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更新于：2025-10-23

Ketamine Hydrochloride

盐酸氯胺酮

更新于：2025-10-23

概要

基本信息

简介小分子药物氯胺酮作为 N-甲基-D-天冬氨酸 (NMDA) 受体的调节剂，以商品名 KETALAR 销售，主要用作麻醉药。 1970 年，Endo International 首次在美国批准氯胺酮用于医疗用途。该药物可作为微酸性无菌溶液用于静脉内或肌肉内注射，每毫升多剂量小瓶含有 10 毫克氯胺酮碱。氯胺酮起效迅速并产生镇静、解离和镇痛作用。它通常用于手术过程中的麻醉，并作为慢性疼痛患者的止痛药。氯胺酮作为抗抑郁药可能具有一定的潜力，但需要更多的研究来确定其对该适应症的疗效和安全性。使用氯胺酮作为麻醉剂或止痛药可能会引起一些副作用，包括幻觉、恶心和呕吐。

药物类型

小分子化药

别名

(+-)-Ketamine、(±)-ketamine、2-(2-Chloro-phenyl)-2-methylamino-cyclohexanone

+ [38]

靶点

NMDA receptor

作用方式

调节剂

作用机制

NMDA receptor调节剂(谷氨酸[NMDA]受体复合体调节剂)

治疗领域

神经系统疾病其他疾病遗传病与畸形+ [5]

在研适应症

疼痛麻醉双相情感障碍及相关疾病+ [18]

非在研适应症

肌萎缩侧索硬化自闭症谱系障碍拇囊炎+ [5]

原研机构

Endo International Plc

在研机构

Psycheceutical, Inc.

武汉久安药业有限公司

Consegna Pharma, Inc.

+ [17]

非在研机构

Douglas Pharmaceuticals Ltd.Cch Pharma Pty Ltd.Novartis Pharma AG

+ [2]

权益机构

Seelos Therapeutics, Inc.

Nephron Pharmaceuticals Corp.

Kymanox Corp.

+ [10]

最高研发阶段批准上市

首次获批日期

美国 (1970-02-19),

麻醉

最高研发阶段(中国)批准上市

特殊审评快速通道 (美国)、孤儿药 (美国)、创新许可和获取途径 (英国)

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结构/序列

分子式C13H17Cl2NO

InChIKeyVCMGMSHEPQENPE-UHFFFAOYSA-N

CAS号1867-66-9

关联

2,178

项与盐酸氯胺酮相关的临床试验

IRCT20161022030421N3

/ Suspended临床3期IIT

Comparison of the effect of intravenous ketamine and midazolam as a premedication in children undergoing cochlear implantation at the time of separation from parents

开始日期2640-01-21

申办/合作机构

Baqiyattallah University of Medical Sciences

NCT05945147

/ Withdrawn临床2期IIT

Feasibility Study Comparing a Ketamine and Midazolam Infusion to a Midazolam-Only Infusion for Complex Regional Pain Syndrome

This study will assess the feasibility of administering ketamine plus midazolam or midazolam alone, when infused over 5 days in an outpatient setting, to adults with complex regional pain syndrome (CRPS).

开始日期2099-01-01

申办/合作机构

Stanford University

NCT07112456

/ Not yet recruiting临床2期IIT

Nebulized Ketamine Plus Standard Care vs. Standard Care Alone in Moderate to Severe Asthma Exacerbations: A Randomized Clinical Trial (KET-AIR Trial)

The goal of this clinical trial is to learn if nebulized ketamine helps treat moderate to severe asthma attacks in adults in the emergency department. It will also learn about the safety of ketamine when inhaled through a nebulizer.
The main questions it aims to answer are:
* Does nebulized ketamine improve breathing more than standard treatment alone?
* What side effects, if any, do participants experience after receiving nebulized ketamine?
Researchers will compare nebulized ketamine to a placebo (a saltwater mist with no medication) to see how well it works and how safe it is.
Participants will:
* Receive either nebulized ketamine or a placebo mist, along with standard asthma treatment
* Have their breathing checked before and after treatment using a peak flow meter
* Be monitored for 60 minutes and have their symptoms, vital signs, and any side effects recorded

开始日期2026-09-01

申办/合作机构-

100 项与盐酸氯胺酮相关的临床结果

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100 项与盐酸氯胺酮相关的转化医学

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100 项与盐酸氯胺酮相关的专利（医药）

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31,652

项与盐酸氯胺酮相关的文献（医药）

2026-02-01·Biomaterials advances

Multimodal topical gel combining 2-hydroxyflavanone, gabapentin, and ketamine alleviates diabetic vulvodynia and allodynia with concurrent tissue regeneration in streptozocin-induced rat models

Article

作者: Bashir, Nasreena ; Ayyaz, Fatima ; Ali, Gowhar ; Islam, Nazar-Ul- ; Ayaz, Muhammad ; Khan, Pordil ; Qayyum, Jibran ; Mir, Mushtaq Ahmad

