更新于：2024-05-16

Ketorolac Tromethamine

酮咯酸氨丁三醇

更新于：2024-05-16

概要

概要

基本信息

简介酮咯酸氨丁三醇，也称为 Toradol®，是一种非甾体抗炎药 (NSAID)，主要用于治疗中度至重度疼痛，包括与类风湿性关节炎、骨关节炎、强直性脊柱炎、月经失调和头痛相关的疼痛。酮咯酸氨丁三醇于1989年由罗氏开发并批准，作为一种COX抑制剂，通过阻断前列腺素的产生有效减轻疼痛。这种药物有口服和注射剂两种形式，使其成为疼痛管理的多功能选择。尽管酮咯酸氨丁三醇有效，但由于其潜在的副作用（包括胃肠道出血和肾脏损伤），不建议长期使用。

药物类型

小分子化药

别名

Acular

+ [14]

靶点

COX-1 x COX-2

作用机制

COX-1抑制剂(环氧化酶-1抑制剂)、COX-2抑制剂(环氧化酶-2抑制剂)

治疗领域

免疫系统疾病神经系统疾病眼部疾病+ [1]

在研适应症

炎症疼痛烧伤+ [5]

非在研适应症

背痛癌症疼痛恶性上皮肿瘤+ [12]

原研机构

F. Hoffmann-La Roche Ltd.

在研机构

Allergan, Inc.

AbbVie, Inc.Zyla Life Sciences US LLC

非在研机构

Egalet Ltd.Roche Palo Alto LLCShandong Institute Of Pharmaceutical Industry

+ [2]

最高研发阶段批准上市

首次获批日期

美国 (1989-11-30),

疼痛

最高研发阶段(中国)批准上市

特殊审评-

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结构

分子式C19H24N2O6

InChIKeyBWHLPLXXIDYSNW-UHFFFAOYSA-N

CAS号74103-07-4

关联

310

项与酮咯酸氨丁三醇相关的临床试验

NCT06201676 / Not yet recruiting临床4期

Low-Dose Short-Term Ketorolac to Reduce Chronic Opioid Use in Orthopaedic Polytrauma Patients

The goal of this randomized clinical trial is to learn if the use of a low-dose nonsteroidal anti-inflammatory drug (NSAID), ketorolac, reduces the rate of chronic opioid use in orthopaedic polytrauma patients. The main questions this study aims to answer are:
1. Are patients who are given scheduled ketorolac during the first five hospital days less likely to develop chronic opioid use at 6 months after injury compared to patients who receive placebo?
2. Does scheduled ketorolac during the first five hospital days improve functional responses to pain at discharge, 3 months, and 6 months after injury?
3. Does early pain control provided by ketorolac decrease chronic opioid use through decreased acute pain and opioid use, improved functional responses to pain, or both?
Participants will be enrolled and randomized to either the ketorolac (treatment) group or placebo group to be given every 6 hours during the first five hospital days. Pain and opioid use will be measured daily during the five-day treatment period. Opioid use will be measured and functional response to pain surveys will be obtained at discharge, 2 weeks, 6 weeks, 3 months, and 6 months after injury.
Researchers will compare ketorolac (treatment) versus saline (placebo) to see if ketorolac reduces chronic opioid use and improves the functional response to pain.

开始日期2024-05-01

申办/合作机构

The General Hospital Corp.

[+1]

NCT04895280 / Not yet recruiting临床4期IIT

Effectiveness of Corticosteroid vs Ketorolac Shoulder Injections: a Prospective Double-Blinded Randomized Trial

The purpose of this study is to compare the functional outcomes of patients with shoulder pathology treated with either ketorolac or corticosteroid injections, in a randomized double-blinded study. Investigators will compare the effectiveness of ketorolac compared to corticosteroid.
Specific Aim 1:
Hypothesis 1: Injection of the shoulder (in the subacromial space) with Ketorolac will be more effective than corticosteroid injection for the treatment of a variety of shoulder pathologies.
The risks associated with this study primarily concern adverse reactions to the study drugs. The drugs used in this study are not narcotics or habit-forming but can have side effects. The patient's physician will screen for any heart, intestinal, or kidney disease or condition that would increase the chance for the patient to have an unwanted side effect.

开始日期2024-04-01

申办/合作机构

The University of Texas Southwestern Medical Center

NCT05875571 / Recruiting临床4期IIT

Intravenous Ketorolac Administration to Attenuate Post-procedural Pain Associated With Intrauterine Device Placement: A Randomized, Double-Blind, Placebo-Controlled Trial

Intrauterine devices (IUDs) are a popular form of long-acting reversible contraception, with a high efficacy rate and few side effects. The insertion procedure for IUDs can be uncomfortable and painful. Sedation may be needed to improve patient comfort. The use of IUDs is increasing in the adolescent population, but perceived pain is a barrier to placement.
Propofol is a commonly used agent for pediatric procedural sedation, but it has no analgesic properties. Ketorolac, a nonsteroidal anti-inflammatory drug, has been shown to reduce pain in adults and improve patient satisfaction when used prior to IUD placement..
The current study aims to determine if ketorolac, given in combination with propofol for IUD placement in adolescents, can improve comfort during placement and reduce pain following the procedure. Enrolled patients will receive ketorolac or placebo, in addition to propofol, for IUD placement. By comparing the outcomes of these two groups of patients, we can gain a better understanding of the optimal approach to sedation for IUD insertion in adolescents.

