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更新于：2025-10-13

Indomethacin

吲哚美辛

更新于：2025-10-13

概要

基本信息

简介吲哚美辛是一种小分子，属于非甾体类抗炎药 (NSAID)，通过抑制 COX 酶，可阻止炎症和疼痛。该药物可用于治疗多种疾病，包括动脉导管、关节炎、网球肘、急性臂神经炎、痛风性关节炎、强直性脊柱炎、滑囊炎、肌腱病、骨关节炎、类风湿性关节炎、肿胀、疼痛、肘部肌腱病、炎症和肌肉骨骼疼痛。由 iROKO Partners Ltd. 开发，于 1965 年 6 月获得批准。

药物类型

小分子化药

别名

IM-P、Indaflex、Indometacin

+ [31]

靶点

COXs

作用方式

抑制剂

作用机制

COX抑制剂(环氧化酶抑制剂)

治疗领域

在研适应症

非在研适应症

原研机构

在研机构

成都第一制药有限公司CHARTWELL MOLECULES LLCZyla Life Sciences US LLC

+ [7]

非在研机构

Novartis AG

Rising Pharmaceuticals, Inc.

Genus Lifesciences, Inc.

+ [4]

权益机构-

最高研发阶段批准上市

首次获批日期

美国 (1965-06-10),

强直性脊柱炎滑囊炎骨关节炎+ [4]

最高研发阶段(中国)批准上市

特殊审评-

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结构/序列

分子式C19H16ClNO4

InChIKeyCGIGDMFJXJATDK-UHFFFAOYSA-N

CAS号53-86-1

关联

218

项与吲哚美辛相关的临床试验

NCT07202559

/ Not yet recruitingN/AIIT

Aggressive Intravenous Hydration With Lactated Ringer's Solution Plus Rectal Indometacin Versus Rectal Indometacin Alone to Prevent Pancreatitis After Pancreatic Extracorporeal Shock Wave Lithotripsy: A Multicentre, Superiority, Randomised, Controlled Trial

This study aims to determine whether combining aggressive intravenous hydration with indometacin is more effective at preventing pancreatitis after a Extracorporeal Shock Wave Lithotripsy (ESWL) than using indometacin alone.
The study will involve patients who are scheduled to undergo ESWL for pancreatic stones. Participants will be randomly assigned to one of two groups: one will receive both the intravenous hydration and the rectal indometacin, while the other will receive only the rectal indometacin.
The trial will be conducted at multiple centers, ensuring a broad and diverse patient population.
The primary outcome of the study will be the incidence of pancreatitis after the ESWL procedure.
This study is important because it could lead to a better understanding of how to prevent pancreatitis after ESWL, potentially improving patient outcomes and reducing the risk of serious complications.

开始日期2025-12-01

申办/合作机构

海军军医大学第一附属医院

[+7]

NCT06572917

/ Not yet recruiting临床2期IIT

Single-dose Prophylactic INdomethacin in Extremely Preterm Infants - A Multicenter Randomized Blinded Placebo-Controlled Trial (the SPIN RCT)

In Canada, about 900 babies each year are born very early (<26 weeks of gestation) and have a high chance of dying or having a serious bleed in the brain. Families of these extremely preterm babies consider preventing severe brain bleeding as critical to their child's health and well-being. A medicine called indomethacin, when given intravenously in 3-doses, is known to reduce severe brain bleeding. But use of this drug is variable among clinicians working in the neonatal intensive care unit (NICU) due to (a) its side effects on the gut; (b) possible harm when used with other medications; (c) a notion that despite reducing brain bleeds, the child's long-term brain development is not improved. Emerging evidence suggests that a single low-dose indomethacin regimen may be equally effective in reducing severe brain bleeding as compared to a traditional 3-dose regimen.
The investigators propose a blinded randomized controlled trial, a study design where babies born <26 weeks will be randomly assigned within 12 hours of birth to either a single dose of intravenous indomethacin or similar looking placebo in the form a saline solution. The study will test if a single dose indomethacin regimen is effective in improving survival of these babies without the devastating complication of severe brain bleeding. In this study the care providers and researchers will be unaware as to which baby receives indomethacin and which baby receives placebo to ensure no one's expectations or biases can influence the results.
The investigators will conduct the study in multiple NICUs across Canada, the United States and Australia in 2 phases: First, an internal pilot phase that will enroll 104 babies born <26 weeks or <750 g birth weight over a period of 1 year. If the investigators are successful in achieving their target enrolment in the pilot phase, they will move on to the second phase and continue enrollment up to a total of 500 babies born <26 weeks or <750 g birth weight over a period of 3 years. The total of 500 babies will include the 104 babies enrolled in the first phase of the study. This study will help the investigators determine in the most unbiased way whether a single dose of indomethacin given immediately after birth in the smallest babies born <26 weeks of gestation can safely and effectively reduce severe brain bleeding.

