Optimization of the Efficacy and Safety of Nalbuphine Combined with Esketamine for Post-Cesarean Analgesia: A Randomized, Double-Blind, Parallel-Controlled Clinical Study

开始日期2025-07-01

申办/合作机构-

ChiCTR2500101701

/ Recruiting临床1期IIT

A Randomized, Controlled, Double-Blind Trial Investigating the Efficacy of Different Doses of Nalbuphine Combined with Sufentanil for Postoperative Patient-Controlled Intravenous Analgesia After Laparoscopic Colorectal Cancer Surgery

开始日期2025-05-05

申办/合作机构

云南省中医医院

CTRI/2025/03/082843

/ Not yet recruiting临床4期

Comparison of nalbuphine and dexmedetomidine as an adjuvant to 0.5% ropivacaine in USG guided supraclavicular plexus block in upper limb surgeries: A randomised double blind prospective study. - NIL

开始日期2025-04-30

申办/合作机构-

100 项与盐酸纳布啡相关的临床结果

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100 项与盐酸纳布啡相关的转化医学

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100 项与盐酸纳布啡相关的专利（医药）

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1,782

项与盐酸纳布啡相关的文献（医药）

2025-11-01·SPECTROCHIMICA ACTA PART A-MOLECULAR AND BIOMOLECULAR SPECTROSCOPY

A novel ultrasensitive derivatization-free synchronous fluorescence approach for the simultaneous analysis of propofol and nalbuphine in human plasma and dosage forms: Compliance with greenness and blueness metrics

Article

作者: Magdy, Galal ; El-Maghrabey, Mahmoud ; Mansour, Fotouh R ; Alshehri, Sultan ; Al-Khateeb, Lateefa A ; Radwan, Aya Saad ; El Hamd, Mohamed A ; Alsehli, Bandar R ; Mahdi, Wael A

This study presents a very sensitive and eco-friendly synchronous spectrofluorimetric method for the simultaneous quantification of propofol (PRP) and nalbuphine (NAL) for the first time. The technique used the intrinsic fluorescence characteristics of the two drugs, providing enhanced sensitivity and specificity. The two drugs were assessed simultaneously at 217 nm and 281 nm for PRP and NAL, respectively, with a synchronous wavelength difference (Δλ) of 80 nm. The proposed method was validated according to ICH Q2 (R2) requirements, exhibiting satisfactory accuracy, precision, linearity, and selectivity within the designated concentration ranges. The concentrations exhibited linearity within the ranges of 15.0-300.0 ng/mL and 0.5-16.0 µg/mL, with detection limits of 2.67 ng/mL and 0.15 µg/mL for PRP and NAL, respectively. The developed approach, owing to its great sensitivity, was utilized to assess the examined drugs in human plasma samples. The results demonstrated good bioanalytical applicability, exhibiting high recovery percentages (98.40-101.70) and low relative standard deviation (%RSD) values (<1.66). The proposed method was applied to accurately analyze the cited drugs in their ampoule dosage forms with great selectivity. The MoGAPI and AGREE metricsdemonstrated the method's exceptional eco-friendliness and sustainability. Additionally, the BAGI tool was employed to assess the method's economic viability, applicability, and practicality. The three tools demonstrated the sustainability and feasibility of the developedapproach, as well as its appropriateness for the routine analysis of the examined drugs. The developed method represents the first analytical technique for the concurrent estimation of PRP and NAL without the necessity for toxic reagents, excessive organic solvents, or complicated instruments. The method is derivatization-free and does not require complicated sample treatment or lengthy extraction procedures. The suggested method's excellent sensitivity, simplicity, speed, environmental friendliness, and cost-effectiveness make it appropriate for therapeutic drug monitoring of the studied drugs.

2025-04-01·JCPSP-Journal of the College of Physicians and Surgeons Pakistan

The Optimal Dosage of the Nalbuphine Preemptive Analgesia on Postoperative Pain in Patients Undergoing Laparoscopic Cholecystectomy: A Randomised, Controlled, Double-Blind Study

Article

作者: Wang, Honghua ; Chen, Peng ; Liu, Dajin ; Jing, Xu

OBJECTIVE:

To investigate the optimal dosage of nalbuphine preemptive analgesia on pain after laparoscopic cholecystectomy.

STUDY DESIGN:

A double-blind, randomised study. Place and Duration of the Study: Department of Anaesthesiology, The Affiliated Huai'an Hospital of Xuzhou Medical University, Huai'an Second Hospital, Jiangsu Province, China, from 2020 to 2023.

METHODOLOGY:

This study enrolled 240 patients requiring elective laparoscopic cholecystectomy. Patients were randomly allocated into four groups receiving placebo (Group NS) or nalbuphine 0.1 mg/kg (Group N1) or 0.2 mg/kg (Group N2) or 0.3 mg/kg (Group N3) intravenously 15 minutes before surgery. The postoperative visual analogue scale (VAS) score, and the rescue analgesic requirement within 72 hours after surgery were evaluated. One-way analysis of variance and a non-parametric Kruskal-Wallis test were used to compare differences between the groups.

