A Phase 2b, Open Label, Single-Arm, Multi-Center, Multiple Dose, 14-Day Study to Evaluate the Safety, Efficacy, and Frequency of Intravesical Administration of VNX001 in Acute Treatment of Subjects With Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS) Who Have an Episode of Acute Bladder Pain of Moderate to Severe Intensity

This is an open-label study that will enroll participants with Interstitial Cystitis / Bladder Pain Syndrome (IC/BPS).
The study will assess PRN (as needed) dosing of up to 6 intravesical (via catheter) doses of VNX001 (study drug) to treat acute instances of moderate to severe bladder pain over a 14-day period. The main aim of the study is to tally the number of doses and assess pain before and after doses. The study will review the safety and tolerability of VNX001.
Participants will need to attend up to seven (7) clinic visits (1 for screening and up to 6 visits for VNX001 dosing) or at least one (1) clinic visit (for a combined screening/dosing visit) and 5 telephone visits over the course of 14 days. Participants will also be asked complete a diary or telephone call each day of the study, in order to record bladder pain, urinary urgency, side effects, and medications taken.

开始日期2024-08-01

申办/合作机构

Vaneltix Pharma, Inc.

[+1]

CTR20242187 / CompletedN/A

间苯三酚口崩片（160 mg）在健康受试者中的单中心、随机、开放、单次给药、两周期、双交叉、餐后状态下的生物等效性研究

主要试验目标：以Teva Sante公司持证的间苯三酚冻干片（160 mg）为参比制剂，广州帝奇医药技术有限公司生产的间苯三酚口崩片（160 mg）为受试制剂，通过单中心、随机、开放、单次给药、两制剂、两周期、双交叉研究来评价两种制剂在餐后状态下的人体生物等效性。次要试验目标：观察受试制剂和参比制剂在中国健康受试者中的安全性。

开始日期2024-06-29

申办/合作机构

广州帝奇医药技术有限公司

CTR20241762 / CompletedN/A

间苯三酚口崩片在中国健康人群中空腹和餐后状态下单次给药的人体生物等效性临床试验

主要目的：以持证商为Teva Sante的间苯三酚口崩片（80mg）为参比制剂，以南京海纳制药有限公司研制的间苯三酚口崩片（80mg）为受试制剂，评价两种制剂在中国健康受试者中空腹和餐后状态下的生物等效性。次要目的：评价受试制剂与参比制剂在中国健康受试者中的安全性。

开始日期2024-05-20

申办/合作机构

南京海纳制药有限公司

100 项与膀胱痛相关的临床结果

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100 项与膀胱痛相关的转化医学

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0 项与膀胱痛相关的专利（医药）

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项与膀胱痛相关的文献（医药）

2024-12-31·Hematology

Hyperbaric oxygen therapy improves the efficacy of conventional supportive treatment for late-onset hemorrhagic cystitis after allogeneic hematopoietic stem cell transplantation

Article

作者: Ding, Xiaojie ; Qu, Yiwen ; Qiao, Xiansen ; Zhao, Peng ; Li, Ying ; Wang, Ling

OBJECTIVEThis study aims to investigate the efficacy and safety of hyperbaric oxygen therapy (HBOT) in the treatment of late-onset hemorrhagic cystitis after allogeneic hematopoietic stem cell transplantation.METHODSThis retrospective analysis included 16 patients with late-onset hemorrhagic cystitis after allogeneic hematopoietic stem cell transplantation between 2016 and 2022. Among them, 8 patients received HBOT in addition to conventional treatment, while the other 8 received only conventional treatment. The clinical efficacy and safety of HBOT were evaluated by comparing the Numeric Rating Scale pain scores and clinical grades of hematuria before and after treatment, reflecting the patients' urinary pain and hematuria status.RESULTSThe patients were divided into two groups based on whether they received HBOT. The group that received HBOT (n = 8) had a shorter duration of illness compared to the non-HBOT group (n = 8) (p < 0.05). The time for the NRS to decrease to below 2 was also shorter in the HBOT group. Furthermore, the patients who received HBOT did not experience any significant adverse reactions.CONCLUSIONThe combination of conventional treatment and hyperbaric oxygen therapy (HBOT) has been shown to improve symptoms such as urinary pain, frequency, urgency, and hematuria in patients with late-onset hemorrhagic cystitis after transplantation. This approach has been proven to be safe and effective.