开始日期2025-11-01

申办/合作机构

University of British Columbia

NCT07088757

/ Recruiting临床4期IIT

Low-Dose Versus Standard-Dose Rectal Indomethacin to Prevent Post-Endoscopic Retrograde Cholangiopancreatography Pancreatitis: A Multicentre, Non-Inferiority, Double-Blind, Randomised, Controlled Trial

Endoscopic Retrograde Cholangiopancreatography (ERCP) is a widely used procedure for diagnosing and treating pancreatic and biliary diseases. Despite its benefits, ERCP carries a risk of post-procedure pancreatitis (PEP), which occurs in approximately 12.2% of cases and can significantly increase healthcare costs and patient morbidity. Preventing PEP is crucial for improving patient outcomes and reducing the economic burden of ERCP.
Nonsteroidal anti-inflammatory drugs (NSAIDs), such as indomethacin, have been shown to be effective in reducing the incidence of PEP when administered rectally before ERCP. The standard dose recommended by guidelines is 100mg, which has been associated with a significant reduction in PEP rates. However, higher doses of NSAIDs can increase the risk of adverse events, including gastrointestinal bleeding and renal impairment. Therefore, there is a need to determine whether a lower dose can provide similar benefits without increasing these risks.
This multicenter, non-inferiority, double-blind, randomized controlled trial will be conducted in China. Participants will be adults aged 18 or older scheduled for ERCP. They will be randomly assigned in a 1:1 ratio to either the low-dose (50mg) or standard-dose (100mg) indomethacin group. The intervention will be administered rectally 30 minutes before the ERCP procedure. The study will follow a double-blind design, ensuring that both patients and investigators are unaware of the treatment allocation.
The results of this trial could significantly influence clinical practice by providing evidence on the effectiveness of a lower dose of indomethacin in preventing PEP. This could lead to a reduction in the risk of adverse events associated with higher doses and potentially decrease healthcare costs without compromising patient safety. By optimizing the dosing of indomethacin, this study aims to improve the safety and cost-effectiveness of ERCP procedures.

开始日期2025-09-15

申办/合作机构

海军军医大学第一附属医院

[+9]

100 项与吲哚美辛相关的临床结果

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100 项与吲哚美辛相关的转化医学

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100 项与吲哚美辛相关的专利（医药）

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45,409

项与吲哚美辛相关的文献（医药）

2026-01-01·SPECTROCHIMICA ACTA PART A-MOLECULAR AND BIOMOLECULAR SPECTROSCOPY

A near-infrared AIE probe targeting COX-2 for imaging of Cancer cells

Article

作者: Liu, Jianxi ; Xue, Ying ; Liu, Wanhui ; Shen, Li ; Zhu, Yanping ; Zhang, Yonglin ; Chen, Shulin ; Wang, Aiping ; Xu, Lixiao ; Hu, Jiale

High expression of cyclooxygenase-2 (COX-2) in the inflammatory tumor microenvironment is a critical target for early cancer diagnosis. We designed and synthesized a series of near-infrared (NIR) fluorescent probes based on the aggregation-induced emission (AIE) mechanism for targeted COX-2 imaging. Leveraging a D-π-A quinoline-malononitrile core, we developed probes YL-180 (non-targeted control), YL-181 (celecoxib conjugate), and YL-186 (indomethacin conjugate). Notably, this work represents the first report combining this specific AIE core with established COX-2 targeting ligands, celecoxib and indomethacin, for this application. These probes exhibit characteristic AIE properties, with YL-181 showing fluorescence enhancement up to approximately 9.7-fold from pure THF in aggregated state, effectively overcoming the aggregation-caused quenching (ACQ) issue. They also possess favorable optical features including NIR emission (>650 nm) and large Stokes shifts (>200 nm). Their aggregation behavior and nanoparticle formation were characterized by DLS and TEM. In vitro cellular imaging revealed that YL-181 achieved superior tumor cell selectivity, demonstrating approximately 22-fold higher fluorescence intensity in MCF-7 cancer cells over normal HUVEC cells (around 4-fold for YL-186 over normal HUVEC cells). A competitive assay confirmed YL-181's specific COX-2 binding. Furthermore, YL-181 sensitively reflected intracellular COX-2 levels, with fluorescence decreasing by approximately 97 % from untreated upon COX-2 inhibition and increasing by around 135 % from untreated upon induction. Molecular docking and dynamics simulations provided insights into the specific binding mode and dynamic stability of YL-181 with COX-2 from an atomic perspective. In vivo imaging validated YL-181's excellent tumor targeting ability and high contrast performance in mouse models, showing a tumor-to-background ratio (TBR) of around 1.83 from normal tissue background, consistent with ex vivo organ analysis. Our highly sensitive and selective COX-2 targeted AIE probe, YL-181, holds significant potential for precise early tumor imaging.

2025-12-31·Green Chemistry Letters and Reviews

Conductometric, physico-chemical, and biological activity investigations of a copper–indometacin complex

作者: Almarri, Modhi S. ; Salem, Shereen E. ; AbouElleef, Elsayed M. ; Alayyafi, AbdulAziz A. ; Gomaa, Esam A. ; Ghanem, Kholoud Z.

