预约演示

更新于：2025-01-16

Guanfacine hydrochloride

盐酸胍法辛

更新于：2025-01-16

概要

基本信息

简介胍法辛（商品名为Tenex、Intuniv、Estulic）是一种作用于中枢的降压剂和α2肾上腺素受体激动剂。其作用机制是刺激脑内的α2肾上腺素受体，导致交感神经系统活动降低，从而降低血压。此外，胍法辛已被发现对调节注意力和行为的前额叶皮层产生影响，因此对治疗注意力缺陷多动障碍（ADHD）有用。胍法辛最初于1986年被FDA批准用于治疗高血压，授权公司是Promius Pharma LLC。随后在2009年，Takeda制药公司获得了美国批准，用于治疗儿童和青少年的ADHD。目前，它在世界多个国家获得了批准。

药物类型

小分子化药

别名

Connexyn、guanfacine、Guanfacine hydrochloride (JAN/USP)

+ [10]

靶点

adrenergic receptor

作用机制

adrenergic receptor激动剂(肾上腺素能受体家族激动剂)

治疗领域

其他疾病

在研适应症

注意缺陷障碍伴多动

非在研适应症

分离性焦虑注意缺陷障碍广泛性焦虑障碍+ [2]

原研机构

Promius Pharma LLC

在研机构

Takeda Pharmaceuticals U.S.A., Inc.Takeda Pharmaceuticals International AG

Takeda Pharmaceutical Co., Ltd.

+ [4]

非在研机构

Shire Plc

Promius Pharma LLC

最高研发阶段批准上市

首次获批日期

美国 (1986-10-27),

高血压

最高研发阶段(中国)临床3期

特殊审评孤儿药 (美国)

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结构/序列

分子式C9H10Cl3N3O

InChIKeyDGFYECXYGUIODH-UHFFFAOYSA-N

CAS号29110-48-3

关联

项与盐酸胍法辛相关的临床试验

NCT06408246

/ Not yet recruiting临床2期IIT

ACE-D: Accelerating Cognition-guided Signatures to Enhance Translation in Depression: Clinical Trial

The purpose of this study is to understand how a psychotropic medication called guanfacine affects brain network functioning in humans, and how this function interacts with cognitive impairments in people experiencing depressive symptoms.

开始日期2026-02-01

申办/合作机构

Stanford University

NCT06629259

/ Not yet recruiting临床2期IIT

Guanfacine for Alcohol Use Disorder (AUD): a Telehealth Approach

The investigators assess whether guanfacine extended release (GXR; 3mg/d) compared with placebo (PBO) will attenuate drinking and drinking-related factors in N=200 men and women with Alcohol Use Disorder (AUD) across 12-weeks.

开始日期2025-03-01

申办/合作机构

Indiana University

[+1]

NCT06642181

/ Not yet recruiting临床1期IIT

Combined Guanfacine and Mindfulness Meditation As an Adjunct to Buprenorphine Maintenance in Opioid Use Disorder

The US is currently going through an opioid crisis, and while Medication Assisted Treatments such as buprenorphine (BUP) have proved highly effective at stabilizing the neurobiology underlying acute withdrawal, they have been less effective at preventing longer-term relapse and adherence. This may be due to the fact that they do not fully engage the neural processes sub-serving the emotional control of sensitized negative mood and reward sensitivity during stress- and opioid-cue provocation, respectively. In contrast while the alpha2 agonist, guanfacine, may attenuate stress-provoked opioid craving by mediating top-down prefrontal control over sensitized dysphoria, the behavioral intervention, Mindfulness Oriented Recovery Enhancement (MORE) may reduce opioid cue-provoked craving by mediating top-down prefrontal control over hedonic dysregulation. Furthermore, while both interventions separately may prove effective as longer-term adjunctive therapies, they may offer greater efficacy together, providing a unique medication/behavioral combination able to target both stress and reward provocation mechanisms. To optimally test this hypothesis, a staged approach is proposed to first confirm the efficacy of both GXR and MORE, independently and combined (R61), prior to elucidating underlying neural mechanisms (R33). Using a 2 X 2 design, N=80 OUD individuals on BUP will be randomized to either 6-weeks of Guanfacine extended release (GXR; 3mgs, n=40) or placebo (PBO; n=40). Half of all participants in each group will then receive either weekly MORE, or a Support Group (SG) control, creating four intervention groups (Control Grp: PBO+SG, n=20); (GXR Grp: GXR+SG, n=20); (MORE Grp: PBO+ MORE, n=20); (Combined Grp: GXR+MORE, n=20). A pre- and post-laboratory study will be conducted before and after six weeks of intervention where participants will be randomly exposed to 3 personalized guided imageries (stress, opioid cue, neutral). Subjective measures of opioid craving, anxiety, mood, stress, emotional reappraisal, and heart rate will be collected before and after imagery exposure. Following milestone completion, an identical design is proposed in N=144 individuals, where participants will be exposed to imageries in the MRI scanner (R33). On the basis of prior research, it is hypothesized in that GXR will attenuate opioid craving and improve emotion regulation during stress, while MORE will demonstrate the same effects during opioid cue exposure. Combined GXR and MORE will also demonstrate additive or synergistic improvements compared with each intervention alone (R61). The effects of GXR on opioid cue- and MORE on stress-provoked opioid seeking will be explored. In the R33 component, it is hypothesized that GXR will improve regulatory and affective brain function during stress, and MORE will improve regulatory and reward function during opioid cue exposure. Combined GXR and MORE may improve regulatory function in an additive or synergistic manner (R33). Findings will help elucidate the efficacy and neural mechanisms underpinning a novel integrated pharmaco-behavioral therapy for OUD individuals maintained on BUP.