Neuropathic pain arises from damage or illness affecting either central or peripheral or both somatosensory systems. Vulvodynia, a chronic neuropathic pain disorder in women, remains largely neglected despite its significant impact. This study was aimed to evaluate safety and efficacy of a multimodal analgesic gel (MMG-10 %) in relieving diabetic neuropathic pain; specifically vulvodynia and allodynia in female rats. We have formulated a highly promising flavonoid, 2'-Hydroxyflavanone (2-HF) with gabapentin and ketamine. Streptozotocin-induced Diabetes Mellitus (DM) was used as a painful neuropathic model. Static and dynamic vulvodynia and allodynia were assessed using parameters including Flinching Response Threshold (FRT), Paw Withdrawal Threshold (PWT), Flinching Response Latency (FRL) and Paw withdrawal Latency (PWL) by applying the stimuli of Von Frey Filaments to the vulvar region and hind mid-planter regions of paws. A uniform quantity for five consecutive days post 29 days of MMG-10 % and control gel (1.0 mg/cm²) was applied three times daily (TDS) on vulvar area for vulvodynia and mid-plantar paws for allodynia studies. Safety with respect to sensorimotor functions was assessed via Rota rod and Balance beam tests. We conducted the vulvar histological tissue study to evaluate diabetes-induced structural damage and assess the therapeutic potential of a multimodal gel in tissue regeneration. Treatment with tested MMG 10 % resulted in a significant increase in FRT, PWT, FRL and PWL respectively (***p < 0.001, ** p < 0.01, p > 0.05) compared to the STZ treated group. Falling latency time was not affected in all treated groups exhibiting sensorimotor safety. The multimodal gel demonstrated significant regenerative efficacy by reducing atrophy, desquamation, and hyperkeratosis, effectively restoring vulvar tissue integrity in diabetic animals. Our MMG-10 %) could be potentially an effective therapeutic remedy for the relief against diabetes-induced vulvodynia and allodynia.

2026-01-01·INTERNATIONAL JOURNAL OF CARDIOLOGY

Feasibility and safety of ketamine for procedural sedation in pediatric patients undergoing electrophysiology procedures: A cohort study

Article

作者: Barengo, Alberto ; Barca, Luca ; Monaco, Fabrizio ; Fioravanti, Francesco ; Schiavone, Marco ; Della Bella, Paolo Emilio ; Rampa, Lorenzo ; Caparra, Francesca ; Paglino, Gabriele ; Tanese, Nikita ; Bisceglia, Caterina ; Martello, Valentina ; Forleo, Giovanni Battista ; Gulletta, Simone ; D'Andria Ursoleo, Jacopo

INTRODUCTION:

Electrophysiology (EP) procedures in the pediatric population are often performed aided by anesthetic support under general anesthesia (GA), provided they require a delicate balance between appropriate sedation depth, analgesia, immobility, and hemodynamic stability. GA is still the standard of care but shows several limitations. Ketamine sedation (KS) offers an alternative to GA with preserved respiratory and cardiovascular function, yet its role in pediatric EP procedures remains understudied.

METHODS:

We retrospectively included 217 consecutive pediatric patients (<18 years) who underwent their first EP procedure at our center between 2016 and 2024. Patients received either KS (n = 37) or GA (n = 180) based on anesthesiologist and cardiologist preference. Primary endpoints were the GA conversion rate, perioperative complications, "door-to-door" operating room occupation time and postprocedural recovery time. Secondary endpoints included results of the electrophysiology study (EPS), change in electrocardiography parameters before, during and after drug infusion and difference of vital signs behavior between the two groups. Propensity score matching (PSM) was performed to correct for age, body mass index (BMI), type of procedure and sex.

RESULTS:

Before PSM, compared with the GA group, the KS cohort was older (mean age 13.5 ± 4.5 vs. 11.3 ± 3.2 years in GA; p = 0.02), while sex distribution and BMI were similar. After PSM, there were no significant differences between the tested variables. No KS patient required GA conversion or experienced complications (e.g., emergence delirium). Shorter operating room door-to-door occupation time (KS 79.3 ± 47.2 min; p = 0.0026 vs GA 100.8 ± 37.2 min) and shorter recovery room time were reported in the KS group compared to the GA group (15 ± 19 min vs 41.5 ± 14 min; p = 0.001). No significant differences in the EPS result was observed between the two groups (19.4 % vs. 22.7 %; p = 0.59). In KS patients, electrocardiographic parameters remained stable before, during and at the end of procedure.

CONCLUSIONS:

Ketamine-based sedation is a safe and effective alternative to GA for pediatric EP procedures, maintaining hemodynamic and electrocardiographic stability. Moreover, KS enhances operating room efficiency by reducing both periprocedural and recovery times.

2026-01-01·JOURNAL OF AFFECTIVE DISORDERS

Ketamine-induced re-organisation of neural oscillations across health, MDD, and TRD: A systematic review of magnetoencephalography insights

Review

作者: Yu, Ying ; Zhang, Xinbi ; Huang, Mingming ; Xu, Wangyang ; Zeng, Jia ; Di, Leiming

Sub-anesthetic ketamine (KT) has become a promising rapid-acting antidepressant candidate, yet its mechanisms have not been comprehensively defined. Magnetoencephalography (MEG) provides millisecond recordings of cortical rhythms, exposing the rapid glutamatergic dynamics underlying ketamine's action. We synthesized evidence on KT-induced oscillatory and connectivity changes in healthy volunteers (HVs), major depressive disorder (MDD) and treatment-resistant depression (TRD), relating neural signatures to symptomatic relief. Following PRISMA and a PROSPERO-registered protocol (CRD42024609670), five databases were searched to June 2025; eighteen eligible trials (605 adults: 242 HVs, 176 MDD, 172 TRD; 41.65 % female; mean Jadad = 3.3) administered intravenous KT ≤ 0.5 mg/kg and reported MEG outcomes. Exploratory trials indicate that a single ketamine infusion reduces MADRS scores by 10-12 points within 4-9 h in MDD and TRD and improves anxiety, psychosis and suicidality, although small sample sizes limit generalisability. MEG studies consistently report increased gamma-band (30-90 Hz) power, posterior alpha and beta suppression, reduced envelope connectivity and enhanced directed flow in thalamocortical and frontoparietal networks, glutamatergic disinhibition and network renormalisation. Task-evoked data show larger M100 and M170 responses, stronger NMDA-mediated feed-forward drive from somatosensory to inferior-frontal cortex and limbic gamma modulation. Preliminary markers such as higher pre-infusion anterior cingulate activity, elevated baseline gamma power and reduced pgACC beta rebound in responders versus delta and alpha coupling in non-responders require validation in larger cohorts and meta-analyses. KT appears to induce a reproducible MEG signature that may track and potentially forecast its rapid antidepressant effects, but such predictive claims remain provisional pending rigorous replication.