Copper-indometacin (Cu-Indo) complex was prepared and X-ray diffraction, IR anal., UV-V spectrophotometric anal. and thermal anal. of the formed (Cu-Indo) complex were used to characterize it.The formation constants for the complexation of CuCl2.2H2O and indometacin in methanol, ethanol, and their binary mixture with water were determined by the conductometric technique.Three stoichiometric complexes of copper-indometacin (1/2), (1/1), and (2/1) (M/L) were detected and their formation constants (Kf) were estimated by using the conductometric method and the Gibbs free energy change (ΔGf) was also estimatedThe antimicrobial activities of indometacin and (Cu-Indo) complex have been studied using the disk diffusion method against Gram-neg. bacteria (P. aeruginosa, E. coli, and K. pneumoniae), Gram-pos. bacteria (S. aureus, B. cereus, and S. epidermidis), and fungi (C. albicans).In B. cereus, the (Cu-Indo) complex has a larger inhibitory zone (Gram-pos. bacteria).As a result, it can be utilized to treat B. cereus bacteria (cytotoxicity testing was not conducted in this study).

2025-12-31·Journal of Maternal-Fetal & Neonatal Medicine

Long-term indomethacin stabilizes the short cervix

Article

作者: Harman, Christopher ; Turan, Sifa ; Driscoll, Colleen ; Cetinkaya Demir, Bilge ; Seif, Karl ; Turan, Ozhan ; Abi Habib, Paola

OBJECTIVE:

Short cervical length (CL) is a known predictor of preterm delivery (PTD). We aimed to study the progression of CL as gestational age (GA) advances in patients with short cervix treated under our long-term Indomethacin therapy (LIT) protocol, and to document the effect of LIT on the cervix.

METHODS:

Retrospective cohort study conducted in a single medical center from 2010 to 2020. Patients with singleton pregnancies and 2^nd trimester CL ≤25 mm received LIT per our clinical protocol which included weekly CL and ultrasound (US) surveillance of amniotic fluid and Doppler indices. We compared initial cervical length (CLI) once LIT was started to final cervical length (CLF) once LIT was stopped, and cervical stabilization was defined as CLF-CLI ≥ 0. A longitudinal analysis of CL as GA progressed was performed using a multivariable linear mixed-effects regression model. A subgroup analysis was performed on patients whose total serial CL surveillance period lasted at least 3 weeks, and GA at delivery was analyzed based on cervical stabilization in this initial 3-week period. Statistical analyses were performed using Stata 16.

RESULTS:

135 patients with short CL treated under our LIT protocol were included. 90 (67%) had CLF-CLI ≥ 0. Based on the regression model, the rate of CL change with time was 0.04 mm/day. This did not change when progesterone (both vaginal and intramuscular) use was added as an interaction term. 105 (78%) delivered >32 weeks, and 68 (50%) delivered at full term. There was no difference in the rate of delivery >28 weeks between those with CLI ≤10mm and those with CLI between 11 and 25 mm (78% v 90%, p > 0.05). 112 patients (83%) had at least 3 weeks of US surveillance. Of those, 76 (68%) had CLF-CLI ≥ 0 and 107 (95.5%) delivered at >28 weeks. The PPV of CLF-CLI ≥ 0 to predict delivery >28 weeks was 95%.

CONCLUSION:

While normally CL shortens progressively throughout pregnancy, patients with short CL managed with LIT had no further shortening. There is a need for a randomized controlled trial of LIT for prevention of PTD in patients with short CL.

项与吲哚美辛相关的新闻（医药）

2025-09-26

·PRNewswire

Sen-Jam Pharmaceutical and KVK Tech Complete Final CMC Deliverables for SJP-002C, Paving the Way for Late-Stage Clinical Development

Completion of submission batches and NDA-ready CMC package strengthens regulatory foundation for upcoming Phase 2b/3 trials and underscores Sen-Jam's leadership in immunoregulation and inflammaging. HUNTINGTON, N.Y., Sept. 26, 2025 /PRNewswire/ -- Sen-Jam Pharmaceutical, in partnership with KVK Tech, today announced the successful completion of the final development deliverables under their Development, Manufacturing, Distribution, and Licence Agreement. KVK Tech has manufactured the required submission batches of SJP-002C and finalized the Chemistry, Manufacturing, and Controls (CMC) package, meeting FDA standards and positioning the program for Phase 2b/3 clinical trials. SJP-002C is a patented novel combination of indomethacin, a potent non-steroidal anti-inflammatory drug, and ketotifen, an H1-antihistamine and mast cell stabilizer. Together, they address inflammation while reducing the gastrointestinal risks typically associated with NSAIDs. "This milestone is about more than manufacturing readiness," said Jackie Iversen, RPh, MS, Co-Founder and Head of Clinical Development at Sen-Jam Pharmaceutical. "It reflects our broader mission to advance a new class of immunoregulators that restore balance to the immune system. By targeting inflammaging and immunosenescence, we are building a pipeline with potential far beyond acute conditions—positioning SJP-002C as both a near-term therapeutic and part of a longer-term longevity strategy." "We are proud to support Sen-Jam by completing the submission batches and CMC package for SJP-002C," said Kiran Vepuri, Executive Vice President of Business Development at KVK Tech. "Our focus has been on quality and readiness so that Sen-Jam can proceed into late-stage clinical studies without delay. As both a strategic partner and equity holder in Sen-Jam, we are deeply committed to advancing much-needed therapies together." Importance of the Milestone Regulatory Readiness: Completion of three validated submission batches and a full CMC package suitable for late-stage clinical and regulatory requirements. De-Risking the Program: Manufacturing and stability work complete, allowing clinical development to advance on schedule. Scientific & Strategic Validation: Recent commentary from Oppenheimer Research noted the role of immunoregulators in addressing inflammaging, highlighting Sen-Jam's pipeline as a differentiated opportunity in the longevity sector. Strong Intellectual Property: Sen-Jam's global patent estate, now including a manufacturing process patent for SJP-002C, provides robust protection and commercialization leverage. Next Step – Phase 2b/3 Trials: With CMC deliverables complete, SJP-002C is now positioned to begin the next phase of clinical testing. About Sen-Jam Pharmaceutical Sen-Jam Pharmaceutical is pioneering a new era of anti-inflammatory therapeutics, combining speed-to-market with accessibility and global health impact. Backed by more is raising capital at wefunder.com/senjam About KVK Tech KVK Tech is a U.S.-based, FDA-registered pharmaceutical manufacturer committed to providing high-quality, affordable medicines. With state-of-the-art facilities and deep expertise in formulation and CMC, KVK partners serves as Sen-Jam's exclusive U.S. manufacturing and distribution partner, KVK Tech is also an equity holder in Sen-Jam, underscoring its long-term commitment to the success of SJP-002C and future programs. CONTACT INFORMATION: Sen-Jam Pharmaceutical Christine Leonard 781-913-1902 [email protected] SOURCE Sen-Jam Pharmaceutical WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

