-term extension study conducted specifically in Japanese patients to evaluate the long-term safety of eptinezumab. 该申请还得到了III期SUNSET长期扩展研究的支持，该研究专门在日本患者中开展，旨在评估依普奈珠单抗的长期安全性。2 2Eptinezumab was first approved by the U.S. Food and Drug Administration in 2020 for the preventive treatment of migraine in adults, followed by additional approvals including in the European Union and most recently South Korea. It has since been launched in more than 30 markets worldwide. Eptinezumab 于2020年首次获得美国食品药品监督管理局批准，用于成人偏头痛的预防性治疗，随后又在包括欧盟以及最近的韩国在内的多个地区获得额外批准。目前，该药已在全球30多个市场上市。About migraine 关于偏头痛Migraine is a complex and disabling neurological disease characterized by recurrent attacks of severe headache typically accompanied by an array of symptoms, including nausea, vomiting, and sensitivity to light or sound. Not only is headache painful, but migraine also imposes both a social and financial burden. 偏头痛是一种复杂且致残的神经系统疾病，其特征是反复发作的严重头痛，通常伴随一系列症状，包括恶心、呕吐以及对光或声音敏感。头痛不仅带来痛苦，偏头痛还会造成社会和经济负担。Migraine can have a profound impact on daily functioning, work productivity, family and social relationships and quality of life.. 偏头痛会对日常功能、工作效率、家庭与社交关系以及生活质量产生深远影响。Migraine is one of the most prevalent neurological diseases worldwide and remains a leading cause of disability, particularly among people under the age of 50. 偏头痛是全球最普遍的神经系统疾病之一，仍然是导致残疾的主要原因，尤其是在50岁以下的人群中。5,6 5,6As migraine frequency and severity increase, attacks may become harder to control, contributing to greater disease burden and, without appropriate preventive management, progression to chronic migraine. 随着偏头痛发作频率和严重程度的增加，发作可能变得更难控制，从而加重疾病负担，并在缺乏适当预防性管理的情况下，进展为慢性偏头痛。7 7AboutVyepti® (eptinezumab) 关于 Vyepti®（eptinezumab）Eptinezumab is a humanized mAb that binds to CGRP which was designed for IV administration. The efficacy and safety of eptinezumab were evaluated in two Phase III clinical trials, PROMISE-1 in episodic migraine Eptinezumab是一种人源化单克隆抗体，可与CGRP结合，专为静脉给药而设计。在两项III期临床试验中评估了Eptinezumab的疗效和安全性，其中PROMISE-1针对发作性偏头痛8 8and PROMISE-2 in chronic migraine. 以及PROMISE-2在慢性偏头痛中的应用。9 9In both trials, eptinezumab met its primary endpoint of decrease in monthly migraine days (MMDs) over weeks 1-12. 在两项试验中，eptinezumab均达到了其主要终点，即在第1至12周内减少每月偏头痛天数（MMDs）。The safety of eptinezumab has been evaluated in more than 5,000 adult patients with migraine who received at least one dose. Common adverse reactions in the placebo-controlled clinical trials for the preventive treatment of migraine were hypersensitivity and infusion-related reactions. 依普奈珠单抗的安全性已在超过5,000名至少接受过一次给药的成年偏头痛患者中进行了评估。在用于偏头痛预防性治疗的安慰剂对照临床试验中，常见的不良反应包括超敏反应和输注相关反应。VYEPTI® (eptinezumab-jjmr) was approved by the U.S. Food and Drug Administration (FDA) for the preventive treatment of migraine in adults in February 2020, and in January 2022, eptinezumab was granted marketing authorization by the European Commission (EC) for the prophylaxis of migraine in adults who have at least four migraine days per month. VYEPTI®（eptinezumab-jjmr）于2020年2月获得美国食品药品监督管理局（FDA）批准，用于成人偏头痛的预防性治疗；2022年1月，eptinezumab获得欧盟委员会（EC）的上市许可，用于每月至少有四天偏头痛的成人患者的偏头痛预防。In Japan, eptinezumab is approved for the prevention of migraine attacks in adults. Today, eptinezumab is launched in more than 30 markets worldwide.. 在日本，Eptinezumab 被批准用于预防成人偏头痛发作。目前，Eptinezumab 已在全球30多个市场上市。Contacts 联系人Anders Crillesen 安德斯·克里勒森Jens Høyer 延斯·霍耶Head of Media Relations, Corp. Communication 媒体关系主管，企业传播部Vice President, Head of Investor Relations 副总裁，投资者关系负责人[emailprotected] [email protected][emailprotected] [email protected]+45 27 79 12 86 +45 27 79 12 86+45 30 83 45 01 +45 30 83 45 01About H.Lundbeck A/S 关于 H. Lundbeck A/SLundbeck is a biopharmaceutical company focusing exclusively on brain health. With more than 70 years of experience in neuroscience, we are committed to improving the lives of people with neurological and psychiatric diseases. 