858

项与盐酸氯胺酮相关的新闻（医药）

2025-10-21

·今日头条

抗抑郁药的“五朵金花”：帮大脑找回“快乐信号”的小帮手

有时候，生活从不缺少阳光，却有人始终感受不到温暖。明明世界色彩斑斓，内心却只剩下灰色。抑郁，远不只是“心情不好”的自我调侃，而是一场大脑化学的风暴。那些看似难以名状的悲伤、无力、兴趣丧失，其实都与大脑中神经递质的微妙变化密切相关。每个人都渴望找回快乐的信号，但当脑内的“化学邮件”送达系统失灵时，单靠意志很难走出泥沼。神经递质：快乐的“邮差” 大脑是一个繁忙的“信使中心”。数十亿神经元之间，靠神经递质来传递信息。血清素、去甲肾上腺素、多巴胺，是其中最著名的“快乐邮差”。血清素负责调节情绪与焦虑，去甲肾上腺素涉及注意力与警觉性，多巴胺则与愉悦、动力密切相关。当这些递质的传递出现障碍——比如血清素回收过快，或者释放量不足，大脑的“快乐通路”就会变得断断续续，甚至堵塞。情绪低落、兴趣丧失、精力减退、睡眠紊乱等症状，往往紧随其后。抑郁症的病理基础，就藏在这些看不见的化学反应背后。正因为如此，单靠自我调整、心理劝慰，难以从根本上解决问题。抗抑郁药的作用机理：不是“补药”，而是“修补工” 许多人对抗抑郁药的理解还停留在“补充大脑化学物质”的阶段。但药物带来的改变远比想象复杂。以选择性血清素再摄取抑制剂（SSRIs）为例，这类药物能有效干预血清素的再吸收过程。它们像设下一道“闸门”，减少血清素的流失，使其在神经元间停留更久，增强信号传递，从而逐步改善情绪。而三环类抗抑郁药（TCAs）和去甲肾上腺素及特异性血清素抗抑郁药（NaSSAs），则通过更为复杂的方式调节多种神经递质，适用于部分症状更为复杂或其他药物效果不佳的人群。药物的真正价值在于，帮助大脑恢复“化学平衡”，让那些被堵塞的快乐信号通道慢慢畅通起来。这一过程并非立竿见影，通常需要几周时间。药物选择的“密码”：个体化才是关键抑郁症的表现千差万别：有的人以持续低落为主，有的人则表现为精力枯竭、兴趣消失，还有的患者常常伴随焦虑、失眠、食欲紊乱。正因如此，抗抑郁药的选择绝非“千人一方”，而是需要医生根据病情、体质、既往用药反应、并发症等多方面因素综合考量。比如，部分患者对SSRIs反应良好，而另一些人则更适合SNRIs或NaSSAs；有心脏疾病史的人，TCAs这类副作用较大的药物就不太适合。药物的调整与组合，实际上是“修路”的科学过程。只有精准匹配，才能让“快乐信号”的修复事半功倍。同时，抗抑郁药并非对每个人都有效。约三分之一的患者对首选药物反应不佳，这种“难治性抑郁症”需要更复杂的治疗方案，可能涉及药物联合、换药，甚至采用新机制的抗抑郁药或辅助治疗手段。 “成瘾”疑云：科学还原抗抑郁药的本质其实，抗抑郁药和具有依赖性的药物在机制上完全不同。抗抑郁药并不会让人产生“越吃越想吃”的冲动，也不会出现戒断时的剧烈心理渴求。抗抑郁药，这个听起来略显冰冷的词汇，却在无声地帮助着无数人。他们并非单纯“化学安慰剂”，而是医学与科学共同探索出来的“钥匙”，为那些在情绪低谷中挣扎的人们，打开一扇窗，让光线重新照进心房。药物的“依赖”更多是出于治疗需要。一旦情绪稳定，医生会根据恢复情况，科学设计减药方案，帮助大脑逐步适应“无药”环境。突然停药，反而容易让症状反弹，甚至加重。因此，规范的减药过程是治疗的重要一环，远比“马上停药”更重要。不少人对抗抑郁药心存戒备，最常见的担忧之一就是“成瘾”。副作用：不可回避的“隐形账单” 任何药物都有副作用，抗抑郁药也不例外。常见的不适包括胃肠道反应、口干、头晕、睡眠障碍等。