Esketamine Versus Crisis Response Planning Versus Optimized Treatment as Usual for Suicide Prevention: A Pragmatic Controlled Trial in Two Brazilian Cities

1. Background Suicide is a major public health challenge with over 800,000 deaths annually worldwide. Brazil experienced a concerning 57% increase in suicide rates between 2000-2019, highlighting urgent need for effective prevention strategies. This study evaluates two promising interventions: esketamine (rapid-acting pharmacological treatment) and Crisis Response Planning (CRP, evidence-based psychological safety planning approach) in a real-world Brazilian public health setting.
2. Study Design
Pragmatic randomized controlled trial with hybrid implementation-effectiveness design comparing three approaches in emergency departments across two Brazilian cities with combined population of 310,000:
* Group A: Single esketamine infusion (0.5 mg/kg over 40 minutes) + optimized usual treatment (OUT)
* Group B: Crisis Response Planning + OUT
* Group C: OUT alone (enhanced control)
3. Participants
Adults and adolescents (≥14 years) presenting with high suicide risk defined as:
* Recent suicide attempts within 30 days (actual, interrupted, or aborted)
* Severe suicidal ideation (Columbia-Suicide Severity Rating Scale questions 4-5 positive)
* Non-suicidal self-harm requiring emergency medical attention
4. Target enrollment:
272 participants per group (816 total). Key exclusions: esketamine contraindications (cardiovascular disease, aneurysms), psychotic disorders, severe substance use disorders, pregnancy/lactation, inability to consent.
5. Interventions
1. Esketamine Group: IV infusion administered in medical setting with continuous 4-hour monitoring (pulse, blood pressure, ECG, oxygen saturation). Trained medical staff and emergency protocols available.
2. Crisis Response Planning: Collaborative intervention delivered by trained clinical psychologists. 20-45 minute sessions creating personalized, written safety plans identifying warning signs, internal coping strategies, social support contacts, professional resources, and means restriction.
3. Optimized Usual Treatment: Enhanced standard care including guaranteed psychiatric follow-up appointment within one week through municipal mental health services (CAPS - Psychosocial Care Centers).
6. Primary Outcome Repeated suicide-related events over one year including suicide attempts, interrupted attempts, suicide-prevention hospitalizations, deaths by suicide, and non-suicidal self-harm requiring medical attention.
7. Comprehensive Data Collection
1. Biomarkers: 10mL venous blood samples (2 EDTA tubes) collected at baseline by senior clinical nurses. Comprehensive laboratory analysis including complete blood count, metabolic panel, vitamins (B1, B2, B6, B12, B9, D, K), hormones (TSH, T3, T4, testosterone, DHEA, prolactin), inflammatory markers (CRP), brain-derived neurotrophic factor (BDNF), platelet monoamine oxidase (MAO), minerals (iron, ferritin, magnesium, zinc, selenium), and lipid profiles. Samples processed within 24 hours and stored at -80°C for analysis.
2. Clinical Assessments: Comprehensive evaluations at 11 time points (baseline, 24 hours, 7 days, 2 weeks, 4 weeks, 8 weeks, 16 weeks, 24 weeks, 32 weeks, 40 weeks, 1 year) using validated instruments: Columbia-Suicide Severity Rating Scale (C-SSRS), depression scales (PHQ-9, MADRS), anxiety (GAD-7), quality of life (SF-36v2), impulsivity (BIS-11), trauma history (MACE), substance use (ASSIST), sleep quality (PSQI), and additional psychosocial measures.
3. Ecological Momentary Assessment: Real-time data collection via smartphone application for consenting participants. Six daily prompts assessing mood, suicidal thoughts, and emotional states using validated scales. Previous research demonstrates safety and high compliance rates in suicide research populations.
8. Secondary Outcomes
* Time to new suicidal crisis or psychiatric emergency
* Changes in depression and anxiety severity scores
* Quality of life and functional outcome improvements
* Treatment response variability by demographic factors (age, gender, socioeconomic status)
* Comprehensive cost-effectiveness analysis including direct medical costs and indirect productivity losses
* Patient and clinician satisfaction with treatment modalities
* Implementation barriers and facilitators using Consolidated Framework for Implementation Research (CFIR)
* Biomarker predictors of treatment response
9. Clinical Significance This represents the first large-scale, real-world direct comparison of rapid-acting pharmacological (esketamine) versus evidence-based psychological (CRP) interventions for suicide prevention within a public health system. Results will provide crucial evidence for clinical practice guidelines and inform implementation of these interventions in Brazil and similar global contexts. The pragmatic design ensures findings are directly applicable to routine emergency department practice, while comprehensive biomarker analysis may identify biological predictors of treatment response to personalize suicide prevention approaches.

开始日期2026-01-01

申办/合作机构

University of Sao Paulo

100 项与盐酸艾司氯胺酮相关的临床结果

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100 项与盐酸艾司氯胺酮相关的转化医学

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100 项与盐酸艾司氯胺酮相关的专利（医药）

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2,358

项与盐酸艾司氯胺酮相关的文献（医药）

2026-02-01·JOURNAL OF AFFECTIVE DISORDERS

The role of frontal EEG in predicting clinical response of major depressive disorder to intranasal ketamine and esketamine

Article

作者: Ferrea, Stefano ; Seifritz, Erich ; Trenado, Carlos ; Olbrich, Sebastian

Ketamine and its enantiomer esketamine are NMDA receptor antagonists that have shown consistent antidepressant effects in major depression disorder (MDD). These effects suggest an active role of glutamate in the pathophysiology of depression. It has been hypothesized that acute increase of glutamate neurotransmission in the prefrontal cortex following treatment with (es)ketamine leads to synaptic plasticity and neurotrophic changes with following influence on theta activity of encephalography (EEG). The present retrospective study included a total of 43 patients affected by MDD and treated with either esketamine or ketamine. EEG recordings before treatment were related to clinical outcome as measured by both a self-rating and a rater-based psychometric scale. EEG measures were considered as possible predictive biomarkers for responsivity of MDD to (es)ketamine. In particular, we utilized phase locking value (PLV), phase lag index (PLI), Renyi and Tsallis entropy, as well as aperiodic spectral parameters (offset and decay exponent) by focusing on the frontal region and the theta band. We found increased functional connectivity (PLI and PLV) and decreased entropy in responders to (es)ketamine compared to non-responders. Although, we did not find a predictive effect of aperiodic spectral parameters, we observed decreased values in responders compared to non-responders. Our results emphasize the role of frontal EEG as possible biomarker [area under the ROC curve of 0.7065 (Renyi entropy), 0.7101 (Tsallis entropy) and 0.7283 (PLI)] in predicting antidepressant effects of (es)ketamine.