开始日期2025-01-02

申办/合作机构

Rutgers State University of New Jersey

[+1]

100 项与盐酸胍法辛相关的临床结果

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100 项与盐酸胍法辛相关的转化医学

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100 项与盐酸胍法辛相关的专利（医药）

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1,105

项与盐酸胍法辛相关的文献（医药）

2025-02-01·BEHAVIOURAL PHARMACOLOGY

Posttraumatic anxiety-like behaviour in zebrafish is dose-dependently attenuated by the alpha-2A receptor agonist, guanfacine

Article

作者: van Staden, Cailin ; Wolmarans, De Wet ; Weinshenker, David ; Botha, Tarryn L. ; Brand, Linda ; Finger-Baier, Karin

Traumatic stress exposure increases noradrenaline (NA) release, which contributes to anxiety and impaired risk-appraisal. Guanfacine, a selective alpha-2A adrenergic receptor agonist, has been used to treat stress-related disorders characterised by impaired prefrontal cortex function. By acting on both presynaptic inhibitory autoreceptors and postsynaptic heteroreceptors, guanfacine attenuates stress reactivity and enhances cognition. However, its effectiveness in treating trauma-related anxiety and risk-taking behaviour remains unclear. Leveraging the advantages of zebrafish (Danio rerio) as a sensitive and efficient preclinical model which is ideal for stress research, we explored the impact of traumatic stress exposure combined with varying concentrations of guanfacine in adult zebrafish. Zebrafish were evaluated for trauma-related anxiety using both the novel tank test (NTT) and a novel version of the open-field test (nOFT), the latter which was also used to investigate risk-taking behaviour. We found that (1) traumatic stress exposure led to heightened risk-taking behaviour in the nOFT, and (2) low-to-moderate concentrations of guanfacine (3–20 µg/L) attenuated anxiety-like, but not risk-taking behaviour, with the highest concentration (40 µg/L), showing no effect. These results highlight the complex role of NA in modulating dysregulated behaviours during traumatic events and indicate the potential of guanfacine for improving trauma-related anxiety and risk-taking behaviour.

2025-02-01·JOURNAL OF PHARMACY PRACTICE

Alpha2 Agonist Use in Critically Ill Adults: A Focus on Sedation and Withdrawal Prevention

Review

作者: Meester, Alyssa ; Yoon, Connie H. ; Caffarini, Erica ; Murray, Danielle ; Harding, Angela ; Heine, Alexander ; Schuler, Ashley

The management of sedation in critically ill adults poses a unique challenge to clinicians. Dexmedetomidine, an α2 agonist, has a unique mechanism and favorable pharmacokinetics, making it an attractive intravenous option for sedation and delirium in the intensive care unit. However, patients may be at risk for withdrawal with prolonged use, adding to the complexity of sedation and agitation management in this patient population. Enteral α2 agents have the benefit of cost savings and ease of administration, thus playing a role in the ability to decrease intravenous sedative use and prevent dexmedetomidine withdrawal. Clonidine and guanfacine are the two most common enteral α2 agents utilized for this purpose, however, there is a paucity of evidence regarding the comparative benefit between the two agents. The decision to use one vs the other agent should be determined based on their differing pharmacology, pharmacokinetics, and side effect profile. The most effective dosing strategy for these agents is also unknown. Ultimately, more robust literature is required to determine enteral α2 agonists place in therapy. This narrative review evaluates the currently available literature on the use of α2 agonists in critically ill adults with an emphasis on sedation, delirium, and withdrawal.

2025-01-01·The Lancet Psychiatry

Comparative efficacy and acceptability of pharmacological, psychological, and neurostimulatory interventions for ADHD in adults: a systematic review and component network meta-analysis

Review

作者: Philipsen, Alexandra ; Cipriani, Andrea ; Farhat, Luis C ; Zangani, Caroline ; Cowen, Phil J ; Ostinelli, Edoardo G ; Chamberlain, Samuel R ; Young, Susan ; Del Giovane, Cinzia ; Cortese, Samuele ; Schulze, Marcel ; Tomlinson, Anneka ; Bilbow, Andrea

BACKGROUND:

The comparative benefits and harms of available interventions for ADHD in adults remain unclear. We aimed to address these important knowledge gaps.

