The investigator's long-term goal is to conduct Naloxone for Opioid Associated out of Hospital Cardiac Arrest (NOPACA), a randomized, double blind, controlled trial to determine the efficacy of naloxone vs. placebo in Opioid Associated out of Hospital Cardiac Arrest. The investigative team plan to randomize patients in OHCA to early naloxone administration vs. placebo after initial resuscitation and measure ROSC and survival. Challenges to designing NOPACA include uncertainty regarding: 1) the available pool of participants and number of EMS agencies needed to meet enrollment targets; 2) acceptability among patients, EMS and Emergency Medicine provider stakeholders, and 3) estimates of the study outcomes needed for sample size estimates. Toward obtaining the necessary information to design NOPACA, the investigators propose a pilot RCT of participants at high risk for OA-OHCA to verify a reasonable recruitment rate; treatment fidelity and acceptability; and adequate retention and measurement of outcomes at follow up. The investigators propose incorporating hypothesis testing of the feasibility outcomes to determine progression to a definitive trial.

开始日期2026-11-01

申办/合作机构

The University of California, San Francisco

NCT07079241

/ Not yet recruitingN/A

REgion Sk?ne Preventing Overdose Through Naloxone Distribution With Emergency Runners: a Feasibility Study for a Model to Save Lives Through a Volunteer First Responder Service Providing Antidote Treatment in Opioid Overdose

Opioids are responsible for the greatest drug-related global health burden. Prevention and treatment programs for people with opioid use disorder are widely implemented, but further actions are required to reduce the mortality and morbidity caused by opioid use and dependence. We suggest a novel and unique approach with a volunteer first responder system for suspected opioid overdoses, integrated with national emergency call services. The idea derives from the success of volunteer first responder systems for out-of-hospital cardiac arrests. Several reports exist globally with results of increased survival rates, less complications and a beneficial time-gain to start of cardiopulmonary resuscitation before emergency services (like ambulance and fire fighters) arrival.
Our model aims to investigate feasibility, acceptability and safety of a smartphone-based volunteer first responder system for suspected opioid overdoses. The volunteer responders will be equipped with an emergency kit including two doses of the opioid antidote naloxone, which can reverse life-threatening respiratory arrest caused by intoxication of opioids. The responders will, prior to registration, accomplish an in-depth overdose and naloxone education, as well as a first aid course aligned with current European and Swedish resuscitation guidelines. The results will be collected through questionnaires to the responder participants, technical data from the responder application, and dispatcher, pre-medical/paramedical and hospital records among others. Both quantitative and qualitative methods will be used. The major question is if the model is feasible in alerting lay persons with naloxone to suspected overdose situations and successfully administer naloxone prior to emergency service arrival. Furthermore, experiences of safety during alerts among volunteer first responders and overdose victims will also be studied.
Our model is unique in its integration with emergency medical dispatch service along with overdose and first aid education prior to participant registration. The respiratory arrest of opioids is an acute life-threatening condition, which - in similarity to cardiac arrests - need emergent actions for survival. A reduced time to naloxone administration through volunteer first responders prior to ambulance arrival could save lives.

开始日期2025-09-01

申办/合作机构

Region Skåne Holding AB

[+3]

NCT04650841

/ Not yet recruiting早期临床1期IIT

The Role of the Opioid System in Placebo Effects on Pain and Social Rejection

The current study probes the involvement of the opioid system in placebo effects on social pain, using the opioid antagonist naloxone. 60 participants who recently experienced an unwanted breakup will experience rejection-related stimuli and receive painful heat and pressure stimuli during fMRI scanning. Participants will be randomized to receive either a naloxone or saline nasal spray, and be informed that the spray is either saline, or an effective pain and negative emotion reducing agent.

开始日期2025-09-01

申办/合作机构

Trustees of Dartmouth College

100 项与盐酸纳洛酮相关的临床结果

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100 项与盐酸纳洛酮相关的转化医学

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100 项与盐酸纳洛酮相关的专利（医药）

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28,326

项与盐酸纳洛酮相关的文献（医药）

2025-12-31·JOURNAL OF DERMATOLOGICAL TREATMENT

Hailey-Hailey disease successfully treated with naloxone: 2 case reports and Review of the literature on efficacy of opioid receptor antagonist in Hailey-Hailey disease patients

Review

作者: Sheng, Nan ; Wu, Jianbing ; Fang, Fang ; Duan, Zhimin ; Li, Chengrang ; Xu, Beilei ; Song, Hao ; Zheng, Junyou

BACKGROUND:

Hailey-Hailey disease (HHD), a genetic blistering disease, is caused by a mutation in a calcium transporter protein in the Golgi apparatus encoded by the ATP2C1 gene. Clinically, HHD is characterized by flaccid vesicles, blisters, erosions, fissures, and maceration mainly in intertriginous regions. Some patients remain refractory to conventional treatments. Previously, a series of reports have confirmed naltrexone as an effective option for those patients. However, in China, naltrexone is unavailable in some hospitals and unaffordable for some patients.

OBJECTIVE:

To confirm naloxone as a treatment option for HHD, and assess the efficacy rate and safety of naltrexone for patients with HHD.

METHODS:

Two patients with biopsy-proven HHD received naloxone (2 mg/d, via intravenous infusion). We followed up with the two patients, assessing the change of skin lesions and obtaining photographs. We searched the PubMed databases using the keywords 'Hailey-Hailey disease' or 'benign familial pemphigus', and 'naltrexone' or 'naloxone', and reviewed English publications of reports and analyzed the efficacy and safety of naltrexone.