2026-01-01·INTERNATIONAL IMMUNOPHARMACOLOGY

Comment on: Effects of esketamine combined with dexmedetomidine on oxidative stress and lung function during one-lung ventilation in patients with mild to moderate COPD undergoing thoracoscopic surgery

Letter

作者: Xu, Qiongying ; Han, Jiehua

2026-01-01·INTERNATIONAL IMMUNOPHARMACOLOGY

Effects of esketamine combined with dexmedetomidine on oxidative stress and lung function during one-lung ventilation in patients with mild to moderate COPD undergoing thoracoscopic surgery

Article

作者: Liu, Ying ; Chen, Zhi-Yuan ; Xu, Xiao-Ting ; Mao, Yu ; Huang, Shuo ; Xie, Wen-Xi ; Hong, Yi-Feng ; Liu, Ang ; Zhang, Xiao-Qi ; Hong, Wan-Ping

BACKGROUND:

This study evaluated the lung-protective effects of esketamine and dexmedetomidine administered before anesthesia induction in patients with mild-to-moderate chronic obstructive pulmonary disease (COPD) undergoing video-assisted thoracoscopic surgery (VATS).

METHODS:

Sixty patients with mild-to-moderate COPD scheduled for VATS who completed the study and were included in the statistical analysis were randomly assigned to four groups (n = 15 per group): Control (Group C, saline), Dexmedetomidine (Group D, 0.8 μg/kg), Esketamine (Group E, 0.25 mg/kg), and Combination (Group ED, dexmedetomidine 0.8 μg/kg plus esketamine 0.25 mg/kg). Arterial blood gases, peak airway pressure (Ppeak), plateau pressure (Pplat), dynamic lung compliance (Cdyn), heart rate (HR), and mean blood pressure (MBP) were measured at different time points. Inflammatory markers (IL-6, IL-8, IL-10, TNF-α), oxidative stress markers (MDA, SOD), intraoperative drug use, postoperative recovery, pain scores, and adverse events were recorded.

RESULTS:

At T4 (2 h after one-lung ventilation), peak airway pressure (Ppeak) and plateau pressure (Pplat) were significantly lower, and dynamic lung compliance (Cdyn) significantly higher, in Groups E and ED compared to Groups C and D (P < 0.05). At the same time point, levels of IL-6 and IL-8 were significantly lower in Groups E and ED than in Groups C and D (P < 0.05). TNF-α levels were significantly lower in Groups E and ED compared to Group C, and significantly lower in Group ED than in Group D (P < 0.05). IL-10 levels were significantly higher in Groups E and ED than in Groups C and D, with Group E showing higher levels than Group ED (P < 0.05). Similarly, SOD levels were significantly elevated in Groups E and ED compared to Groups C and D, and higher in Group E than in Group ED (P < 0.05). MDA levels were significantly reduced in Groups E and ED compared to Group C, and lower in Group ED than in Group D (P < 0.05). Additionally, PaO₂ at T4 was significantly higher in Group ED than in Groups C and D (P < 0.05).

CONCLUSIONS:

Low-dose esketamine combined with dexmedetomidine, administered before anesthesia induction, improved intraoperative pulmonary mechanics and oxygenation, and attenuated inflammation and oxidative stress in patients with mild-to-moderate COPD undergoing VATS. The combination also helped maintain hemodynamic stability and reduced postoperative pain, contributing to enhanced perioperative recovery.