RESULTS:

The VAS scores at rest and on movement were significantly lower in the N2 and N3 groups compared to the placebo group at 4, 12, 24, and 48 hours after surgery (p <0.05). Moreover, the VAS scores of the N2 group were significantly lower than N1 and N3 groups. The first rescue analgesia time was significantly longer (p <0.05), and the rescue analgesic requirements were considerably reduced in the N2 group than in the placebo group (p <0.05).

CONCLUSION:

Nalbuphine preemptive analgesia provided effective analgesia in patients undergoing laparoscopic cholecystectomy. The results showed that the optimal dose was 0.2 mg/kg for nalbuphine preemptive analgesia in laparoscopic cholecystectomy.

KEY WORDS:

Nalbuphine, Preemptive analgesia, Laparoscopic cholecystectomy, Postoperative pain, Rescue analgesia, VAS score.

2025-04-01·OBESITY SURGERY

Intravenous Ibuprofen Versus Ketorolac for Perioperative Pain Control in Patients with Morbid Obesity Undergoing Bariatric Surgery: A Randomized Controlled Trial

Article

作者: Amin, Sarah ; Hasanin, Ahmed ; Zakaria, Dina ; Abdallah, Ahmed S ; Soliman, Suzy ; Abdelkader, Amr ; Mostafa, Maha

Abstract:

Background:

We aimed to compare the perioperative analgesic efficacy of intravenous ibuprofen versus ketorolac in patients with obesity undergoing bariatric surgery.

Methods:

This randomized controlled trial included adult patients with obesity undergoing bariatric surgery. Participants were randomized to receive either ibuprofen or ketorolac intravenously every 8 h. All patients received paracetamol intravenously 1 gm/6 h. Inadequate intraoperative analgesia was managed by fentanyl boluses, while inadequate postoperative analgesia was managed by nalbuphine boluses. The primary outcome was static visual analogue scale (VAS) 0.5 h postoperatively. Secondary outcomes were postoperative static and dynamic VAS, intra- and postoperative opioids consumption, postoperative nausea and vomiting, and patients’ satisfaction.

Results:

Fifty-three patients were analyzed in each group. The median VAS (quartiles) at 0.5 h postoperatively was lower in the ketorolac group (3 [3, 6]) than in the ibuprofen group (7 [4, 8]), P-value < 0.001. The static and dynamic VAS were lower in the ketorolac group than in the ibuprofen group up to 6 h postoperatively. The intra- and postoperative opioid consumption was lower in the ketorolac group than in the ibuprofen group. The incidence of postoperative nausea and vomiting was also lower in the ketorolac group than in the ibuprofen group. Patients in the ketorolac group had higher level of satisfaction than patients in the ibuprofen group.

Conclusion:

In patients with obesity undergoing bariatric surgery, perioperative administration of ketorolac provided improved pain control, reduced opioid consumption, and lowered the risk of postoperative nausea and vomiting, compared to ibuprofen. Additionally, patients reported higher satisfaction with ketorolac.

212

项与盐酸纳布啡相关的新闻（医药）

2025-05-22

·米内网

【火热】11个独家品种遴选进院，7亿高端注射剂在列

精彩内容近日，通用医疗三六三医院发布一则公告，拟遴选引进50款新药以满足临床用药需求，其中独家品种（含剂型独家，下同）有11个，不乏氢吗啡酮注射液等2024年在中国公立医疗机构终端销售额超7亿元的畅销药，以及多库酯钠片等2024年销售额增速达两位数的潜力品种。50款拟遴选进院的新药以注射剂和片剂为主，各占17个和15个席位；按治疗大类统计，神经系统药物以11个产品在数量上领跑，血液和造血系统药物（8个）、消化系统及代谢药（6个）、肌肉-骨骼系统（5个）、心脑血管系统药物（5个）等十一个类别位居其后。拟遴选进院新药名单来源：通用医疗三六三医院，米内网整理注：带*为独家品种盐酸氢吗啡酮注射液是一种阿片类受体激动剂，属于止痛药和麻醉剂，主要用于缓解中度到重度的疼痛，特别是在手术后、癌症疼痛和其他慢性疼痛病情下使用。米内网数据显示，目前国内仅人福医药拥有该药生产批文及独家过评批件。得益于医保助力及其产品优势，盐酸氢吗啡酮注射液近年来在中国城市公立医院、县级公立医院、城市社区中心以及乡镇卫生院（简称中国公立医疗机构）终端销售额稳步攀升，2024年收获超7亿元，为止痛药（化+生）TOP7产品。2024年中国公立医疗机构终端止痛药产品TOP10来源：米内网中国公立医疗机构药品终端竞争格局值得一提的是，人福医药日前发布公告称，已收到德国联邦药品和医疗器械管理局（BfArM）核准签发的盐酸氢吗啡酮注射液上市许可批准信，该产品用于需使用阿片类药物镇痛的患者。这将为公司国际业务拓展带来积极影响。多库酯钠片是湖南华纳大药厂的独家品种，临床常用于慢性功能性便秘等，目前已纳入全国医保乙类药目录。近年来，多库酯钠片在中国公立医疗机构终端销售额“稳中带升”，除2023年略有回落，2020-2022年及2024年均保持两位数的同比增速，分别达26.69%、33.7%、29.79%和12.29%。从渠道格局上看，城市公立医院常年高居首位，市场份额均在70%以上；县级公立医院排在第二，市场份额呈逐年扩容之势，从2019年的约7%增长至2024年的超23%。近年来中国公立医疗机构终端多库酯钠片销售趋势（单位：万元）来源：米内网中国公立医疗机构药品终端竞争格局此外，拟遴选进院的新药还包括：治疗慢性心力衰竭的沙库巴曲缬沙坦钠片、用于复合麻醉时麻醉诱导的盐酸纳布啡注射液、治疗缺血性心血管病变的吲哚布芬片、用于外科术后疼痛的注射用盐酸丙帕他莫等，其均为2024年中国公立医疗机构终端销售规模超10亿元的大品种。来源：米内网数据库、通用医疗三六三医院注：米内网《中国公立医疗机构药品终端竞争格局》，统计范围是：中国城市公立医院、县级公立医院、城市社区中心以及乡镇卫生院，不含民营医院、私人诊所、村卫生室；上述销售额以产品在终端的平均零售价计算。数据统计截至5月22日，如有疏漏，欢迎指正！免责声明：本文仅作医药信息传播分享，并不构成投资或决策建议。本文为原创稿件，转载文章或引用数据请注明来源和作者，否则将追究侵权责任。投稿及报料请发邮件到872470254@qq.com稿件要求详询米内微信首页菜单栏商务及内容合作可联系QQ：412539092【分享、点赞、在看】点一点不失联哦