灵北制药是一家专注于脑部健康的生物制药公司。凭借在神经科学领域超过70年的经验，我们致力于改善神经和精神疾病患者的生活。Brain disorders affect a large part of the world's population, and the effects are felt throughout society. With the rapidly improving understanding of the biology of the brain, we hold ourselves accountable for advancing brain health by curiously exploring new opportunities for treatments. 脑部疾病影响着全球大量人口，其影响波及整个社会。随着我们对大脑生物学的理解迅速加深，我们有责任通过好奇地探索新的治疗机会来推动大脑健康的发展。As a focused innovator, we strive for our research and development programs to tackle some of the most complex neurological challenges. We develop transformative medicines targeting people for whom there are few or no treatments available, expanding into neuro-specialty and neuro-rare from our strong legacy within psychiatry and neurology.. 作为一家专注的创新企业，我们致力于通过研发项目应对一些最复杂的神经系统挑战。我们开发变革性药物，面向那些几乎没有或完全没有治疗选择的患者群体，并依托我们在精神病学和神经学领域的深厚积淀，向神经专科和神经罕见病领域拓展。We are committed to fighting stigma and we act to improve health equity. We strive to create long term value for our shareholders by making a positive contribution to patients, their families and society as a whole. 我们致力于消除污名化，并采取行动改善健康公平。我们通过为患者、其家庭以及整个社会作出积极贡献，努力为股东创造长期价值。Lundbeck has more than 5,000 employees in more than 20 countries and our products are available in more than 80 countries. For additional information, we encourage you to visit our corporate site 灵北制药在全球20多个国家拥有5,000多名员工，产品销往80多个国家。如需更多信息，欢迎访问我们的企业网站。www.lundbeck.com www.lundbeck.comand connect with us via 并通过以下方式与我们联系LinkedIn 领英. 。References: 参考文献：Sakai F, Igarashi H. Cephalalgia. 1997;17(1):15-22 Sakai F, Igarashi H. 《头疼痛》. 1997;17(1):15-22Takeshima T, et al. J Headache Pain. 2025;26(1):275 竹岛 T 等. 《头痛与疼痛杂志》. 2025;26(1):275Sakai F (2010) Olesen J, Ramadan N (eds) Headache care, research and education worldwide, vol 17. Oxford University Press, New York, pp 35–40 Sakai F（2010）载于：Olesen J，Ramadan N（编）《全球头痛诊疗、研究与教育》，第17卷。牛津大学出版社，纽约，第35–40页Yu S, et al. Cephalalgia. 2025;45(10):3331024251386095 Yu S, 等. 《头ache》. 2025;45(10):3331024251386095Steiner TJ, et al. J Headache Pain. 2018;19(1):17 Steiner TJ，等. 《头痛与疼痛杂志》. 2018;19(1):17Leonardi M, et al. J Headache Pain. 2005; 6(6):429– 440 Leonardi M 等. 《头痛与疼痛杂志》. 2005; 6(6):429–440LiptonRB, et al. J Neurol. 2023;270(12);5692–5710 Lipton RB 等. 《神经病学杂志》. 2023;270(12):5692–5710Ashina M, et al. Cephalalgia. 2020;40(3):241-254 Ashina M 等. 《头 Cephalalgia》. 2020;40(3):241-254LiptonRB, et al. Neurology. 2020;94(13):e1365-e1377 Lipton RB 等. 《神经病学》. 2020;94(13):e1365-e1377CONTACT: 联系方式：H. Lundbeck A/S H. Lundbeck A/SOttiliavej 9, 2500 Valby, Denmark 丹麦瓦尔比，邮编2500，奥蒂利亚街9号+45 3630 1311 +45 3630 1311[emailprotected] [emailprotected]This information was brought to you by Cision 本信息由 Cision 提供http://news.cision.com http://news.cision.comhttps://news.cision.com/h--lundbeck-a-s/r/lundbeck-receives-marketing-authorization-for-vyepti---eptinezumab--in-japan-for-the-prevention-of-m,c4396357 https://news.cision.com/h--lundbeck-a-s/r/lundbeck-receives-marketing-authorization-for-vyepti---eptinezumab--in-japan-for-the-prevention-of-m,c4396357The following files are available for download: 以下文件可供下载：https://mb.cision.com/Main/18215/4396357/4271814.pdf https://mb.cision.com/Main/18215/4396357/4271814.pdfPress release Japan MA Final 新闻稿日本最终批准21 二十一% 百分比more press release views with 更多新闻稿浏览量，通过Request a Demo 申请演示