开始日期2024-02-05

申办/合作机构

Arkansas Children's Hospital Research Institute

100 项与酮咯酸氨丁三醇相关的临床结果

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100 项与酮咯酸氨丁三醇相关的转化医学

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100 项与酮咯酸氨丁三醇相关的专利（医药）

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670

项与酮咯酸氨丁三醇相关的文献（医药）

2024-06-01·International Journal of Pharmaceutics: X

Formulation, optimization and evaluation of ocular gel containing nebivolol Hcl-loaded ultradeformable spanlastics nanovesicles: In vitro and in vivo studies

Article

作者: Elfar, Nehal ; Teaima, Mahmoud H ; Elhabal, Sammar Fathy ; El-Nabarawi, Mohamed A ; Yasser, Mohamed ; El Naggar, Eman E

The study aims to improve the ocular delivery of Nebivolol HCL (NBV) belonging to the Biopharmaceutics classification system (BCSII) by using spanlastic nanovesicles (SNVs) for ophthalmic delivery and incorporating them into hydroxypropyl methylcellulose gel with ketorolac tromethamine (KET) as an anti-inflammatory to improve glaucoma complications like Conjunctivitis. SNVs were prepared by ethanol injection technique using span (60) as a surfactant and labrasol as an edge activator (EA). The impact of formulation factors on SNVs properties was investigated using a Box-Behnken design. In vitro evaluations showed that the formulations (F1, F4, and F14), containing Span 60 and labrasol as EA (25%, 50%, and 25%), exhibited high EE% with low PS and high ZP and DI. Additionally, 61.72 ± 0.77%, 58.97 ± 1.44%, and 56.20 ± 2.32% of the NBV amount were released from F1, F4, and F14 after 5 h, compared to 93.94 ± 1.21% released from drug suspension. The selected formula (G1), containing F1 in combination with KET and 2% w/w HPMC, exhibited 76.36 ± 0.90% drug release after 12 h. Ex vivo Confocal laser scanning revealed a high penetration of NBV-SNVs gel that ascertained the results of the in-vitro study. In vivo studies showed a significant decrease in glaucoma compared to drug suspension, and histopathological studies showed improvement in glaucomatous eye retinal atrophy. G1 is considered a promising approach to improving ocular permeability, absorption, and anti-inflammatory activity, providing a safer alternative to current regimens.

2024-02-01·Advances in Therapy

A Randomized Controlled Trial of a Novel Formulation of Ketorolac Tromethamine for Continuous Infusion (NTM-001) in Healthy Volunteers

Article

作者: Pergolizzi, Joseph V ; Schmidt, William K ; Batra, Amanjot

INTRODUCTIONThere is an urgent unmet medical need for a safe, effective, nonopioid analgesic agent for postoperative pain control.METHODSThis first-in-man study was designed to explore a data-informed, model-based candidate dosage regimen and safety of a novel formulation of ketorolac tromethamine (NTM-001) delivered as a 12.5-mg intravenous (IV) bolus followed immediately by 3.5 mg/h continuous infusion over 24 h compared versus IV bolus dosing of 30 mg generic ketorolac every 6 h. The study evaluated pharmacokinetic parameters and safety profiles based on a targeted product profile. A graphical overlay method and model-based comparisons were used to assess the concentration-time curve.RESULTSHealthy adults (n = 28, 50% men) received NTM-001 and bolus dosing in an open-label crossover design. Observed plasma concentrations were tightly aligned with predicted values with no outliers. Graphical overlay comparisons showed low between-subject variability and agreed with forecasted concentration-time targets. The pharmacokinetic (PK) base models fit with preliminary PK data from both the NTM-001 and bolus groups with model fit median profiles within 95% prediction limits and no updating of the models. Consistent with serum concentration-time profiles, pain relief scores fell within predicted limits, with initial pain relief scores of NTM-001 slightly above the target profile, likely because the initial serum ketorolac concentrations were somewhat higher than predicted. The 24-h pain relief predicted for NTM-001 based on the area under the median ketorolac pain relief versus time curve was about 6% below that of the pain relief target. Both treatments were well tolerated and no subject withdrew because of adverse events.CONCLUSIONSThe PK parameters for NTM-001 and comparator bolus were similar to the modeling targets with no updating of the base model. There were no outliers and little intersubject variability. NTM-001 delivered as a bolus of 12.5 mg IV followed immediately by continuous infusion of 3.5 mg/h using a standard hospital infusion pump may offer an alternative to opioids for acute postoperative pain control.

2024-02-01·Bioanalysis

Ocular bioanalysis of moxifloxacin and ketorolac tromethamine in rabbit lacrimal matrix using liquid chromatography–tandem mass spectrometry

Article

作者: Bhatta, Rabi Sankar ; Bisen, Amol Chhatrapati

Aim: The fixed-dose combination of moxifloxacin (MOXI) and ketorolac tromethamine (KTR) is widely used for the treatment of bacterial keratitis. Thus, a new LC–MS/MS method was developed to determine MOXI and KTR in lacrimal fluid. Methods: Bioanalysis was performed using a Shimadzu 8050 LC–MS/MS in electrospray ionization-positive mode and the method was validated per US FDA guidelines. Isocratic separation was performed with a Waters Symmetry C18 column using methanol and 0.1% formic acid containing deionized water (85:15, v/v). Results & conclusion: An easy, quick and selective method was established and applied to assess the ocular pharmacokinetic profile of a commercially available formulation containing MOXI and KTR. Based on the pharmacokinetic data, this work describes pharmacokinetics-based dosage regimen calculations and their clinical significance.