2024-09-10·Biomedicines

The Pathomechanism and Current Treatments for Chronic Interstitial Cystitis and Bladder Pain Syndrome.

Review

作者: Jhang, Jia-Fong ; Yu, Wan-Ru ; Kuo, Hann-Chorng ; Jiang, Yuan-Hong

Interstitial cystitis/bladder pain syndrome (IC/BPS) is a chronic and debilitating condition characterized by symptoms such as bladder pain, frequent urination, and nocturia. Pain is typically perceived in the lower abdomen, pelvic floor, or urethra, causing significant discomfort and impacting quality of life. Due to the similarity of its symptoms with those of overactive bladder and acute bacterial cystitis, patients often face misdiagnosis and delayed appropriate treatment. Hunner's (HIC) and non-Hunner's IC (NHIC), each with distinct clinical presentations, urothelial dysfunction, chronic inflammation, and central sensitization and thus multimodal symptomatic treatment approaches, may be the most common pathogeneses of IC/BPS. Treatment of IC/BPS should involve identifying the different clinical phenotypes and underlying pathophysiology causing clinical symptoms and developing strategies tailored to the patient's needs. This review discusses the roles of urine biomarkers, bladder inflammation, and glycosaminoglycans in the pathogenesis of IC/BPS. Various bladder treatment modalities are explored, including glycosaminoglycan replenishment, botulinum toxin A injection, platelet-rich plasma injection, low-energy shock waves, immunosuppression, and low-dose oral prednisolone. Pelvic floor muscle physiotherapy and bladder therapy combined with psychiatric consultation can help alleviate psychological stress and enhance the quality of life of patients with IC/BPS. Elucidating the pathological mechanisms and exploring diverse treatment options would help advance the care of individuals suffering from this challenging bladder condition.

2024-09-01·Heliyon

Pathology and physiology of acid-sensitive ion channels in the bladder

Review

作者: Zhang, Jialong ; Zhang, Yang ; Chen, Binghai ; cheng, Kang ; Dong, Di ; Cheng, Kang ; Zhen, Fang ; Li, Mei

Acid-sensitive ion channels (ASICs) are sodium-permeable channels activated by extracellular acidification. They can be activated and trigger the inward flow of Na⁺ when the extracellular environment is acidic, leading to membrane depolarization and thus inducing action potentials in neurons. There are four ASIC genes in mammals (ASIC1-4). ASIC is widely expressed in humans. It is closely associated with pain, neurological disorders, multiple sclerosis, epilepsy, migraines, and many other disorders. Bladder pain syndrome/interstitial cystitis (BPS/IC) is a specific syndrome characterized by bladder pain. Recent studies have shown that ASICs are closely associated with the development of BPS/IC. A study revealed that ASIC levels are significantly elevated in a BPS/IC model. Additionally, researchers have reported differential changes in ASICs in the bladders of patients with neurogenic lower urinary tract dysfunction (NLUTD) caused by spinal cord injury (SCI). In this review, we summarize the structure and physiological functions of ASICs and focus on the mechanisms by which ASICs mediate bladder disease.

