An Open Label, Randomized, Single-dose Crossover Study to Evaluate the Pharmacokinetic Interaction of Dapoxetine 30 mg and Mirodenafil 100 mg in Healthy Male Volunteers

Healthy male volunteers were administered alone and in combination with dapoxetine 30mg mirodenafil 100mg for three times, respectively and the pharmacokinetic interaction was compared between the two drugs.

开始日期2014-11-01

申办/合作机构

SK CHEMICALS CO LTD

NCT02485028

/ Completed临床1期

An Open Label, Randomized, Single-dose Crossover Study to Evaluate the Pharmacokinetic Interaction of Dapoxetine 30mg and Mirodenafil 50mg in Healthy Male Volunteers

Healthy male volunteers were administered alone and in combination with dapoxetine 30mg mirodenafil 50mg for three times, respectively and the pharmacokinetic interaction was compared between the two drugs.

开始日期2013-10-01

申办/合作机构

SK CHEMICALS CO LTD

NCT01232010

/ Completed临床1期IIT

Clinical Study to Investigate the Safety and Pharmacokinetics of Udenafil Tablet in Renal Impaired Male Patients

This study is designed to investigate the effect of renal impairment on the safety and pharmacokinetics of SK3530 in subjects with renal impairment compared to healthy subjects.

开始日期2009-11-01

申办/合作机构

Asan Medical Center

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100 项与米罗那非相关的临床结果

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100 项与米罗那非相关的转化医学

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100 项与米罗那非相关的专利（医药）

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项与米罗那非相关的文献（医药）

2026-03-01·NEUROPHARMACOLOGY

Protective effects of phosphodiesterase 5 inhibitor, mirodenafil, on traumatic brain injury-induced neuronal death

Article

作者: Suh, Sang Won ; Jung, Hyun Ho ; Yang, Hyun Wook ; Choung, Jai Jun ; Woo, Seo Young ; Shin, Sol Jae ; Park, Min Kyu ; Choi, Bo Young

Traumatic brain injury (TBI) is a serious neurological condition caused by external physical forces that lead to extensive brain damage. The underlying pathological processes involve complex interactions, including neuronal death driven by cerebrovascular dysfunction, inflammation, and oxidative stress. A key contributor to these processes is the enzyme phosphodiesterase 5 (PDE5), which reduces cyclic guanosine monophosphate (cGMP) levels, leading to impaired vasodilation, reduced cerebral blood flow, and disruption of protective cellular pathways. Nitric oxide (NO) and zinc play significant roles in the progression of TBI-related damage. NO is a signaling molecule that supports cerebral blood flow and redox balance by boosting antioxidant defenses such as glutathione (GSH) levels. Zinc, an essential element for neural function, can become toxic in excess, contributing to oxidative stress and neuronal damage. During TBI, reduced NO availability and disrupted zinc homeostasis exacerbate these harmful effects, with increased PDE5 activity further depleting cGMP and limiting the activation of protective factors like Nrf2 and HO-1. This study explores the therapeutic potential of mirodenafil, a PDE5 inhibitor, in mitigating TBI-induced damage. Administered subcutaneously at 2 mg/kg, mirodenafil was evaluated through histological and biochemical techniques, including markers for neuronal degeneration, zinc accumulation, and NO synthesis. Results showed that mirodenafil reduced neuronal loss, regulated zinc levels, and restored NO signaling. These findings suggest that mirodenafil supports neuronal survival by preserving cGMP levels, enhancing NO function, and mitigating oxidative stress related to zinc dysregulation. This study highlights mirodenafil as a potential therapeutic option for limiting TBI-induced neuronal injury and preserving brain function.