METHODS:

In this systematic review and component network meta-analysis (NMA), we searched multiple databases for published and unpublished randomised controlled trials (RCTs) investigating pharmacological and non-pharmacological interventions for ADHD in adults from database inception to Sept 6, 2023. We included aggregate data from RCTs comparing interventions against controls or any other eligible active intervention for the treatment of symptoms in adults (ages ≥18 years) with a formal diagnosis of ADHD. Pharmacological therapies were included only if their maximum planned doses were considered eligible according to international guidelines. We included RCTs of at least 1-week duration for medications, of at least four sessions for psychological therapies, and of any length deemed appropriate for neurostimulation. For RCTs of medications, cognitive training, or neurostimulation alone, we included only double-blind RCTs. At least two authors independently screened the identified records and extracted data from eligible RCTs. Our primary outcomes were efficacy (change in ADHD core symptom severity on self-rated and clinician-rated scales at timepoints closest to 12 weeks) and acceptability (all-cause discontinuation). We estimated standardised mean differences (SMDs) and odds ratios (ORs) using random effects pairwise and component NMA, dismantling interventions into specific therapeutic components. This study was registered with PROSPERO (CRD42021265576). People with relevant lived experience were involved in the conduct of the research and writing process.

FINDINGS:

Of 32 416 records, 113 unique RCTs encompassing 14 887 participants were eligible for analysis (6787 [45·6%] females, 7638 [51·3%] males, 462 [3·1%] sex not reported). The RCTs encompassed pharmacological therapies (63 [55·8%] of 113 RCTs; 6875 participants), psychological therapies (28 [24·8%] of 113 RCTs; 1116 participants), neurostimulatory therapy and neurofeedback (ten [8·8%] of 113 RCTs; 194 participants), and control conditions (97 [85·8%] of 113 RCTs; 5770 participants). For reduction of ADHD core symptoms at 12 weeks on both self-reported and clinician-reported rating scales, atomoxetine (self-reported scale SMD -0·38, 95% CI -0·56 to -0·21; clinician-reported scale -0·51, -0·64 to -0·37) and stimulants (0·39, -0·52 to -0·26; -0·61, -0·71 to -0·51) had higher efficacy than placebo (Confidence in Network Meta-Analysis [CINeMA] ranging between very low and moderate). Cognitive behavioural therapy (-0·76, -1·26 to -0·26), cognitive remediation (-1·35, -2·42 to -0·27), mindfulness (-0·79, -1·29 to -0·29), psychoeducation (-0·77, -1·35 to -0·18), and transcranial direct current stimulation (-0·78; -1·13 to -0·43) were better than placebo only on clinician-reported measures. Regarding acceptability, all therapeutic components were similar to placebo other than atomoxetine (OR 1·43, 95% CI 1·14 to 1·80; CINeMA moderate) and guanfacine (3·70, 1·22 to 11·19; high), which had lower acceptability compared with placebo. Baseline severity of self-reported ADHD core symptoms, year of publication, percentage of male individuals, and percentage of individuals with ADHD and another mental health condition did not explain the heterogeneity observed in unadjusted non-component models of self-reported ADHD core symptoms. Treatment length had little effect on heterogeneity.

INTERPRETATION:

Stimulants and atomoxetine were the only interventions with evidence of beneficial effects in terms of reducing ADHD core symptoms in the short term, supported by both self-reported and clinician-reported ratings. However, atomoxetine was less acceptable than placebo. Medications for ADHD were not efficacious on additional relevant outcomes, such as quality of life, and evidence in the longer term is underinvestigated. The effects of non-pharmacological strategies were inconsistent across different raters. Our network meta-analysis represents the most comprehensive synthesis of available evidence to inform future guidelines in the field.

FUNDING:

UK National Institute for Health and Care Research.