申请上市医药出海

2025-05-20

·PRNewswire

Trevi Therapeutics Announces Additional Analyses from Phase 2a RIVER Trial of Haduvio in Patients with Refractory Chronic Cough

Results of analyses presented at an investor meeting during the American Thoracic Society 2025 International Conference NEW HAVEN, Conn., May 20, 2025 /PRNewswire/ -- Trevi Therapeutics, Inc. (Nasdaq: TRVI), a clinical-stage biopharmaceutical company developing the investigational therapy Haduvio™ (oral nalbuphine ER) for the treatment of chronic cough in patients with idiopathic pulmonary fibrosis (IPF) and in patients with refractory chronic cough (RCC), today announced additional analyses from the Phase 2a RIVER trial of Haduvio for the treatment of patients with RCC (N=66). In March 2025, the Company announced positive topline results, where Haduvio met the primary endpoint with a statistically-significant reduction in the objective 24-hour cough frequency of 67% from baseline and 57% on a placebo-adjusted basis (p<0.0001). "We continue to evaluate the full results from the Phase 2a RIVER trial and remain impressed with both the magnitude and consistency of effect of nalbuphine ER in this trial. We are looking forward to the results from our Phase 2b trial in IPF patients with chronic cough to finalize the development path forward for both indications," said James Cassella, Ph.D., Chief Development Officer of Trevi Therapeutics. Additional Analyses: Responder analyses of 24-hour cough frequency reduction at 30%, 50%, and 75% thresholds were statistically significant for patients on Haduvio across all doses. Patients on Haduvio experienced a statistically-significant improvement (p<0.0001) in the patient-reported Leicester Cough Questionnaire at Day 21 (108 mg BID). There were no significant treatment period effects from the crossover design for the primary efficacy analysis of relative change from baseline in 24-hour cough frequency. Similar to previous studies, adverse events for patients on Haduvio were more frequently observed following initial exposure to the drug at 27 mg BID in the first week and diminished over time despite dose escalation to 108 mg BID. Discontinuations primarily occurred in the first two weeks of Haduvio dosing and were mostly related to adverse events, typically central nervous system and gastrointestinal in nature. The additional analyses were presented as part of a KOL panel discussion which took place during the American Thoracic Society's 2025 International Conference. Click here to see the additional analyses slide set. About the Phase 2a RIVER Trial The Phase 2a RIVER trial was a randomized, double-blind, placebo-controlled, two treatment period, crossover study designed to evaluate the efficacy, safety, and tolerability of Haduvio for the treatment of patients with RCC. Each treatment period lasted 21 days, separated by a 21-day washout period. During the Haduvio treatment period, patients were titrated with assessments at 27 mg twice daily (BID), 54 mg BID and 108 mg BID, with objective cough and other assessments at each dose. The primary endpoint of the trial was the mean change in 24-hour cough frequency, as determined by an objective cough monitor, for the full analysis set (FAS) population at Day 21. The FAS population included all patients who received at least one dose of study drug and have objective cough count data on both Baseline and Day 21 in at least one treatment period. About Refractory Chronic Cough (RCC) Refractory chronic cough has no approved therapies in the U.S. and is defined as a persistent cough lasting >8 weeks despite treatment for an underlying condition (i.e., asthma, gastroesophageal reflux disease, non-asthmatic eosinophilic bronchitis, and upper airway cough syndrome or post-nasal drip) and includes unexplained chronic cough. RCC affects ~2-3 million patients in the U.S. and is caused by cough reflex hypersensitivity in both the central and peripheral nerves. It is a highly debilitating disease and accompanied by a wide range of complications, ranging from urinary incontinence in females to sleep disruption and social embarrassment that causes significant social and economic burdens for patients and those around them. About Trevi Therapeutics, Inc. Trevi Therapeutics, Inc. is a clinical-stage biopharmaceutical company developing the investigational therapy Haduvio™ (oral nalbuphine extended-release) for the treatment of chronic cough in patients with idiopathic pulmonary fibrosis (IPF) and in patients with refractory chronic cough (RCC). Haduvio is the first and only investigational therapy to show a statistically significant reduction in cough frequency in clinical trials with IPF chronic cough patients and RCC patients. Haduvio acts on the cough reflex arc both centrally and peripherally as a kappa agonist and a mu antagonist (KAMA), targeting opioid receptors that play a key role in controlling chronic cough. Nalbuphine is not currently scheduled by the U.S. Drug Enforcement Agency. Chronic cough is a highly prevalent condition in IPF patients, impacting up to 85% of the IPF population. There are ~150,000 U.S. IPF patients and the impact of chronic cough is significant with patients coughing up to 1,500 times per day. This consistent cough and any associated damage may lead to worsening disease, a higher risk of progression, death, or need for lung transplant. Chronic cough also often leads to a decline in patients' social, physical, and psychological quality of life. There are no approved therapies for the treatment of chronic cough in patients with IPF and current off-label treatment options provide minimal benefit to patients. Trevi intends to propose Haduvio as the trade name for oral nalbuphine ER. Its safety and efficacy have not been evaluated by any regulatory authority. For more information, visit and follow Trevi on X (formerly Twitter) and LinkedIn. Forward-Looking Statements Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements are subject to risks and uncertainties and actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding Trevi's business plans and objectives, including future plans or expectations for Haduvio and plans and timing with respect to clinical trials and clinical data, expectations regarding Trevi's uses and sufficiency of capital, and other statements containing the words "believes," "anticipates," "plans," "expects," and similar expressions. Risks that contribute to the uncertain nature of the forward-looking statements include: uncertainties regarding the success, cost and timing of Trevi's product candidate development activities and clinical trials; the risk that positive data from a clinical trial may not necessarily be predictive of the results of later clinical trials in the same or a different indication; uncertainties regarding Trevi's ability to execute on its strategy; uncertainties with respect to regulatory authorities' views as to the data from Trevi's clinical trials and next steps in the development path for Haduvio in the United States and foreign countries; uncertainties inherent in estimating Trevi's cash runway, future expenses and other financial results, including Trevi's ability to fund future operations, including clinical trials, as well as other risks and uncertainties set forth in the quarterly report on Form 10-Q for the quarter ended March 31, 2025 filed with the Securities and Exchange Commission and in subsequent filings with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. Trevi undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made. Investor Contact Jonathan Carlson Trevi Therapeutics, Inc. (203) 654 3286 [email protected] Media Contact Rosalia Scampoli 914-815-1465 [email protected] SOURCE Trevi Therapeutics, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