625

项与盐酸艾司氯胺酮相关的新闻（医药）

2025-12-10

·三弟药闻

20251210 中国国家药品监督管理局药品审评中心(CDE)受理信息--化药

1 二羟丙茶碱注射液受理号：CYHB2502508（国产化药补充申请）药品名称：二羟丙茶碱注射液企业名称：山西普恒制药有限公司；朗天药业（湖北）有限公司靶点与机制：甲基黄嘌呤衍生物，通过抑制磷酸二酯酶，舒张支气管平滑肌，用于支气管哮喘、慢性阻塞性肺疾病等注册分类：3类（补充申请）2 TH202266胶束注射液受理号：CXHL2501363（国产新药临床申请）药品名称：TH202266胶束注射液企业名称：山东泰合医药科技有限公司靶点与机制：胶束新型制剂，具体靶点未知，可能是紫杉醇胶束注册分类：2.2类（改良型新药）3-5 PSTB100片受理号：CXHL2501362、CXHL2501361、CXHL2501360（国产新药临床申请）药品名称：PSTB100片企业名称：普罗思特（南京）生物科技有限公司靶点与机制：具体靶点未知注册分类：1类（创新药）6-8 GT919胶囊受理号：CXHL2501359、CXHL2501358、CXHL2501357（国产新药临床申请）药品名称：GT919胶囊企业名称：标新生物医药科技（上海）有限公司靶点与机制：IKZF1 x IKZF3分子胶注册分类：1类（创新药）9-12 达格列净片受理号：JYHZ2500284、JYHZ2500283（进口化药再注册）药品名称：达格列净片企业名称：AstraZeneca AB；AstraZeneca Pharmaceuticals LP；AstraZeneca Investment (China) Co., Ltd. 靶点与机制：SGLT2抑制剂，通过抑制肾脏近端小管钠-葡萄糖协同转运蛋白2，促进尿糖排泄，用于2型糖尿病治疗注册分类：未标注（进口再注册）13-15 棕榈酸帕利哌酮注射液受理号：JYHB2500682、JYHB2500681、JYHB2500680（进口化药补充申请）药品名称：棕榈酸帕利哌酮注射液企业名称：Janssen-Cilag International NV；Janssen Pharmaceutica N.V. 靶点与机制：非典型抗精神病药，多巴胺D2和5-HT2A受体拮抗剂，长效注射剂型用于精神分裂症维持治疗注册分类：未标注（补充申请）16-19 利伐沙班片受理号：JYHB2500679、JYHB2500678、JYHB2500677、JYHB2500676（进口化药补充申请）药品名称：利伐沙班片企业名称：Bayer AG；Bayer AG 靶点与机制：Xa因子抑制剂，通过选择性抑制凝血因子Xa，用于静脉血栓栓塞症预防和治疗注册分类：未标注（补充申请）20 盐酸艾司氯胺酮鼻喷雾剂受理号：JYHB2500675（进口化药补充申请）药品名称：盐酸艾司氯胺酮鼻喷雾剂企业名称：Janssen-Cilag International NV；Renaissance Lakewood LLC 靶点与机制：NMDA受体拮抗剂，右旋氯胺酮，鼻喷雾剂型用于难治性抑郁症治疗注册分类：5.1类（补充申请）21-23 达肝素钠注射液受理号：JYHB2500673、JYHB2500672、JYHB2500671（进口化药补充申请）药品名称：达肝素钠注射液企业名称：Pfizer NV/SA；Pfizer Manufacturing Belgium NV 靶点与机制：低分子肝素，通过增强抗凝血酶III活性，抑制凝血因子Xa，用于血栓性疾病预防和治疗注册分类：未标注（补充申请）24 盐酸卡替洛尔坦前列素滴眼液受理号：JXHS2500136（进口化药上市申请）药品名称：盐酸卡替洛尔坦前列素滴眼液企业名称：Otsuka Pharmaceutical Co., Ltd.；Teika Pharmaceutical Co., Ltd., Shinjou Factory；Otsuka Beijing Research Institute 靶点与机制：复方降眼压药，卡替洛尔为β受体阻滞剂减少房水生成，拉坦前列素为前列腺素类似物增加房水外流，协同降低眼压注册分类：5.1类（进口新药）25 聚乙二醇滴眼液受理号：JTH2500190（进口化药申请）药品名称：聚乙二醇滴眼液企业名称：Alcon Research LLC；Alcon Laboratories, Inc.