2025-04-01·SPECTROCHIMICA ACTA PART A-MOLECULAR AND BIOMOLECULAR SPECTROSCOPY

Identification of Phosphodiesterase type 5 inhibitors (PDE5is) analogues using surface-enhanced Raman scattering and machine learning algorithm

Article

作者: Huang, Jiadong ; He, Hongyuan ; Li, Yujing ; Luan, Yujing

Phosphodiesterase type 5 inhibitors (PDE5is), primarily used for the treatment of erectile dysfunction, have been severely misused in recent years, posing a threat to public health and safety. This study developed a method that combines Surface-enhanced Raman spectroscopy (SERS) with machine learning algorithms to rapidly identify different PDE5is types. A total of 948 SERS spectra from 79 PDE5is were collected using gold nanoparticles (AuNPs) as the enhancement agent, and dimensionality reduction was performed through principal component analysis (PCA). Subsequently, six traditional machine learning models, partial least squares discriminant analysis (PLS-DA), orthogonal partial least squares discriminant analysis (OPLS-DA), support vector machines (SVM), k-nearest neighbors (KNN), random forest (RF), and multilayer perceptron (MLP) were applied for data classification and identification. Results showed that the MLP model achieved the highest classification accuracy of 99.65 %, with only 1.82 % of the samples misclassified from thiosildenafil to sildenafil analogues, significantly outperforming the other models. This method offers a rapid, cost-effective, and accurate alternative for the detection of PDE5is in health foods, with implications for improving regulatory oversight and public health safety.

2025-01-01·Neurotherapeutics

Therapeutic effects of mirodenafil, a phosphodiesterase 5 inhibitor, on stroke models in rats

Article

作者: Xi, Tianyang ; Kim, Fred ; Ku, Sae Kwang ; Choung, Jai Jun ; Jo, Hyunji ; Singh, Padmanabh ; Song, Dong-Keun

Mirodenafil is a phosphodiesterase 5 (PDE5) inhibitor with high specificity for its target and good blood-brain barrier permeability. The drug, which is currently used for treatment of erectile dysfunction, reduces Aβ and pTau levels and improves cognitive function in mouse models of Alzheimer's disease. In the present study, we investigated the effect of mirodenafil in the transient and permanent middle cerebral artery occlusion (tMCAO and pMCAO) models of stroke in rats. Starting 24 h after cerebral artery occlusion, mirodenafil was administered subcutaneously at doses of 0.5, 1, and 2 mg/kg per day for 9 days in the tMCAO model and for 28 days in the pMCAO model. Mirodenafil significantly increased sensorimotor and cognitive recovery of tMCAO and pMCAO rats compared to saline control rats, and significantly decreased the amount of degenerative cells and cleaved caspase-3 and cleaved PARP immunoreactive cells. Effects were seen in a dose-dependent manner up to 1 mg/kg mirodenafil. The benefits of mirodenafil treatment increased with longer treatment duration, and the largest improvements over control were typically observed on the last assessment day. There was no effect of mirodenafil on infarct volume in both tMCAO and pMCAO rats. In an experiment to determine the treatment window for mirodenafil effects, a protective effect was observed when treatment was delayed 72 h after MCAO, although the most improvement was observed with shorter treatment windows. Using pMCAO and tMCAO rat models of stroke, we determined that mirodenafil improves the recovery of sensorimotor and cognitive functions after MCAO and protects cortical cells from apoptosis and degeneration. Greater benefit was observed with longer duration of treatment, and improvement was seen even when treatment was delayed.

项与米罗那非相关的新闻（医药）

2024-04-29

·BioSpace

AriBio Receives EMA Phase 3 Clinical Trial Authorisation for AR1001 in Treatment of Alzheimer’s Disease (POLARIS-AD)