临床3期临床结果

2026-09-17

·百度百家

偏头痛老不好？免疫治疗新突破，告别反复发作

偏头痛老不好？专家发现免疫系统可能是“幕后黑手”，这种新疗法值得了解很多人被头痛折磨得死去活来，吃止痛药、做理疗，效果却时好时坏。尤其是那种一阵一阵的剧烈搏动性疼痛，甚至伴有恶心呕吐，去医院一查，说是偏头痛。但你知道吗？这背后可能藏着免疫系统的“小动作”。过去我们总觉得头痛就是血管收缩扩张的问题，但现在越来越多的研究证实，神经源性炎症和免疫反应在偏头痛发作中扮演着关键角色。简单来说，就是人体的免疫细胞被“误激活”了，攻击了自己的神经系统，导致了疼痛。一、为什么免疫系统会“帮倒忙”？我们的身体里有一种叫“降钙素基因相关肽”（CGRP）的物质，它在偏头痛发作时会大量释放。研究发现，CGRP不仅是一种神经递质，它还能招募免疫细胞（如肥大细胞、T细胞）聚集在三叉神经周围，引发无菌性炎症。这些炎症介质刺激神经末梢，就会产生剧烈的头痛。所以，偏头痛不仅仅是“脑子疼”，更是一场局部的免疫风暴。二、靶向免疫的“精准打击” 既然找到了病因，治疗思路就变了。传统的止痛药是“事后诸葛亮”，等疼起来再吃，往往效果有限且副作用大。而针对免疫通路的生物制剂，则是“防患于未然”。目前，全球已有几类针对CGRP通路的单抗药物获批上市。它们能特异性地结合CGRP或其受体，阻断炎症信号的传递。 1. 预防性治疗的新选择对于每月发作超过4次、或者常规预防药物无效的慢性偏头痛患者，这类生物制剂提供了一种新的长期管理方案。临床数据显示，使用这类药物后，部分患者的偏头痛发作频率可减少50%以上，生活质量显著改善。而且，相比传统药物，它的针对性更强，全身副作用相对较少。 2. 起效时间与费用考量需要提醒的是，这类药物通常不是“一针见效”的止痛药，而是需要定期注射的预防针。一般建议连续使用3-6个月评估疗效。另外，由于属于生物制剂，价格相对较高，目前部分已纳入医保，但具体报销比例因地而异，建议咨询当地医院。三、除了打针，日常如何调节免疫？当然，药物治疗只是辅助，生活方式的调整才是基础。免疫系统的稳定离不开良好的生活习惯：首先，规律作息，拒绝熬夜。睡眠不足是诱发偏头痛的常见因素，它会扰乱免疫平衡。建议每晚7-8小时高质量睡眠。其次，管理压力，放松身心。焦虑和紧张会导致免疫应激反应增强。可以尝试冥想、瑜伽或深呼吸练习，帮助神经系统“冷静下来”。再次，记录头痛日记。找出自己的触发因素，比如某些食物（奶酪、巧克力、红酒）、强光、噪音等，尽量避免接触。最后，适度运动。每周150分钟中等强度运动，如快走、游泳，有助于调节免疫功能和减轻压力。四、重要提醒：切勿自行用药所有生物制剂均为处方药，必须在神经内科医生评估后使用。医生会根据你的病史、发作频率、合并症等情况，判断是否适合使用此类免疫靶向治疗。辨证论治一人一方，自行抓药或网购药物风险大，务必专业医生指导。头痛虽小，牵动神经。如果你正被顽固性偏头痛困扰，不妨与医生探讨一下免疫治疗的新可能。科学应对，才能告别“痛”苦。【引用】1. 中华医学会神经病学分会头痛学组. 中国偏头痛诊治指南[J]. 中华神经科杂志, 2021.2. Layton T, et al. Eptinezumab for the Prevention of Migraine: A Systematic Review. Headache, 2023.3. Goadsby PJ, et al. CGRP-targeted therapies for migraine: from bench to bedside. Lancet Neurol, 2022.