临床2期临床结果

2025-05-18

·信狐药迅

百济神州盘中涨近7% BCL2抑制剂索托克拉第二项适应症提交上市申请|新受理（5.12-5.18）

本周药品注册受理数据，分门别类呈现，一目了然。(5.12-5.18）新药上市申请药品名称企业注册分类受理号吡洛西利片轩竹生物科技股份有限公司1CXHS2500051索托克拉片百济神州(苏州)生物科技有限公司1CXHS2500050索托克拉片百济神州(苏州)生物科技有限公司1CXHS2500049索托克拉片百济神州(苏州)生物科技有限公司1CXHS2500048索托克拉片百济神州(苏州)生物科技有限公司1CXHS2500047盐酸吉卡昔替尼片苏州泽璟生物制药股份有限公司1CXHS2500046注射用重组巴曲酶上海腾瑞制药股份有限公司1CXSS2500050新药临床申请药品名称企业注册分类受理号HRN77片北京华睿鼎信科技有限公司1CXHL2500483HRN77片湖南明瑞制药股份有限公司1CXHL2500482ACE-232片优领医药科技(上海)有限公司1CXHL2500479ACE-232片优领医药科技(上海)有限公司1CXHL2500478Safusidenib胶囊葆元生物医药科技(杭州)有限公司1CXHL2500473WJ47DZ片南京逸境生物医药科技有限公司1CXHL2500472WJ47DZ片南京逸境生物医药科技有限公司1CXHL2500471HRS-5041片江苏恒瑞医药股份有限公司1CXHL2500470HRS-5041片江苏恒瑞医药股份有限公司1CXHL2500469HRS-5041片江苏恒瑞医药股份有限公司1CXHL2500468HRS-2162注射液福建盛迪医药有限公司1CXHL2500467HRS-5041片江苏恒瑞医药股份有限公司1CXHL2500466PTT-501片北京炎明生物科技有限公司1CXHL2500465PTT-501片北京炎明生物科技有限公司1CXHL2500464KW-040注射液北京凯因科技股份有限公司1CXHL2500463SP-101注射液斯莱普泰(上海)生物医药科技有限公司1CXHL25004601536A北京康联智汇科技有限公司2.2CXHL2500484帕拉米韦吸入溶液湖南先施制药有限公司2.2CXHL2500481帕拉米韦吸入溶液湖南先施制药有限公司2.2CXHL2500480SBK017口服溶液成都施贝康生物医药科技有限公司2.2CXHL2500477TQC3302吸入喷雾剂正大天晴(广州)医药有限公司2.3CXHL2500476TQC3302吸入喷雾剂正大天晴(广州)医药有限公司2.3CXHL2500475TQC3302吸入喷雾剂正大天晴(广州)医药有限公司2.3CXHL2500474舒沃替尼片迪哲(江苏)医药股份有限公司2.4CXHL2500462舒沃替尼片迪哲(江苏)医药股份有限公司2.4CXHL2500461SCTB14注射液神州细胞工程有限公司1CXSL2500393SCTB14注射液神州细胞工程有限公司1CXSL2500392重组人IL12/15单纯疱疹I型双调控溶瘤病毒注射液(Vero细胞)上海复诺健生物科技有限公司1CXSL2500390SCT640C注射液神州细胞工程有限公司1CXSL2500389GB261注射液上海坦蒂生物医药科技有限公司1CXSL2500387ABO2102注射剂苏州艾博生物科技有限公司1CXSL2500388NW-101C注射液新景智源生物科技(苏州)有限公司1CXSL2500386NW-101C注射液新景智源生物科技(苏州)有限公司1CXSL2500385TQB2825注射液(皮下注射)上海正大天晴医药科技开发有限公司1CXSL2500384TQB2825注射液(皮下注射)上海正大天晴医药科技开发有限公司1CXSL2500383SENL103自体T细胞注射液河北森朗生物科技有限公司1CXSL2500382注射用TQB2103上海正大天晴医药科技开发有限公司1CXSL2500378TQB2868注射液正大天晴药业集团南京顺欣制药有限公司1CXSL2500377注射用HS-20093上海翰森生物医药科技有限公司1CXSL2500380SIBP-A16 注射液上海生物制品研究所有限责任公司1CXSL2500379SYS6026注射液石药集团巨石生物制药有限公司1CXSL2500376EXG202注射液杭州嘉因生物科技有限公司1CXSL2500375自体天然肿瘤浸润淋巴细胞注射液上海君赛生物药业有限公司1CXSL2500374仿制药申请药品名称企业注册分类受理号布立西坦片浙江和泽医药科技股份有限公司3CYHS2501808布立西坦片浙江和泽医药科技股份有限公司3CYHS2501807氯化钾口服溶液安徽杰玺医药有限公司3CYHS2501803维生素B12注射液海南海和制药有限公司3CYHS2501802硝酸咪康唑乳膏苏州高迈药业有限公司3CYHS2501801唑尼沙胺口服混悬液山东朗诺制药有限公司3CYHS2