项与盐酸胍法辛相关的新闻（医药）

2024-07-30

·Pharmaceutical Technology

Collegium buys Ironshore for $525m and enter ADHD market

Collegium will also pay an additional $25m if the sales of Ironshore’s Jornay PM exceed the defined revenue expectation in 2025. Image Credit: tomertu / Shutterstock. Collegium Pharmaceuticals has signed a definitive agreement to acquire Ironshore Therapeutics in a bid to expand its portfolio beyond pain management. Collegium will pay $525m in cash to acquire outstanding shares of Ironshore. Following the transaction, Collegium will gain Ironshore’s US Food and Drug Administration (FDA)-approved therapy, Jornay PM (methylphenidate hydrochloride), for treating attention deficit hyperactivity disorder (ADHD) in patients aged six years and older. The company will also pay an additional $25m if the sales of Jornay PM exceed Collegium’s defined revenue expectations in 2025. The deal is expected to close in Q3 this year. Concurrent with the acquisition, Collegium also secured $646m as part of a five-year loan from Pharmakon Advisors, which, along with Collegium’s cash reserves, will fund the Ironshore acquisition. “The Ironshore acquisition is a unique opportunity to deliver a transaction that is immediately accretive to Collegium while meeting all of our strategic objectives through the addition of a growing commercial asset that diversifies our portfolio, has significant revenue potential and exclusivity into the 2030s,” said Michael Heffernan, chairman and interim president and chief executive officer of Collegium. Whilst there is a significant unmet need for new ADHD therapeutics, simulant treatments like Jornay PM face significant disadvantages due to their abuse potential and their prescribed use being limited to 30 days. See Also: Pipeline power: Sionna’s AbbVie deal could redefine CF therapeutics Podcast #5: Doing Digital Deals in Life Sciences | Deal Structure, Terms, and Series Conclusions The current market leader in the ADHD space is Takeda with two FDA-approved treatments, Vyvanse (lisdexamfetamine dimesylate) and Intuniv (guanfacine hydrochloride). However, the overall market for ADHD therapeutics across seven major markets (US, France, Germany, Italy, Spain, UK, and Japan) is expected to decline to $10.9bn by 2032 from $11.9bn in 2022, as per GlobalData analysis. This is mainly driven by the launch and uptake of generics. GlobalData is the parent company of Pharmaceutical Technology . Late-stage ADHD therapies in development include Otsuka Pharmaceuticals’ non-stimulant therapy centanafadine and Cingulate’s CTx-1301 (dexmethylphenidate) , a once-daily stimulant therapy. In October 2023, Otsuka reported positive data from two Phase III trials showing centanafadine’s efficacy in treating ADHD in adolescents and children.