引进/卖出

2025-09-03

·摩熵医药

年销近30亿，14次驳回！浙江药企挑战凝胶贴膏TOP1品种

注：本文不构成任何投资意见和建议，以官方/公司公告为准；本文仅作医疗健康相关药物介绍，非治疗方案推荐（若涉及），不代表平台立场。任何文章转载需要得到授权。 9月3日，CDE官网显示，浙江赛默制药与浙江百代医药联合申报的氟比洛芬凝胶贴膏上市申请已获受理。该药物在我国院内年销售额已突破28亿元，武汉法玛星制药于今年1月拿下首家过评，打破了其仿制上市困难的僵局。截图来源：CDE官网氟比洛芬凝胶贴膏是一种非甾体类解热镇痛抗炎药物（NSAIDs），主要适用于治疗骨关节炎、肩周炎、肌腱及腱鞘炎、腱鞘周围炎、肱骨外上髁炎（网球肘）、肌肉痛，以及外伤所致肿胀、疼痛等。该药物由日本三笠制药原研，2010年，泰德制药通过“原研进口、国内分包”的方式将其引入中国市场（商品名为“泽普思”），成为国内首个化药凝胶贴膏剂。摩熵医药数据库显示，2023年氟比洛芬凝胶贴膏在我国院内市场销售额超28亿元，同比增长23.11%；2024年度进一步达到28.62亿元，再增2.08%；其院内累计销售额突破151亿元。截图来源：摩熵医药全国医院销售（全终端）数据库 2011年泰德制药的自研仿制药“得百安”成功上市，并以每年超20%的销售额增速迅速占领市场，目前院内市场占比超过九成，堪称国产替代原研药物的成功标杆。截图来源：摩熵医药全国医院销售（全终端）数据库 2023年我国药用贴膏剂市场规模约为204亿元，中成药贴膏市场为135亿元，占总市场比例的66%；化药贴膏占比逐年增长，同比提升至34%。2024年贴膏剂院内销售额达142亿元，市场前景极为广阔。截图来源：摩熵医药全国医院销售（全终端）数据库据摩熵医药数据，在贴膏剂产品排名中，氟比洛芬凝胶贴膏近年来稳居首位，面对如此广阔的市场，国内众多制药企业都心动不已，积极展开布局。截图来源：摩熵医药全国医院销售（全终端）数据库但由于其工艺复杂，仿制难度较大，自2020年至今的31条仿制申请上市的受理号中，14条被驳回，多家企业在首次申报时折戟沉沙。截图来源：摩熵医药中国药品审评数据库今年1月，武汉法玛星的的氟比洛芬凝胶贴膏获批上市，为国产第2家获批且首家视同过评，打破了北京泰德“一家独大”的局面，让众多布局的药企看到了上市曙光。6月30日乐明药业也顺利获批。截图来源：摩熵医药中国药品批文数据库目前江苏万高药业、福元药业、南京海纳制药、北京百奥药业、湖南九典制药等18家企业的产品还在审评审批中。截图来源：摩熵医药中国药品审评数据库近年来，国产企业在凝胶贴膏仿制药领域的水平与技术显著提升，众多药企投身于该赛道。但受限于多重因素，我国当前仅上市了五款化药凝胶贴膏产品：氟比洛芬凝胶贴膏、利多卡因凝胶贴膏、酮洛芬凝胶贴膏、洛索洛芬钠凝胶贴膏及吲哚美辛凝胶贴膏。截图来源：摩熵医药全国医院销售（全终端）数据库尽管当前氟比洛芬凝胶贴膏的上市似乎暂遇波折，但国内化药凝胶贴膏品类走向多元化发展已是大势所趋。当更多品种成功落地后，行业将面临关键命题：化药贴膏是瞄准中药贴膏市场寻求增量，还是在同品类中内卷降价以进入集采？最终走向如何，不妨拭目以待。 END 本文为原创文章，转载请留言获取授权近期热门资源获取中国临床试验趋势与国际多中心临床展望-202505 2024年医药企业综合实力排行榜-202505 中国带状疱疹疫苗行业分析报告-202505 2023H2-2024H1中国药品分析报告-202504 数据透视：中药创新药、经典验方、改良型新药、同名同方的申报、获批、销售情况-202503 2024年中国1类新药靶点白皮书-202503 中国AI医疗健康企业创新发展百强榜单-202502 解码护肤抗衰：消费偏好洞察与市场格局分析-202502 2024年FDA批准上市的新药分析报告-202501 小分子化药白皮书（上）-202501 2024年中国医疗健康投融资全景洞察报告-202501 2024年医保谈判及市场分析报告-202501 近期更多摩熵咨询热门报告，识别下方二维码领取联系我们，体验摩熵医药更多专业服务会议合作园区服务数据库咨询定制服务媒体合作点击上方图片，即可开启摩熵化学数据查询点击阅读原文，申请摩熵医药企业版免费试用！