项与酮咯酸氨丁三醇相关的新闻（医药）

2024-05-13

·信狐药迅

仿制药上市申请有14个品规发通知件；临床申请品种均默示许可| 新获批（5.6-5.12）

每周药品注册获批数据，分门别类呈现，一目了然。(5.6-5.12）小编收到有些用户反应，不想收到咱们每周文章的推送提醒，而有些用户又特别需要这个提醒，在小编强烈要求下，我们给力的程序员终于实现了可以关闭提醒的功能，这个绝对全网独一家喔，不想收到提醒的，只要在信狐药迅对话框内回复关键词“拒收文章提醒”，那么就可以不受推送的打扰啦!新药上市申请药品名称企业注册分类受理号TQB2450注射液正大天晴药业集团南京顺欣制药有限公司1CXSS2300003新药临床申请药品名称企业注册分类受理号TQ05105片正大天晴药业集团股份有限公司1CXHL2400232TQ05105片正大天晴药业集团股份有限公司1CXHL2400231SPH7485片上海医药集团股份有限公司1CXHL2400219SPH7485片上海医药集团股份有限公司1CXHL2400220SPH7485片上海医药集团股份有限公司1CXHL2400221SPH7485片上海医药集团股份有限公司1CXHL2400222ENN0403胶囊轶诺(浙江)药业有限公司1CXHL2400216ENN0403胶囊轶诺(浙江)药业有限公司1CXHL2400215HS-10382片江苏豪森药业集团有限公司1CXHL2400207HS-10382片江苏豪森药业集团有限公司1CXHL2400206SIPI6398片上海中泽医药科技有限公司1CXHL2400205SSS39注射剂沈阳三生制药有限责任公司1CXHL2400204INR101注射液云核医药(天津)有限公司1CXHL2400200ISM3412胶囊英矽智能科技(上海)有限公司1CXHL2400184ISM3412胶囊英矽智能科技(上海)有限公司1CXHL2400183ISM3412胶囊英矽智能科技(上海)有限公司1CXHL2400181GP681干混悬剂江西青峰药业有限公司1CXHL2400185BW-20507注射液杭州舶临医药科技有限公司1CXHL2400176JYP0066乳膏广州嘉越医药科技有限公司1CXHL2400167JYP0066乳膏广州嘉越医药科技有限公司1CXHL2400166JYP0066乳膏广州嘉越医药科技有限公司1CXHL2400165JYP0066乳膏广州嘉越医药科技有限公司1CXHL2400164JYP0066乳膏广州嘉越医药科技有限公司1CXHL2400163JYP0066乳膏广州嘉越医药科技有限公司1CXHL2400162BIOS2207浙江赛默制药有限公司2.2CXHL2400229BIOS2207浙江赛默制药有限公司2.2CXHL2400228GBI268注射液广州智耀生物科技有限公司2.2CXHL2400230注射用瑞卢戈利诺桥制药(成都)有限责任公司2.2CXHL2400194布立西坦注射液江西银涛药业股份有限公司3CYHL2400040糠酸莫米松富马酸福莫特罗吸入气雾剂长风药业股份有限公司3CYHL2400038酒石酸匹莫范色林胶囊华中药业股份有限公司3CYHL2400037JP001片北京慧宝源生物技术股份有限公司2.4;2.3CXHL2400202BAT1308注射液百奥泰生物制药股份有限公司1CXSL2400161注射用BAT8006百奥泰生物制药股份有限公司1CXSL2400162QX013N注射液江苏荃信生物医药股份有限公司1CXSL2400165注射用BL-B16D1成都百利多特生物药业有限责任公司1CXSL2400159LAE102注射液来凯医药科技(上海)有限公司1CXSL2400155CM383注射液康诺亚生物医药科技(成都)有限公司1CXSL2400154混合活化杀伤(MAK)免疫细胞注射液北京拓华伟业生物科技有限公司1CXSL2400119异体人源脂肪间充质干细胞注射液江苏得康生物科技有限公司1CXSL2400111RJK002注射液上海瑞吉康生物医药有限公司1CXSL2400117仿制药申请药品名称企业注册分类受理号酮咯酸氨丁三醇注射液福建天泉药业股份有限公司3CYHS2301619盐酸哌罗匹隆片四川科瑞德制药股份有限公司3CYHS2301594恩格列净二甲双胍缓释片上海汇伦江苏药业有限公司3CYHS2301339恩格列净二甲双胍缓释片上海汇伦江苏药业有限公司3CYHS2301337恩格列净二甲双胍缓释片上海汇伦江苏药业有限公司3CYHS2301336双氯芬酸钠注射液北京世桥生物制药有限公司3CYHS2301043盐酸多巴胺注射液山东达冠医药科技有限公司3CYHS2300596盐酸多巴胺注射液山东达冠医药科技有限公司3CYHS2300594阿齐沙坦片浙江诺得药业有限公司3CYHS2300009国;CYHS2300009盐酸奥洛他定颗粒南京明生医药有限公司3CYHS2202150国;CYHS2202150盐酸丙卡特罗颗粒安徽百奥药业有限公司3CYHS2201846国;CYHS2201846盐酸苯达莫司汀注射液齐鲁制药有限公司3CYHS2201798国;CYHS2201798盐酸多柔比星脂质体注射液常州吾合生物医药有限责任公司3CYHS2201562国;CYHS2201562盐酸多柔比星脂质体注射液常州吾合生物医药有限责任公司3CYHS2201561国;CYHS2201561低钙腹膜透析液(乳酸盐-G2.5)安徽丰原药业股份有限公司3CYHS2201233国;CYHS2201233低钙腹膜透析液(乳酸盐-G1.5)安徽丰原药业股份有限公司3CYHS2201232国;CYHS2201232注射用甲氨蝶呤上海上药睿尔药品有限公司3CYHS2102209国;CYHS2102209卡络磺钠注射液康普药业股份有限公司3CYHS2101509国;CYHS2101509氟比洛芬凝胶贴膏江苏万高药业股份有限公司4CYHS2301698盐酸罗匹尼罗缓释片江西金水宝制药有限公司4CYHS2301463碘克沙醇注射液通用电气药业(上海)有限公司4CYHS2301166硝酸异山梨酯注射液河北东圣科宇医药科技有限公司4CYHS2300695氢溴酸伏硫西汀片福建省闽东力捷迅药业股份有限公司4CYHS2300559泮托拉唑钠肠溶片寿光富康制药有限公司4CYHS2300571他达拉非片安徽贝克生物制药有限公司4CYHS2300404多索茶碱注射液赤峰万泽药业股份有限公司4CYHS2300257盐酸帕罗西汀肠溶缓释片山东京卫制药有限公司4CYHS2300150盐酸帕罗西汀肠溶缓释片山东京卫制药有限公司4CYHS2300149二甲双胍维格列汀片(III)浙江诺得药业有限公司4CYHS2300142地氯雷他定片合肥国药诺和药业有限公司4CYHS2201952国;CYHS2201952沙库巴曲缬沙坦钠片常州制药厂有限公司4CYHS2201907国;CYHS2201907沙库巴曲缬沙坦钠片常州制药厂有限公司4CYHS2201906国;CYHS2201906替米沙坦氢氯噻嗪片南京海纳医药科技股份有限公司4CYHS2201841国;CYHS2201841盐酸二甲双胍缓释片河南羚锐制药股份有限公司4CYHS2201750国;CYHS2201750注射用美罗培南江苏睿实生物科技有限公司4CYHS2201715国;CYHS2201715注射用美罗培南江苏睿实生物科技有限公司4CYHS2201714国;CYHS2201714头孢泊肟酯片齐鲁制药有限公司4CYHS2201687国;CYHS2201687盐酸托莫西汀口服溶液长兴制药股份有限公司4CYHS2201404国;CYHS2201404盐酸帕罗西汀肠溶缓释片北京北陆药业股份有限公司4CYHS2201525国;CYHS2201525复方聚乙二醇电解质散(III)浙江诺得药业有限公司4CYHS2201517国;CYHS2201517吸入用乙酰半胱氨酸溶液扬子江药业集团江苏紫龙药业有限公司4CYHS2201444国;CYHS2201444苯磺酸左氨氯地平片平光制药股份有限公司4CYHS2200990国;CYHS2200990苯磺酸左氨氯地平片平光制药股份有限公司4CYHS2200989国;CYHS2200989注射用硫酸艾沙康唑江苏奥赛康药业有限公司4CYHS2200985国;CYHS2200985盐酸多奈哌齐口腔崩解片迪沙药业集团有限公司4CYHS2200968国;CYHS2200968盐酸多奈哌齐口腔崩解片迪沙药业集团有限公司4CYHS2200967国;CYHS2200967阿普米司特片江苏知原药业股份有限公司4CYHS2200944国;CYHS2200944阿普米司特片江苏知原药业股份有限公司4CYHS2200942国;CYHS2200942他达拉非片浙江康恩贝制药股份有限公司4CYHS2200884国;CYHS2200884碘佛醇注射液成都倍特药业股份有限公司4CYHS2200395国;CYHS2200395进口申请药品名称企业注册分类受理号注射用盐酸曲拉西利G1 Therapeutics, Inc.5.1JXHS2300075吡仑帕奈片Eisai Europe Limited5.1JXHS2300026吡仑帕奈片Eisai Europe Limited5.1JXHS2300025卡替拉韦注射液ViiV Healthcare Pty Ltd.5.1JXHS2200099国;JXHS2200099卡替拉韦钠片ViiV Healthcare Pty Ltd.5.1JXHS2200098国;JXHS2200098重组人促卵泡激素δ注射液辉凌医药咨询(上海)有限公司3.1JXSS2100014国;JXSS2100014重组人促卵泡激素δ注射液辉凌医药咨询(上海)有限公司3.1JXSS2100013国;JXSS2100013重组人促卵泡激素δ注射液辉凌医药咨询(上海)有限公司3.1JXSS2100012国;JXSS2100012盐酸昂丹司琼注射液Gland Pharma Limited5.2JYHS2000049国;JYHS2000049PF-07220060Pfizer Inc.1JXHL2400059PF-07220060Pfizer Inc.1JXHL2400058PF-07220060Pfizer Inc.1JXHL2400057注射用JR8603JiaRay Pharmaceuticals, Inc.1JXHL2400043镥[177Lu]Lu-NeoB注射液Novartis Pharma AG1JXHL2400032米罗那非片AriBio Co., Ltd.2.4JXHL2400048米罗那非片AriBio Co., Ltd.2.4JXHL2400047甲磺酸贝舒地尔片Kadmon Pharmaceuticals, LLC2.4JXHL2400045布地奈德硫酸沙丁胺醇吸入气雾剂AstraZeneca Pharmaceuticals LP2.4JXHL2400036注射用BL-8040冻干粉BioLineRx Ltd.5.1JXHL2400046DE-117B滴眼液Santen Pharmaceutical Co., Ltd.5.1JXHL2400033盐酸羟甲唑啉滴眼液Santen Pharmaceutical Co., Ltd.5.2JYHL2400001MEDI5752AstraZeneca AB1JXSL2400055Amlitelimab注射液Sanofi-Aventis Recherche & Developpement1JXSL2400054Amlitelimab注射液Sanofi-Aventis Recherche & Developpement1JXSL2400053AMG 451Amgen Inc.1JXSL2400047Itepekimab注射液Sanofi-Aventis Recherche & Developpement1JXSL2400044中药相关申请药品名称企业注册分类受理号宝心艾维西木口服液新疆维吾尔药业有限责任公司4CYZL2400001注：灰色字体部分结论为不批准或收到通知件；