临床结果临床3期并购上市批准

2024-07-16

·米内网

超40个品种优先审评火热来袭！正大天晴、海思科……“弯道超车”，康缘中药1类新药亮眼

精彩内容近日，CDE官网显示，辽宁海思科制药的HSK21542注射液被纳入优先审评品种名单。今年以来，已有超过40个品种被纳入优先审评名单，涉及恒瑞医药、正大天晴药业集团、信达生物等企业。从理由来看，纳入突破性治疗药物程序的药品最多；从治疗大类来看，抗肿瘤和免疫调节剂化药最为火热，其中不乏重磅品种。此外，2个中药1类新药亮眼；注射用头孢比罗酯钠、盐酸胍法辛缓释片、盐酸依匹斯汀滴眼液等品种国内暂无仿制药企业获批，深圳华润九新药业、四川百利药业等有望拿下首仿。利好不断，创新药、罕见病药、儿童药优先审评不断提速今年5月，CDE官网发布通告，为落实对具有明显临床价值儿童用药采取优先审评审批程序，利于研发单位更好地了解与把握儿童用药创新研发方向，药审中心网站“儿童用药专栏”将持续公示优先审评审批的儿童用药批准信息。近年，在国家顶层政策支持下，明确对临床急需创新药、罕见病药、儿童药等予以优先审评审批，新药、好药上市不断提速。 2020-2023年纳入优先审评审批程序的注册申请情况（件）国家药监局发布《2023年度药品审评报告》显示，全年共纳入优先审评审批注册申请108件（80个品种），同比增加56.9%；有85件（59个品种）注册申请按照优先审评审批程序批准上市，包括远大医药（中国）的卡谷氨酸片、石家庄四药的司替戊醇干混悬剂等15个罕见病用药，成都倍特药业的地高辛注射液、江苏恒瑞医药的环磷酰胺胶囊、成都硕德药业的布洛芬注射液等26个儿童用药。优先审评审批程序明确药品上市许可申请时，对于6种具有明显临床价值的药品，可以申请适用优先审评审批程序。而获得适用优先审评审批程序的上市注册申请的审评时限由常规程序的200日缩短为130日，其中临床急需的境外已上市境内未上市的罕见病药品审评时限为70日。正大天晴、海思科……“弯道超车”，康缘中药1类新药亮眼近日，CDE官网显示，辽宁海思科制药的HSK21542注射液被纳入优先审评品种名单，拟用于治疗慢性肾脏疾病相关性瘙痒。今年以来，已有超过40个品种（受理号超过60个）被纳入优先审评名单，涉及恒瑞医药、正大天晴药业集团、信达生物等企业。从优先审评理由来看，纳入突破性治疗药物程序的药品最多，其次是符合儿童生理特征的儿童用药品新品种、剂型和规格及符合附条件批准的药品，分别涉及品种17个、9个和8个。 HSK21542注射液优先审评公示详细信息 HSK21542是海思科自主研发的强效外周kappa阿片受体选择性激动剂。日前，海思科发布公告，其创新药HSK21542注射液新适应症IND申请获受理，拟用于治疗术后恶心呕吐。资料显示，HSK21542注射液在2023年10月提交腹部手术术后镇痛适应症的NDA申请，目前正进行技术审评；该产品的肾脏疾病相关性瘙痒适应症目前正开展Ⅲ期临床研究，2024年7月该适应症被纳入优先审评品种名单。从治疗大类来看，抗肿瘤和免疫调节剂化药最为火热，涉及品种超过20个，其中不乏重磅品种，甲磺酸奥希替尼片、盐酸安罗替尼胶囊等在2023年中国三大终端六大市场抗肿瘤和免疫调节剂化药TOP20产品之列。米内网数据显示，抗肿瘤和免疫调节剂化药在近年中国三大终端六大市场持续扩容，销售规模均超过2000亿元，2023年同比增长5.34%。 2个中药1类新药亮眼，分别是江苏康缘药业的龙七胶囊和北京东方运嘉药业的小儿黄金止咳颗粒，均以“国家药品监督管理局规定其他优先审评审批的情形”纳入优先审评审批程序；此外，注射用头孢比罗酯钠、盐酸胍法辛缓释片、盐酸依匹斯汀滴眼液等品种国内暂无仿制药企业获批，深圳华润九新药业、四川百利药业、润尔眼科药物（广州）等有望拿下首仿。龙七胶囊优先审评公示详细信息龙七胶囊是康缘药业研发的中药1类新药，有祛痰化瘀、清肺消积功效，用于治疗肺癌之痰瘀阻肺证所致的咳嗽、咯痰、痰血、气喘（气急）、胸闷、胸痛，并能缓解疼痛，缩小或稳定肿瘤，延长无疾病进展生存期，提高生存质量。该产品在今年4月报产，目前在审评审批中。小儿黄金止咳颗粒优先审评公示详细信息小儿黄金止咳颗粒是北京东方运嘉药业研发的中药1类新药，有清肺化痰、宣肺止咳功效，用于儿童急性咳嗽痰热阻肺证，症见咳嗽，咯痰，痰黄或黄白相兼、或痰粘稠，咽喉不利，口渴，或大便干燥，舌红苔薄黄或黄腻；儿童急性气管-支气管炎咳嗽见上述证候者。该产品在今年2月报产，目前在审评审批中。今年以来被纳入优先审评品种名单注：以公示日期计资料来源：CDE官网、米内网数据库等注：米内网《中国三大终端六大市场药品竞争格局》，统计范围是：城市公立医院和县级公立医院、城市社区中心和乡镇卫生院、城市实体药店和网上药店，不含民营医院、私人诊所、村卫生室，不含县乡村药店；上述销售额以产品在终端的平均零售价计算。如有疏漏，欢迎指正！本文为原创稿件，转载请注明来源和作者，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