RESULTS:

Two patients prescribed naloxone showed completely remission in two weeks without any adverse reactions. The total remission rate of naltrexone for HHD is approximately 80%, without severe adverse effects.

CONCLUSION:

Naltrexone is effective and safe in the treatment of HHD. Naloxone, an analog of naltrexone, can also effectively and safely treat HHD, potentially offering a new therapeutic option for patients with refractory HHD.

2025-12-31·Future Science OA

Evaluating cytidine, uridine, and gabapentin combinations for pain modulation and p-CREB expression in neuropathic model

Article

作者: Alzaghari, Lujain F. ; Qnais, Esam Y. ; Al-Najjar, Mohammad A. A. ; Barakat, Muna ; Chellappan, Dinesh Kumar ; Alqudah, Abdelrahim ; Athamneh, Rabaa Y.

AIMS:

To evaluate the analgesic and neuroprotective effects of cytidine, uridine, and gabapentin-administered alone and in combination-in models of diabetic neuropathy and formalin-induced acute and inflammatory pain.

MATERIALS & METHODS:

Oral doses of cytidine, uridine, and gabapentin (100 mg/kg each) were administered to rats with streptozotocin-induced diabetic neuropathy and in a formalin test model. Behavioral responses were recorded at 30, 60, and 120 minutes following treatment after five weeks of diabetes induction. Spinal cord p-CREB expression was measured to assess molecular changes, and pretreatments with naloxone, yohimbine, and methysergide were employed to explore opioid, adrenergic, and serotonergic contributions.

RESULTS:

All treatments significantly reduced formalin-induced pain in both acute and inflammatory phases (p < 0.05; p < 0.001) and increased mechanical pain thresholds in the diabetic neuropathy model at all-time points (p < 0.05). Combination therapy proved more effective than gabapentin alone (p < 0.05) and was associated with decreased spinal p-CREB levels, indicating altered anti-nociceptive signaling.

CONCLUSIONS:

The combined use of cytidine, uridine, and gabapentin enhances analgesia and neuroprotection compared to monotherapy, supporting its potential as a novel, analgesic-free treatment strategy for diabetic neuropathy.

2025-11-01·NEUROPHARMACOLOGY

Antibiotic treatment improves gut dysbiosis and depression-like behavior induced by morphine withdrawal

Article

作者: Gu, Bo-Yuan ; Liu, Jun-Lin ; Yu, Dong-Yu ; Zhang, Yu-Xiang ; Gao, Jing-Qi ; Yan, Chun-Xia ; Gao, Fei-Fei ; Shen, Meng-Qing ; Yang, Xi-Xi

Opioid withdrawal poses a significant neuropsychiatric challenge, notably contributing to the onset of depression. Depression intertwines with gut flora richness and diversity, frequently coinciding with synaptic plasticity alterations in the brain. Gut microbiota dysbiosis potentially contributes to withdrawal-triggered depression via gut-brain axis. This research delves into the impact of antibiotic-induced gut microbiota alteration on behavioral and synaptic protein variations in mice subjected to morphine withdrawal-induced depression. A murine model was established using escalating doses of morphine followed by naloxone-precipitated withdrawal. Depression-like behaviors were assessed through tail suspension, sucrose preference, forced swimming tests, while histopathology evaluated ileocolonic inflammation. Synaptic markers, Synaptophysin (SYP) and Synapsin 1 (SYN1), in the hippocampus were analyzed via Western blotting, and gut microbiota composition was assessed through 16S rRNA sequencing. An antibiotic intervention model was employed to explore microbiota-dependent mechanisms. Morphine withdrawal induced characteristic depression-like behaviors, including prolonged immobility in forced swimming and reduced sucrose preference. Microbiota diversity metrics demonstrated significant declines in α-diversity. Histological analysis revealed marked inflammatory infiltration in ileal tissues, accompanied by reduction in hippocampal SYP expression. Antibiotic administration attenuated behavioral impairments, mitigated gut dysbiosis, reduced intestinal inflammation, and partially rescued SYP expression. These findings establish that morphine withdrawal induces intestinal dysbiosis, hippocampal synaptic plasticity deficits and depression-like behaviors, which are reversible through microbiota modulation. The results highlight the antibiotic treatment as a potential therapy for opioid withdrawal sequelae.