申请上市临床申请

2024-05-08

·药通社

以创新、可及的产品，引领皮肤健康行业！—领业医药 | 汇聚北京CPI2024

2024.5.10-11 • 中国北京CPI•2024 中国制药工业博览会展位号：C17号*转发文章到朋友圈赠送会议当天午餐券（简餐），数量有限，提前登记，现场先到先得！01企业介绍杭州领业医药科技有限公司成立于2010年，由国家级领军人才盛晓霞博士创立，是一家深耕皮肤健康领域，集研发、生产、销售于一体的研发驱动型药企。公司凭借创新技术，深度布局皮肤领域创新药及复杂制剂，拥有超10年制剂开发成功经验，以 “讲效率” “重质量”的服务赢得行业美誉。公司实行精细化与高质量并行的过程管理，已助力数十个产品在美国和中国获批，凭借其专业技术和有温度的服务成为客户粘性最高的企业之一。02基本情况“软”实力和“硬”实力齐头并进雄厚的研发实力研发团队150余人本科以上学历100%硕士博士以上学历超40%3000㎡研发创新中心1000㎡中试车间100+项目经验丰富的产品解决方案定制化技术服务清单产品立项调研药物固态研究处方前研究毒理配方研究复杂制剂研发质量研究及分析检测制剂GMP生产临床/ BE 研究法规及注册申报完善质量管理零缺陷通过美国FDA的GMP现场核查符合最新版中国GMP要求通过CNAS体系认证超十年灵活高效的生产能力满足中美欧GMP标准8000㎡多功能生产车间拥有稀缺的半固体制剂生产线资源（防爆/激素/泵瓶）多规格真空乳化罐:2L, 5L, 50L, 300L, 1000L, 3000L，满足不同产能需求固体制剂、半固体制剂，多剂型、多批量外用制剂年产能9000万支口固制剂年产能4亿片，3.8亿粒全球化注册申报具有多个DMF和ADNA项目申报、答复和官方沟通的成功经验，以实现产品在预期时间内顺利获批成熟的注册申报团队，熟知中、美、欧、日法规，多项目申报成功经验知识产权规划灵活、精准攻克仿制药专利壁垒全面、多维度布局创新药专利屏障专业细致的专利布局，为核心技术保驾护航侵权风险监控，避免研发投入的浪费商务管理和项目管理专业的国际化商务团队客户导向项目管理质量和进度双保障03成熟经验品种外用制剂软膏剂莫匹罗星软膏地奈德软膏克立硼罗软膏卡泊三醇倍他米松软膏三联抗生素软膏他克莫司软膏卡泊三醇软膏乳膏剂利丙双卡因乳膏夫西地酸乳膏地奈德乳膏克拉考特酮乳膏磷酸芦可替尼乳膏丙酸氟替卡松乳膏凝胶剂阿达帕林凝胶阿达帕林过氧苯甲酰凝胶克林霉素磷酸酯过氧苯甲酰凝胶氨苯砜凝胶依匹哌唑原位凝胶西罗莫司凝胶搽剂艾氟康唑搽剂盐酸阿莫罗芬搽剂米诺地尔搽剂乳胶剂双氯芬酸二乙胺乳胶剂洗剂地奈德洗剂口服制剂片剂阿戈美拉汀片磷酸芦可替尼片盐酸伐昔洛韦片达罗他胺片恩那度司他片恩扎卢胺片阿立哌唑片伐昔洛韦片枸橼酸托法替布片依维莫司片乌帕替尼缓释片琥珀酸美托洛尔缓释片碳酸镧咀嚼片蔗糖氢氧化氧铁咀嚼片阿立哌唑口崩片胶囊他克莫司胶囊艾司奥美拉唑镁肠溶胶囊软胶囊ω-3脂肪酸乙酯90软胶囊布洛芬软胶囊骨化三醇软胶囊注射剂粉针剂注射用舒巴坦钠注射用头孢哌酮钠他唑巴坦钠注射用头孢尼西钠注射用赖氨匹林冻干剂注射用醋酸卡泊芬净注射用达托霉素注射液酮咯酸氨丁三醇注射液其他剂型气雾剂硫酸沙丁胺醇吸入气雾剂喷雾剂盐酸氨溴索喷雾剂盐酸氨溴索喷雾剂滴眼剂他氟前列素滴眼液吸入溶液吸入用盐酸氨溴索溶液04联系我们联系电话：0571-86925019联系地址：杭州市钱塘区白杨街道6号大街260号1幢领业医药潘先生邸女士郑女士点击图片查看大会具体议程↓↓关于药融圈药融圈PRHub旨在帮助生物医药科技型企业进行品牌推广及商务拓展服务，针对客户的真实需求制定系统化解决方案，通过“翻译-降维-场景化”将客户的品牌信息以直白易懂的方式被公众知悉，同时在流量渠道覆盖100万+垂直用户基础上实现合作目的，帮助合作伙伴完成从品牌开始到商务为终的闭环营销服务。我们已经完成了数十场线下1000人规模的生物医药研发类会议，涵盖小分子新药，大分子新药，改良型新药，BD跨境交易等领域，品牌会议包括中国国际生物及化学制药产业大会，药物递送系列峰会，新药创新者系列峰会，服务了百余家上市/独角兽/生物技术/制药企业。