部分药物还可能引起体重变化、血压波动等。对此，医学界不断优化药物结构，力求在疗效与安全之间找到平衡。副作用的出现并不可怕。大多数人在用药初期可能会有轻微不适，随着身体逐渐适应，症状往往会减轻乃至消失。早期服药时，情绪改善可能并不明显，甚至偶有波动。医生通常建议坚持用药4-6周再进行疗效评估。情绪缓解后，药物并非立刻停用。稳定阶段的维持治疗，有助于巩固疗效、预防复发。部分患者需要长期甚至数年的药物维持，但这并不等于“终身服药”。只要症状稳定，医生会协助逐步减量，最终实现停药。新药物的突破与希望神经科学的进步，为抗抑郁药物研发打开了新大门。过去几十年，药物主要围绕血清素、去甲肾上腺素、多巴胺三大递质展开。近年来，研究人员将目光投向了更多神经调节因子，比如谷氨酸、GABA等。如果副作用明显影响生活，及时与医生沟通，调整剂量或更换药物，是科学用药的关键。抗抑郁药的疗程通常较长。很多人期待“立竿见影”的效果，实际上，大脑化学的调整需要时间。以氯胺酮为代表的新型抗抑郁药，展现出起效快、作用机制新颖的特点，为部分难治性抑郁患者带来了新希望。还有一些靶向神经营养因子、炎症反应的新药物，正处于临床研究阶段。未来，抗抑郁药物有望变得更加个性化，精准匹配每个人的“化学钥匙”。综合治疗：药物只是“快乐拼图”的一块抗抑郁药固然重要，但并非万能。心理治疗、运动疗法、饮食调节，都已被证实对抑郁症的康复有积极作用。药物可以修复大脑“化学通道”，但日常生活的改变，才能让大脑“快乐回路”真正稳固。有些药物则通过影响去甲肾上腺素、甚至多巴胺的传递，提供更全面的“快乐修复”。比如去甲肾上腺素-血清素再摄取抑制剂（SNRIs），能双管齐下，既提升情绪，也增强动力。有人会疑惑：为什么服药后情绪改善总要“等一等”？这是因为大脑需要重新适应新的化学环境，神经元之间的信号“重建”，同样需要时间。心理治疗如认知行为疗法（CBT），帮助患者纠正消极思维，增强自我调节能力。规律运动，如快走、慢跑、瑜伽等，有助于提升神经递质水平，改善睡眠与情绪。科学饮食、充足睡眠、社会支持，同样是不可忽视的“自愈力量”。个体化治疗的未来：智能与精准随着基因检测与人工智能的发展，未来的抗抑郁药选择有望更加精准。医生可以通过基因信息，预测个体对不同药物的反应与副作用风险，减少“试错”过程，缩短康复时间。一些新型干预手段，如脑刺激治疗、神经调控技术，也在不断完善，为难治性抑郁症提供更多选择。服用抗抑郁药，不应成为讳莫如深的话题。无数临床研究已证实，规范用药可以明显提升生活质量，降低自杀风险，帮助患者重获自信与希望。抗抑郁药不等于“软弱”，而是现代医学赋予每个人的自救工具。结尾；科学理性看待“快乐信号” 每一次药物结构的优化、每一项新靶点的发现，都是科学家为人类心理健康筑起的坚固防线。抗抑郁药的“五朵金花”，像大脑里勤劳的修补匠，不知疲倦地为快乐信号扫清障碍。科学用药，理性认知，坚定信心，每个人都可以在大脑的“化学迷宫”中找到属于自己的出口。阳光不会缺席，只需给自己多一点耐心，大脑的快乐信号就会再次响起。参考文献国家卫生健康委员会. 《中国抑郁障碍防治指南（2022年版）》. 人民卫生出版社. 中华医学会精神病学分会. 《中国成人抑郁障碍临床诊疗指南（第二版）》，2022年. 李凌江, 王刚, 王传跃. 《抗抑郁药临床应用专家共识（2021版）》，中国神经精神疾病杂志, 2021, 47(6): 337-346. 声明：本文内容均是根据权威医学资料结合个人观点撰写的原创内容，意在科普健康知识请知悉；如有身体不适请咨询专业医生。