100 项与艾普奈珠单抗相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D11303	艾普奈珠单抗	L01XC	DB14040

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
偏头痛	美国	Lundbeck Seattle BioPharmaceuticals, Inc.	2020-02-21

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
头痛	临床3期	-	H. Lundbeck A/S	2026-06-22
假性脑肿瘤	临床3期	-	H. Lundbeck A/S	2026-06-22
药物引起的头痛	临床3期	美国	H. Lundbeck A/S	2021-02-17
药物引起的头痛	临床3期	韩国	H. Lundbeck A/S	2021-02-17
药物引起的头痛	临床3期	西班牙	H. Lundbeck A/S	2021-02-17
继发性头痛症	临床3期	美国	H. Lundbeck A/S	2021-02-17
继发性头痛症	临床3期	中国	H. Lundbeck A/S	2021-02-17
继发性头痛症	临床3期	韩国	H. Lundbeck A/S	2021-02-17
继发性头痛症	临床3期	西班牙	H. Lundbeck A/S	2021-02-17
继发性头痛症	临床3期	中国台湾	H. Lundbeck A/S	2021-02-17

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临床结果

适应症

分期

评价

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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


EAN2026	N/A	偏头痛	201	Eptinezumab 100 mg	鹹鹹鏇築網鹹鏇襯淵願(夢壓選艱顧衊壓範積艱) = 餘廠艱糧遞憲築構範醖鹹壓廠獵獵齋觸獵糧構 (廠繭憲獵網構廠鬱構鹹 ) 更多	积极	2026-06-26
				Eptinezumab 300 mg	繭淵鏇廠餘觸壓襯鏇鬱(窪蓋觸廠鏇憲糧餘壓壓) = 鏇積願選衊願獵醖繭顧廠衊願鹽憲憲築餘構壓 (選憲繭製蓋壓膚齋餘築 )
NCT05452239 (RESOLUTION, Pubmed \| J Headache Pain)	临床4期	偏头痛 \| 继发性头痛症	608	Eptinezumab	積鏇淵窪糧廠獵遞窪遞(構蓋蓋鬱襯衊廠鑰願憲) = 襯醖構製齋壓艱糧鏇蓋餘膚築網餘醖鑰遞夢範 (憲網夢鹹範糧繭選鏇築 )	积极	2026-06-13
				Placebo	積鏇淵窪糧廠獵遞窪遞(構蓋蓋鬱襯衊廠鑰願憲) = 鏇壓獵窪醖積窪製簾齋餘膚築網餘醖鑰遞夢範 (憲網夢鹹範糧繭選鏇築 )
NCT05570149 (EMBRACE III, Pubmed \| Neurol Ther)	N/A	偏头痛	124	Eptinezumab 100 mg	製餘艱膚構廠範糧壓艱(簾構觸範構鏇蓋餘艱鬱) = 艱顧齋顧醖鏇願構範艱蓋鬱繭壓構齋顧衊鹽構 (範鏇夢鏇顧製鹹願齋顧 ) 更多	积极	2026-06-09