生物类似药专利侵权

2024-02-26

·信狐药迅

兆科痤疮新药阿达帕林克林霉素凝胶，卓和中药新药风叶咳喘平口服液获批文 | 新获批（2.19-2.25）

每周药品注册受理数据，分门别类呈现，一目了然。（2.19-2.25）新药上市申请药品名称企业名称分类受理号阿达帕林盐酸克林霉素复方凝胶兆科(广州)眼科药物有限公司2.3CXHS2100002特立帕肽注射液上海联合赛尔生物工程有限公司3.3CXSS2200068新药临床申请药品名称企业名称分类受理号ADC189颗粒嘉兴安谛康生物科技有限公司1CXHL2301377BEBT-109胶囊广州必贝特医药股份有限公司1CXHL2301363BEBT-109胶囊广州必贝特医药股份有限公司1CXHL2301364GLB-001胶囊杭州格博生物医药有限公司1CXHL2301360GLB-001胶囊杭州格博生物医药有限公司1CXHL2301361GLB-001胶囊杭州格博生物医药有限公司1CXHL2301362HP537片海创药业股份有限公司1CXHL2301351HP537片海创药业股份有限公司1CXHL2301352HRS-1167片江苏恒瑞医药股份有限公司1CXHL2301200JMKX003561颗粒浙江杭煜制药有限公司1CXHL2301356JMKX003561颗粒浙江杭煜制药有限公司1CXHL2301357JP-1366片丽珠集团丽珠医药研究所1CXHL2301335JW202232吸入气雾剂山东泰合医药科技有限公司2.2CXHL2301319TL938胶囊苏州韬略生物科技股份有限公司1CXHL2301355盐酸安罗替尼胶囊正大天晴药业集团股份有限公司2.4CXHL2301373盐酸安罗替尼胶囊正大天晴药业集团股份有限公司2.4CXHL2301374盐酸安罗替尼胶囊正大天晴药业集团股份有限公司2.4CXHL2301375aT19注射液北京永泰瑞科生物科技有限公司1CXSL2300808JWK001注射液成都金唯科生物科技有限公司1CXSL2300827QX007N注射液江苏荃信生物医药股份有限公司1CXSL2300850WG1025北京唯源立康生物科技股份有限公司1CXSL2300809注射用HS-20089上海翰森生物医药科技有限公司1CXSL2300849注射用PRO1107普方生物制药(苏州)有限公司1CXSL2300847注射用SIBP-A17上海生物制品研究所有限责任公司1CXSL2300851重组带状疱疹疫苗(CHO细胞)上海生物制品研究所有限责任公司1.3CXSL2300817重组带状疱疹疫苗(CHO细胞)上海生物制品研究所有限责任公司1.3CXSL2300818仿制药申请药品名称企业名称分类受理号丙泊酚中/长链脂肪乳注射液石家庄四药有限公司4CYHS2201195丙泊酚中/长链脂肪乳注射液石家庄四药有限公司4CYHS2201196乙酰半胱氨酸泡腾片宁波美诺华天康药业有限公司4CYHS2201771乙酰半胱氨酸泡腾片江苏安必生制药有限公司4CYHS2201683低钙腹膜透析液(乳酸盐-G1.5)上海华源安徽锦辉制药有限公司4CYHS2201024低钙腹膜透析液(乳酸盐-G2.5)上海华源安徽锦辉制药有限公司4CYHS2201009依托考昔片山西同达药业有限公司4CYHS2200527依托考昔片山西同达药业有限公司4CYHS2200528依替巴肽注射液沈阳双鼎制药有限公司3CYHS2200579利伐沙班片天津力生制药股份有限公司4CYHS2201017利伐沙班片天津力生制药股份有限公司4CYHS2201018利伐沙班片天津力生制药股份有限公司4CYHS2201016利奈唑胺葡萄糖注射液江苏晨牌药业集团股份有限公司4CYHS2200161去氧肾上腺素酮咯酸溶液苏州朗易生物医药研究有限公司3CYHS2301443吡拉西坦注射液华夏生生药业(北京)有限公司3CYHS2201887吡拉西坦注射液华夏生生药业(北京)有限公司3CYHS2201888吲哚布芬片仁合益康集团有限公司3CYHS2301213吸入用乙酰半胱氨酸溶液云南龙海天然植物药业有限公司4CYHS2201984呋塞米口服液成都倍特得诺药业有限公司3CYHS2200938地夸磷索钠滴眼液成都普什制药有限公司4CYHS2201668地屈孕酮片杭州和泽坤元药业有限公司4CYHS2201435头孢地尼颗粒海南葫芦娃药业集团股份有限公司4CYHS2200370头孢托仑匹酯颗粒北京诚济制药股份有限公司4CYHS2302749奥硝唑注射液西安信百欣医药科技有限公司3CYHS2201249奥硝唑注射液西安信百欣医药科技有限公司3CYHS2201250对乙酰氨基酚维生素C泡腾片山东新鲁医药科技有限公司3CYHS2301569左乙拉西坦缓释片华润赛科药业有限责任公司3CYHS2200992左乙拉西坦缓释片华润赛科药业有限责任公司3CYHS2200993己酮可可碱注射液山东泰合医药科技有限公司3CYHS2201467异硫蓝注射液广东和博制药有限公司3CYHS2200409枸橼酸托法替布片黑龙江珍宝岛药业股份有限公司4CYHS2102173氟维司群注射液轩竹生物科技股份有限公司4CYHS2201150氢溴酸伏硫西汀片辰欣药业股份有限公司4CYHS2201399氢溴酸伏硫西汀片辰欣药业股份有限公司4CYHS2201400氧湖南昇宇科技开发有限公司4CYHS2300752氨磺必利口服溶液山东朗诺制药有限公司3CYHS2201774氯化钾注射液广州艾奇西医药科技有限公司3CYHS2201393氯化钾注射液广州艾奇西医药科技有限公司3CYHS2201394氯化钾注射液海南紫程众投生物科技有限公司3CYHS2201317氯化钾颗粒杭州和泽坤元药业有限公司3CYHS2201694氯替泼诺妥布霉素滴眼液天津金耀药业有限公司4CYHS2300842