AHA会议

2025-10-20

·BiG生物创新社

FDA发新券，审评缩至1个月！

作者｜YY 2025年10月16日，美国食品药品监督管理局（FDA）宣布了“局长国家优先券”（CNPV, Commissioner’s National Priority Vouchers，简称“国家优先券”）试点项目首批九家药企及其在研项目。这是FDA在原有优先审评券（Priority Review Voucher, PRV）制度之外新增的一种“国家优先”版本的制度，被视为对审评资源重新分配的一次制度试验。 FDA在今年6月正式推出这一试点项目，其目的在于奖励那些“符合国家卫生优先事项”的企业或产品。与传统的罕见儿科疾病、热带病和生物威胁应对的三类PRV覆盖范畴不同，国家优先券并不限定具体疾病领域，而是将适应症的公共卫生意义、生产布局及社会价值纳入考虑范围。根据FDA公布的说明，持券药物的审评周期可从常规的10-12个月压缩到约1至2个月，并享受更紧密的监管沟通。 01 认证一张，黄金万两在FDA的审评体系中，药品能以多快的速度获批，往往决定了它能否在市场上领先一步，享受更长的市场独占期。常规的新药审评周期约为十至十二个月，这一标准审评流程主要针对大多数非急迫性药物。若药物被授予优先审评（Priority Review）资格，将使审评时间从常规的十至十二个月缩短至六个月。 2007年，美国国会进一步建立了“优先审评券（PRV）”制度。它并不直接授予某个药物加速资格，而是授予开发者一张“可用于未来任意药品”的加速券，即PRV。企业在获得这张券后，可以为任何新药申请优先审评，将审评期同样缩短至六个月。PRV最初用于激励企业开发被忽视的热带病、罕见儿科疾病及生物威胁防治药物。而2025年推出的“国家优先券（CNPV）”，在速度与范围上都迈出了更大一步。它承诺将审评周期压缩至仅一至两个月，并不限于特定疾病类型。只要药物被认为符合“国家健康优先事项”，或者能增强美国药品制造能力、提高可负担性，就有资格申请。换言之，CNPV不再只是科研激励，更是一项兼具公共卫生与产业战略导向的制度创新。在制药业，一天的时间差往往意味着上百万美元的收入差距。优先审评券（PRV）之所以被称为“黄金券”，并非比喻，而是可以被精确计算的现实数字。以年销售额10亿美元的“重磅炸弹”药物为例，折算到每日收入约为274万美元。如果企业能通过CNPV将上市时间从常规的10个月缩短至仅1至2个月，就意味着可以提前约240天（约8个月）进入市场。这240天的优势如果发生在重磅炸弹类型的药物身上，对应的潜在销售额约至少将为6.58亿美元；若药物的年销售额为20亿美元，则意味着超过13亿美元的额外收益。这还只是账面上的直接回报，未计入市场先发优势、竞争排他期延长及资本估值提升等连锁效应。这张“时间券”的回报率在现实案例中已被验证。礼来的2型糖尿病药物Mounjaro于2022年凭借一张优先审评券提前四个月上市。公司并未披露所用凭证的具体来源，但普遍认为是其在2018年以约8000万美元购得的一张PRV。8000万美元换来十几亿美元的季度销售回报，使PRV成为名副其实的“黄金万两”。更关键的是，Mounjaro既不属于热带病，也非罕见儿科疾病，更与生物威胁防治无关，却享受到了与公共卫生急需药物相同的加速待遇。从企业角度看，这张券的吸引力无可比拟：在资本驱动的研发体系中，能让药物提前几个月上市的制度，有可能会为企业及其产品享受更多的真正市场独占期，从而带来巨大的利润。根据现有统计，至少有八款获得PRV的药物后来成为年销售额超过10亿美元的重磅产品，包括辉瑞的Paxlovid和Comirnaty、Moderna的Spikevax、Vertex的Trikafta、吉利德的Veklury、Biogen的Spinraza、诺华的Zolgensma以及罗氏的Evrysdi。它们的存在证明，优先审评券已不再局限于激励冷门药物的工具，而成为进入重磅市场的加速器。这些数据解释了为何当FDA宣布推出CNPV，一项承诺将审评周期压缩至仅1至2个月的新计划时，整个行业都为之震动，这意味着政策杠杆的力度再次升级。 02 九家首获CNPV黄金券在首批九张“国家优先券”的名单中，既包括在传统创新领域具有突破性的药物，也包括被视为契合国家战略目标的生产型项目，显示出FDA在科学创新与产业安全之间寻求平衡的意图。德国默克旗下的EMD Serono成为外界关注的焦点。其生育药物Pergoveris是一种重组促卵泡激素与促黄体生成素的复方制剂，能够刺激卵泡发育，用于辅助生殖治疗。该药已在全球74个国家上市，但在美国尚未获得批准。白宫宣布与 EMD Serono 达成大幅降价与直售安排；公司同时表示将按 CNPV 路径申报 Pergoveris。两项举措并行，体现 CNPV 将“药品可负担性”与国家利益纳入考量。此举体现了CNPV制度将“药品可负担性”纳入遴选考量的导向。另一家入选的跨国药企是赛诺菲。其单克隆抗体Teplizumab用于延缓1型糖尿病的发病进程，目标人群为处于疾病早期阶段、尚能分泌部分胰岛素的患者。1型糖尿病是典型的自身免疫疾病，目前尚无治愈手段。该药此前已被FDA批准用于高风险人群的预防性治疗。此次获券的理由，是其对未被满足的代谢疾病需求具有潜在的公共卫生意义。FDA在说明中指出，1型糖尿病是“极具社会负担但治疗进展有限的领域”，因此被纳入国家卫生优先事项。 Regeneron的基因疗法DB-OTO是名单中技术含量最高的项目之一。该疗法针对一种罕见的遗传性耳聋，通过基因递送修复听觉功能。《新英格兰医学杂志》披露的结果显示，12 例中 11 例出现临床意义的改善，其中3 例达到正常听力；试验按预设主要终点要求9 例改善且已达成。这类罕见病基因疗法代表了FDA支持前沿技术加速转化的取向。监管方表示，选择DB-OTO的理由在于“其为首批可恢复感官功能的基因疗法之一，对残疾群体具有重大影响”。意大利的Dompé Farmaceutici凭借Cenegermin-bkbj获得一席。这是一种重组人神经营养因子，用于治疗神经性角膜炎（neurotrophic keratitis），该病可导致角膜损伤甚至失明。Cenegermin-bkbj此前已在美国获批用于这一罕见适应症，但此次列入名单的原因，是FDA认为该药“可代表视觉功能康复领域的重要治疗方向”，反映出监管部门对恢复性疗法的重视。来自美国的Revolution Medicines提交的RMC-6236是一种靶向胰腺癌的候选药物。该公司在去年公布的1期研究中报告了积极结果，显示对部分KRAS突变患者的临床获益。FDA将其纳入CNPV名单，是出于“在高致死率肿瘤中加快潜在创新治疗的考量”。胰腺癌长期被认为是抗癌药开发中最具挑战性的领域之一。 