SEONGNAM-SI, South Korea--(BUSINESS WIRE)-- AriBio Co., Ltd. (AriBio) announced authorisation from the European Medicines Agency (EMA) for POLARIS-AD (AR1001-ADP3-US01), a global, phase 3, early Alzheimer’s disease clinical trial. EMA now aligns with the U.S. Food and Drug Administration (FDA) and UK Medicines and Healthcare Products Regulatory Agency (MHRA) on the Clinical Trial Authorisation of POLARIS-AD. The final decision from EMA was completed on April 24th with clinical trial approvals in the following member states: Czech Republic, Denmark, France, Germany, Italy, Spain and The Netherlands. Currently, 1,150 participants are expected to be randomized into the Phase 3 clinical trial across 200 sites globally. POLARIS-AD is a double-blind, randomized, placebo-controlled, multi-center registration trial evaluating the efficacy and safety of AR1001 (Mirodenafil) in treatment of patients with early Alzheimer’s disease (AD) with confirmed amyloid pathology. This trial utilizes the U.S. Food and Drug Administration (FDA) and EMA accepted primary endpoint, Clinical Dementia Rating Scale–Sum of Boxes (CDR-SB), as well as secondary endpoints including Alzheimer’s Disease Assessment Scale-Cognitive Subscale 13 (ADAS-Cog 13), Amsterdam-Instrumental Activities of Daily Living Questionnaire (A-iADL), Geriatric Depression Scale (GDS), Mini-Mental Status Examination (MMSE), in addition to changes in cerebral spinal fluid (CSF) and plasma biomarkers. James Rock, the Chief Clinical Officer of AriBio stated, “Following the acceptance of the POLARIS-AD in the United Kingdom (UK), the expansion into the additional European countries is another milestone for the registration program for AR1001. This acceptance represents the fourth region that will be actively screening and enrolling participants starting from Q2’2024. The company has committed significant resources to expeditiously and efficiently expand the footprint of the phase 3 program into these regions. This coupled with strong interest for alternative treatment options for patients with AD has fueled global interest in AR1001. Operating this study globally makes the asset extremely attractive for worldwide access should efficacy and safety be demonstrated.” About AR1001 AR1001 is a phosphodiesterase-5 (PDE5) inhibitor being developed as an investigational oral agent for the treatment of Alzheimer’s disease. Pre-clinical studies have confirmed neuroprotective effects of AR1001 via inhibiting neuron apoptosis and restoring synaptic plasticity, demonstrating multiple mechanisms of action for disease modifying effects that may ameliorate the course of AD. About AR1001-ADP3-US01 (POLARIS-AD) AR1001-ADP3-US01 (NCT05531526) is a Phase 3 double-blind, randomized, placebo-controlled, multi-center trial evaluating the efficacy and safety of AR1001 in patients with early Alzheimer’s disease. The details of the clinical trial are available at ClinicalTrials.gov. About AriBio AriBio Co., Ltd. is a biopharmaceutical company based in South Korea with offices in the United States. The company focuses on the development of novel therapies for neurodegenerative diseases including Alzheimer’s disease. European Medicines Agency (EMA) aligns with the U.S. Food and Drug Administration (FDA) and UK Medicines and Healthcare Products Regulatory Agency (MHRA) on the Clinical Trial Authorisation of POLARIS-AD, a Phase 3 Early Alzheimer’s Disease Trial Sponsored by AriBio Co., Ltd. View source version on businesswire.com: Contacts Fred Kim fredkim@aribiousa.com Source: AriBio Co., Ltd. View this news release online at:

临床3期临床2期临床申请

2024-03-31

·药研发

【药研发0401】华昊中天化疗新药获孤儿药资格 | 霍德中美双报iPSC获批IND...