项与膀胱痛相关的新闻（医药）

2024-10-22

·药通社

【论药海南】专供特色化学原料药-山西阳和药业，涉及呼吸系统、消化系统等领域

2023年12月3-4日 2024MAH&DDS制剂合作大会·海南站展位号：37号公司简介山西阳和药业有限公司成立于2017年，坐落于山西省大同市阳高县龙泉工业园区。公司注册资本5100万元，总占地面积100亩。阳和药业作为化学原料药的商业化生产基地，专业从事特色化学原料药的研发、生产、销售。公司现拥有多条原料药生产线，产品涉及呼吸系统、消化系统等多个领域。目前公司可大批量生产乙酰半胱氨酸、间苯三酚、间苯三酚三甲醚、聚乙烯醇等原料药。 COMPANY PROFILE Shanxi Yanghe Pharmaceutical Co., Ltd. was established in 2017 and is located in Longquan lndustrial Park, Yanggao County, Datong city, shanxi Province. The registered capital of the company is 51 million yuan, and the total area is 100 acres.As a commercial production base of chemical APls, Yanghe Pharmaceutical specializes in the R&D, production and sales of specialty chemical APls. The company now has a number of API production lines, and its products involve respiratory system, digestive system and other fields. At present,the company can produce acetylcysteine, resorcinol, and resorcinol trimethyl ether in large quantities, polyvinyl alcohol and other APls. 公司团队公司拥有一支年轻有干劲的新型团队；建立了完善的生产和质量管理体系；公司建有多个原料药多功能车间，实现从小试研究、中试放大、注册申报、大规模生产的一条龙服务；严格的质量控制，完善的检验设施和仪器设备，严密的质量保证系统，能够有效保障法规符合性、CFDl注册核查和客户审计的要求。 COMPANY TEAM The company has a young and energetic new team, has established a sound production and QMS system, the company has built a number of APl multifunctional workshops, to achieve a small test research, pilot scale-up, registration declaration, large-scale production one-stop service, strict QC, perfect inspection facilities and equipment, strict QA system, can effectively ensure regulatory compliance,CFDl registration verification and customer audit requirements. 01 乙酰半胱氨酸化学名：N-乙酰基-L-半胱氨酸 CAS No.: 616-91-1 登记号：Y20210001235 用途：呼吸系统药物，具有祛痰的作用，其注射液用于肝衰竭早期治疗，也可用于配置复合氨基酸输液、特医食品及保健品。符合ChP2020年版、BP2022、EP10.8、JPX VlII、USP-NF2022药典标准；已获得GMP、CP Chemical name: N-acetyl-L-cysteine CAS No.: 616-91-1 Registration No.: Y20210001235 Uses: Respiratory system drug, with expectorant effect, its injection for the early treatment of liver failure, can also be used to configure complex amino acid infusion, special medical food and health care products. In accordance with ChP2020、BP2022、EP10.8、JPX VlII、USP-NF2022；GMP and CP have been obtained 02 间苯三酚三甲醚化学名：1，3，5-三甲氧基苯 CAS NO.: 621-23-8 登记号：Y20220000338 用途：消化系统和胆道功能障碍引起的急性痉挛性疼痛；急性痉挛性尿道、膀胱、肾绞痛；妇科痉挛性疼痛已获得GMP、CP Chemical name: 1,3,5-Trimethoxybenzene CAS No.: 621-23-8 Registration No.: Y20220000338 Uses: Acute spasmodic pain caused by digestive system and biliary tract dysfunction; Acute spastic colic of urethra, bladder and kidney; Gynecologic spasmodic pain GMP and CP have been obtained 03 间苯三酚化学名：苯基-1，3，5-三酚二水合物 CAS No.: 6099-90-7 登记号：Y20220000471 用途：消化系统和胆道功能障碍引起的急性痉挛性疼痛；急性痉挛性尿道、膀胱、肾绞痛；妇科痉挛性疼痛符合BP2022、EP10. 8药典标准；已获得GMP、CP Chemical name: Benzene-1,3,5-triol dihydrate CAS No.: 6099-90-7 Registration No.: Y20220000471 Uses: Acute spasmodic pain caused by digestive system and biliary tract dysfunction; Acute spastic colic of urethra, bladder and kidney; Gynecologic spasmodic pain In accordance with BP2022, EP10.8；GMP and CP have been obtained 04 聚乙烯醇化学名：聚乙烯醇 CAS NO.: 9002-89-5 用途：用于润滑和滋润眼睛表面，有助于暂时缓解干眼症（DED）或环境因素引起的干燥、刺激、灼热、不适和/或任何其他症状符合ChP2020年版、BP2022、EP10.8、USP-NF2022药典标准；已获得GMP Chemical name: Poly(vinyl alcohol) macromolecule CAS No.: 9002-89-5 Use: To lubricate and moisturize the surface of the eye to help temporarily relieve dryness, irritation, burning, discomfort and/or any other symptoms of dry eye (DED) or environmental factors。 In accordance with ChP2020、BP2022、EP10.8、USP-NF2022；GMP have been obtained 联系方式周女士13306586060 薛女士15958675001 点击查看大会详情 ▽ 立即扫码报名 ▽