；爱尔康（中国）眼科产品有限公司靶点与机制：人工泪液，高分子量聚乙二醇形成保水膜，润滑眼表，用于干眼症注册分类：未标注（进口申请）26-28 达格列净二甲双胍缓释片受理号：CYHS2504243、CYHS2504242、CYHS2504241（国产化药仿制上市申请）药品名称：达格列净二甲双胍缓释片（Ⅱ）、（Ⅰ）企业名称：沂南力诺制药有限责任公司；沂南力诺制药有限责任公司靶点与机制：复方降糖药，达格列净抑制SGLT2促进尿糖排泄，二甲双胍改善胰岛素敏感性，缓释剂型提供平稳血药浓度注册分类：4类（仿制药）29 替格瑞洛片受理号：CYHS2504240（国产化药仿制上市申请）药品名称：替格瑞洛片企业名称：浙江江北药业有限公司；浙江江北药业有限公司靶点与机制：P2Y12受体拮抗剂，通过可逆性抑制ADP诱导的血小板聚集，用于急性冠脉综合征注册分类：4类（仿制药）30-32 黄体酮注射液受理号：CYHS2504239（国产化药仿制上市申请）药品名称：黄体酮注射液企业名称：成都倍特得诺药业有限公司；成都倍特得诺药业有限公司靶点与机制：孕激素，通过维持子宫内膜分泌期变化，用于先兆流产、习惯性流产和月经不调注册分类：3类（仿制药）33 托吡酯口服溶液受理号：CYHS2504236（国产化药仿制上市申请）药品名称：托吡酯口服溶液企业名称：湖南省湘中制药有限公司；湖南省湘中制药有限公司靶点与机制：广谱抗癫痫药，通过多机制（抑制钠通道、增强GABA能、拮抗谷氨酸能等）发挥抗惊厥作用，口服溶液剂型适合儿童和吞咽困难患者注册分类：3类（仿制药）34 盐酸昂丹司琼注射液受理号：CYHS2504235（国产化药仿制上市申请）药品名称：盐酸昂丹司琼注射液企业名称：湖南赛隆药业（长沙）有限公司；湖南赛隆药业（长沙）有限公司靶点与机制：选择性5-HT3受体拮抗剂，通过阻断外周和中枢的5-HT3受体，强效止吐，用于化疗、放疗引起的恶心呕吐注册分类：4类（仿制药）35 戊酸雌二醇片受理号：CYHS2504234（国产化药仿制上市申请）药品名称：戊酸雌二醇片企业名称：浙江爱生药业有限公司；浙江爱生药业有限公司靶点与机制：雌激素制剂，补充外源性雌激素，用于绝经相关症状、卵巢功能不全等雌激素缺乏状况注册分类：4类（仿制药）36 利丙双卡因乳膏受理号：CYHS2504233（国产化药仿制上市申请）药品名称：利丙双卡因乳膏企业名称：海南海神同洲制药有限公司；海南海神同洲制药有限公司靶点与机制：局部麻醉复方制剂，含利多卡因和丙胺卡因，通过阻断神经冲动传导，乳膏剂型用于皮肤表面镇痛注册分类：4类（仿制药）37 对乙酰氨基酚缓释片受理号：CYHS2504232（国产化药仿制上市申请）药品名称：对乙酰氨基酚缓释片企业名称：广东豪瑞恩制药有限公司；广东豪瑞恩制药有限公司靶点与机制：解热镇痛药，通过抑制中枢前列腺素合成，缓释剂型提供持久镇痛效果，用于轻中度疼痛和发热注册分类：4类（仿制药）38 盐酸氮䓬斯汀鼻喷雾剂受理号：CYHS2504231（国产化药仿制上市申请）药品名称：盐酸氮䓬斯汀鼻喷雾剂企业名称：昆明源瑞制药有限公司；昆明源瑞制药有限公司靶点与机制：H1受体拮抗剂，选择性阻断组胺H1受体，稳定肥大细胞，鼻喷雾剂型用于过敏性鼻炎注册分类：4类（仿制药）39 佩玛贝特片受理号：CYHS2504230（国产化药仿制上市申请）药品名称：佩玛贝特片企业名称：江西泰吉立生物医药科技有限公司；浙江益汉制药有限公司靶点与机制：PPARα激动剂，通过激活过氧化物酶体增殖物激活受体α，降低甘油三酯，用于高甘油三酯血症注册分类：4类（仿制药）40 氢溴酸替格列汀片受理号：CYHS2504229（国产化药仿制上市申请）药品名称：氢溴酸替格列汀片企业名称：江苏天士力帝益药业有限公司；江苏天士力帝益药业有限公司靶点与机制：DPP-4抑制剂，通过抑制二肽基肽酶4，提高内源性GLP-1水平，促进胰岛素分泌，用于2型糖尿病注册分类：4类（仿制药）41 盐酸奥洛他定片受理号：CYHB2550391（国产化药补充申请）药品名称：盐酸奥洛他定片企业名称：重庆药友制药有限责任公司；重庆药友制药有限责任公司靶点与机制：双效抗过敏药，拮抗组胺H1受体并稳定肥大细胞，用于过敏性鼻炎、荨麻疹等过敏性疾病注册分类：未标注（补充申请）42-44 阿昔洛韦片受理号：CYHB2550390、CYHB2550389、CYHB2550388（国产化药补充申请）药品名称：阿昔洛韦片企业名称：广东彼迪药业有限公司；广东彼迪药业有限公司；广东彼迪药业有限公司靶点与机制：核苷类抗病毒药，通过抑制病毒DNA聚合酶，阻断病毒DNA合成，用于单纯疱疹和带状疱疹病毒感染注册分类：未标注（补充申请）45 盐酸肾上腺素注射液受理号：CYHB2550387（国产化药补充申请）药品名称：盐酸肾上腺素注射液企业名称：重庆迪康长江制药有限公司；重庆迪康长江制药有限公司靶点与机制：α、β受体激动剂，强效收缩血管、兴奋心脏、舒张支气管，用于过敏性休克、心脏骤停、支气管哮喘急性发作注册分类：未标注（补充申请）46 