「本文共：15条资讯，阅读时长约：3分钟」今日头条华昊中天化疗新药获孤儿药资格。华昊中天埃博霉素类似物优替德隆注射液获FDA授予孤儿药资格，用于治疗乳腺癌脑转移。这是一种能够穿透血脑屏障的化疗新分子，已在国内获批上市，用于治疗既往接受过至少一种蒽环类或紫杉类药物化疗方案的复发或转移性乳腺癌患者。本月初，该产品的口服胶囊制剂也获得FDA授予用于治疗胃癌的孤儿药资格。国内药讯1.和黄「呋喹替尼」新适应症报产。和黄医药VEGFR抑制剂呋喹替尼胶囊新适应症上市申请获CDE受理，推测适应症为“联合信迪利单抗用于既往系统性抗肿瘤治疗后疾病进展且不适合进行根治性手术治疗或根治性放疗的晚期pMMR或non MSI-H子宫内膜癌患者”。此前，该适应症已被纳入优先审评。值得一提的是，这一组合用于“治疗既往至少一线含铂治疗失败的pMMR晚期子宫内膜癌”已被CDE纳入突破性治疗品种。2.再鼎引进肺癌新药启动Ⅲ期临床。再鼎医药与Mirati公司（已被BMS收购）开发的KRAS G12C抑制剂Adagrasib（Krazati）在中国登记一项国际（含中国）Ⅲ期临床，拟评估adagrasib联合PD-1单抗帕博利珠单抗一线治疗KRAS G12C突变且TPS≥50%的非小细胞肺癌（NSCLC）患者的有效性和安全性。该项试验主要研究者为上海市胸科医院陆舜教授。据悉，再鼎将在今年向NMPA提交该新药用于二线及以上KRAS G12C突变NSCLC治疗的上市申请。3.恒瑞卵巢癌ADC获快速通道资格。恒瑞医药TROP-2-ADC产品注射用SHR-A1921获FDA授予快速通道资格，用于治疗铂耐药复发上皮性卵巢癌、输卵管癌及原发性腹膜癌。今年1月下旬，该新药在clinicaltrials.gov网站上注册一项III期临床试验，拟评估SHR-A1921对比铂类双重化疗治疗复发性上皮性卵巢癌患者的有效性与安全性。在I期研究中，SHR-A1921治疗实体瘤达到33.3%的客观缓解率，疾病控制率为80%。4.驯鹿CAR-T获批新IND。驯鹿生物与信达生物联合开发的靶向BCMA的CAR-T产品伊基奥仑赛注射液（CT103A）获CDE批准临床许可，拟扩大适应症用于治疗既往经过1-2线治疗且来那度胺耐药的复发/难治性多发性骨髓瘤患者。去年6月，该新药已被CDE批准用于治疗既往经过至少3线治疗后进展的复发或难治性多发性骨髓瘤成人患者。5.霍德中美双报iPSC获批IND。霍德生物iPSC衍生异体通用型前脑神经前体细胞注射液hNPC01获FDA临床默示许可，预计将在2025年启动针对缺血性脑卒中偏瘫后遗症的美国I/IIa注册临床。在国内治疗颅脑移植缺血性脑卒中12个月以上患者的I期临床结果中，hNPC01治疗显示出对中风后运动及语言功能障碍的持续改善潜力，且药物安全性良好。国际药讯1.吉利德乙肝新药获批扩展适用范围。吉利德新型核苷类逆转录酶抑制剂（NRTI）Vemlidy（tenofovir alafenamide）获FDA批准新适应症，用于每日一次（25mg）治疗≥6岁儿童慢性乙型肝炎病毒（HBV）患者。在Ⅱ期临床（试验1092）中，与安慰剂相比，Vemlidy治疗显著提高了患者的病毒抑制率。此前，该新药已被批准用于治疗患有慢性乙型肝炎并带有影响肝功能的肝脏疾病成人患者，以及≥12岁慢性乙型肝炎儿科患者的治疗。2.BMS肺癌新药III期临床积极。百时美施贵宝KRAS G12C抑制剂adagrasib治疗KRAS G12C突变、局部晚期或转移性非小细胞肺癌（NSCLC）患者的III期KRYSTAL-12研究达到了主要终点和关键次要终点。与标准化疗相比，adagrasib用于二线或后线治疗显著改善了患者的无进展生存期（PFS）和客观缓解率（ORR）。目前，该项研究正继续评估患者的总生存期（OS）。研究期间，未出现新的安全信号。3.韩国AriBio公司AD新药获批Ⅲ期临床。韩国AriBio公司磷酸二酯酶 5（PDE5）抑制剂AR1001（Mirodenafil，米罗地那非）获英国药品和保健品监管局（MHRA）批准开展Ⅲ期临床POLARIS-AD，评估用于治疗早期阿尔茨海默病患者的疗效和安全性。AR1001旨在通过抑制神经元凋亡和恢复突触可塑性，以保护神经和缓解AD病程。3月24日，该公司已将Mirodenafil在中国的独家营销权授予一家中国药企，首付达9000万美元。