优先审批上市批准突破性疗法临床研究

2024-06-22

·医药地理

国家药监局发布7条公告通告，凝血因子VIII替代疗法Altuvoct近日获EC批准上市

扫描二维码即可下载《数图药讯》2024年第25期目录政策解读 1. 国家卫健委：新闻发布会介绍进一步健全机制持续推动城市医疗资源向县级医院和城乡基层下沉有关情况 2. 国家药监局：发布7条通告及公告 3. 国家医保局：全国医保系统“学党纪知法规强业务”知识竞赛在河南郑州举办 4. 国家中医药管理局：召开第十六届海峡论坛2024海峡两岸中医药发展与合作研讨会 5. 上海阳光医药采购网：关于公布部分中药饮片和中药配方颗粒挂网采购信息动态调整的通知行业动态 1. 药讯动态：重磅获批 2. 药讯动态：重磅临床 3. 药企动态：市场动态零售品类数据洞见 1. 处方药头孢菌素类抗感染药物市场趋势分析 2. 头孢克肟零售放大市场销售分析 3. 头孢克肟零售放大市场销售企业分析政策解读 1、国家卫生健康委新闻发布会介绍进一步健全机制持续推动城市医疗资源向县级医院和城乡基层下沉有关情况在6月18日国家卫生健康委2号楼新闻发布厅（西城区北礼士路甲38号）召开新闻发布会，介绍进一步健全机制持续推动城市医疗资源向县级医院和城乡基层下沉有关情况，并答记者问。 2、国家药监局：关于发布仿制药参比制剂目录（第八十一批）的通告（2024年第21号）、3条说明书修订公告、1条医疗器械注册公告、1条药品目录增补公告 6月17日经国家药品监督管理局仿制药质量和疗效一致性评价专家委员会审核确定，发布仿制药参比制剂目录（第八十一批）。 6月19日关于将溴啡等46种物质列入《非药用类麻醉药品和精神药品管制品种增补目录》的公告。国家药监局共批准注册医疗器械产品265个。其中，境内第三类医疗器械产品197个，进口第三类医疗器械产品40个，进口第二类医疗器械产品27个，港澳台医疗器械产品1个（2024年5月）（2024年第74号）。国家药监局关于修订环磷腺苷葡胺注射剂等药品说明书的公告（2024年第71号）（2024年第72号）（2024年第73号）。具体信息请登录国家药监局官网查看。 3、国家医保局：全国医保系统“学党纪知法规强业务”知识竞赛在河南郑州举办 6月16日-17日，全国医保系统“学党纪知法规强业务”知识竞赛在河南郑州举办。为不增加基层负担，各代表队不搞选拔、直接组队，力求更加真实地展现医保干部队伍的政治素质、纪法素养、业务水准。 4、国家中医药局：国家中医药管理局等部门召开第十六届海峡论坛2024海峡两岸中医药发展与合作研讨会 6月14-15日“第十六届海峡论坛2024海峡两岸中医药发展与合作研讨会”在厦门召开，该研讨会涵盖多场主题论坛及中医药特色适宜技术展示体验、中医药文化交流参访等相关配套活动。来自海峡两岸的500余名专家学者、企业家围绕“促进融合发展，共创绵长福祉”进行了交流探讨。 5、上海阳光医药采购网：关于公布部分中药饮片和中药配方颗粒挂网采购信息动态调整的通知根据关于进一步完善中药饮片阳光采购管理工作的通知6月20日上海市医药采购服务与监管信息系统向相关单位推送中药饮片和中药配方颗粒的采购信息动态调整6月26日执行。相关文件请扫描上方二维码查看行业动态 01 药讯动态：重磅获批和重磅临床最近重磅获批复星医药旗下万邦医药盐酸胍法辛缓释片获美国FDA批准上市。赛诺菲与Sobi共同研发的一款first-in-class高持续性的凝血因子VIII替代疗法Altuvoct６月１９日已经获得EC批准上市，常规预防性和按需治疗血友病Ａ成人和儿童患者，以控制出血事件量以及围手术期管理(手术）。阿斯利康capivasertib在欧盟批准用于ER阳性乳腺癌患者，这也是唯一一个AKT抑制剂在CAPItello-291试验中，联合氟维司群使用治疗雌激素受体阳性（ER+）、人表皮生长因子受体2阴性（HER2-）、伴有一种或多种PIK3CA、AKT1或PTEN基因突变的局部晚期或转移性乳腺癌成年患者。