上市批准引进/卖出

2025-08-27

·PRNewswire

American Regent® Launches Gvoke VialDx™ (glucagon injection)

First concentrated, ready-to-dilute liquid glucagon available for diagnostic procedures SHIRLEY, N.Y., Aug. 27, 2025 /PRNewswire/ -- American Regent, Inc.® is pleased to announce the commercial launch and availability of Gvoke VialDx™ (glucagon injection). Gvoke VialDx (glucagon injection) is a gastrointestinal motility inhibitor indicated for intravenous use as a diagnostic aid during radiologic examinations to temporarily inhibit movement of the gastrointestinal tract in adult patients. Gvoke VialDx (glucagon injection) vial The launch of Gvoke VialDx is the result of a partnership between American Regent and Xeris Pharmaceuticals, Inc. Under the terms of the agreement, Xeris will be responsible for product supply, and American Regent will be responsible for the commercialization of Gvoke VialDx in the U.S. Joann Gioia, Vice President and Chief Commercial Officer at American Regent, said, "We are eager to bring our commercial expertise in the hospital and acute care setting to our partnership with Xeris and contribute to the success of Gvoke VialDx. The addition of Gvoke VialDx to our portfolio aligns perfectly with our mission to provide patients with the essential medicines they need." "We're proud to mark the commercial launch of Gvoke VialDx in partnership with American Regent. Gvoke VialDx is the first liquid glucagon available for use as a diagnostic aid and provides an important new option for hospitals and clinics. American Regent is a natural partner to commercialize Gvoke VialDx given their longstanding reputation as a leading provider of high-quality sterile injectable products," said Kevin McCulloch, President and COO of Xeris. Gvoke VialDx will be available as a 1-count, or 10-count package of 1 mg per 0.2 mL single-dose vials and is available for immediate shipment. Customers can order the product through their wholesaler, distributor, or by contacting the American Regent Customer Support Group at 1-800-645-1706. Please see the Important Safety Information below. To view the Full Prescribing Information, please click here. For additional information on Gvoke VialDx, please visit . IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS GVOKE VialDx is contraindicated in patients with: Pheochromocytoma, because of the risk of substantial increase in blood pressure Insulinoma, because of the risk of hypoglycemia Prior hypersensitivity reaction to glucagon or to any of the excipients in GVOKE VialDx. Serious hypersensitivity reactions have been reported with glucagon and include anaphylactic shock with breathing difficulties and hypotension Glucagonoma, because of risk of hypoglycemia. WARNINGS AND PRECAUTIONS Substantial Increase in Blood Pressure in Patients with Pheochromocytoma GVOKE VialDx is contraindicated in patients with pheochromocytoma because glucagon may stimulate the release of catecholamines from the tumor. If the patient develops a substantial increase in blood pressure and a previously undiagnosed pheochromocytoma is suspected, 5 to 10 mg of phentolamine mesylate, administered intravenously, has been shown to be effective in lowering blood pressure. Hypoglycemia in Patients with Insulinoma In patients with insulinoma, administration of glucagon may produce an initial increase in blood glucose; however, glucagon administration may directly or indirectly (through an initial rise in blood glucose) stimulate exaggerated insulin release from an insulinoma and cause hypoglycemia. GVOKE VialDx is contraindicated in patients with insulinoma. If a patient develops symptoms of hypoglycemia after a dose of GVOKE VialDx, give glucose orally or intravenously. Serious Hypersensitivity Reactions Serious hypersensitivity reactions have been reported with glucagon products, including generalized rash, and in some cases anaphylactic shock with breathing difficulties and hypotension. Discontinue GVOKE VialDx if symptoms of serious hypersensitivity reactions occur. Advise patients and/or caregivers to seek immediate medical attention if the patient experiences any symptoms of serious hypersensitivity reactions. GVOKE VialDx is contraindicated in patients with a prior hypersensitivity reaction to glucagon, or any of the excipients in GVOKE VialDx. Necrolytic Migratory Erythema (NME) NME, a skin rash commonly associated with glucagonomas (glucagon-producing tumors) and characterized by scaly, pruritic erythematous plaques, bullae, and erosions, has been reported post marketing following continuous glucagon infusion. GVOKE VialDx is not approved for continuous infusion. NME lesions may affect the face, groin, perineum, and legs or be more widespread. In the reported cases, NME resolved with discontinuation of the glucagon, and treatment with corticosteroids was not effective. Should NME occur, consider whether the benefits of continuous glucagon infusion outweigh the risks. Hyperglycemia With Intravenous Use as a Diagnostic Aid in Patients with Diabetes Mellitus GVOKE VialDx in patients with diabetes mellitus may cause hyperglycemia. Monitor patients with diabetes for changes in blood glucose levels during treatment with GVOKE VialDx and treat hyperglycemia, if indicated. Blood Pressure and Heart Rate Increase in Patients with Cardiac Disease When Used as a Diagnostic Aid