501795中性低钙腹膜透析液(碳酸氢盐-G2.5%)石家庄四药有限公司3CYHS2501794硫酸阿米卡星注射液吉林敖东药业集团延吉股份有限公司3CYHS2501791叶酸片安徽圣鹰药业有限公司3CYHS2501789硫酸阿米卡星注射液吉林敖东药业集团延吉股份有限公司3CYHS2501788福多司坦片南京易亨制药有限公司3CYHS2501784注射用盐酸多西环素苏州朗科生物技术股份有限公司3CYHS2501777复方聚乙二醇(3350)电解质散重庆赛诺生物药业股份有限公司3CYHS2501787复方电解质醋酸钠葡萄糖注射液浙江高跖医药科技股份有限公司3CYHS2501786复方电解质醋酸钠葡萄糖注射液浙江高跖医药科技股份有限公司3CYHS2501785维生素B12注射液海南慧通生物医药科技有限公司3CYHS2501770盐酸拉贝洛尔注射液浙江同伍生物医药有限公司3CYHS2501769复方聚乙二醇(3350)电解质口服溶液安徽四环科宝制药有限公司3CYHS2501766中性腹膜透析液(碳酸氢盐-G2.5%)石家庄四药有限公司3CYHS2501765阿立哌唑口服溶液安徽四环科宝制药有限公司3CYHS2501763阿立哌唑口服溶液安徽四环科宝制药有限公司3CYHS2501762阿立哌唑口服溶液安徽四环科宝制药有限公司3CYHS2501761阿立哌唑口服溶液安徽四环科宝制药有限公司3CYHS2501760磷酸奥司他韦干糖浆浙江华海制药科技有限公司3CYHS2501759维生素D口服溶液昆明邦宇制药有限公司3CYHS2501755醋酸钙口服溶液安徽四环科宝制药有限公司3CYHS2501753醋酸钙口服溶液安徽四环科宝制药有限公司3CYHS2501752醋酸钙口服溶液安徽四环科宝制药有限公司3CYHS2501749醋酸钙口服溶液安徽四环科宝制药有限公司3CYHS2501748盐酸克林霉素棕榈酸酯颗粒江苏诺泰澳赛诺生物制药股份有限公司3CYHS2501776复方电解质醋酸钠葡萄糖注射液东莞市普济药业有限公司3CYHS2501751复方电解质醋酸钠葡萄糖注射液东莞市普济药业有限公司3CYHS2501750美索巴莫注射液石药集团欧意药业有限公司3CYHS2501745黄体酮注射液呋欧医药科技(湖州)有限公司3CYHS2501743联苯苄唑溶液重庆万霖生物医药科技有限公司3CYHS2501742盐酸甲氧氯普胺注射液海南盈达润泽药业有限公司3CYHS2501741盐酸奥普力农注射液云南药科院生物医药股份有限公司3CYHS2501740硫辛酸片山东新时代药业有限公司3CYHS2501735盐酸甲氧氯普胺注射液沈阳光大制药有限公司3CYHS2501734盐酸溴己新口服溶液北京民康百草医药科技有限公司3CYHS2501730甲硝唑片海南海神同洲制药有限公司3CYHS2501729甲硝唑阴道凝胶湖北午时药业股份有限公司3CYHS2501728生理氯化钠溶液浙江赛默制药有限公司3CYHS2501720盐酸纳布啡注射液福安药业集团庆余堂制药有限公司3CYHS2501717盐酸纳布啡注射液福安药业集团庆余堂制药有限公司3CYHS2501716米诺地尔搽剂广东科泓药业有限公司3CYHS2501714米诺地尔搽剂广东科泓药业有限公司3CYHS2501713米诺地尔搽剂山东诺明康药物研究院有限公司3CYHS2501712米诺地尔搽剂山东诺明康药物研究院有限公司3CYHS2501711阿司匹林维生素C泡腾片浙江同伍生物医药有限公司4CYHS2501809聚多卡醇注射液西洲医药科技(浙江)有限公司4CYHS2501806盐酸莫西沙星片海南海力制药有限公司4CYHS2501805注射用头孢他啶阿维巴坦钠海南合瑞制药股份有限公司4CYHS2501804他达拉非片云鹏医药集团有限公司4CYHS2501800比索洛尔氨氯地平片湖南千金协力药业有限公司4CYHS2501799碘佛醇注射液南京正大天晴制药有限公司4CYHS2501798碘佛醇注射液南京正大天晴制药有限公司4CYHS2501797利格列汀片海南赛立克药业有限公司4CYHS2501796盐酸达泊西汀片成都恒瑞制药有限公司4CYHS2501793甲磺酸酚妥拉明注射液北京六环药业有限公司4CYHS2501792吡仑帕奈口服混悬液湖南科伦制药有限公司4CYHS2501783盐酸戊乙奎醚注射液仁合益康汇泽药业河北有限公司4CYHS2501782盐酸戊乙奎醚注射液仁合益康汇泽药业河北有限公司4CYHS2501781艾普拉唑肠溶片浙江美迪深生物医药有限公司4CYHS2501780克立硼罗软膏山东明仁福瑞达制药股份有限公司4CYHS2501779盐酸屈他维林注射液德全药品(江苏)股份有限公司4CYHS2501778长链脂肪乳注射液(OO)辰欣药业股份有限公司4CYHS2501790培唑帕尼片江苏华鑫制药有限公司4CYHS2501775利培酮口服溶液安徽四环科宝制药有限公司4CYHS2501774利培酮口服溶液安徽四环科宝制药有限公司4CYHS2501773利