氯雷他定糖浆河北三禾实创生物科技有限公司4CYHS2300789氯雷他定糖浆河北三禾实创生物科技有限公司4CYHS2300790注射用头孢他啶阿维巴坦钠上海欣峰制药有限公司4CYHS2200952注射用盐酸瑞芬太尼宜昌人福药业有限责任公司3CYHS2202145注射用盐酸瑞芬太尼宜昌人福药业有限责任公司3CYHS2202146注射用盐酸瑞芬太尼宜昌人福药业有限责任公司3CYHS2202147注射用盐酸罗沙替丁醋酸酯北京品尚品医药科技有限公司3CYHS2200371注射用艾司奥美拉唑钠重庆中创科医药有限公司4CYHS2201720注射用阿扎胞苷齐鲁制药(海南)有限公司4CYHS2200759盐酸帕罗西汀片江苏睿实生物科技有限公司4CYHS2201063盐酸氨溴索口服溶液南京卡文迪许生物工程技术有限公司4CYHS2300569盐酸特比萘芬喷雾剂华润三九医药股份有限公司4CYHS2200820盐酸特比萘芬喷雾剂浙江恒研医药科技有限公司4CYHS2200544盐酸纳洛酮注射液东阳祥昇医药科技有限公司3CYHS2201420盐酸达泊西汀片江苏万高药业股份有限公司4CYHS2201054盐酸鲁拉西酮片辰欣药业股份有限公司4CYHS2102298硝酸甘油葡萄糖注射液仁合益康集团有限公司3CYHS2301226硝酸甘油葡萄糖注射液仁合益康集团有限公司3CYHS2301227硫酸氨基葡萄糖胶囊青岛百洋制药有限公司4CYHS2201008硫酸特布他林注射液成都利尔药业有限公司3CYHS2200341硫酸镁注射液北京民康百草医药科技有限公司3CYHS2201519碳酸氢钠林格注射液石家庄四药有限公司3CYHS2201309磷酸奥司他韦胶囊吉林敖东洮南药业股份有限公司4CYHS2201343磷酸奥司他韦胶囊吉林敖东洮南药业股份有限公司4CYHS2201344磷酸奥司他韦胶囊吉林敖东洮南药业股份有限公司4CYHS2201345维格列汀片惠升生物制药股份有限公司4CYHS2201303罗库溴铵注射液吉林振澳制药有限公司4CYHS2200841罗库溴铵注射液吉林振澳制药有限公司4CYHS2200842美阿沙坦钾片仁合益康集团有限公司4CYHS2301049美阿沙坦钾片仁合益康集团有限公司4CYHS2301050聚乙烯醇滴眼液远大医药(中国)有限公司3CYHS2300885舒更葡糖钠注射液海南睿智医药科技投资有限公司4CYHS2200321西格列汀二甲双胍缓释片上海安必生制药技术有限公司3CYHS2200155西洛他唑片北京福元医药股份有限公司3CYHS2201576酒石酸溴莫尼定滴眼液北京诺思兰德生物技术股份有限公司4CYHS2200665酮咯酸氨丁三醇注射液江苏明圣康源药业有限公司3CYHS2303616酮咯酸氨丁三醇注射液成都瑞尔医药科技有限公司3CYHS2300791铝碳酸镁混悬液四川益生智同医药生物科技发展有限公司3CYHS2200912长链脂肪乳注射液(OO)成都国为生物医药有限公司4CYHS2200467阿司匹林肠溶片江苏万高药业股份有限公司4CYHS2201656阿哌沙班片华润双鹤药业股份有限公司4CYHS2201597阿立哌唑口服溶液山东百诺医药股份有限公司3CYHS2201251骨化三醇软胶囊江苏中治制药有限公司4CYHS2201535进口申请药品名称企业名称分类受理号Camonsertib胶囊F.Hoffmann-La Roche Ltd.1JXHL2300307CagriSema注射液Novo Nordisk A/S1JXSL2300221CagriSema注射液Novo Nordisk A/S1JXSL2300222CagriSema注射液Novo Nordisk A/S1JXSL2300223CagriSema注射液Novo Nordisk A/S1JXSL2300224CagriSema注射液Novo Nordisk A/S1JXSL2300225MK-7240注射液Merck Sharp & Dohme LLC1JXSL2300219MK-7240注射用浓溶液Merck Sharp & Dohme LLC1JXSL2300220SAR443765注射液Sanofi-Aventis Recherche & Developpement1JXSL2300216注射用重组单链人凝血因子VIIICSL Behring GmbH3.1JXSL2300208注射用重组单链人凝血因子VIIICSL Behring GmbH3.1JXSL2300209注射用重组单链人凝血因子VIIICSL Behring GmbH3.1JXSL2300210注射用重组单链人凝血因子VIIICSL Behring GmbH3.1JXSL2300211注射用重组单链人凝血因子VIIICSL Behring GmbH3.1JXSL2300212注射用重组单链人凝血因子VIIICSL Behring GmbH3.1JXSL2300213注射用重组单链人凝血因子VIIICSL Behring GmbH3.1JXSL2300214恩曲替尼胶囊Roche Pharma (Schweiz) AG5.1JXHS2300045恩曲替尼胶囊Roche Pharma (Schweiz) AG5.1JXHS2300046硫酸羟氯喹片Amneal EU, Limited5.2JYHS2300128醋酸锌片Nobelpharma Co.,Ltd.5.1JXHS2300017醋酸锌片Nobelpharma Co.,Ltd.5.1JXHS2300018珂罗利单抗注射液Roche Pharma (Schweiz) AG1JXSS2200031中药相关申请药品名称企业名称分类受理号风叶咳喘平口服液卓和药业集团股份有限公司1.1CXZS2200014注：灰色字体部分结论为不批准或收到通知件；