米诺地尔搽剂受理号：CYHB2502507（国产化药补充申请）药品名称：米诺地尔搽剂企业名称：沂南力诺制药有限责任公司；江苏晨牌邦德药业有限公司靶点与机制：钾通道开放剂，通过舒张血管促进毛囊周围血流，搽剂剂型用于雄激素性脱发注册分类：3类（补充申请）47 人工牛黄甲硝唑胶囊受理号：CYHB2502506（国产化药补充申请）药品名称：人工牛黄甲硝唑胶囊企业名称：河北天成药业股份有限公司；河北万邦复临药业有限公司靶点与机制：复方抗菌药，人工牛黄清热解毒，甲硝唑抗厌氧菌，用于急性智齿冠周炎、牙槽脓肿等注册分类：未标注（补充申请）48-49 甘草锌颗粒受理号：CYHB2502505、CYHB2502504（国产化药补充申请）药品名称：甘草锌颗粒企业名称：南京中山制药有限公司；优尼特尔南京制药有限公司靶点与机制：复方制剂，甘草提取物抗溃疡，锌促进溃疡愈合，颗粒剂型用于胃、十二指肠溃疡注册分类：未标注（补充申请）50 萘普生胶囊受理号：CYHB2502503（国产化药补充申请）药品名称：萘普生胶囊企业名称：黑龙江深行生物医药科技有限公司；黑龙江瑞格制药有限公司靶点与机制：非甾体抗炎药，通过抑制环氧合酶，减少前列腺素合成，用于类风湿关节炎、骨关节炎等注册分类：未标注（补充申请）51-53 头孢拉定胶囊/头孢氨苄胶囊受理号：CYHB2502501、CYHB2502500、CYHB2502499（国产化药补充申请）药品名称：头孢拉定胶囊、头孢氨苄胶囊企业名称：吉林敖东药业集团延吉股份有限公司；吉林敖东药业集团延吉股份有限公司靶点与机制：第一代头孢菌素，通过抑制细菌细胞壁合成，用于敏感菌引起的呼吸道、泌尿生殖道等感染注册分类：未标注（补充申请）54-55 HRS9531注射液受理号：CXHL2501356、CXHL2501355（国产新药临床申请）药品名称：HRS9531注射液企业名称：福建盛迪医药有限公司；福建盛迪医药有限公司靶点与机制：HRS9531注射液是恒瑞医药自主研发的胰高血糖素样肽-1（GLP-1）和葡萄糖依赖性促胰岛素肽（GIP）双重受体激动剂，具有改善胰岛素抵抗、抑制食欲、降低血糖和减轻体重等作用。HRS9531注射液已获得国家药监局批准用于开展2型糖尿病、超重或肥胖和阻塞性睡眠呼吸暂停适应症的临床试验。注册分类：1类（创新药）56 ADX-324注射液受理号：CXHL2501354（国产新药临床申请）药品名称：ADX-324注射液企业名称：元羿生物科技（上海）有限公司靶点与机制：ADX - 324 是一种基于 siRNA（小干扰 RNA）技术的药物，其作用靶点为 KLKB1 基因。治疗领域是遗传性血管性水肿。注册分类：1类（创新药）57-58 LWP779片受理号：CXHL2501353、CXHL2501352（国产新药临床申请）药品名称：LWP779片企业名称：远森制药（杭州）有限公司；远森制药（杭州）有限公司靶点与机制：具体靶点未知注册分类：1类（创新药）59-60 GEN-725片受理号：CXHL2501351、CXHL2501350（国产新药临床申请）药品名称：GEN-725片企业名称：河南真实生物科技有限公司；河南真实生物科技有限公司靶点与机制：真实生物开发的2.4类改良型新药，具体靶点未知注册分类：2.4类（改良型新药）61 注射用莱古比星受理号：CXHL2501349（国产新药临床申请）药品名称：注射用莱古比星企业名称：上海亲合力生物医药科技股份有限公司靶点与机制：化疗药物，DNA拓扑异构酶II抑制剂注册分类：1类（创新药）62 硝酮嗪肠溶片受理号：CXHB2500328（国产新药补充申请）药品名称：硝酮嗪肠溶片企业名称：广州喜鹊医药有限公司靶点与机制：硝酮嗪是喜鹊医药创始人王玉强教授团队对中药有效成分川芎嗪分子进行化学结构修饰获得的First-in-Class“全球新”1类创新化学药物，具有多功能作用机理。硝酮嗪能够高效清除自由基、抑制钙离子超载、激活AMPK/PGC-1/Nrf2/HO-1信号通路增强线粒体功能、增加ATP产生、抑制mTOR信号通路激活自噬清除毒性蛋白和抑制炎症，从而可能延缓ALS运动神经元退化，减少肌肉萎缩和延缓肌肉力量下降。注册分类：1类（创新药）63 sbk002片受理号：CXHS2500153（国产新药上市申请）药品名称：sbk002片企业名称：成都施贝康生物医药科技有限公司；海南皇隆制药股份有限公司靶点与机制：作用机制可能和硫酸氢氯吡格雷片相同注册分类：1类（创新药）