4.FIC肝硬化疗法Ⅱ期临床积极。Lipocine公司潜在“first-in-class”雄激素受体激动剂LPCN 1148治疗肝硬化男性患者的Ⅱ期临床达到主要终点。第24周时，LPCN 1148治疗患者的L3-骨骼肌指数（SMI）较基线显著增加，且疗效持续至52周；且这一改善较安慰剂组具有统计学意义。治疗期间，患者发生明显肝性脑病（OHE）事件较少。此外，LPCN 1148耐受性良好。5.Avalo公司引入一款炎症靶向疗法。Avalo公司宣布收购AlmataBio公司，并获得该公司临床期在研白介素-1β（IL-1β）靶向单抗AVTX-009，应用于化脓性汗腺炎（HS）和其他皮肤科、胃肠科、风湿科的炎症性疾病。Avalo同时完成了由Commodore Capital和TCGX领投的1.85亿美元的私募融资（其中包含初始前期投资1.156亿美元）。目前，AVTX-009正在Ⅱ期临床中评估治疗化脓性汗腺炎的潜力，预计其主要结果将在2026年发布。6.Avenzo公司融资开发抗肿瘤小分子。Avenzo公司宣布完成1.5亿美元超额A-1轮融资，用于加速推进其潜在“best-in-class”细胞周期蛋白依赖性激酶2（CDK2）选择性抑制剂AVZO-021的临床开发。CDK2对细胞周期调控至关重要，在多种癌症中经常高度激活。目前，AVZO-021正在美国开展Ⅰ期临床评估用于治疗晚期实体瘤的安全性、耐受性以及初步疗效。医药热点1.WHO启用冠状病毒全球监测网络。世卫组织27日发布新闻公报说，已启用“冠状病毒网络”（CoViNet），以促进和协调全球的专业知识和能力，及早准确地检测、监测和评估新冠病毒、中东呼吸综合征冠状病毒和其他可能新出现的冠状病毒。“冠状病毒网络”由在人类、动物和环境冠状病毒监测方面具有专长的全球实验室组成。该网络目前包括21个国家的36个实验室，涵盖世卫组织划分的全球六大区域。2.上海交大医学院临床药学院成立。3月28日，上海交通大学医学院临床药学院正式揭牌成立，旨在充分整合医学院基础药学和附属医院临床药学的科研力量和人才资源，联动校部药学相关优势学科，加强交叉，协同开展“大药学”领域的学科建设、教育教学、人才培养，开展药学基础研究和科技成果转化，培养创新型、研究型、服务型的高素质临床药学人才，推动我国生物医药药学的高质量发展。3.重庆医科大学新增一家附属医院。3月28日，重庆医科大学和南川区人民政府举行共建重庆医科大学附属南川医院战略合作协议签约暨揭牌仪式，南川区人民医院正式挂牌“重庆医科大学附属南川医院”。据悉，2009年南川区人民医院成为重庆医科大学教学医院，已过去15年。如今正式成为重庆医科大学附属医院，标志着该院在医疗、教学、科研领域的地位将得到进一步提升，同时也预示着未来将有更多高质量的医疗资源向公众开放。评审动态 1. CDE新药受理情况（03月30日) 2. FDA新药获批情况（北美03月28日）股市资讯上个交易日 A 股医药板块 +0.42%涨幅前三跌幅前三微芯生物+12.37% 大理药业 -8.77%江苏吴中 +9.99% 海创药业 -6.15%回盛生物 +9.19% 特宝生物 -5.87%【安图生物】收到河南省药品监督管理局针对“抗核糖体P蛋白抗体IgG校准品、抗β2糖蛋白1抗体校准品、抗B2糖蛋白1抗体IgG校准品、类风湿因子校准品、抗β2糖蛋白1抗体IgA校准品，类风湿因子IgM校准品，类风湿因子IgG校准品，抗双链DNA抗体IgG校准品、抗双链DNA抗体IgG检测试剂盒(磁微粒化学发光法》、抗环瓜氨酸肽抗体IgG校准品、抗线粒体 M2抗体IgG校准品”颁发的医疗器械注册证。【复星医药】与日本Meiji Seika Pharma株式会社共同开发的OP0595(通用名:Nacubactam)与头孢吡肟或氨曲南联合给药，针对治疗方案有限的成人需氧革兰氏阴性菌感染于中国境内(不包括港澳台地区)近期启动两项11I期临床试验，【成大生物】与北京康乐卫士生物技术股份有限公司合作研发的15价HPV疫苗正式进入I期临床试验。【海思科】获得创新药HSK16149胶囊新适应症“用于治疗中枢神经病理性疼痛”的《药物临床试验批准通知书》- The End -戳“阅读原文”，了解更多医药研发及股市资讯。