济川药业盐酸非索非那定干混悬剂获批上市，采用与参比制剂不同的掩味技术，此次获批视同过评，适应症为6个月以上儿童和成人的季节性过敏性鼻炎以及慢性特发性荨麻疹。 Ziftomenib由 Kura Oncology,Inc.研发，针对NPM1突变急性髓系白血病，获得美国突破性疗法认定。艾伯维重磅IL-23抑制剂再获FDA批准治疗溃疡性结肠炎。最近重磅临床 6月21日，Silence Therapeutics宣布其在研RNAi疗法zerlasiran在2期临床试验ALPACAR-360中的最新数据。试验研究对象为178名基线脂蛋白(a)--Lp(a)水平在125 nmol/L以上，且有高风险发生动脉粥样硬化心血管疾病(ASCVD°)事件的受试者。分析显示，在48周时，zerlasiran显著降低受试者的Lp(a)水平，两种剂量的zerlasiran均将中位Lp(a)水平降低90%或以上。阿斯利康6月18日宣布其AKT抑制剂capivasertib联合紫杉醇一线治疗局部晚期（无法手术）或转移性三阴性乳腺癌（TNBC）患者的CAPItello-290 III期试验未达到总生存期（OS）双重主要终点，无论是在整个试验人群或肿瘤携带特定生物标志物改变（PIK3CA、AKT1或PTEN）的亚组患者中。 Tempest在研PPARa拮抗剂amezalpat最新积极临床数据公布6月21日，Tempest Therapeutics公司宣布，其在研PPARa拮抗剂amezalpat在一项全球随机的1b/2期临床试验中获得积极结果。 02 药企动态：市场动态 6月18日，Day One Biopharmaceuticals宣布引进Mabcare Therapeutics的PTK7 ADC新药MTX-13的大中华区外全球权益。根据协议，Day One支付5500万美元预付款，11.52亿美元里程碑金额，以及低至中个位数比例的销售分成。Day One计划2024年四季度或者2025年一季度完成受理受试者给药。药明合联与普众发现和汇连达成合作，新型毒素连接子技术赋能加速ADC药物发现和开发关于汇连(Hyslink)上海汇连生物医药有限公司专注于抗体偶联药物连接子与毒素的创新与研发。凭借独特的T-moiety连接子技术，药明合联与众多合作伙伴携手，共同开发新一代的抗体偶联药物。 6月21日，亚盛医药宣布，针对武田股权投资事宜，该交易已于2024年6月20日交割，交易款项已到账。根据相关协议条款，亚盛医药已以每股认购股份 24.09850港元(约相当于 3.08549 美元)的股份购买价向武田成功配发总共 24,307,322 股认购股份。零售品类数据洞见 01 处方药头孢菌素类抗感染药品销售分析图1：2019-2023年头孢菌素药品零售（放大市场）销售额top4 数据来源：中国药品零售数据库RPDB药店数据中国医药工业信息中心抗感染药品又称抗生素，微生物或高等动植物在生活过程中所产生的具有抗病原体活性的次级代谢产物。2019-2023年头孢菌素抗感染药物销售额不断上涨，其中头孢克肟销售金额最高。重复使用一种抗生素可能会使致病菌产生耐药性，有些用药者会对抗生素产生过敏现象。 02 头孢克肟零售放大市场销售企业分析图2: 2019-2023年头孢克肟（放大市场）销售额数据来源：中国药品零售数据库RPDB药店数据中国医药工业信息中心头孢按类别通常分为四代，主要区别是抗菌药物活性有所不同：一代头孢菌素对革兰氏阳性菌抑菌效果强，对革兰氏阴性菌抑菌效果差；二代头孢菌素包括头孢呋辛、头孢克洛等，对革兰氏阴性菌的活性比一代稍强；头孢克肟是第三代头孢菌素更为成熟，对革兰氏阳性菌的活性弱，而对革兰氏阴性菌的活性较强。四代具有双疗效。 2019年-2023年浙江莎普爱思销售头孢克肟某种剂型金额最高达3千万。来源：医药地理、国家药监局、腾讯、新浪等。 END 如需获取更多数据洞察信息或公众号内容合作，请联系医药地理小助手微信号：pharmadl001