GVOKE VialDx may increase myocardial oxygen demand, blood pressure, and pulse rate, which may be life-threatening in patients with cardiac disease. Cardiac monitoring is recommended in patients with cardiac disease during use of GVOKE VialDx as a diagnostic aid, and an increase in blood pressure and pulse rate may require therapy. Hypoglycemia in Patients with Glucagonoma GVOKE VialDx administered to patients with glucagonoma may cause secondary hypoglycemia. GVOKE VialDx is contraindicated in patients with glucagonoma when used as a diagnostic aid. Test patients suspected of having glucagonoma for blood levels of glucagon prior to treatment and monitor for changes in blood glucose levels during treatment. If a patient develops symptoms of hypoglycemia after a dose of GVOKE VialDx, give glucose orally or intravenously. ADVERSE REACTIONS Clinical Trials Experience The most common adverse reactions occurring in ≥5% of adult healthy volunteers who received 0.75 mg GVOKE VialDx intravenously were nausea, dysgeusia, headache, hot flush, and dizziness. Postmarketing Experience The following reactions have been identified during post-approval use of glucagon. Because these reactions are reported voluntarily from a population of uncertain size, it is generally not possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Necrolytic migratory erythema (NME) cases have been reported postmarketing in patients receiving continuous infusion of glucagon Hypoglycemia and hypoglycemic coma. Patients taking indomethacin may be more likely to experience hypoglycemia following glucagon administration DRUG INTERACTIONS Patients taking beta-blockers may have a transient increase in pulse and blood pressure when given GVOKE VialDx. Insulin acts antagonistically to glucagon. The concomitant use of anticholinergic drugs and GVOKE VialDx increases the risk of gastrointestinal adverse reactions due to additive effects on inhibition of gastrointestinal motility. GVOKE VialDx may increase the anticoagulant effect of warfarin. USE IN SPECIFIC POPULATIONS Pediatric Use Safety and effectiveness of GVOKE VialDx for use as a diagnostic aid during radiologic examinations to temporarily inhibit movement of the gastrointestinal tract in pediatric patients have not been established. Geriatric Use Clinical studies of GVOKE VialDx did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger adult patients. OVERDOSAGE If overdosage occurs, the patient may experience nausea, vomiting, inhibition of GI tract motility, increase in blood pressure, and pulse rate. In case of suspected overdosing, serum potassium may decrease and should be monitored and corrected if needed. If the patient develops a dramatic increase in blood pressure, phentolamine mesylate has been shown to be effective in lowering blood pressure for the short time that control would be needed. INDICATIONS AND USAGE GVOKE VialDx is indicated for intravenous use as a diagnostic aid during radiologic examinations to temporarily inhibit movement of the gastrointestinal tract in adult patients. Please see Full Prescribing Information. You are encouraged to report Adverse Drug Events to Xeris Pharmaceuticals, Inc. at 1-877-937-4737, or to the FDA by visiting , or by calling 1-800-FDA-1088. About American Regent American Regent, Inc.®, a Daiichi Sankyo Group company, is an industry-leading injectable manufacturer. For over 50 years, American Regent has been developing, manufacturing, and supplying quality generic and branded injectables for healthcare providers. For more than 20 years, we have been a leader in IV iron therapy. American Regent is committed to US-based manufacturing. To that end, over the last several years we have made significant investments in expanding and modernizing our manufacturing facilities in Ohio and New York. This expansion will nearly double our capacity and allow us to better serve our customers now and in the future. Speed counts. Flexibility matters. Reliability and quality are paramount. Because patients should never have to wait for the medications they need. For more information, please visit About Xeris Xeris Pharmaceuticals, Inc., a wholly owned subsidiary of Xeris Biopharma Holdings, Inc. (Nasdaq: XERS), is a fast-growing biopharmaceutical company committed to improving patient lives by developing and commercializing innovative products across a range of therapies. Xeris has three commercially available products: Recorlev®, for the treatment of endogenous hypercortisolemia in patients with Cushing's syndrome; Gvoke®, a ready-to-use liquid glucagon for the treatment of severe hypoglycemia, and a gastrointestinal motility inhibitor when used during radiology exams as a diagnostic aid; and Keveyis®, a proven therapy for primary periodic paralysis. Xeris also has a pipeline of development programs led by XP-8121, a Phase 3-ready, once-weekly subcutaneous injection for hypothyroidism, as well as multiple early-stage programs leveraging Xeris' technology platforms, XeriSol® and XeriJect®, for its partners. Xeris Biopharma Holdings, Inc. is headquartered in Chicago, IL. For more information, visit , or follow on X, LinkedIn, or Instagram. All trademarks are the property of their respective owners.© 2025 American Regent, Inc. All rights reserved. PP-GL-US-0005 SOURCE American Regent, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