2024-08-27

·药融云

石家庄四药拿下15亿+临床短缺药，两大品种同日获批！

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。 8月27日，据NMPA公示，石家庄四药提交的重酒石酸去甲肾上腺素注射液、间苯三酚注射液两大品种同日获批并视同通过一致性评价。据药融云数据库显示，重酒石酸去甲肾上腺素注射液在2023年全国院内市场的销售额超15亿元。截图来源：NMPA官网重酒石酸去甲肾上腺素注射液属于临床必需易短缺药，也是国家医保甲类品种和基药品种。主要用于治疗急性心肌梗塞、体外循环、嗜铬细胞瘤切除等引起的低血压，对血容量不足所致的休克或低血压，也可用于治疗椎管内阻滞时的低血压及心跳骤停复苏后血压维持。据药融云数据库显示，重酒石酸去甲肾上腺素注射液在2023年全国院内市场的销售额超15亿元。截图来源：药融云全国医院销售数据库此前，重酒石酸去甲肾上腺素注射液有海南倍特药业、华润双鹤药业、山东新华制药等12家药企拥有生产批文；有32家企业报产在审，包括石家庄四药、倍特药业、天方药业、福安药业等。目前，重酒石酸去甲肾上腺素注射液有远大医药（首家）、天津金耀药、合肥亿帆生物医药、海南倍特药业、石家庄四药等9家药企过评。截图来源：药融云过评药品汇总数据库间苯三酚注射液用于治疗消化道和胆道功能障碍引起的急性痉挛性疼痛；治疗急性痉挛性尿道、膀胱、肾绞痛；治疗妇科痉挛性疼痛。据药融云数据库显示，该品种在2023年全国院内市场的销售额超8亿元，同比增长达11.08%。截图来源：药融云全国医院销售数据库此前，间苯三酚注射液有27家企业拥有生产批文；在仿制药布局方面，湖南科伦制药、山东新时代药业等38家报产在审。 2024年至今，石家庄四药有盐酸利多卡因注射液、硫酸镁注射液、丙泊酚中/长链脂肪乳注射液等36个品种过评，其中利奈唑胺干混悬剂、卡左双多巴缓释片、恩他卡朋双多巴片(Ⅱ)、甲磺酸倍他司汀片4个品种为首家过评。 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后台回复关键词“报告”，获取数十篇药融云出品独家报告后台回复关键词“CSCO”，获取2023CSCO指南后台回复关键词“ASCO”，获取2023ASCO分癌种摘要后台回复关键词“2023首仿”，获取2023年首仿药物获批名单后台回复关键词“医保”，获取2022年医保目录联系我们，体验药融云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阅读原文，申请药融云企业版免费试用！

ASCO会议一致性评价CSCO会议申请上市

2024-08-08

·赛柏蓝

一致性评价TOP10药企：华润、国药、齐鲁...