培酮口服溶液安徽四环科宝制药有限公司4CYHS2501772利培酮口服溶液安徽四环科宝制药有限公司4CYHS2501771左氧氟沙星氯化钠注射液江苏欣力元生物制药有限公司4CYHS2501768左氧氟沙星氯化钠注射液江苏欣力元生物制药有限公司4CYHS2501767沙库巴曲缬沙坦钠片石家庄市华新药业有限责任公司4CYHS2501758沙库巴曲缬沙坦钠片石家庄市华新药业有限责任公司4CYHS2501757替米沙坦氨氯地平片海南赛立克药业有限公司4CYHS2501756平衡盐溶液(供灌注用)山西诺成制药有限公司4CYHS2501754甲氨蝶呤注射液湖北知化医药科技有限公司4CYHS2501747硫酸氨基葡萄糖胶囊四川赛卓药业股份有限公司4CYHS2501746多替拉韦钠片安徽贝克生物制药有限公司4CYHS2501764吡美莫司乳膏上海朝晖药业有限公司4CYHS2501744奥卡西平片安徽省先锋制药有限公司4CYHS2501739奥卡西平片安徽省先锋制药有限公司4CYHS2501738盐酸奥洛他定片郑州韩都药业集团有限公司4CYHS2501737盐酸奥洛他定片郑州韩都药业集团有限公司4CYHS2501736苯磺酸左氨氯地平片乐声药业石家庄有限公司4CYHS2501733苯磺酸左氨氯地平片乐声药业石家庄有限公司4CYHS2501732依西美坦片上海安必生制药技术有限公司4CYHS2501731盐酸屈他维林注射液湖南赛隆药业(长沙)有限公司4CYHS2501727盐酸伐地那非片山东百诺医药股份有限公司4CYHS2501726硫酸艾沙康唑胶囊安徽瑞旗药业有限公司4CYHS2501725甲磺酸沙非胺片华北制药股份有限公司4CYHS2501724甲磺酸沙非胺片华北制药股份有限公司4CYHS2501723阿司匹林肠溶片云鹏医药集团有限公司4CYHS2501722氯雷他定糖浆天大药业(珠海)有限公司4CYHS2501721注射用阿糖胞苷广东星昊药业有限公司4CYHS2501719注射用阿糖胞苷广东星昊药业有限公司4CYHS2501718艾拉莫德片湖南方盛制药股份有限公司4CYHS2501715布瑞哌唑片宁波大红鹰药业股份有限公司4CYHS2501710布瑞哌唑片宁波大红鹰药业股份有限公司4CYHS2501709布瑞哌唑片宁波大红鹰药业股份有限公司4CYHS2501708帕拉米韦氯化钠注射液山西诺成制药有限公司4CYHS2501707来特莫韦注射液仁合益康汇泽药业河北有限公司4CYHS2501706瑞卢戈利片江苏联环药业股份有限公司3CYHL2500092布立西坦口服溶液山东达因海洋生物制药股份有限公司3CYHL2500091艾考糊精腹膜透析液仁合益康集团有限公司4CYHL2500093克霉唑阴道片浙江高跖医药科技股份有限公司4CYHL2500090进口申请药品名称企业注册分类受理号那米司特片Boehringer Ingelheim International GmbH1JXHS2500058那米司特片Boehringer Ingelheim International GmbH1JXHS2500057达雷妥尤单抗注射液(皮下注射)Janssen-Cilag International NV3.1JXSS2500061度普利尤单抗注射液Sanofi Winthrop Industrie3.1JXSS2500060度普利尤单抗注射液Sanofi Winthrop Industrie3.1JXSS2500059度普利尤单抗注射液Sanofi Winthrop Industrie3.1JXSS2500058度普利尤单抗注射液Sanofi Winthrop Industrie3.1JXSS2500057度普利尤单抗注射液Sanofi Winthrop Industrie3.1JXSS2500056度普利尤单抗注射液Sanofi Winthrop Industrie3.1JXSS2500055司库奇尤单抗注射液Novartis Pharma Schweiz AG3.1JXSS2500054AZD9833片ASTRAZENECA AB1JXHL2500107CHF1535-IICHIESI FARMACEUTICI SPA2.2JXHL2500110匹妥布替尼片Eli Lilly and Company2.4JXHL2500113Capivasertib片AstraZeneca AB2.4JXHL2500109Capivasertib片AstraZeneca AB2.4JXHL2500108AZD9793AstraZeneca AB1JXSL2500075中药相关申请药品名称企业注册分类受理号菖麻熄风颗粒黑龙江省济仁药业有限公司2.2CXZS2500020金丹附延颗粒江西华太药业有限公司2.3CXZL2500029苓桂术甘颗粒河北万邦复临药业有限公司3.1CXZS2500019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