引进/卖出上市批准

100 项与吲哚美辛相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D00141	吲哚美辛	C01EB03 S01BC01 M01AB01	DB00328

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
急性疼痛	美国	Genus Lifesciences, Inc.	2014-02-24
动脉导管未闭	美国	Fresenius Kabi USA LLC	2010-03-17
炎症	日本	Hisamitsu Pharmaceutical Co., Inc.	1989-10-06
肌痛	日本	Teikoku Seiyaku Co. Ltd.	1989-10-06
网球肘	日本	Teikoku Seiyaku Co. Ltd.	1989-10-06
痛风性关节炎	美国	Rising Pharmaceuticals, Inc.	1984-04-20
肩周炎	日本	Kowa Co., Ltd.	1980-03-18
腱鞘炎	日本	Kowa Co., Ltd.	1980-03-18
肿胀	日本	Kowa Co., Ltd.	1980-03-18
疼痛	日本	Kowa Co., Ltd.	1980-03-18
强直性脊柱炎	美国	Zyla Life Sciences US LLC	1965-06-10
滑囊炎	美国	Zyla Life Sciences US LLC	1965-06-10
骨关节炎	美国	Zyla Life Sciences US LLC	1965-06-10
原发性痛风	美国	Zyla Life Sciences US LLC	1965-06-10
类风湿关节炎	美国	Zyla Life Sciences US LLC	1965-06-10
肩痛	美国	Zyla Life Sciences US LLC	1965-06-10
肌腱病	美国	Zyla Life Sciences US LLC	1965-06-10

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
腰痛	临床3期	中国	Teikoku Seiyaku Co. Ltd.	2013-10-10
腰痛	临床3期	中国	北京世纪利伟医药科技发展有限公司	2013-10-10
软组织损伤	临床3期	中国	北京世纪利伟医药科技发展有限公司	2013-10-10
软组织损伤	临床3期	中国	Teikoku Seiyaku Co. Ltd.	2013-10-10
软组织疼痛	临床3期	中国	Teikoku Seiyaku Co. Ltd.	2013-10-10
软组织疼痛	临床3期	中国	北京世纪利伟医药科技发展有限公司	2013-10-10
急性偏头痛	临床3期	美国	Novartis AG	2013-10-01
膝关节炎	临床3期	中国	北京世纪利伟医药科技发展有限公司	2013-09-27
膝关节炎	临床3期	中国	Teikoku Seiyaku Co. Ltd.	2013-09-27
术后疼痛	临床3期	美国	Iroko Pharmaceuticals LLC	2012-02-01

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临床结果

适应症

分期

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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