临床3期免疫疗法快速通道优先审批孤儿药

2024-03-30

·药融圈

国内药企收购：海外阿尔兹海默新药权益，首付达9000万美元

▲5月30-31日第八届广州生物医药创新者峰会扫码立即报名注：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。任何文章转载需得到授权。药融云数据（www.pharnexcloud.com）监测显示：2024年2月25日，来自韩国的生物制药初创企业AriBio Co., Ltd.（AriBio）收到英国药品和保健品监管局（MHRA）签发的早期阿尔茨海默症3期临床试验POLARIS-AD的受理通知。MHRA于2月21日完成审查并确认了有利的意见，公司预计于2024年第一季度末之前在英国启动该项临床试验。Pipeline of AriBio药融云数据www.pharnexcloud.comPOLARIS-AD是一项双盲、随机、安慰剂对照、多中心注册试验，旨在评估AR1001（Mirodenafil，音译米罗地那非）治疗早期阿尔茨海默病患者52周的疗效和安全性。该试验使用美国食品和药物管理局（FDA）和欧洲药品管理局（EMA）认可的主要终点：临床痴呆评分 – 分数框总和（CDR-SB）以及次要终点：包括阿尔茨海默病评分 – 认知子评分13 （ADAS-Cog 13）、阿姆斯特丹日常生活工具活动问卷（A-iADL）、老年抑郁评分（GDS）、简易精神状态检查（MMSE），以及脑脊液（CSF）的变化和血浆生物标志物。所有早期阿尔茨海默氏病参与者均已入组，并将确认淀粉样蛋白。AriBio首席临床官James Rock表示：“英国接受POLARIS-AD临床研究是AR1001研发的又一成果。本次接受表明第三个地区将在2024年第一季度积极筛选并招募参与者。如前所述，AriBio会继续将该研究扩展到监管和商业市场支持新型阿尔茨海默病治疗方法的其他地区。”关于AR1001AR1001是一种正在开发的磷酸二酯酶 5（PDE5）抑制剂，是一种治疗阿尔茨海默病的研究性口服药物。临床前研究已证实AR1001通过抑制神经元凋亡和恢复突触可塑性，从而具有神经保护作用，并显示出可能缓解AD病程的多种作用机制。本品在中国已提交2项新药IND申请,目前正在审评中，注册分类为2.4类，改良新药，老药的新适应症探索。其中的CRO为Panacro (Hefei) Pharmaceutical Technology Co., Ltd.。原型分子最早由韩国SK开发。就在近期：2024年3月24日，该公司宣布与中国制药企业达成一项独家营销权合作协议。该协议首付款为1200亿韩元（约9000万美元）(不可退还)，交易总额最多高达55.9亿元人民币（约合7.7亿美元），首付款将于2024年年中开始支付。但是中国制药企业表示暂时不想透露名字，令坊间同行吃惊与猜测。（考虑到阿尔茨海默氏病药物在中国的市场竞争和销售策略，被许可方要求在商定时间之前不对外披露。）https://www.aribio.com/关于AR1001-ADP3-US01AR1001-ADP3-US01 (NCT05531526) 是3期双盲、随机、安慰剂对照、多中心试验，用于评估AR1001在52周内对早期阿尔茨海默病参与者的疗效和安全性。该研究旨在通过各种认知和功能评估来评估AR1001在减缓阿尔茨海默病进展方面的功效和安全性。临床试验的详细信息可参见ClinicalTrials.gov。关于AriBioAriBio Co., Ltd.是一家总部位于韩国，并且在美国设有办事处的生物制药公司。