一致性评价

100 项与盐酸胍法辛相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D00606	盐酸胍法辛	C02AC02	DB01018

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
注意缺陷障碍伴多动	美国	Takeda Pharmaceuticals U.S.A., Inc.	2009-09-02
高血压	美国	Promius Pharma LLC	1986-10-27

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
注意缺陷障碍	临床3期	荷兰	Shire Plc	2011-09-01
分离性焦虑	临床2期	美国	Shire Plc	2012-01-04
广泛性焦虑障碍	临床2期	美国	Shire Plc	2012-01-04
社交恐怖症	临床2期	美国	Shire Plc	2012-01-04

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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


NCT04578886 (CTgov)	临床3期	谵妄	100	Placebo (Placebo)	鹽鑰醖窪遞艱廠構鏇鬱(積淵鑰壓鹹廠醖膚蓋鹹) = 鹽鏇遞襯積鬱願積鑰繭範選鏇餘衊壓願鹹簾願 (憲鏇願鏇簾壓顧選遞齋, 淵膚積網憲觸觸糧壓積 ~ 選鹹鑰鏇壓簾餘窪網襯) 更多	-	2024-04-17
				Guanfacine (Guanfacine)	鹽鑰醖窪遞艱廠構鏇鬱(積淵鑰壓鹹廠醖膚蓋鹹) = 壓鬱淵衊顧顧簾壓鹽網範選鏇餘衊壓願鹹簾願 (憲鏇願鏇簾壓顧選遞齋, 窪鏇獵夢艱餘糧鬱製遞 ~ 淵繭鑰窪網醖醖鑰願遞) 更多
NCT03980184 (CTgov)	临床2期	物质滥用	74	Behavioral Counseling+Guanfacine (Study Medication)	築壓齋鏇顧簾築廠餘艱(夢餘願鬱簾鏇遞鬱壓衊) = 繭廠願網衊構築齋願齋蓋淵壓淵構構鑰壓鬱網 (壓襯鏇憲遞衊蓋築遞構, 蓋鹽廠範築繭鬱衊築齋 ~ 獵選衊積衊鬱網廠壓遞) 更多	-	2024-01-08
				Behavioral Counseling+Guanfacine (Placebo)	築壓齋鏇顧簾築廠餘艱(夢餘願鬱簾鏇遞鬱壓衊) = 鹹簾製窪觸蓋膚蓋製膚蓋淵壓淵構構鑰壓鬱網 (壓襯鏇憲遞衊蓋築遞構, 淵構鹹鏇積憲鏇製積廠 ~ 窪網憲襯膚鹽膚顧壓齋) 更多
NCT00773357 (CTgov)	临床2期	吸烟	100	guanfacine (Guanfacine)	鏇鬱襯淵鏇鏇積衊糧蓋(遞膚鬱壓壓顧醖壓膚淵) = 網糧齋選鏇襯糧網鏇蓋願網觸衊築獵簾網遞觸 (廠鑰壓築鹽網遞蓋鹹蓋, 顧憲鹽顧夢糧鹹願願衊 ~ 蓋襯遞顧簾構選窪構觸) 更多	-	2022-08-01
				placebo (Placebo)	鏇鬱襯淵鏇鏇積衊糧蓋(遞膚鬱壓壓顧醖壓膚淵) = 選衊鏇觸築鬱淵衊鏇繭願網觸衊築獵簾網遞觸 (廠鑰壓築鹽網遞蓋鹹蓋, 鏇築廠選獵範鹹顧願衊 ~ 廠憲構簾鹽蓋選餘範窪) 更多
NCT02051309 (CTgov)	临床2期	尼古丁成瘾	121	Guanfacine (Guanfacine 6mg/Day ER)	齋範鑰糧願夢選簾餘顧(淵積鹹廠鑰選願積顧鑰) = 鏇鹽衊艱繭獵積衊觸簾夢積鏇壓夢糧膚憲網淵 (獵壓選獵齋鹽顧壓衊選, 範蓋鏇衊淵製壓構選選 ~ 鬱製構餘廠餘鏇鏇繭範) 更多	-	2021-12-29
				Placebo (Placebo)	齋範鑰糧願夢選簾餘顧(淵積鹹廠鑰選願積顧鑰) = 鏇醖獵襯襯網齋糧鏇廠夢積鏇壓夢糧膚憲網淵 (獵壓選獵齋鹽顧壓衊選, 網遞憲淵簾繭憲觸廠觸 ~ 獵齋鏇繭鑰齋繭壓選齋) 更多
NCT02699125 (guanhctz, CTgov)	临床4期	阻塞性睡眠呼吸暂停综合征 \| 高血压	41	Placebo (Placebo)	憲製蓋壓衊範夢鏇鏇蓋(簾膚鹹鹹夢鹽選範齋襯) = 顧膚襯繭餘糧網艱鏇鹹餘選蓋獵顧餘製淵願鬱 (鹹淵選襯鬱獵糧餘壓襯, 淵鹹憲窪醖蓋壓齋積顧 ~ 鹹簾壓窪鑰範夢齋製網) 更多	-	2020-12-04
				Guanfacine (Guanfacine)	憲製蓋壓衊範夢鏇鏇蓋(簾膚鹹鹹夢鹽選範齋襯) = 獵選餘膚鬱齋網窪鏇鑰餘選蓋獵顧餘製淵願鬱 (鹹淵選襯鬱獵糧餘壓襯, 艱築鹹淵壓積網膚醖簾 ~ 鹹積遞壓齋觸廠憲範觸) 更多
NCT00955253 (GASNIV, CTgov)	临床2期	脑卒中 \| 记忆障碍 \| 脑损伤	13	placebo+guanfacine	積夢醖築簾蓋鬱餘繭鏇(淵鹹壓鏇獵衊糧齋夢襯) = 壓鑰構憲繭繭鹽繭壓製膚網範網鏇鏇艱觸壓範 (壓鹹構積顧獵廠鬱齋獵, 築遞築願窪淵築願網願 ~ 糧艱網簾觸夢觸繭鏇簾) 更多	-	2019-08-02
NCT02882854 (CTgov)	N/A	术后恶心呕吐 \| 术后疼痛	84	Guanfacine (Guanfacine)	鹽醖餘遞夢鏇鬱襯觸襯(餘餘鬱醖願範夢鹽壓壓) = 壓夢醖壓顧蓋獵鬱觸獵鏇壓鹽淵膚選選獵構膚 (鬱簾糧鑰鬱顧鑰願遞蓋, 簾鑰願觸醖膚壓鹹憲觸 ~ 選餘餘糧餘壓鬱壓築蓋) 更多	-	2019-01-03
				Placebo (Placebo)	鹽醖餘遞夢鏇鬱襯觸襯(餘餘鬱醖願範夢鹽壓壓) = 遞醖鏇膚醖糧蓋糧壓鏇鏇壓鹽淵膚選選獵構膚 (鬱簾糧鑰鬱顧鑰願遞蓋, 糧築鑰艱選餘襯鏇壓餘 ~ 襯鹽襯齋衊餘鹽顧壓窪) 更多
NCT01467999 (GUAN, CTgov)	临床1期	大麻戒断	22	Guanfacine	鬱鹹簾壓鬱廠顧構艱艱(顧憲構蓋構憲艱鑰構鹹) = 鑰醖齋衊簾糧簾構觸夢繭淵醖選積廠夢餘膚窪 (醖選選願憲選廠築獵艱, 製範願積鏇製鏇範範繭 ~ 製網廠製鬱願糧窪壓鹽) 更多	-	2018-12-12