Disc Medicine的Bitopertin则代表了血液罕见病方向。该药用于治疗卟啉病（porphyria），这是一种导致光敏性极强、影响皮肤及肝脏功能的罕见代谢病。公司在9月提交了加速批准申请。FDA指出，该药物能够“改善长期被忽视的罕见代谢性疾病患者的生活质量”，因而获得优先审评券。 Achieve Life Sciences的Cytisinicline是一种源自植物的戒烟辅助药，靶向尼古丁成瘾的神经通路。与传统尼古丁替代疗法不同，它以非尼古丁方式缓解戒断反应。FDA将其列入名单的理由之一，是“应对电子烟使用人群迅速上升的公共健康挑战”。在名单的最后，两家美国本土制造企业的入选，即Phlow Corporation与US Antibiotics，反映了制度设计的另一层意图。Phlow是一家在疫情期间承接政府合同、致力于恢复美国仿制药制造能力的公司，此次凭借麻醉药物氯胺酮（Ketamine）获得CNPV；US Antibiotics则因生产复方抗生素Augmentin XR（阿莫西林和克拉维酸钾）而获券。FDA在新闻稿中提到，这两项授予旨在支持国内制药供应链的稳定性，显示出CNPV制度将“制造业回流”视为与创新同等重要的评估维度。 FDA局长Marty Makary在社交媒体视频中表示，获券项目的提名由各药品审评中心提出，最终由多学科团队评审决定。评审依据包括疾病负担、患者可及性、以及产品对美国卫生体系的战略价值。他强调，这些产品将获得“更紧密的沟通和更快的决定”，但“加速并不等于放宽标准”。 03 从PRV到CNPV 制度的延展与再定义如果说这些入选项目勾勒出“国家优先券”所覆盖的边界，那么它们背后的政策逻辑，正是FDA在传统PRV框架上作出的主动延展。 “优先审评券（PRV）”制度起源于2007年，当时美国国会通过法案，授权FDA对开发被忽视的热带病药物的企业给予可转让的审评加速凭证。随后，这一机制被扩展至罕见儿科疾病和生物威胁防治药物领域。它的核心机制是：当一家企业在这些领域获得FDA批准后，可获得一张PRV，用于任何后续药物申请，使审评周期由约10个月缩短至6个月。企业既可自用，也可转售，形成了一个独特的政策市场。随着时间推移，这些凭证的交易价格一度达到数亿美元。2015年，艾伯维以3.5亿美元的价格从United Therapeutics购得一张PRV，加速类风湿性关节炎药物Rinvoq的适应症审查。这类交易表明，PRV已成为“时间即金钱”的象征，也逐渐偏离了当初为鼓励冷门领域研发而设立的初衷。在此背景下，CNPV的推出显然带有重新校准政策重心的意图。首先，CNPV是不允许转让的；其次，它不再仅限于治疗被忽视疾病的激励，而是试图让FDA的审评加速资源，与更广义的“国家卫生与产业优先级”对齐。从Pergoveris的价格承诺，到Phlow与US Antibiotics的本土生产，再到Teplizumab和DB-OTO代表的临床创新，CNPV的首批名单实际上构成了一张政策地图，显示出监管机构如何在激励创新、保障可负担性与维护供应链安全之间寻找新的平衡点。此次“国家优先券”是PRV体系的进一步衍生，与以往不同之处在于，除疗效与疾病负担外，FDA首次将产业政策因素纳入考量。部分获券项目与美国药品本地化生产、供应链安全直接挂钩。例如Phlow和US Antibiotics的获选理由，正是其在美国境内生产仿制药，符合“制造业回流”的战略要求。但这一新的遴选维度也引起部分监管观察者的担忧。报道指出，FDA在近两年经历了超过3500人的裁员与离职，外界担心加速审评可能加重审评团队负担，影响审评质量。另有评论指出，该计划的遴选标准相对模糊，容易被政治意图或商业游说所左右。 FDA方面在声明中回应称，获券药物仍需通过完整的安全性与有效性审查流程，审评团队将采用“肿瘤委员会式”的跨学科会议机制集中评议，确保快速但不草率。对于不完整申请或存在生产问题的项目，FDA仍可延后审评进度。结语从热带病和罕见儿科疾病，到国家卫生优先事项，优先审评券制度的演变，映射了FDA在不同历史阶段的政策取向。它曾是为了让资本流向被忽视的医学空白，如今却成为影响整个产业节奏的制度杠杆。PRV和CNPV之间的差别，不只是审评速度的不同，更是价值分配逻辑的重构：谁能更快获批，谁就能先进入市场，谁就能占据时间的红利。这种加速无疑让患者更早获得治疗，也让企业收获了更高的商业回报。时间与价值被放在同一坐标轴上，政策激励与市场动力开始互为放大。然而，随着审评通道的层级化加深，如何确保资源分配仍以临床需求为中心，而非被商业利益牵引，正在成为新的考验。监管者希望通过CNPV激励创新、保障供应链、强化产业韧性，但每一次“提速”也都意味着更高的审评压力、更大的透明度要求。制度的成功，不仅取决于它能否让药物更快抵达患者，更取决于它是否能让社会信任这种“速度”的正当性。 CNPV也许是一个新的起点。它让人重新思考：在一个以科学、资本与政策共同驱动的行业里，什么样的速度，才是真正值得被奖励的。 Ref. FDA Awards First-Ever National Priority Vouchers to Nine Sponsors. FDA. https://www.fda.gov/news-events/press-announcements/fda-awards-first-ever-national-priority-vouchers-nine-sponsors Sibbesen, J. B. et al. Understanding the FDA Approval Process and PDUFA Dates. Pharmacy Times. 20. 03. 2025. Priority Review. FDA. https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/priority-review CENTER FOR DRUG EVALUATION AND RESEARCH. APPLICATION NUMBER: 215866Orig1s000. SUMMARY REVIEW DB-OTO Results in the New England Journal of Medicine Showcase Dramatic and Sustained Improvements in Hearing and Speech Perception in Children with Profound Genetic Hearing Loss. Regeneron Press Release. 12. 10. 2025. 共建Biomedical创新生态圈！如何加入BiG会员？