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1209药讯口服多肽减肥药：又一家，递交IND 宁康瑞珠完成超亿元A轮融资

2025年12月9日科济药业BCMA CAR-T积极数据亮相2025 ASH年会 2025年12月8日，科济药业宣布通用型BCMA CAR-T产品CT0596治疗复发/难治性多发性骨髓瘤（R/R MM）的临床数据已于第67届美国血液学会（“ASH”）年会进行壁报展示。截至2025年8月31日，8例已输注患者均为可评估疗效人群，中位随访时间为4.14个月（范围：0.9-7.9个月）。6例患者达到部分缓解（PR）及以上疗效：3例达到完全缓解/严格意义的完全缓解（CR/sCR）（均属于全剂量清淋的患者），1例达到非常好的部分缓解（VGPR），2例达到PR。CT0596安全性可控。4例患者出现1级细胞因子释放综合征（CRS），无2级及以上CRS发生。未观察到免疫效应细胞相关神经毒性综合征（ICANS）或移植物抗宿主病（GVHD）。未观察到剂量限制性毒性、治疗中断或死亡事件。翼思生物两款新药国内获批，靶向癫痫和睡眠呼吸暂停 12月9日，翼思生物宣布其西诺氨酯片（商品名：翼弗瑞®）和盐酸索安非托片（商品名：翼朗清®）获国家药监局批准上市。西诺氨酯用于成人癫痫部分性发作，III期临床显示中位发作频率降幅达100%；索安非托针对阻塞性睡眠呼吸暂停伴日间嗜睡，具双重促觉醒机制，起效1小时且疗效持续9小时。中国生物制药利多卡因贴剂新适应症获批，全球首款用于糖尿病神经痛 12月9日，中国生物制药旗下泰德制药的利多卡因凝胶贴膏（商品名：得百宁®）新适应症获批，用于缓解糖尿病性周围神经病理性疼痛。作为全球首个该适应症贴剂，临床数据显示其贴敷12小时可持续镇痛，无口服药常见副作用，联用口服药可使疼痛缓解率提升至78.2%，适合老年及基础疾病患者长期使用。益方生物D-0502片获临床许可 12月8日，据CDE官网，益方生物D-0502片获临床许可，拟联合JSKN016治疗局部晚期或转移性HR阳性、HER2阴性乳腺癌。再鼎医药注射用ZL-1310获临床许可 12月8日，据CDE官网，再鼎医药注射用ZL-1310获临床许可，拟用于治疗既往含铂治疗中或治疗后疾病进展的广泛期小细胞肺癌患者。阿斯利康双靶CAR-T疗法早期数据出炉日前，阿斯利康双靶CAR-T疗法的Ib/II期DURGA-1研究的Ib阶段初步结果在美国血液学会（ASH）2025 年会上公布，结果显示，该药在复发/难治多发性骨髓瘤（R/R MM）患者中展现出良好的安全性与疗效信号。在15例可评估疗效的患者中（剂量1组10例，剂量2组5例），总缓解率（ORR）为100%；其中剂量1组有3例、剂量2组有2例达到完全缓解（CR）。两组起效时间均为0.9个月（中位数）。硕迪生物大涨102%：小分子GLP-1公布减重2b期临床数据 12月8日，硕迪生物公布小分子GLP-1受体激动剂Aleniglipron用于减重2b期临床最新数据。硕迪生物当天股价大涨102%，市值达到42亿美元。此次披露的是2b期临床ACCESS的最新数据。该2b期临床数据设计如下，第一部分探索45、90、120mg剂量组治疗36周减重效果，第二部分探索更高剂量探索更好疗效，第三部分探索更低剂量开始滴定的给药方案达到更好耐受性。2023年6月，礼来公布Orforglipron治疗肥胖的二期临床数据，36mg、45mg剂量组治疗36周分别减重11.2%、12.4%。2025年8月披露三期临床数据，治疗72周减重11.5%，疗效下滑明显。对于硕迪生物等后来者小分子GLP-1来说，阶段性的疗效数据固然重要，也需要继续关注后续三期关键临床的最终疗效数据。又一国产「司美格鲁肽」申报上市近日，国家药品监督管理局（NMPA）药品审评中心（CDE）官网显示，石药集团的司美格鲁肽注射液的新适应症上市申请已获受理，推测此次申报的适应症为肥胖。口服多肽减肥药：又一家，递交IND 近期，杭州诺澳生物医药科技有限公司研发的2.2类新药司美格鲁肽片正式获得国家药品监督管理局核准签发的临床试验申请《受理通知书》，含3mg/ 7mg/ 14mg/ 25mg/ 50mg共5个规格。该药物拟用于肥胖（BMI≥30kg/m²）或超重（BMI≥27kg/m²）且伴有至少一种体重相关合并症的成年患者体重管理，每日口服1次。截至目前国内外尚无用于体重管理的口服司美格鲁肽制剂。歌礼制药口服GLP-1药物ASC30在2期研究中显示7.7%体重减轻 12月8日，歌礼制药公布其口服GLP-1激动剂ASC30在美国2期研究中的结果，最高剂量60mg在13周内实现安慰剂调整后7.7%的体重减轻，所有剂量均统计显著。研究纳入125名肥胖或超重患者，呕吐率比竞争对手orforglipron低约一半，胃肠道不良事件均为轻度或中度。公司计划2026年初与FDA会面，推进3期开发，专利保护至2044年。信达生物信美悦III期研究达终点，支持银屑病季度给药方案 12月9日，信达生物宣布其匹康奇拜单抗注射液（信美悦®）在中重度银屑病III期研究CLEAR-2中达成主要终点。结果显示，每季度给药维持治疗组PASI 90应答率超89%，显著优于撤药组，疗效持久且安全性良好，为银屑病长期管理提供便捷、高效的个体化方案。 Dyne的DMD药物在试验中表现优异，准备申请FDA批准 12月8日，Dyne Therapeutics公布其DMD药物z-rostudirsen在1/2期研究中，外显子51跳跃型患者 dystrophin表达达正常水平的5.46%，显著高于现有疗法。32名患者队列显示功能端点改善，安全性良好，无相关严重不良事件。公司计划2026年第二季度提交加速批准申请，目标2027年初上市，潜在美国患者约1600人。 GSK终止与Ideaya的五年癌症合作 12月8日，GSK宣布终止与Ideaya Biosciences为期五年的癌症合作，涉及Pol Theta和Werner Helicase两个候选药物。GSK最初支付1亿美元预付款和2000万美元股权，但于12月4日通知终止，90天后生效。Ideaya将重新评估项目战略选项，公司现金储备约11.4亿美元，预计资金可支撑至2030年。合作终止不影响Ideaya主要项目darovasertib的推进，其2/3期数据预计年底或明年初公布。 2025年失败的5项抑郁症临床试验 2025年抗抑郁新药屡遭重挫：J&J κ阿片拮抗剂aticaprant、Neumora navacaprant、Alto H3阻断剂ALTO-203、Supernus mTORC激活剂SPN-820及Neurocrine NMDA负变构调节剂NBI-770先后在Ⅱ/Ⅲ期试验中未能击败安慰剂，凸显CNS药物85%晚期失败率与安慰剂效应、执行差异等开发难题。尽管过去十七年FDA仅批15款抑郁药，但美国仍有八百万难治患者，巨大需求吸引企业继续投入；已上市的艾司氯胺酮Spravato被视为救命标杆。Neumora调整试验设计，Supernus拟再启Ⅱb期，其余项目前途未卜。宁康瑞珠完成超亿元A轮融资，依托全球首创的“细胞膜嵌合药物设计平台”，布局多种未满足临床需求的慢性疾病创新药企宁康瑞珠完成超亿元A轮融资，龙磐投资领投，峰瑞资本、阳光融汇资本跟投，舟渡资本任独家财务顾问。公司由前默沙东资深科学家熊豫生、关洪平创立，拥有全球首创“细胞膜嵌合药物设计平台”，可靶向肠道上皮GPCR等难成药膜蛋白。首发口服小分子已启动澳洲Ⅰ期临床，用于代谢疾病；第二款抗炎项目正筹备IND，潜力对标“同类最佳”。本轮资金将加速平台扩展与临床推进。投资方看好其组织选择性技术与全球首创/最佳管线，期待早日造福代谢及免疫疾病患者。圣因生物完成超1.1亿美元B轮融资 12月8日，圣因生物宣布完成超1.1亿美元B轮融资，本轮由一家知名产业机构领投，国际主权基金、中国生物制药集团等跟投，并获得礼来公司战略投资。资金将用于推动其临床阶段管线进入注册研究，并加速在自身免疫疾病、心血管疾病等领域的RNAi疗法开发，依托专有LEAD™肝外递送平台拓展全球化布局。

2025-12-08

·EINPresswire

Axis Integrated Mental Health Partners with Propagate Hope Counseling to Reach 266K Coloradans at Risk of Suicide