619

项与盐酸纳洛酮相关的新闻（医药）

2025-08-10

·信狐药迅

石药集团司美格鲁肽和君实生物特瑞普利单抗提交2.2类新适应症上市申请|新受理（8.4-8.10）

本周药品注册受理数据，分门别类呈现，一目了然。(8.4-8.10）新药上市申请药品名称企业注册分类受理号司美格鲁肽注射液石药集团百克(山东)生物制药股份有限公司2.2CXHS2500090司美格鲁肽注射液石药集团百克(山东)生物制药股份有限公司2.2CXHS2500091特瑞普利单抗注射液上海君实生物医药科技股份有限公司2.2CXSS2500080特瑞普利单抗注射液上海君实生物医药科技股份有限公司2.2CXSS2500079 新药临床申请药品名称企业注册分类受理号HRS-7058片山东盛迪医药有限公司1CXHL2500832HRS-7058片山东盛迪医药有限公司1CXHL2500831HRS-7058胶囊山东盛迪医药有限公司1CXHL2500830HRS-7058胶囊山东盛迪医药有限公司1CXHL2500829HRS-4642注射液上海恒瑞医药有限公司1CXHL2500827HRS-4642注射液上海恒瑞医药有限公司1CXHL2500826TQB3122胶囊正大天晴药业集团股份有限公司1CXHL2500825TQB3122胶囊正大天晴药业集团股份有限公司1CXHL2500824HRS-4642注射液上海恒瑞医药有限公司1CXHL2500821HRS-4642注射液上海恒瑞医药有限公司1CXHL2500820注射用TQB3142正大天晴药业集团股份有限公司1CXHL2500819HECN30227注射液广东东阳光药业股份有限公司1CXHL2500818ZN-F-6418胶囊苏州赞荣医药科技有限公司1CXHL2500817ZN-F-6418胶囊苏州赞荣医药科技有限公司1CXHL2500816IPG7236片南京艾美斐生物医药科技有限公司1CXHL2500814IPG7236片南京艾美斐生物医药科技有限公司1CXHL2500813HRS-2430注射液江苏恒瑞医药股份有限公司1CXHL2500810HRS-2430注射液江苏恒瑞医药股份有限公司1CXHL2500811SYH2061注射液石药集团中奇制药技术(石家庄)有限公司1CXHL2500812FNX020片成都凡诺西生物医药科技有限公司1CXHL2500805FNX020片成都凡诺西生物医药科技有限公司1CXHL2500804DM2080贴北京德默高科医药技术有限公司2.2CXHL2500807DM2080贴北京德默高科医药技术有限公司2.2CXHL2500808多替拉韦拉米夫定替诺福韦片上海迪赛诺医药集团股份有限公司2.3CXHL2500806苹果酸法米替尼胶囊江苏恒瑞医药股份有限公司2.4CXHL2500828羟乙磺酸达尔西利片江苏恒瑞医药股份有限公司2.4CXHL2500823羟乙磺酸达尔西利片江苏恒瑞医药股份有限公司2.4CXHL2500822瑞维鲁胺片江苏恒瑞医药股份有限公司2.4CXHL2500815注射用西罗莫司(白蛋白结合型)石药集团中奇制药技术(石家庄)有限公司2.4CXHL250080920价肺炎球菌多糖结合疫苗艾美探索者生命科学研发有限公司2.2CXSL2500667注射用SHR-1826苏州盛迪亚生物医药有限公司1CXSL2500689注射用SHR-A2009苏州盛迪亚生物医药有限公司1CXSL2500688注射用FH-006上海甫弘生物医药有限公司1CXSL2500687SHR-4610注射液上海盛迪医药有限公司1CXSL2500686注射用SHR-9839 (sc)苏州盛迪亚生物医药有限公司1CXSL2500685注射用SHR-A2102苏州盛迪亚生物医药有限公司1CXSL2500683注射用SHR-A2102苏州盛迪亚生物医药有限公司1CXSL2500682注射用BL-M24D1成都百利多特生物药业有限责任公司1CXSL2500680QX029N注射液江苏荃信生物医药股份有限公司1CXSL2500679IBI363信达生物制药(苏州)有限公司1CXSL2500672IBI363信达生物制药(苏州)有限公司1CXSL2500671SCTC21C注射液神州细胞工程有限公司1CXSL2500670GK01细胞注射液北京极客基因科技有限公司1CXSL2500669JH032注射液百泰生物药业有限公司1CXSL2500668SHR-1701注射液苏州盛迪亚生物医药有限公司1CXSL2500677SHR-7367注射液上海恒瑞医药有限公司1CXSL2500675注射用GenSci139长春金赛药业有限责任公司1CXSL2500673注射用HS-20093上海翰森生物医药科技有限公司1CXSL2500666异体自然杀伤(NK)细胞注射液苏州迈德通医药科技有限公司1CXSL2500665异体自然杀伤(NK)细胞注射液苏州迈德通医药科技有限公司1CXSL2500664异体自然杀伤(NK)细胞注射液苏州迈德通医药科技有限公司1CXSL2500663HM2002注射液上海环码生物医药有限公司1CXSL2500662注射用间充质干细胞(脐带)天津昂赛细胞基因工程有限公司1CXSL2500661IBI3026信达生物科技有限公司1CXSL2500660SYS6002石药集团巨石生物制药有限公司1CXSL2500654IBI3009信达生物制药(苏州)有限公司1CXSL2500657SYS6043石药集团巨石生物制药有限公司1CXSL2500656SYS6010石药集团巨石生物制药有限公司1CXSL2500658DP303c注射液石药集团巨石生物制药有限公司1CXSL2500655QLS2309注射液齐鲁制药有限公司1CXSL2500659注射用瑞康曲妥珠单抗苏州盛迪亚生物医药有限公司2.2CXSL2500684阿得贝利单抗注射液上海盛迪医药有限公司2.2CXSL2500681SHR-8068注射液苏州盛迪亚生物医药有限公司2.2CXSL2500678贝伐珠单抗注射液苏州盛迪亚生物医药有限公司2.2CXSL2500676阿得贝利单抗注射液上海盛迪医药有限公司2.2CXSL2500674 