申请上市抗体药物偶联物疫苗

100 项与酮咯酸氨丁三醇相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	酮咯酸氨丁三醇	M01AB15 S01BC05	DB05364

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
炎症	美国	AbbVie, Inc.	2009-07-22
疼痛	美国	AbbVie, Inc.	2009-07-22
烧伤	美国	AbbVie, Inc.	2003-05-30
眼睛疼痛	美国	AbbVie, Inc.	2003-05-30
急性疼痛	中国	-	2001-03-14
变应性结膜炎	中国	Allergan, Inc.	1999-09-17
术后炎症	美国	AbbVie, Inc.	1992-11-09
季节性过敏性结膜炎	美国	AbbVie, Inc.	1992-11-09

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
阻生牙	临床2期	美国	Egalet Ltd.	2004-02-01
背痛	药物发现	-	EMS-Chemie Holding AG	2013-03-01
慢性疼痛	药物发现	中国	Shandong Institute Of Pharmaceutical Industry	2007-07-12
重度疼痛	药物发现	中国	Shandong Institute Of Pharmaceutical Industry	2007-07-12
牙痛	药物发现	中国	Shandong Institute Of Pharmaceutical Industry	2007-07-12
术后疼痛	药物发现	新西兰	Egalet Ltd.	2003-06-01
疼痛	药物发现	美国	Roche Palo Alto LLC	1989-11-30