NCT04207060 (PAIR, Pubmed \| Clin Transl Gastroenterol)	临床1/2期	慢性胰腺炎	27	Indomethacin 50 mg	鑰廠築構醖淵鏇鏇顧觸(膚齋築鹽構窪積鏇獵壓): P-Value = 0.25 更多	不佳	2025-09-01
				Placebo
NCT04207060 (PAIR, CTgov)	临床1/2期	慢性胰腺炎	27	Endoscopy for Pancreatic Function Testing+Indomethacin (Indomethacin)	齋餘糧艱壓廠遞遞窪範(膚餘選範觸選窪鬱鏇醖) = 餘艱餘鹽夢製構簾廠壓網顧遞壓壓觸積艱觸憲 (齋廠鹽築齋餘築淵艱淵, 489.8) 更多	-	2024-09-04
				Placebo (Placebo)	齋餘糧艱壓廠遞遞窪範(膚餘選範觸選窪鬱鏇醖) = 觸獵糧顧觸製淵淵鏇願網顧遞壓壓觸積艱觸憲 (齋廠鹽築齋餘築淵艱淵, 865.6) 更多
DDW2024	N/A	可见病灶 \| 胰腺炎	-	RECTAL INDOMETHACIN (No Prophylaxis)	蓋憲獵遞簾糧壓製壓鹹(齋壓壓遞壓醖壓壓構構) = 1 case of acute renal failure was noted in the no prophylaxis group 醖鏇鹽淵艱構鬱糧築淵 (鬱願觸網構鬱鹽醖艱獵 ) 更多	-	2024-05-20
NCT02950259 (P212, CTgov)	临床1期	男性乳腺肿瘤 \| 三阴性乳腺癌 \| 早期乳腺癌	16	Multivitamin+Indomethacin+Omeprazole+Cyclophosphamide (IRX-2 Regimen -Early Stage Breast Cancer)	鑰夢鹽構鏇衊夢選選艱 = 衊鹽餘鹽鹹獵鹽願淵餘遞範廠窪製觸選範艱繭 (範蓋構壓願壓鑰壓廠齋, 餘壓淵餘觸製淵網艱願 ~ 觸觸壓壓範繭憲蓋鑰醖) 更多	-	2024-01-30
				Multivitamin+Indomethacin+Omeprazole+Cyclophosphamide (IRX-2 Regimen -Triple Negative Breast Cancer)	鑰夢鹽構鏇衊夢選選艱 = 醖鹹選鑰鏇遞鏇製選壓遞範廠窪製觸選範艱繭 (範蓋構壓願壓鑰壓廠齋, 襯襯選鹽遞膚蓋淵窪構 ~ 餘鹽蓋膚簾壓壓憲憲襯) 更多
NCT02797067 (RIPEP, CTgov)	临床4期	ERCP术后胰腺炎	1,370	indomethacin suppository (Indomethacin)	糧鬱遞獵壓淵蓋選窪鹽 = 夢衊襯繭窪壓鑰鏇膚衊築繭醖觸膚蓋鹽網簾顧 (夢窪顧觸獵膚選簾艱鏇, 觸簾構憲餘遞願襯淵鬱 ~ 築鏇鏇構齋衊憲網範蓋) 更多	-	2022-05-26
				Glycerin Suppository (Glycerin)	糧鬱遞獵壓淵蓋選窪鹽 = 壓醖餘廠餘獵願築觸憲築繭醖觸膚蓋鹽網簾顧 (夢窪顧觸獵膚選簾艱鏇, 範膚範鏇觸糧蓋鑰襯窪 ~ 遞構蓋鏇範壓壓醖壓醖) 更多
NCT02797067 (RIPEP, Pubmed \| Lancet Gastroenterol Hepatol) 人工标引	临床4期	胰腺炎	1,370	indometacin	憲膚鹹製醖獵簾鏇範鏇(淵餘網壓壓構鬱觸鏇艱) = 淵構鑰顧鑰觸齋鏇鬱鏇顧簾繭簾廠鏇衊衊鑰淵 (鏇醖膚蓋鏇淵蓋簾鹽構 ) 更多	积极	2022-03-01
				Placebo	憲膚鹹製醖獵簾鏇範鏇(淵餘網壓壓構鬱觸鏇艱) = 蓋醖築製艱選遞範襯製顧簾繭簾廠鏇衊衊鑰淵 (鏇醖膚蓋鏇淵蓋簾鹽構 ) 更多
NCT02438371 (CTgov)	临床4期	早产	49	Nifedipine (Nifedipine)	糧範廠選廠醖鬱衊築淵 = 獵壓壓艱膚願遞網衊選鏇膚艱製憲鏇繭艱淵範 (廠選構築膚醖鹽顧網襯, 簾積鏇觸構製夢積鏇淵 ~ 憲鹽蓋鏇憲襯構築壓範) 更多	-	2021-11-24
				Indomethacin+Nifedipine (Nifedipine Plus Indomethacin)	糧範廠選廠醖鬱衊築淵 = 範構觸願膚襯繭壓範製鏇膚艱製憲鏇繭艱淵範 (廠選構築膚醖鹽顧網襯, 憲糧觸淵壓窪遞鏇膚鹽 ~ 廠憲窪積窪壓鏇顧夢壓) 更多
NCT03129945 (CTgov)	N/A	早产	36	Nifedipine (Nifedipine)	鏇餘衊蓋鑰網窪夢簾獵 = 觸膚鹹蓋獵醖繭鹹廠醖艱衊構願窪齋顧積鑰鹽 (遞鏇齋壓簾簾鏇製觸糧, 鹹鑰顧餘顧壓廠夢鏇觸 ~ 築醖築糧選廠製願積憲) 更多	-	2021-11-05
				Indomethacin (Indomethacin)	鏇餘衊蓋鑰網窪夢簾獵 = 簾顧淵顧淵鑰憲鬱觸鹹艱衊構願窪齋顧積鑰鹽 (遞鏇齋壓簾簾鏇製觸糧, 憲襯顧蓋襯獵觸繭餘構 ~ 積壓鏇選積夢蓋觸糧窪) 更多
IRCT20080921001264N11 (Pubmed \| J Clin Gastroenterol)	临床4期	ERCP术后胰腺炎	530	Intravenous Somatostatin + Rectal Indomethacin	簾鹽繭蓋醖簾餘築鹽願(壓遞夢遞壓網繭齋糧獵) = PEP was the most common adverse event with 50 (13.2%) episodes, including 21 (5.5%) mild, 23 (6.1%) moderate, and 6 (1.2%) severe 淵構廠鏇積繭齋選夢鹹 (觸蓋艱觸餘簾廠醖糧觸 )	不佳	2021-05-28
				Placebo + Rectal Indomethacin
NCT02692391 (CTgov)	临床3期	胰腺炎	42	Placebo (Placebo)	艱蓋鹽蓋憲膚淵壓鹹獵(淵繭願衊製願窪遞衊醖) = 淵廠壓顧艱膚繭顧鬱窪製衊鬱製餘夢積選觸製 (醖醖選廠鏇鑰餘醖獵鑰, 0.81) 更多	-	2021-04-22
				Indomethacin (Indomethacin Suppository)	艱蓋鹽蓋憲膚淵壓鹹獵(淵繭願衊製願窪遞衊醖) = 範鏇憲積遞觸衊餘襯壓製衊鬱製餘夢積選觸製 (醖醖選廠鏇鑰餘醖獵鑰, 1.24) 更多