仿制药申请药品名称企业注册分类受理号格隆溴铵注射液河南普瑞药业有限公司3CYHS2502894格隆溴铵注射液河南普瑞药业有限公司3CYHS2502893艾拉戈克钠片南京正大天晴制药有限公司3CYHS2502892艾拉戈克钠片南京正大天晴制药有限公司3CYHS2502891盐酸纳洛酮注射液云南药科院生物医药股份有限公司3CYHS2502890氯化钾缓释片澳美制药(海南)有限公司3CYHS2502865西咪替丁片河北新石制药有限公司3CYHS2502862盐酸普萘洛尔片寿光富康制药有限公司3CYHS2502861吸入用盐酸丙卡特罗溶液成都康泰源医药科技有限责任公司3CYHS2502860吸入用盐酸丙卡特罗溶液成都康泰源医药科技有限责任公司3CYHS2502859醋酸葡萄糖维持液西安万隆制药股份有限公司3CYHS2502880注射用奈达铂吉斯美(武汉)制药有限公司3CYHS2502879复方匹可硫酸钠口服溶液湖南科伦制药有限公司3CYHS2502878注射用奈达铂吉斯美(武汉)制药有限公司3CYHS2502877法莫替丁片安若维他药业泰州有限公司3CYHS2502875阿仑膦酸钠口服溶液北京民康百草医药科技有限公司3CYHS2502869中性低钙腹膜透析液(碳酸氢盐-G1.5%)成都青山利康药业股份有限公司3CYHS2502887对乙酰氨基酚维生素C泡腾片新乡市常乐制药有限责任公司3CYHS2502868中性低钙腹膜透析液(碳酸氢盐-G1.5%)成都青山利康药业股份有限公司3CYHS2502886中性低钙腹膜透析液(碳酸氢盐-G1.5%)成都青山利康药业股份有限公司3CYHS2502885注射用氨苄西林钠/氯化钠注射液湖南科伦制药有限公司3CYHS2502884注射用氨苄西林钠/氯化钠注射液湖南科伦制药有限公司3CYHS2502883醋酸葡萄糖维持液西安万隆制药股份有限公司3CYHS2502881酮咯酸氨丁三醇片浙江华海制药科技有限公司3CYHS2502900氨溴特罗口服溶液千海始德堂(鹤壁)制药有限公司3CYHS2502856氢溴酸加兰他敏口服溶液(Ⅱ)湖北民康制药有限公司3CYHS2502854吡拉西坦注射液华中药业股份有限公司3CYHS2502825吡拉西坦注射液华中药业股份有限公司3CYHS2502824重酒石酸去甲肾上腺素注射液广东南国药业有限公司3CYHS2502844注射用盐酸多西环素江苏联环药业股份有限公司3CYHS2502839异丙托溴铵沙丁胺醇吸入喷雾剂南昌谷森生物制药有限公司3CYHS2502820盐酸溴己新口服溶液江西科为制药有限公司3CYHS2502813依巴斯汀口服溶液重庆希尔安药业有限公司3CYHS2502814盐酸肾上腺素注射液辰欣药业股份有限公司3CYHS2502823注射用硫酸多黏菌素B河北锐健医药科技有限公司3CYHS2502821聚普瑞锌颗粒福建海西新药创制股份有限公司3CYHS2502808倍他米松磷酸钠注射液安徽均大高科医药科技有限公司3CYHS2502807中性腹膜透析液(乳酸盐-G2.5%)石家庄四药有限公司3CYHS2502806中性低钙腹膜透析液(乳酸盐-G2.5%)石家庄四药有限公司3CYHS2502805硫酸镁注射液酒泉大得利制药股份有限公司3CYHS2502804法莫替丁注射液绪必迪药业(沧州)有限公司3CYHS2502800苯甲酸阿格列汀片石家庄四药有限公司4CYHS2502905来特莫韦注射液浙江海正药业股份有限公司4CYHS2502904复方氨基酸(15)双肽(2)注射液西安力邦制药有限公司4CYHS2502903苯磺酸左氨氯地平片辽宁康博士制药有限公司4CYHS2502902苯磺酸左氨氯地平片辽宁康博士制药有限公司4CYHS2502901注射用头孢他啶阿维巴坦钠浙江普洛巨泰药业有限公司4CYHS2502899乙酰半胱氨酸注射液武汉先路医药科技股份有限公司4CYHS2502898乳果糖口服溶液浙江康恩贝制药股份有限公司4CYHS2502896乳果糖口服溶液浙江康恩贝制药股份有限公司4CYHS2502895非奈利酮片浙江贝得药业有限公司4CYHS2502889非奈利酮片浙江贝得药业有限公司4CYHS2502888美阿沙坦钾片江苏天士力帝益药业有限公司4CYHS2502864美阿沙坦钾片江苏天士力帝益药业有限公司4CYHS2502863替尔泊肽注射液礼来苏州制药有限公司4CYHS2502874磷酸奥司他韦胶囊海南赛科药业有限公司4CYHS2502873替尔泊肽注射液礼来苏州制药有限公司4CYHS2502872替尔泊肽注射液礼来苏州制药有限公司4CYHS2502871替尔泊肽注射液礼来苏州制药有限公司4CYHS2502870腹膜透析液(乳酸盐-G4.25%)辰欣药业股份有限公司4CYHS2502867注射用甲苯磺酸奥马环素湖南科伦制药有限公司4CYHS2502882氟马西尼注射液浙江华海药业股份有限公司4CYHS2502897左卡尼汀口服溶液烟台万润药业有限公司4CYHS2502857瑞维那新吸入溶液广东洛斯特制药有限公司4CYHS2502855他克莫司软膏山东辰欣佛都药业股份有限公司4CYHS2502853他克莫司软膏山东辰欣佛都药业股份有限公司4CYHS2502852注射用醋酸卡泊芬净浙江华海药业股份有限公司4CYHS2502866瑞舒伐他汀依折麦布片(Ⅰ)陕西白鹿制药股份有限公司4CYHS2502858脂肪乳(10%)/氨基酸(15)/葡萄糖(20%)注射液沈阳海思科制药有限公司4CYHS2502876莫匹罗星软膏上海理想制药有限公司4CYHS2502835莫匹罗星软膏上海理想制药有限公司4CYHS2502834褪黑素颗粒宿州亿帆药业有限公司4CYHS2502833雌二醇片/雌二醇地屈孕酮片复合包装华润紫竹药业有限公司4CYHS2502832雌二醇片/雌二醇地屈孕酮片复合包装华润紫竹药业有限公司4CYHS2502831舒更葡糖钠注射液石药集团欧意药业有限公司4CYHS2502830注射用头孢哌酮钠舒巴坦钠/氯化钠注射液湖南科伦制药有限公司4CYHS2502829注射用头孢哌酮钠舒巴坦钠/氯化钠注射液湖南科伦制药有限公司4CYHS2502828沙库巴曲缬沙坦钠片北京双鹭药业股份有限公司4CYHS2502827沙库巴曲缬沙坦钠片北京双鹭药业股份有限公司4CYHS2502826丁二磺酸腺苷蛋氨酸肠溶片成都赛璟生物医药科技有限公司4CYHS2502845达格列净二甲双胍缓释片(IV)上海现代制药股份有限公司4CYHS2502843达格列净二甲双胍缓释片(I)上海现代制药股份有限公司4CYHS2502842乙酰半胱氨酸注射液浙江恒研医药科技有限公司4CYHS2502841盐酸乐卡地平片福建省宝诺医药研发有限公司4CYHS2502840达格列净二甲双胍缓释片(Ⅰ)浙江普洛康裕制药有限公司4CYHS2502838头孢托仑匹酯颗粒沐源(安徽)药业有限公司4CYHS2502837头孢托仑匹酯颗粒沐源(安徽)药业有限公司4CYHS2502836阿达帕林凝胶广州乐宓医药科技有限公司4CYHS2502851苯磺酸美洛加巴林片华北制药股份有限公司4CYHS2502850富马酸伏诺拉生片湖南迪诺制药股份有限公司4CYHS2502849罗沙司他胶囊杭州仟源保灵药业有限公司4CYHS2502848罗沙司他胶囊杭州仟源保灵药业有限公司4CYHS2502847盐酸罗哌卡因注射液峨眉山通惠制药有限公司4CYHS2502846非奈利酮片山东百诺医药股份有限公司4CYHS2502822双氯芬酸钠缓释片湖南九典制药股份有限公司4CYHS2502819羟考酮纳洛酮缓释片甘肃农垦药物碱厂有限公司4CYHS2502818左乙拉西坦片山东普瑞曼药业有限公司4CYHS2502815左乙拉西坦片山东普瑞曼药业有限公司4CYHS2502816左乙拉西坦片山东普瑞曼药业有限公司4CYHS2502817精氨酸布洛芬颗粒海南赛立克药业有限公司4CYHS2502812注射用硫酸艾沙康唑湖南华纳大药厂股份有限公司4CYHS2502811氧长春巨洋气体有限责任公司4CYHS2502810盐酸二甲双胍缓释片白云山东泰商丘药业有限公司4CYHS2502809阿托伐他汀钙片宁波大红鹰药业股份有限公司4CYHS2502803阿托伐他汀钙片宁波大红鹰药业股份有限公司4CYHS2502802碘普罗胺注射液鲁南贝特制药有限公司4CYHS2502801硫酸氨基葡萄糖胶囊郑州韩都药业集团有限公司4CYHS2502799西妥昔单抗注射液广东安普泽生物医药股份有限公司3.3CXSS2500081破伤风人免疫球蛋白广东丹霞生物制药有限公司3.4CXSS2500078注射用多黏菌素E甲磺酸钠南京正科医药股份有限公司3CYHL2500139普瑞巴林缓释片宜昌人福药业有限责任公司3CYHL2500138普瑞巴林缓释片宜昌人福药业有限责任公司3CYHL2500137精蛋白人胰岛素混合注射液(30R)恒敬合创生物医药(浙江)有限公司3.3CXSL2500653 进口申请药品名称企业注册分类受理号泊沙康唑口服混悬液Hetero Labs Limited5.2JYHS2500039司来帕格片MSN LABORATORIES PRIVATE LIMITED5.2JYHS2500038司来帕格片MSN LABORATORIES PRIVATE LIMITED5.2JYHS2500037司来帕格片MSN LABORATORIES PRIVATE LIMITED5.2JYHS2500036司来帕格片MSN LABORATORIES PRIVATE LIMITED5.2JYHS2500035MK-1084片Merck Sharp & Dohme LLC1JXHL2500210MK-1084片Merck Sharp & Dohme LLC1JXHL2500209MK-4280A注射液Merck Sharp & Dohme LLC1JXSL2500143ALXN1920注射液Alexion Pharmaceuticals, Inc.1JXSL2500142BAY 3401016 注射液Bayer AG1JXSL2500141AZD0486AstraZeneca AB1JXSL2500139AZD0486AstraZeneca AB1JXSL2500138Lebrikizumab注射液Eli Lilly and Company2.2JXSL2500140 中药相关申请药品名称企业注册分类受理号川芎定痛颗粒北京阳光合和中医药科技开发有限公司1.1CXZL2500064黄葶肺心平颗粒重庆希尔安药业有限公司1.1CXZL2500063杜仲木脂素胶囊江西普正制药股份有限公司1.2CXZL2500061杜仲木脂素提取物江西普正制药股份有限公司1.2CXZL2500060小儿肺热咳喘口服液黑龙江葵花药业股份有限公司2.3CXZL2500062清肺汤颗粒江西药都樟树制药有限公司3.1CXZS2500032颈舒颗粒黄山精制药业有限公司4CYZS2500008 注：绿色字体部分为潜在首仿品种；不包含原料药、医用氧、注射用水、氯化钠或葡萄糖注射液等申请，不包含再注册、一次性进口、技术转移、复审申请。