100 项与盐酸纳布啡相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D00843	盐酸纳布啡	N02AF02	DB00844

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
麻醉	美国	Endo Operations Ltd.	1979-05-15
疼痛	美国	Endo Operations Ltd.	1979-05-15

未上市

10 条进展最快的记录,

后查看更多信息

适应症	最高研发状态	国家/地区	公司	日期
镇痛	临床3期	中国	宜昌人福药业有限责任公司	2023-10-09
呼吸功能不全	临床3期	中国	宜昌人福药业有限责任公司	2023-08-30
结节性痒疹	临床3期	美国	Trevi Therapeutics, Inc.	2015-03-01
结节性痒疹	临床3期	德国	Trevi Therapeutics, Inc.	2015-03-01
结节性痒疹	临床3期	波兰	Trevi Therapeutics, Inc.	2015-03-01
瘙痒	临床3期	德国	Trevi Therapeutics, Inc.	2015-03-01
尿毒症瘙痒	临床3期	美国	Trevi Therapeutics, Inc.	2014-06-01
尿毒症瘙痒	临床3期	波兰	Trevi Therapeutics, Inc.	2014-06-01
尿毒症瘙痒	临床3期	罗马尼亚	Trevi Therapeutics, Inc.	2014-06-01
慢性咳嗽	临床2期	澳大利亚	Trevi Therapeutics, Inc.	2024-02-06

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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