编者按：本文来自米内网，作者玲珑；赛柏蓝授权转载，编辑凯西 2024上半年，国内有1927个受理号通过或视同通过一致性评价，涉及650余个品种（以产品名称计），570余家药企（以集团计）。TOP10集团中，复星、华润、石四药领跑。 01 TOP10集团：复星、石四药、华润、国药等上榜过评品种数TOP10集团中，复星医药、华润医药、石家庄四药以27个品种并列领跑；国药集团以25个品种排位第四，齐鲁制药以23个品种排位第五，科伦药业、倍特药业、石药集团、上海医药、福安药业、正大制药等企业亦上榜。 2024H1过评品种数TOP5集团（以上市持有人计）复星医药27个品种包含12个注射剂、10个普通片剂/胶囊剂、2个缓释片、2个口服溶液剂及1个口崩片，集中在神经系统药物、全身用抗感染药物、心脑血管系统药物、抗肿瘤和免疫调节剂等治疗领域。目前复星医药总过评品种数已超过110个，在已开展的国采中累计中选约30个品种。 2024H1复星医药过评品种国药集团25个品种包含15个注射剂、6个普通片剂、1个吸入剂、1个缓释片、1个口服溶液剂及1个滴眼剂，集中在全身用抗感染药物、呼吸系统用药、消化系统及代谢药等治疗领域，目前国药集团总过评品种数已超过90个。 2024H1国药集团过评品种齐鲁制药23个品种包含13个普通片剂/胶囊剂、6个注射剂、2个干混悬剂、1个颗粒剂及1个缓释片，集中在全身用抗感染药物、抗肿瘤和免疫调节剂等治疗领域。目前齐鲁制药总过评品种数已超过170个，领跑国内其他企业，在已开展的国采中累计中选60余个品种。 2024H1齐鲁制药过评品种 02 TOP10品种：6个超10亿大品种在列，13亿注射剂遭“哄抢” 过评企业数TOP10品种中，他达拉非片最为“抢手”，2024上半年有18家企业过评或视同过评；间苯三酚注射液以16家企业紧接在后，帕拉米韦注射液以15家企业位列第三，地夸磷索钠滴眼液、磷酸奥司他韦胶囊以13家企业并列第四；此外，吸入用乙酰半胱氨酸溶液、注射用头孢唑林钠、己酮可可碱注射液、盐酸莫西沙星滴眼液等品种上半年过评企业数均达10家及以上。 2024H1过评企业数TOP10品种注：低于1亿元用*代表从市场规模看，他达拉非片、磷酸奥司他韦胶囊、吸入用乙酰半胱氨酸溶液、玻璃酸钠滴眼液、盐酸达泊西汀片、磷酸西格列汀片2023年在中国三大终端六大市场的销售额均超过10亿元。他达拉非片是环磷酸鸟苷(cGMP)特异性磷酸二酯酶5(PDE5)的选择性、可逆性抑制剂，主要用于治疗勃起功能障碍。该产品已被纳入第二批国采，但由于其主要销售渠道在零售药店（城市实体药店+网上药店），因此受集采影响较小，近年来在中国三大终端六大市场的销售额均以两位数的增速增长，2023年首次突破30亿元。他达拉非片已有62家企业过评或视同过评，为目前过评企业数最多的品种。近年来中国三大终端六大市场他达拉非片销售情况（单位：万元）从国采情况看，过半品种暂未纳入国采，包括间苯三酚注射液、帕拉米韦注射液、吸入用乙酰半胱氨酸溶液、己酮可可碱注射液、盐酸多巴酚丁胺注射液、氯化钾注射液、注射用尼可地尔及磷酸西格列汀片。间苯三酚注射液为非罂粟碱、非阿托品类纯平滑肌解痉药物，适用于消化系统和胆道功能障碍引起的急性痉挛疼痛；急性痉挛性尿道、膀胱、肾绞痛等。 2023年中国三大终端六大市场间苯三酚注射剂（间苯三酚注射液、注射用间苯三酚）的销售额超过13亿元，其中院内市场（公立医院+公立基层医疗）销售占比超过99%。目前有26家企业的间苯三酚注射液过评或视同过评，该产品有望纳入第十批国采。近年来中国三大终端六大市场间苯三酚注射剂销售情况（单位：万元） 03 131个品种迎首家过评齐鲁、健康元等收获颇丰 2024上半年，131个品种迎首家过评企业（以产品名称计，含并列首家，下同），其中有39个以一致性评价补充申请方式获批过评，92个以新注册分类（仿制3类/仿制4类/进口5.2类）报产获批而视同过评。 2024H1首家过评品种 131个品种涵盖13个治疗大类，集中在消化系统及代谢药（24个）、全身用抗感染药物（18个）、血液和造血系统药物（16个）、神经系统药物（16个）、心脑血管系统药物（13个）等。从企业情况看，齐鲁制药以5个首家过评品种领跑，其中氯苯唑酸葡胺软胶囊、艾曲泊帕乙醇胺片为首仿+首家过评，原研产品2023年全球销售额分别超过30亿美元、20亿美元；芜湖道润药业以4个首家过评品种紧接在后，均为血液和造血系统药物。健康元药业、石药集团、新和成、正大制药各有3个品种首家过评或视同过评，其中健康元药业的盐酸哌罗匹隆片为国内首家获批，沙美特罗替卡松吸入粉雾剂、丙酸氟替卡松雾化吸入用混悬液均为吸入剂，GSK的沙美特罗替卡松吸入粉雾剂2023年在中国三大终端六大市场的销售额超过17亿元；石药集团的罗沙司他胶囊为首仿+首家过评，原研产品2023年在中国三大终端六大市场的销售额超过20亿元；正大制药3个品种均为首仿+首家过评，其中艾拉莫德片2023年在中国三大终端六大市场的销售额超过13亿元。此外，倍特药业、科伦药业、福安药业、复星医药、一品红制药、国药集团、华润医药、奥赛康、鲁南制药、天津医药等10余家企业均有2个品种首家过评或视同过评。资料来源：米内网数据库 END 内容沟通：郑瑶（13810174402）左下角「关注账号」，右下角「在看」，防止失联

一致性评价