申请上市临床申请

2025-08-01

·EndPoints

FDA requires opioid label updates to highlight long-term risks

The FDA on Thursday required new safety label updates for all opioids to “further emphasize and characterize the risks associated with long-term use,” following a May advisory committee meeting that discussed new postmarketing data. Specifically, the FDA told companies to pull the phrase “extended treatment period” in the Indications and Usage section of their labels, “to avoid misinterpretation that there are data to support safety and efficacy of opioid analgesics over an indefinitely long duration.” The updates also clarify that extended-release/long-acting opioids “should only be used” when alternatives, such as immediate-release opioids, “are inadequate to manage severe and persistent pain, and to emphasize the importance of avoiding rapid dose reduction or abrupt discontinuation in patients who may be physically dependent on opioid pain medicines,” the agency said in the update . In May, panelists on an FDA advisory committee offered mixed takes on whether the agency should update opioid labels with data from two required postmarketing studies. Some panelists found the studies’ findings difficult to interpret and not generalizable to current medical practice, since they were several years old. The FDA opted to add that information to the labels, which shows that over a 12-month period, approximately 1% to 6% of participants across the two postmarket groups newly met the criteria for addiction, and about 9% to 22% of participants newly met criteria for prescription opioid abuse and misuse. The FDA first approved extended-release/long-acting opioids in 1987. In 2013, it sought five additional postmarketing studies after concluding that more data were needed regarding the serious risks of misuse, abuse, addiction, overdose and death associated with long-term use. Allergan, Endo Pharmaceuticals, Hikma, Janssen, Mallinckrodt, Pfizer and Purdue Pharma were among those tasked with conducting the four observational studies and one prospective clinical trial. The agency also said it’s requiring label updates on which opioid overdose reversal agents are currently available. The FDA in March 2023 approved the first over-the-counter nasal spray version of naloxone, and in August 2024, FDA approved the first nalmefene hydrochloride auto-injector to treat opioid overdose in adults and children 12 years and older. Manufacturers must further “emphasize that higher doses are associated with increased risk of serious harm, and that the risks of serious harms persist over the course of therapy,” the FDA said.

上市批准

2025-07-29

·GlobeNewswire-Health Care

Branded Legacy, Inc. Signs Letter of Intent to Acquire Bio-Legacy Evaluative Group, Advancing Innovations in Intranasal Drug Delivery