优先审批加速审批快速通道申请上市突破性疗法

2025-10-20

·Pharmaceutical Technology

Infertility treatment heads first drugs on FDA’s new priority review scheme

Pharma companies wishing to reap the benefits of the programme need to demonstrate US-centric potential for their drug candidates. kemalbas via GettyImages. The US Food and Drug Administration (FDA) has selected the first products to be included on the Commissioner’s National Priority Voucher (CNPV) pilot programme. A total of nine drug candidates have joined the scheme launched in June 2025 , which will see its developers receive a voucher that will significantly expedite their path to approval. The group is headed by Merck’s Pergoveris (follitropin alfa/lutropin alfa), which is already approved in Europe, for the treatment of infertility. President Donald Trump specifically identified Pergoveris’ inclusion, touting the drug’s potential to offer a cheaper option to US patients. “This drug would directly compete against a much more expensive option that currently has a monopoly in the American market, and this will bring down costs very significantly,” Trump said during an IVF news conference at the White House. Trump was likely referring to Gonal-f, made by Merck’s US and Canadian healthcare business EMD Serono. Gonal-f generated global sales of €833m in 2024. The pharma company plans to use its CNPV to file for FDA approval of its new drug, which it disclosed while announcing a broader deal with the US government to expand fertility access treatment. Elsewhere on the list, candidates being developed for hearing and vision loss have been included in the form of Regeneron’s gene therapy DB-OTO and Dompé Farmaceutici’s Oxervate (cenegermin-bkbj), respectively. GlobalData Strategic Intelligence US Tariffs are shifting - will you react or anticipate? Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis. By GlobalData Learn more about Strategic Intelligence Sanofi’s teplizumab, which is already FDA-approved to delay the onset of stage 3 type 1 diabetes, has been included on the list. The agency said it was selected for “type 1 diabetes,” hinting that the review could be for a broader label approval. Revolution Therapeutics’ RMC-6236, in development for the treatment of pancreatic cancer, and Disc Medicine’s porphyria therapy bitopertin round off the list of products for specific diseases. The FDA selected cytisinicline for nicotine vaping addiction, while ketamine and Augmentin XR were chosen to boost domestic manufacturing of anaesthesia and antibiotics, respectively. The CNPV programme is the latest move by the Trump administration to bolster its pharmaceutical armoury and incentivise the development of new drugs specifically for Americans . Pharma companies wishing to reap the benefits of the programme need to demonstrate US-centric potential for their drug candidates. Therapies need to address a health crisis in the country, produce an innovative cure for American patients, meet public health needs, or increase domestic drug manufacturing as a national security issue. In its statement sharing the first batch of recipients, the FDA said that each product has significant potential to address one or more of these major national priorities. The agency stated that it would likely add another group of CNPV recipients in the coming months. Companies with a product in the programme will receive a decision within 1-2 months, compared to the usual 10-12 months, following filing of a complete application for a drug or biologic. Sponsors will also be able to undertake enhanced feedback with FDA staff during development and the review window. “One of our core goals is to deliver more cures and meaningful treatments – especially ones that have an outsized impact on our most pressing national priorities. We must modernise the review process and try new approaches to meet the needs of the American people,” said FDA commissioner Marty Makary. While the CNPV pilot begins its journey in the US regulatory landscape, experts have been concerned that its activity could take attention away from similar programmes that incentivise rare diseases. Pharmaceutical Technology Excellence Awards - The Benefits of Entering Gain the recognition you deserve! The Pharmaceutical Technology Excellence Awards celebrate innovation, leadership, and impact. By entering, you showcase your achievements, elevate your industry profile, and position yourself among top leaders driving pharmaceutical advancements. Don’t miss your chance to stand out—submit your entry today! Nominate Now

上市批准优先审批

100 项与盐酸氯胺酮相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D00711	盐酸氯胺酮	N01AX03	DBSALT000396

研发状态

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10 条最早获批的记录,

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适应症	国家/地区	公司	日期
疼痛	美国	Pharmather Holdings Ltd.	2025-08-08
麻醉	美国	Ph Healthcare Services	1970-02-19

未上市

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适应症	最高研发状态	国家/地区	公司	日期
双相情感障碍及相关疾病	临床3期	美国	NeuroRx, Inc.	2022-01-30
躁郁症	临床3期	美国	NeuroRx, Inc.	2019-06-25
自杀意念	临床3期	美国	NeuroRx, Inc.	2019-06-25
酒精使用障碍	临床3期	英国	Awakn Life Sciences Corp.	-
创伤后应激障碍	临床2期	美国	Seelos Therapeutics, Inc.	2023-11-27
Rett综合征	临床2期	美国	Pharmather Holdings Ltd.	2023-02-02
药物性运动障碍	临床2期	美国	Pharmather, Inc.	2021-10-05
帕金森病	临床2期	美国	Pharmather, Inc.	2021-10-05
丛集性头痛	临床2期	丹麦	Cch Pharma Pty Ltd.	2019-11-20
重度抑郁症	临床2期	澳大利亚	Douglas Pharmaceuticals Ltd.	2019-05-30

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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