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临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT02084576 (Pubmed)	临床4期	白内障	106	Ketorolac tromethamine 0.5%	(夢製壓夢鏇築醖壓糧憲) = 糧積淵繭襯鹹構餘衊鏇網壓窪蓋製製壓簾繭醖 (鹹構積築淵醖鏇壓鹹醖 )	积极	2008-01-01
				prophylactic nonsteroidal antiinflammatory drugs (Control group)	(夢製壓夢鏇築醖壓糧憲) = 範顧觸夢鹽製簾鹽選齋網壓窪蓋製製壓簾繭醖 (鹹構積築淵醖鏇壓鹹醖 )
ARVO2013	N/A	-	32	Ketorolac 0.2% formulated in DuraSite	(醖壓鑰構範鬱構憲鹹網) = 艱觸積遞製選簾簾願製範憲選鬱鏇壓餘壓鹹獵 (蓋鹹構淵廠窪餘膚簾淵 ) 更多	积极	2013-06-01
				Ketorolac 0.4% formulated in DuraSite	(醖壓鑰構範鬱構憲鹹網) = 獵鹹積簾鬱觸糧繭憲鏇範憲選鬱鏇壓餘壓鹹獵 (蓋鹹構淵廠窪餘膚簾淵 ) 更多
AUA2020	N/A	-	50	Norco	鏇製繭廠鑰鑰餘鏇壓膚(遞鹹網網齋膚鹹簾衊網) = Two patients complained of discomfort on application due to accidental inhalation 鬱願鏇鏇簾醖廠鏇衊觸 (構觸觸遞壓觸遞選艱憲 )	积极	2020-04-01
				SPRIX
ASCO2016	N/A	进展期胃腺癌	341	PFtax	(積範夢構壓衊構憲願簾) = 壓簾衊壓鹹製膚獵願獵憲襯築鹽製鹽衊壓鹽鹹 (構鑰遞遞觸鹹繭簾築觸 ) 更多	积极	2016-05-20
				PF	(積範夢構壓衊構憲願簾) = 憲膚餘衊簾繭憲齋選顧憲襯築鹽製鹽衊壓鹽鹹 (構鑰遞遞觸鹹繭簾築觸 ) 更多
ARVO2007	N/A	-	20	Ketorolac tromethamine ophthalmic solution 0.4%	築醖夢鹹鹽衊遞蓋鏇廠(簾選襯衊艱鏇醖選簾願) = 願艱簾願範齋鹹齋餘廠壓鹽網膚憲艱壓鹽構顧 (夢遞齋築網簾壓鹹鹹夢 ) 更多	-	2007-05-01
				Bromfenac ophthalmic solution 0.09%	築醖夢鹹鹽衊遞蓋鏇廠(簾選襯衊艱鏇醖選簾願) = 膚糧鏇淵壓憲膚憲壓蓋壓鹽網膚憲艱壓鹽構顧 (夢遞齋築網簾壓鹹鹹夢 ) 更多
Pubmed	N/A	-	-	Ice packs, Tylenol, and Toradol	(醖艱淵淵鬱鑰壓簾糧網) = 齋獵憲壓鹹淵網夢鏇鑰衊壓齋壓範網鹽顧鏇醖 (繭築淵繭繭獵餘構獵遞 )	积极	2019-11-01
PO444 (AAO2018)	N/A	眼睑下垂	-	IVK	簾願積築網憲鑰網壓觸(築艱艱鬱簾淵憲鹽醖鹹) = 廠鏇網膚鏇蓋蓋艱網鹽夢選窪鹽繭網憲製製憲 (艱繭顧簾願壓糧膚餘窪 )	积极	2018-10-29
				Intravenous Ketorolac	簾願積築網憲鑰網壓觸(築艱艱鬱簾淵憲鹽醖鹹) = 憲築鑰選範壓窪壓鹽壓夢選窪鹽繭網憲製製憲 (艱繭顧簾願壓糧膚餘窪 )
NCT00865540 (ARVO2012)	临床4期	眼科外科手术	46	Topical prednisolone acetate 1% + dextran 70/hypromellose	(鏇廠糧顧襯獵蓋網製襯) = 餘憲網觸選廠鏇繭窪夢願淵襯製蓋簾齋獵憲簾 (積鏇夢範窪範鹹蓋鬱憲 ) 更多	不佳	2012-03-01
				Topical prednisolone acetate 1% + ketorolac tromethamine 0.4%	(鏇廠糧顧襯獵蓋網製襯) = 衊齋鹽顧獵醖積鏇積蓋願淵襯製蓋簾齋獵憲簾 (積鏇夢範窪範鹹蓋鬱憲 ) 更多
ChiCTR-TRC-11001197 (ASCO2016)	临床2期	转移性食管癌一线	150	PF + 10 μg/m<sup>2</sup>/d rhLTα-Da	(壓選蓋鑰齋製構窪窪夢) = 選蓋範窪夢願膚願壓繭繭壓範蓋鑰壓鹹憲餘顧 (製簾齋簾鹽觸餘築艱淵 ) 更多	-	2016-05-20
				PF + 20 μg/m<sup>2</sup>/d rhLTα-Da	(壓選蓋鑰齋製構窪窪夢) = 觸餘鹽遞鑰齋艱繭願獵繭壓範蓋鑰壓鹹憲餘顧 (製簾齋簾鹽觸餘築艱淵 ) 更多
NCT01001806 (ARVO2010)	临床4期	-	122	Ketorolac tromethamine 0.45%	(構範糧窪鏇窪製繭衊鹹) = 壓艱憲窪壓餘憲淵鹹淵鑰鏇遞壓製壓廠窪鏇糧 (齋齋鹽顧網願衊夢顧糧 )	积极	2010-04-01
				Bromfenac 0.09%	(構範糧窪鏇窪製繭衊鹹) = 衊鏇夢網簾願艱築簾遞鑰鏇遞壓製壓廠窪鏇糧 (齋齋鹽顧網願衊夢顧糧 )