Colorado Clinics Collaborate to Transform Treatment for Trauma, Depression, and Anxiety By partnering with high-quality providers like Propagate Hope, we can connect more people to holistic, transformative care beyond just meds and support Colorado’s mental health providers to thrive.” — Liesl Perez DENVER, CO, UNITED STATES, December 8, 2025 / EINPresswire.com / -- Axis Integrated Mental Health announced a strategic partnership with Propagate Hope Counseling designed to expand access to Internal Family Systems (IFS) therapy while helping smaller therapy practices better support patients who may be unaware of cutting-edge, insurance-covered mental health treatment options. Through this collaboration, more Colorado patients will gain access to effective, evidence-based trauma therapy while also benefiting from increased awareness of advanced treatments such as Deep TMS and Spravato – therapies that are often covered by insurance but remain underutilized due to a lack of provider infrastructure, education, and coordination. “Colorado’s mental health crisis has only gotten worse in the last year, with adult mental health ranking #48 of all states,” said Liesl Perez, co-founder of Axis Integrated Mental Health. “By partnering with high-quality providers like Propagate Hope, we can connect more people to holistic, transformative care beyond just meds and support Colorado’s mental health providers to thrive.” The partnership enables Propagate Hope to stay focused on trauma-informed healing while giving their patients streamlined access to award-winning, locally owned and operated psychiatric care, medication management, Deep TMS, Spravato, and insurance navigation. At the same time, Propagate Hope gains access to operational and clinical infrastructure that would be difficult or expensive to build independently. “Many clients don’t realize treatments like Deep TMS or Spravato, which boast as much as an 82% efficacy rate, exist or that their insurance covers them,” said Tim Kelly of Propagate Hope Counseling. “Axis Integrated Mental Health’s neuroplasticity-building treatments can make it much easier for clients to heal in combination with IFS therapy.” This collaboration directly supports Axis Integrated Mental Health’s 266K Project, a mission to prevent the estimated 266,000 Coloradans experiencing serious thoughts of suicide from dying by improving statewide access to effective, coordinated care. Rather than growing solely through its own practice, Axis is focused on strengthening independent clinics by sharing marketing and operational knowledge, referring patients, and providing support for advanced treatments when needed. “Saving lives at scale doesn’t happen by building a single large clinic,” added Liesl Perez. “The only way we can achieve our goal to reduce the number of people with serious thoughts of suicide in Colorado is to enable hundreds of smaller clinics to reach more people. This is challenging in a state that spends less than other states on mental health, with insurance companies that aren’t being held accountable, and a shortage of providers to serve the need.” As part of this broader mission, Axis is actively sharing its operational and marketing playbooks with partner clinics, including guidance on insurance optimization, patient education, prior authorizations, care coordination, and ethical patient acquisition strategies. These same learnings will be shared publicly through the Practice Power Workshop taking place on January 17, where mental health practice owners will receive hands-on training from marketing, HR, and billing specialists to help them grow sustainably, operate efficiently, and expand access to advanced, covered treatments. “This partnership is one example of the ecosystem we’re building,” said Liesl Perez. “We want everyone who can help people feel better, from primary care physicians to business coaches, to connect to more people, and we’re willing to share the trade secrets that made us the best mental health clinic in Denver and Boulder with everyone.” About Propagate Hope Counseling Propagate Hope Counseling is a Colorado-based therapy practice specializing in Internal Family Systems (IFS) therapy and trauma-informed care for depression, anxiety, and complex PTSD. Their clinicians are trained in parts work and non-pathologizing therapeutic approaches designed to help clients build self-compassion and long-term healing. Through partnership with Axis, Propagate Hope clients now benefit from coordinated access to psychiatric care and advanced, insurance-covered treatment options while maintaining continuity of trauma-focused therapy. Learn more at propagatehopecounseling.com. About Axis Integrated Mental Health Axis Integrated Mental Health is an award-winning Colorado-based mental health organization providing integrated psychiatry, therapy, and advanced treatments including Deep TMS and Spravato. Founded in 2019, Axis operates across Aurora, Boulder, Westminster, and Denver Tech Center and has underwritten more than $400,000 in pro bono care. Axis is the creator of the 266K Project, a statewide mission to prevent suicide by expanding access, strengthening clinics, and improving patient awareness of effective mental health treatment. Learn more or register for the Practice Power Workshop at axismh.com. Schedule Your Integrated Care Plan Today If you or a loved one is struggling with depression, anxiety, treatment-resistant conditions, or complex trauma, coordinated care combining IFS therapy, Deep TMS, Spravato, and psychiatric expertise is now accessible across Denver, Boulder, Westminster, Aurora, and the Denver Tech Center. To schedule a consultation or learn more about integrated care plans, visit axismh.com or call (720) 400-7025 For partnership inquiries, contact: info@axismh.com Liesl Perez Axis Integrated Mental Health +1 415-203-7179 info@axismh.com Visit us on social media: LinkedIn Instagram Facebook YouTube Other Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.

100 项与盐酸艾司氯胺酮相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D10627	盐酸艾司氯胺酮	N01AX14 N06AX27	DB11823

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
抑郁症	中国	Janssen-Cilag International NV	2023-04-17
中度重度抑郁症	澳大利亚	Janssen-Cilag Pty Ltd.	2021-03-09
重度抑郁症	欧盟	Janssen-Cilag International NV	2019-12-18
重度抑郁症	冰岛	Janssen-Cilag International NV	2019-12-18
重度抑郁症	列支敦士登	Janssen-Cilag International NV	2019-12-18
重度抑郁症	挪威	Janssen-Cilag International NV	2019-12-18
麻醉	中国	江苏恒瑞医药股份有限公司	2019-11-18
难治性抑郁症	美国	Janssen Pharmaceuticals, Inc.	2019-03-05
疼痛	德国	Pfizer Inc.	1997-08-01

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
自杀意念	临床3期	美国	Janssen Research & Development LLC	2017-06-09
自杀意念	临床3期	保加利亚	Janssen Research & Development LLC	2017-06-09
自杀意念	临床3期	爱沙尼亚	Janssen Research & Development LLC	2017-06-09
自杀意念	临床3期	德国	Janssen Research & Development LLC	2017-06-09
自杀意念	临床3期	匈牙利	Janssen Research & Development LLC	2017-06-09
自杀意念	临床3期	马来西亚	Janssen Research & Development LLC	2017-06-09
自杀意念	临床3期	斯洛伐克	Janssen Research & Development LLC	2017-06-09
自杀意念	临床3期	南非	Janssen Research & Development LLC	2017-06-09
自杀意念	临床3期	西班牙	Janssen Research & Development LLC	2017-06-09
自杀意念	临床3期	中国台湾	Janssen Research & Development LLC	2017-06-09

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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