NCT06588907 (Pubmed \| Am J Emerg Med)	N/A	疼痛	85	Procedural Sedation and Analgesia (PSA) with Ketamine	艱夢壓糧簾觸願製齋顧(觸窪壓鹽窪繭餘網廠簾) = higher in the PSA group 餘壓鹽餘壓願製願遞夢 (糧衊淵鹽網鏇積廠構鏇 ) 更多	积极	2025-10-01
				Infraclavicular Block (IB)
NCT05907213 (CTgov)	临床1期	产后抑郁症 \| 术后疼痛	12	Dose Level 1 (Ketamine (Ketalar) Dose Level 1)	遞鏇積積範積憲壓窪淵 = 憲鏇鏇糧窪範觸鑰壓構襯鹽願觸糧鏇積願廠壓 (醖艱觸糧糧壓鹹鬱製顧, 觸遞觸積襯願鏇繭廠獵 ~ 遞鹹鏇構觸糧鑰獵糧醖) 更多	-	2025-09-12
				Ketamine (Ketalar) Dose Level 2 (Ketamine (Ketalar) Dose Level 2)	遞鏇積積範積憲壓窪淵 = 壓窪構構遞壓淵衊製餘襯鹽願觸糧鏇積願廠壓 (醖艱觸糧糧壓鹹鬱製顧, 淵膚窪鑰鏇構範製構構 ~ 鬱積簾積鑰構壓襯憲積) 更多
NCT00210210 (KETAMINE, CTgov)	临床3期	乳腺癌 \| 术后疼痛	230	ketamine (Ketamine Arm)	積築網糧選築淵齋觸鬱 = 願鹹鏇鏇鏇壓鏇艱襯壓鏇淵獵淵構糧選繭觸壓 (餘築窪鹽鏇網觸蓋築積, 鏇淵壓簾構鹽網壓製鏇 ~ 淵簾鹹繭觸獵艱衊廠選) 更多	-	2025-09-08
				Saline solution (Reference Arm)	積築網糧選築淵齋觸鬱 = 顧廠鹽蓋夢繭鹽夢構鏇鏇淵獵淵構糧選繭觸壓 (餘築窪鹽鏇網觸蓋築積, 鏇顧構艱構鬱夢遞觸餘 ~ 繭繭製齋艱醖鹹築鏇齋) 更多
NCT04625283 (IMPAKT ERAS, Pubmed \| Br J Anaesth)	临床4期	-	1,522	Ketamine	鑰壓顧鬱構夢窪壓鹽網(網鬱繭鏇窪鹽廠觸蓋繭): OR = 2.03 (95.0% CI, 1.14 ~ 3.63) 更多	不佳	2025-09-01
				Saline placebo
NCT04226963 (Pubmed \| Neuropsychopharmacol Rep)	N/A	难治性抑郁症	35	Intravenous 0.5 mg/kg Ketamine	遞選淵鑰襯醖廠窪獵蓋(鹹糧襯鬱鬱艱襯鹹蓋糧) = 淵鬱簾餘鏇構壓蓋壓鹹廠顧繭鏇鹹鏇齋網鹽廠 (繭淵齋艱獵願遞鹽觸範 ) 更多	积极	2025-09-01
				Oral 2.0/2.5 mg/kg Ketamine	遞選淵鑰襯醖廠窪獵蓋(鹹糧襯鬱鬱艱襯鹹蓋糧) = 構糧鹹淵鹹選鏇憲築觸廠顧繭鏇鹹鏇齋網鹽廠 (繭淵齋艱獵願遞鹽觸範 ) 更多
NCT04613453 (CTgov)	临床2期	抑郁症 \| 重度抑郁症	12	Ketamine Infusion (Ketamine Infusion)	餘觸鏇憲網選齋選簾壓(範艱範餘窪餘鹹鬱淵齋) = 鑰膚鹹觸憲獵範鑰製鹽鹽壓鏇餘醖衊艱鏇顧鏇 (醖製築觸鑰蓋範糧夢網, 1.34) 更多	-	2025-08-26
				Midazolam Infusion (Midazolam Infusion)	餘觸鏇憲網選齋選簾壓(範艱範餘窪餘鹹鬱淵齋) = 艱窪鬱艱憲淵糧獵範鬱鹽壓鏇餘醖衊艱鏇顧鏇 (醖製築觸鑰蓋範糧夢網, 1.37) 更多
NCT05796791 (CTgov)	早期临床1期	尼古丁成瘾 \| 尼古丁依赖	7	Motivational enhancement therapy+Ketamine Hydrochloride	憲構鏇遞窪觸觸遞餘範 = 選鏇窪壓選膚鏇網廠壓獵鹹選獵夢衊艱膚憲獵 (淵鏇構窪鹽廠餘衊衊壓, 醖餘餘鏇鏇範壓夢觸衊 ~ 憲憲繭鬱糧夢鹹範壓繭) 更多	-	2025-07-18
NCT03431285 (CTgov)	N/A	血管闭塞危机 \| 疼痛 \| 镰状细胞血症	278	standard IV hydration+Morphine (Morphine Group)	蓋顧獵簾窪鏇廠繭餘鑰(鹹醖糧觸憲顧鹽夢壓齋) = 窪衊齋遞醖餘齋製鹽蓋夢製選繭鹽鹽觸鏇鏇衊 (齋餘窪鏇衊齋膚網鑰襯, 1.90) 更多	-	2025-05-28
				standard IV hydration+Ketamine Group (Ketamine Group)	蓋顧獵簾窪鏇廠繭餘鑰(鹹醖糧觸憲顧鹽夢壓齋) = 簾簾鑰顧簾選鬱襯衊餘夢製選繭鹽鹽觸鏇鏇衊 (齋餘窪鏇衊齋膚網鑰襯, 2.13) 更多
NCT06001372 (TREK, CTgov)	早期临床1期	焦虑症 \| 胃肠道肿瘤	2	Ketamine	醖衊鏇願膚顧襯鏇簾鬱 = 鏇夢簾觸齋鬱繭積顧顧積選構鹹範夢艱獵壓顧 (獵壓艱築膚壓淵膚鹽鹽, 膚鏇簾願鹽壓鏇壓淵鑰 ~ 網襯襯願窪鬱選膚範蓋) 更多	-	2025-04-16
NCT04141696 (CTgov)	临床1/2期	疲劳	10	Ketamine (Ketamine Administration)	獵遞鏇憲糧獵製築觸醖(淵壓鹹繭襯鹹餘獵繭鹽) = 範構觸範簾製餘鑰鏇願艱壓膚廠簾積鹽壓遞積 (獵築壓鹹構餘夢觸艱壓, 範積糧鹽醖廠衊壓糧願 ~ 願鹹齋遞鑰淵積淵鬱憲) 更多	-	2025-04-15
				Midazolam (Midazolam Administration)	獵遞鏇憲糧獵製築觸醖(淵壓鹹繭襯鹹餘獵繭鹽) = 範遞積網簾遞觸襯遞願艱壓膚廠簾積鹽壓遞積 (獵築壓鹹構餘夢觸艱壓, 顧廠構齋範獵鬱繭淵鑰 ~ 觸艱夢餘窪淵齋簾衊鬱) 更多