Strategic Acquisition Positions Branded Legacy to Enter the Growing Naloxone and Vaccine Markets, Enhancing Shareholder Value; Leadership Transition Planned with Amin Janmohamed as New CEO and ChairmanMELBOURNE, Fla., July 29, 2025 (GLOBE NEWSWIRE) -- via IBN -- Branded Legacy, Inc. (OTC: BLEG), a diversified holdings company focused on innovative health and wellness solutions, today announced the execution of a non-binding Letter of Intent (LOI) to acquire Bio-Legacy Evaluative Group, a pioneering health innovation company specializing in advanced intranasal drug delivery technologies. The LOI, fully executed by both parties, outlines the proposed acquisition of 100% of Bio-Legacy Evaluative Group's equity interests, assets, intellectual property, and operations in exchange for $1.5 million worth of Branded Legacy's Preferred D stock. This strategic move aligns with Branded Legacy's commitment to expanding its portfolio into high-growth sectors addressing global health crises, such as addictions and vaccine accessibility. Bio-Legacy Evaluative Group, led by President & CEO Amin Janmohamed, has assembled a world-class team of experts including Prof. Eran Bendavid, MD (Research Lead, Stanford Professor), Prof. Sonal Singh, MD (Medical Lead, UMass Professor), Prof. Martin Schechter, MD, PhD (Scientific Advisor), and others renowned in addiction medicine, biostatistics, and business development. Bio-Legacy Evaluative Group's patented all-in-one intranasal naloxone delivery device addresses key limitations in the current market, including high costs, inconsistent dosing, and complex systems. By simplifying manufacturing and enhancing dose precision, the technology aims to make naloxone more accessible amid a projected market growth from $371 million in 2022 to over $1.16 billion by 2032, at a CAGR of approximately 11.9%. Additionally, Bio-Legacy Evaluative Group's platform enables nasal administration of compounds previously constrained by physical, chemical, or manufacturing challenges, opening new opportunities in vaccines, cold-chain dependent medications and medications unstable in solution. This could facilitate faster pandemic responses, self-use vaccination, and improved logistics for underserved regions globally. Under the terms of the LOI, the Preferred D stock issued as consideration will be subject to a two-year holding period and convertible only upon Bio-Legacy Evaluative Group achieving a $40 million post-acquisition valuation, as determined by an independent third-party firm. Branded Legacy has also committed to a $1 million research and development budget for Bio-Legacy Evaluative Group's initiatives, effective upon the company's uplisting to the OTCQB market tier and achieving a minimum share price of $0.01 per share. The parties intend to close the transaction within 14 days, subject to due diligence, definitive agreements, and necessary approvals. Upon completion, Bio-Legacy Evaluative Group will become a wholly-owned subsidiary of Branded Legacy, integrating its innovative pipeline—including manufacturing prototyping targeted for Q3 2025, clinical trials in 2026, and market readiness for the naloxone device by Q1 2027—to drive revenue growth. Projected revenues for Bio-Legacy Evaluative Group under average growth scenarios could reach up to $183.3 million by Year 5. Following the closing of the acquisition, Amin Janmohamed will assume the roles of CEO and Chairman of Branded Legacy, Inc., leveraging his experience as a pharmacist, clinical studies investigator, and executive to guide the combined entity's strategic direction. "We are thrilled to announce this LOI with Bio-Legacy Evaluative Group, a company at the forefront of tackling the escalating global addictions crisis through cutting-edge technology," said Robison, CEO of Branded Legacy, Inc. "This acquisition not only bolsters our health innovation capabilities but also positions us to capitalize on expanding markets like naloxone and intranasal vaccines, ultimately creating long-term value for our shareholders." Amin Janmohamed, CEO of Bio-Legacy Evaluative Group, added, "Partnering with Branded Legacy represents a significant milestone in our mission to make life-saving treatments more effective and accessible. Their resources and vision will accelerate our development timeline and help us reach patients worldwide who need these solutions most. I am excited to step into the role of CEO post-acquisition to lead this next phase of growth." The LOI includes standard provisions for exclusivity during negotiations and confidentiality. The transaction is expected to enhance Branded Legacy's competitive edge in the biotech and medical device sectors. For more information about Branded Legacy, Inc., visit www.brandedlegacy.com. About Branded Legacy, Inc. Branded Legacy, Inc. (OTC: BLEG) is a diversified holdings company dedicated to acquiring and growing innovative businesses in the health, wellness, and technology sectors. With a focus on strategic partnerships and shareholder value, Branded Legacy aims to deliver cutting-edge solutions that address real-world challenges. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements are based on current expectations and beliefs and involve risks and uncertainties that could cause actual results to differ materially. Branded Legacy undertakes no obligation to update these statements except as required by law. Investor Relations: Branded Legacy, Inc. Email: info@brandedlegacy.com Phone: 877-814-4188

并购

100 项与盐酸纳洛酮相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D01340	盐酸纳洛酮	A06AH04 V03AB15	DB01183

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
急性淋巴细胞白血病	加拿大	Hikma Pharmaceuticals LLC	2025-02-01
阿片类药物过量	美国	Emergent Devices, Inc.	1971-04-13

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
阿片滥用	临床前	美国	Consegna Pharma, Inc.	-

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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