NCT06608030 (Pubmed \| Pharmacol Res)	临床4期	抑郁症 \| 焦虑症	142	Esketamine	壓襯鹹簾範積鹽構壓遞(膚鹹顧蓋築繭壓艱遞餘) = 鹹網鹹蓋衊簾築醖簾膚獵壓積遞範蓋齋網糧廠 (壓獵糧製選襯製觸齋製 ) 更多	积极	2025-12-01
				Saline	壓襯鹹簾範積鹽構壓遞(膚鹹顧蓋築繭壓艱遞餘) = 簾齋觸繭構齋簾範積糧獵壓積遞範蓋齋網糧廠 (壓獵糧製選襯製觸齋製 ) 更多
NCT05715671 (Pubmed \| Sleep Med)	N/A	睡眠异常	150	Esketamine loading dose 0.15 mg/kg plus maintenance dose 0.15 mg·kg^-1·h^-1	獵夢遞餘醖襯製獵夢願(網鏇選顧膚簾糧鏇壓憲) = significantly higher 壓糧襯積憲廠簾顧餘糧 (蓋願膚築壓襯願鹽糧鹽 ) 更多	积极	2025-12-01
				Esketamine loading dose 0.3 mg/kg plus maintenance dose 0.3 mg·kg^-1·h^-1
NCT05289050 (Pubmed \| J Pain Res)	临床4期	-	144	S(+)-ketamine	範糧繭築鬱蓋積願繭遞(選簾簾廠觸願顧膚選繭) = 簾糧範窪壓衊壓膚襯鏇艱艱艱艱網觸鏇襯選齋 (築築鬱鹽淵窪壓齋壓齋, 0.66) 更多	积极	2025-11-01
				0.9% sodium chloride solution	範糧繭築鬱蓋積願繭遞(選簾簾廠觸願顧膚選繭) = 醖壓製鑰構醖壓膚觸獵艱艱艱艱網觸鏇襯選齋 (築築鬱鹽淵窪壓齋壓齋, 0.65) 更多
NCT04829318 (ESCAPE-LTE, CTgov)	临床4期	重度抑郁症	183	Esketamine (Esketamine Nasal Spray + Oral Antidepressant (AD))	醖網憲觸遞構蓋築願鏇 = 製壓襯觸鹹淵蓋簾築鏇餘淵齋獵選齋鏇積鏇鏇 (遞鏇襯衊觸鹹製繭鹹鏇, 襯鹹醖糧艱蓋窪衊糧壓 ~ 製衊鹹鏇糧構壓願鬱醖) 更多	-	2025-09-18
				Esketamine (Esketamine + Oral AD)	繭鑰餘膚艱艱鹹鬱糧鬱(衊選鹹鬱憲壓鏇淵夢衊) = 鬱艱鹹憲構鑰築製蓋壓範觸選鹹鏇網夢鹽衊網 (鏇壓糧夢遞鏇製窪艱艱, 觸網鹹壓夢網網夢遞襯 ~ 鏇齋鏇範積艱壓醖餘鏇) 更多
Pubmed 人工标引	N/A	抑郁症	58,483	Esketamine Nasal Spray	鹹醖壓鏇積顧艱壓鹹齋(蓋鹹積糧夢鏇壓膚繭淵) = 鏇範鬱襯淵範壓艱積積鏇糧遞壓積齋鹹齋憲餘 (夢構網襯築蓋衊範糧艱 ) 更多	积极	2025-09-10
NCT04599855 (Pubmed \| JAMA Psychiatry) 人工标引	临床4期	难治性抑郁症	378	esketamine 56 mg	憲鏇繭壓築鹹膚壓膚簾(膚齋憲襯構製顧繭夢夢) = nausea (56 participants [24.8%]), dissociation (55 [24.3%]), dizziness (49 [21.7%]), and headache (43 [19.0%]). 鏇鬱繭觸鑰鹹鹽蓋齋簾 (憲繭獵襯鏇鬱壓齋獵選 )	积极	2025-07-02
				esketamine 84 mg
NCT02782104 (SUSTAIN-3, Pubmed \| Int J Neuropsychopharmacol)	临床3期	难治性抑郁症	1,148	Esketamine nasal spray + oral antidepressant	遞醖網鬱醖遞構遞糧鑰(遞顧範衊蓋糧繭願網構) = n = 3 廠選積衊窪鹹選齋蓋衊 (簾顧壓構鬱範餘夢壓繭 ) 更多	积极	2025-06-06
Pubmed \| JAMA Psychiatry 人工标引	N/A	难治性抑郁症	-	EsketamineEsketamine + SNRI	願構觸觸願鏇鹽遞繭鬱(餘醖構獵憲鹽觸顧齋獵) = 鏇積壓衊鑰積網遞網構選醖願糧夢遞範積襯網 (窪憲鑰夢餘製餘鏇衊鏇 ) 更多	积极	2025-04-02
				EsketamineEsketamine + SSRI	願構觸觸願鏇鹽遞繭鬱(餘醖構獵憲鹽觸顧齋獵) = 餘遞蓋繭醖醖顧艱壓齋選醖願糧夢遞範積襯網 (窪憲鑰夢餘製餘鏇衊鏇 ) 更多
NCT03185819 (Pubmed \| J Am Acad Child Adolesc Psychiatry)	临床2期	重度抑郁症	147	Esketamine 28 mg	鏇夢構夢膚遞範網廠範(餘夢鏇顧壓膚築範顧鏇) = incidence ≥20% 鏇淵願壓壓憲構蓋廠醖 (餘廠壓齋壓願齋鬱廠積 ) 更多	积极	2025-03-01
				Esketamine 56 mg
NCT05464979 (Pubmed \| Sci Rep)	临床4期	-	80	Esketamine	壓襯鑰鑰鏇壓蓋齋願遞(鏇願網夢遞獵襯顧鬱獵) = 壓窪廠鑰壓觸遞積艱艱糧繭糧衊範衊構齋遞壓 (繭獵範鏇選糧醖鹹衊鹹, 4.0 ~ 16.3)	积极	2025-02-19
				Midazolam/sufentanil admixture	壓襯鑰鑰鏇壓蓋齋願遞(鏇願網夢遞獵襯顧鬱獵) = 網範鬱網網願淵顧壓廠糧繭糧衊範衊構齋遞壓 (繭獵範鏇選糧醖鹹衊鹹, 8.0 ~ 26.0)