PRNewswire 人工标引	N/A	慢性咳嗽	-	Placebo	廠繭襯憲鬱襯壓選窪醖(憲鑰獵壓製憲餘糧積鹽) = 糧鑰齋範憲壓鹽範繭衊蓋艱製鏇簾鑰鑰憲鑰遞 (壓鹹齋齋觸築願艱餘糧 ) 更多	积极	2024-12-03
				IV Butorphanol 6mg	廠繭襯憲鬱襯壓選窪醖(憲鑰獵壓製憲餘糧積鹽) = 鬱築夢膚範衊憲簾齋範蓋艱製鏇簾鑰鑰憲鑰遞 (壓鹹齋齋觸築願艱餘糧 ) 更多
NCT02820051 (CTgov)	N/A	镇静	102	Transcutaneous CO2 monitor+Midazolam+Lidocaine+nalbuphine (Midazolam)	顧糧糧醖鑰鏇製廠夢製(獵構廠餘壓選鹽窪選膚) = 齋網艱壓窪網觸築網廠範鬱鬱顧壓廠醖積鏇選 (糧鏇觸醖顧餘鏇憲鬱鬱, 7.5) 更多	-	2024-12-02
				Transcutaneous CO2 monitor+propofol+Lidocaine+nalbuphine (Propofol)	顧糧糧醖鑰鏇製廠夢製(獵構廠餘壓選鹽窪選膚) = 顧觸糧簾遞遞窪糧夢鹹範鬱鬱顧壓廠醖積鏇選 (糧鏇觸醖顧餘鏇憲鬱鬱, 9.6) 更多
NCT05041270 (ZU-IRB#:7045-15-8-2021, Pubmed \| BMC Anesthesiol)	N/A	-	69	Bupivacaine + Normal Saline	構繭窪蓋憲網鏇齋構觸(壓襯獵範蓋鏇齋鹹繭餘) = 襯餘鑰艱鏇醖遞艱鏇壓鹹遞壓積齋齋齋網繭簾 (膚獵觸範襯廠顧衊襯願 ) 更多	积极	2023-12-06
				Bupivacaine + Nalbuphine	構繭窪蓋憲網鏇齋構觸(壓襯獵範蓋鏇齋鹹繭餘) = 鹽積衊遞夢築構簾選廠鹹遞壓積齋齋齋網繭簾 (膚獵觸範襯廠顧衊襯願 ) 更多
NCT03497975 (PRISM, EADV2023) 人工标引	临床2/3期	结节性痒疹	247	Haduvio	鬱鏇鹹鑰醖鏇淵鏇齋膚(築糧壓襯齋製鑰網襯範) = 願築鹽鏇積獵築糧選蓋齋鹹淵繭觸衊蓋鏇鑰積 (選衊鹹蓋膚鹹糧廠膚窪 ) 更多	积极	2023-10-13
ATS2023	N/A	慢性咳嗽	-	Nalbuphine ER	遞觸積夢積窪築積構餘(壓製積膚簾築夢構壓網) = 61% of patients treated with nalbuphine ER improved, 21% had no change, and 18% worsened, compared with 18%, 68%, and 14%, respectively, of patients receiving placebo 淵顧醖憲糧網鹹鹹餘繭 (糧齋夢糧網築顧願願憲 ) 更多	-	2023-05-21
				Placebo
NCT03059511 (Pubmed \| Arch Dis Child)	临床1期	-	52	Intranasal nalbuphine	鬱遞夢淵廠膚衊製窪餘(餘衊醖繭獵簾鹽築憲觸) = 夢觸憲選糧廠觸簾遞窪蓋壓簾膚鬱範窪獵齋鬱 (醖淵窪鏇遞繭鏇膚鬱遞 )	-	2022-09-13
				Intravenous nalbuphine	鬱遞夢淵廠膚衊製窪餘(餘衊醖繭獵簾鹽築憲觸) = 夢糧遞構構觸襯築糧膚蓋壓簾膚鬱範窪獵齋鬱 (醖淵窪鏇遞繭鏇膚鬱遞 )
NCT03497975 (PRISM study, EADV2022)	临床2/3期	结节性痒疹	-	Oral Nalbuphine Extended-Release 162 mg	積繭遞鏇襯製鹹壓鹹範(願網廠餘範齋鹽壓鏇淵) = 鑰窪鬱餘壓夢遞鹽衊築壓築觸糧廠襯夢選醖壓 (獵遞觸選願鏇鑰繭簾網 )	积极	2022-09-07
				Placebo	積繭遞鏇襯製鹹壓鹹範(願網廠餘範齋鹽壓鏇淵) = 夢蓋憲鑰淵範襯襯夢夢壓築觸糧廠襯夢選醖壓 (獵遞觸選願鏇鑰繭簾網 )
ERS2022	临床2期	特发性肺纤维化	45	NAL ER 27 mg once daily	鏇艱廠簾壓願觸廠淵窪(襯蓋夢廠淵鑰醖壓鏇願) = 繭鹽鏇窪製衊齋鑰鬱鹹鹹製網醖蓋壓選窪範夢 (夢鹽醖衊築蓋衊顧糧獵 )	积极	2022-09-04
NCT03497975 (PRISM, Corporate Publications) 人工标引	临床2/3期	结节性痒疹	344	Haduvio	範鬱繭餘繭齋艱繭選構(廠鬱餘壓繭鏇艱鹽鏇鏇) = 襯觸壓顧蓋繭窪鏇膚齋願衊艱齋艱築窪簾鏇積 (齋選選顧築餘齋窪憲襯 ) 更多	积极	2022-06-29
				Placebo	範鬱繭餘繭齋艱繭選構(廠鬱餘壓繭鏇艱鹽鏇鏇) = 艱窪憲淵餘襯艱廠淵積願衊艱齋艱築窪簾鏇積 (齋選選顧築餘齋窪憲襯 ) 更多
NCT02174432 (CTgov)	临床2/3期	结节性痒疹	36	nalbuphine HCl ER	鬱觸網積鹽選構願襯願 = 壓夢鹹鏇鹹壓壓範繭廠鹽選窪觸獵鏇網襯衊廠 (衊鑰顧窪鬱鹹願衊膚艱, 壓鹹鹹醖糧淵醖觸獵選 ~ 願壓築襯獵遞積繭製淵) 更多	-	2020-10-23