该公司专注于开发针对包括阿尔茨海默病在内的神经退行性疾病的新疗法。AI制药驱动的新药公司。参考：NMPA/CDE；药融云数据www.pharnexcloud.com；FDA/EMA/PMDA；相关公司公开披露；https://www.aribio.com/；https://www.businesswire.com/news/home/20240324424175/zh-CN/；美国商业资讯；MHRA Issues Notice of Acceptance for POLARIS-AD, a Phase 3 Early Alzheimer’s Disease Trial Sponsored by AriBio Co., Ltd.；2期临床结果，https://www.businesswire.com/news/home/20211104005378/en/AriBio-Co.-Ltd.-Announces-Topline-Results-from-Phase-2-Study-of-AR1001-in-Mild-to-Moderate-Alzheimer%E2%80%99s-Patients；https://www.businesswire.com/news/home/20240223575719/zh-CN；等等。本文仅用于向医疗卫生专业人士提供科学信息，不代表平台立场，不作任何用药推荐活动推荐 5月 • 第八届大湾区生物医药创新者峰会关键词：抗体、多肽、核酸、核药，XDC、小分子、注册、临床、CMC（点击下方图片查看详情）▼【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跨境交易等多个领域，服务了百余家上市/独角兽/生物技术/制药企业。

临床3期并购引进/卖出

100 项与米罗那非相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	米罗那非	G04BE	DB11792

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
勃起功能障碍	韩国	SK CHEMICALS CO LTD	2007-07-18

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
高血压	临床3期	美国	SK CHEMICALS CO LTD	2007-12-01
1型糖尿病	临床3期	美国	SK CHEMICALS CO LTD	2007-11-01
阿尔茨海默症	临床申请批准	中国	ARIBIO Co., Ltd.	2024-05-10

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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


NCT00626743 (CTgov)	临床1期	高血压	13	Amlodipine+SK3530 (Amlodipine + SK3530)	範觸鑰鬱廠糧鏇膚簾夢(齋鏇夢鬱餘簾糧構餘淵) = 網淵淵網襯願艱製鏇選網觸觸餘壓鹽遞淵醖憲 (憲窪築衊廠夢壓鑰蓋遞, 5.60) 更多	-	2014-04-21
				Placebo+Amlodipine (Amlodipine + Placebo)	範觸鑰鬱廠糧鏇膚簾夢(齋鏇夢鬱餘簾糧構餘淵) = 壓構鏇願齋鹹鏇網鏇廠網觸觸餘壓鹽遞淵醖憲 (憲窪築衊廠夢壓鑰蓋遞, 5.37) 更多