NCT03751111 (CTgov)	临床1/2期	瘙痒 \| 肛门瘙痒	126	Naloxone (Naloxone)	願觸網齋糧窪糧鹽願製(積淵鏇繭築選網餘觸窪) = 觸鬱餘選醖鏇簾憲壓糧憲觸選遞齋衊鏇築築蓋 (選範築鹹構窪網壓夢願, 2.15) 更多	-	2025-04-20
				Placebo (Placebo)	願觸網齋糧窪糧鹽願製(積淵鏇繭築選網餘觸窪) = 顧糧繭壓壓艱窪鏇鏇製憲觸選遞齋衊鏇築築蓋 (選範築鹹構窪網壓夢願, 1.99) 更多
NCT04473950 (CTgov)	临床1期	阿片相关性障碍 \| 慢性疼痛	10	Placebo+Naloxone Hydrochloride (Pain Group)	簾蓋簾衊糧鏇願構蓋夢(壓鹹獵衊範蓋鑰獵壓廠) = 製繭淵糧壓築鑰遞觸憲製觸艱鹹廠遞選壓積襯 (鹹範觸範壓夢遞鬱鏇艱, 1.17) 更多	-	2025-03-26
				Placebo+Naloxone Hydrochloride (No Pain Group)	簾蓋簾衊糧鏇願構蓋夢(壓鹹獵衊範蓋鑰獵壓廠) = 製網鹹遞製獵襯淵醖蓋製觸艱鹹廠遞選壓積襯 (鹹範觸範壓夢遞鬱鏇艱, 0.92) 更多
NCT03176316 (FusionIleus, CTgov)	临床4期	肠阻塞	53	Naloxone	醖窪願鑰鑰遞鏇築壓網 = 鑰選選製糧膚願觸網顧構醖選艱糧艱鑰膚鹹網 (餘築膚選網獵齋網觸膚, 餘鏇獵壓鹹鏇襯衊顧鏇 ~ 遞醖製廠築鹹範夢積積) 更多	-	2024-07-01
NCT03149770 (CTgov)	临床2期	1型糖尿病 \| 低血糖	30	Naloxone (Naloxone)	構構醖餘鬱網膚蓋夢壓(築鏇築淵簾淵築顧鏇窪) = 蓋築鏇淵衊廠網鑰壓顧簾遞艱鹽遞艱壓淵糧鹽 (憲顧選觸艱襯醖蓋願艱, 12) 更多	-	2024-04-16
				placebo (Placebo)	構構醖餘鬱網膚蓋夢壓(築鏇築淵簾淵築顧鏇窪) = 壓膚範淵網蓋壓艱繭簾簾遞艱鹽遞艱壓淵糧鹽 (憲顧選觸艱襯醖蓋願艱, 13) 更多
NCT04764630 (Pubmed \| JAMA Netw Open)	临床1期	阿片类药物过量	21	1 dose at 0, 2.5, 5, and 7.5 minutes	糧積糧醖夢鏇鹽鏇顧願(艱願鏇構選衊築襯製構) = 鹹醖襯願醖壓顧鹹淵襯遞鑰顧觸築窪構餘顧鹽 (衊觸廠鹽鑰獵積餘膚製 )	-	2024-01-23
				2 doses at 0 and 2.5 minutes	糧積糧醖夢鏇鹽鏇顧願(艱願鏇構選衊築襯製構) = 夢網淵蓋艱淵繭製糧願遞鑰顧觸築窪構餘顧鹽 (衊觸廠鹽鑰獵積餘膚製 )
NCT03570099 (Pubmed \| BMJ Open)	N/A	阿片类药物过量	-	Take-home naloxone distribution	積築構餘淵壓齋艱選夢(淵鑰積積選範襯鏇範憲) = 簾糧範鹹廠淵網壓夢襯繭淵範鬱夢鏇選鏇窪餘 (鑰選窪淵襯遞鏇壓簾網 )	-	2024-01-01
				intranasal naloxone (Control period (2013-2017))	積築構餘淵壓齋艱選夢(淵鑰積積選範襯鏇範憲) = 蓋餘範蓋鑰餘觸鹽淵鹹繭淵範鬱夢鏇選鏇窪餘 (鑰選窪淵襯遞鏇壓簾網 )
NCT02700048 (CTgov)	临床1/2期	1型糖尿病 \| 低血糖 \| 意识丧失	11	Intra-nasal saline (Placebo)	廠遞醖壓夢鹽艱鏇醖鏇(廠觸觸淵製鏇醖膚遞衊) = 鑰齋膚膚遞夢鏇醖願壓淵糧獵網夢鏇簾淵鹹憲 (選範鹹蓋鑰願鑰廠襯鏇, 鹹夢積鬱繭糧選鑰糧願 ~ 簾壓構範艱遞壓鹽鏇窪) 更多	-	2023-03-27
				intra-nasal naloxone (Treatment With Intra-nasal Naloxone)	廠遞醖壓夢鹽艱鏇醖鏇(廠觸觸淵製鏇醖膚遞衊) = 艱齋鹽觸鏇獵醖範顧構淵糧獵網夢鏇簾淵鹹憲 (選範鹹蓋鑰願鑰廠襯鏇, 觸網夢憲選顧夢鏇選窪 ~ 醖膚艱鹹積鹹鹹鬱鑰壓) 更多
NCT04713709 (Corporate Publications) 人工标引	临床1期	阿片类药物过量	56	FMXIN001	網遞淵鬱選選遞積網鹹(淵窪遞鑰醖淵鏇艱憲壓) = 鹹鏇夢遞淵鹽簾鹽糧夢遞網鏇艱膚衊遞構鬱獵 (製構餘淵夢夢選鏇選壓 ) 更多	相似	2022-07-28
				NARCAN	網遞淵鬱選選遞積網鹹(淵窪遞鑰醖淵鏇艱憲壓) = 鑰鬱繭獵簾積願齋窪襯遞網鏇艱膚衊遞構鬱獵 (製構餘淵夢夢選鏇選壓 ) 更多
NCT04764630 (CTgov)	临床1期	-	21	naloxone (A. Four Naloxone Nasal Spray Doses (1 Every 2.5 Min))	齋鏇醖築鏇築憲鏇簾齋(衊繭鏇膚廠窪網餘艱鹹) = 鹹淵範鹽淵築構鑰製獵壓壓糧獵膚醖繭窪壓鬱 (襯窪鹽鏇選構膚鏇廠鬱, 70) 更多	-	2022-07-15
				naloxone (C. Two Naloxone Nasal Spray Doses (1 Every 2.5 Min))	齋鏇醖築鏇築憲鏇簾齋(衊繭鏇膚廠窪網餘艱鹹) = 築構積窪壓廠蓋艱膚獵壓壓糧獵膚醖繭窪壓鬱 (襯窪鹽鏇選構膚鏇廠鬱, 159) 更多
NCT02805972 (BEE, CTgov)	临床2期	肥胖	41	Placebo+Naloxone (Placebo, Then Naloxone)	廠遞衊艱艱選繭廠觸願(簾選廠齋壓構鏇遞夢窪) = 繭壓糧積艱顧膚壓壓鑰範餘糧鑰鑰範窪衊觸顧 (鬱築鹹簾鑰鏇網範淵構, 襯憲網鹹觸獵繭醖齋鏇 ~ 選願壓簾窪餘鹽衊廠淵) 更多	-	2021-11-03
				Placebo+Naloxone (Naloxone, Then Placebo)	廠遞衊艱艱選繭廠觸願(簾選廠齋壓構鏇遞夢窪) = 醖壓範鹹鏇鏇醖廠顧繭範餘糧鑰鑰範窪衊觸顧 (鬱築鹹簾鑰鏇網範淵構, 醖蓋艱衊憲製襯膚築觸 ~ 鬱艱願廠範獵鏇構製衊) 更多