				Eptinezumab 100 mg	製餘艱膚構廠範糧壓艱(簾構觸範構鏇蓋餘艱鬱) = 鹽廠膚獵淵網齋積積鏇蓋鬱繭壓構齋顧衊鹽構 (範鏇夢鏇顧製鹹願齋顧 )
NCT05452239 (RESOLUTION, Pubmed \| Cephalalgia)	临床4期	偏头痛 \| 继发性头痛症	602	Eptinezumab 100 mg (Brief Educational Intervention)	襯糧餘範襯鬱鬱繭築顧(膚願獵獵鏇鑰廠憲窪襯) = 憲齋壓齋鏇壓繭選網簾觸艱膚鹹糧醖鑰築醖觸 (廠壓簾觸製夢糧鬱遞夢 )	积极	2026-05-01
				Placebo (Brief Educational Intervention)	襯糧餘範襯鬱鬱繭築顧(膚願獵獵鏇鑰廠憲窪襯) = 顧範窪鏇醖艱夢範壓築觸艱膚鹹糧醖鑰築醖觸 (廠壓簾觸製夢糧鬱遞夢 ) 更多
AAN2026	N/A	偏头痛	17,220	Erenumab	衊鏇選襯顧壓鏇憲選壓(廠願蓋製顧餘襯選艱憲) = 遞願夢廠淵選鑰製網網願顧製廠積糧鏇遞壓簾 (鑰醖鬱蓋廠糧獵膚膚觸, 0.96 ~ 1.21) 更多	积极	2026-04-25
				Fremanezumab	憲觸鹽衊膚餘鏇齋簾簾(壓衊襯鬱鬱鬱壓淵齋壓) = 鏇齋構鏇構夢網蓋遞製鹹鏇選獵網製夢製憲範 (窪壓鹹廠構顧積製遞淵 ) 更多
DELIVER (AAN2026)	临床3期	偏头痛	832	Eptinezumab 100-mg	築鑰膚齋繭簾淵鹹襯鬱(遞積網構積繭餘憲齋製) = a higher proportion of eptinezumab-treated participants achieved a clinically meaningful response on HIT-6 (≥5-point total score reduction) versus placebo. 鏇鬱艱壓鏇鹽願艱壓製 (繭鏇齋築蓋壓簾憲繭夢 )	积极	2026-04-25
				Eptinezumab 300-mg
INFUSE (AAN2026)	N/A	偏头痛	75	Eptinezumab	願窪窪膚艱網鏇蓋製窪(願遞憲淵憲壓願積醖鏇) = 蓋觸構鑰製醖選壓鑰範衊醖餘簾築簾蓋襯糧構 (鏇壓淵齋夢憲鑰顧餘窪 ) 更多	积极	2026-04-25
AAN2026	N/A	偏头痛	112	Eptinezumab	糧鑰壓齋壓壓壓願蓋膚(醖窪糧醖簾鏇鑰衊獵窪) = at 24,-0.622, p=0.001 and 48 months,-0.611; p=0.003 夢膚繭餘鏇衊衊繭簾醖 (艱觸網製鹽醖鑰艱繭簾 ) 更多	积极	2026-04-25
INFUSE (AAN2026)	N/A	偏头痛	48	Eptinezumab	繭蓋觸襯糧範鑰艱壓鑰(鬱築簾餘顧積壓鬱鬱選) = 獵選獵網願繭積顧衊鹽鹹憲鑰窪製選窪鬱艱齋 (簾鬱築遞觸憲獵築憲鹽 ) 更多	积极	2026-04-25
AAN2026	N/A	偏头痛	2	Eptinezumab desensitization	願鏇網繭顧積鬱夢觸鹽(築構網齋齋齋遞鏇蓋襯) = 選膚繭構糧遞積選鬱獵築獵網壓齋選構獵廠淵 (鑰範獵壓築襯鹽鏇選簾 )	积极	2026-04-25