The goal of this clinical trial is to test if bexagliflozin lowers the sleep apnea severity in adults who are overweight or obese with moderate to severe obstructive sleep apnea (OSA) compared with a placebo (look-alike substance that contains no active drug).
The main question it aims to answer is:
* If SGLT2i will reduce anatomic and physiologic traits, clinical measures of OSA and sleep deficiency in participants
* If improvement in clinical measures are because of improvement in the anatomic and physiologic traits.
Participants will be placed on either drug or placebo and get routine normal care for 6 months. At the start and end of the study, participants will undergo different clinical measurements to see if the drug makes the sleep apnea better.

开始日期2024-03-27

申办/合作机构

Yale University

[+1]

NCT05369078

/ Unknown status临床1期

Phase I Clinical Study to Evaluate the Safety, Tolerance and Pharmacokinetics of THR-1442 in Chinese Healthy Subjects

The purpose of this study was to investigate Safety, tolerability and pharmacokinetics in Chinese healthy subjects.

开始日期2021-12-01

申办/合作机构

恒翼生物医药（上海）股份有限公司

CTR20212958

/ Completed临床1期

评价THR-1442在中国健康受试者中安全性、耐受性、药代动力学特征的开放、单次和多次给药的I期临床研究

主要目的评价THR-1442在健康受试者中的安全性和耐受性；次要目的建立THR-1442健康受试者中的药代动力学特征；根据THR-1442在美国人群和日本人群的健康受试者药代动力学数据，进行间接比较在中国人群的药代动力学特征。

开始日期2021-11-30

申办/合作机构

恒翼生物医药（上海）股份有限公司

[+2]

100 项与 Bexagliflozin 相关的临床结果

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100 项与 Bexagliflozin 相关的转化医学

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100 项与 Bexagliflozin 相关的专利（医药）

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项与 Bexagliflozin 相关的文献（医药）

2025-04-17·Cureus Journal of Medical Science

Bexagliflozin on Renal Outcomes in Type 2 Diabetes Mellitus: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

Review

作者: Min, Matthew ; Gobbo, Marília ; Milbradt, Tanize L ; Poli-de-Figueiredo, Carlos E ; Reinheimer, Isabel Cristina ; Ura Sudo, Renan Y

Sodium-glucose cotransporter-2 (SGLT2) inhibitors are important for treating type 2 diabetes mellitus (T2DM). However, it remains unclear whether the newest SGLT2 inhibitor, bexagliflozin, provides benefits for renal- or urinary-related outcomes. The ClinicalTrials.gov, PubMed, Embase, and Cochrane databases were searched for randomized controlled trials. Using R software version 4.3.1 (R Foundation for Statistical Computing, Vienna, Austria), a random-effects model was employed to compute mean differences (MD) and risk ratios for continuous and binary endpoints. The Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) approach was used to rate the certainty of evidence. The International Prospective Register of Systematic Reviews (PROSPERO) identification number is CRD42023478336. Nine studies involving 4,352 patients were included. Over a follow-up that ranged from 12 to 96 weeks, patients taking bexagliflozin showed no changes in serum creatinine levels (MD: 0.05 mg/dL; 95% CI: -0.06 to 0.15; p = 0.35) or estimated glomerular filtration rate (MD: -0.43 mL/min/1.73 m^²; 95% CI: -6.92 to 6.06; p = 0.89). However, there was a significant reduction in systolic blood pressure in the treatment group (MD: -4.2 mmHg; 95% CI: -5.6 to -2.8; p < 0.01). In large placebo-controlled trials, we observed no beneficial effect of bexagliflozin on kidney function, as described with other SGLT2 inhibitors.

2025-01-01·JOURNAL OF VETERINARY PHARMACOLOGY AND THERAPEUTICS

SGLT2 inhibitor use in the management of feline diabetes mellitus

Review

作者: Cook, Audrey K. ; Behrend, Ellen

Abstract:

Sodium‐glucose cotransporter‐2 (SGLT2) inhibitors are routinely used in the management of human type 2 diabetes and have been shown to effectively mitigate hyperglycemia and reduce the risks of cardiovascular and renal compromise. Two SGLT2 inhibitors, namely bexagliflozin and velagliflozin, were recently FDA approved for the treatment of uncomplicated feline diabetes mellitus. These oral hypoglycemic agents are a suitable option for many newly diagnosed cats, with rapid improvements in glycemic control and clinical signs. Suitable candidates must have some residual β‐cell function, as some endogenous insulin production is required to prevent ketosis. Appropriate patient selection and monitoring are necessary, and practitioners should be aware of serious complications such as euglycemic diabetic ketoacidosis.

2024-12-01·REPRODUCTIVE TOXICOLOGY

Male premating treatment in FEED studies: Length is not everything

Review

作者: Barrow, Paul

The ICH S5(R3) guideline recommends that male rodents in a FEED study are treated for ≥2 weeks before mating, which has frequently been criticized as being too short for the detection of all effects on sperm maturation, mating behavior and male fertility. In a FEED study, males generally continue for ≥5 weeks after the start of cohabitation. This review determines how often a 2-week premating treatment period for males was used in FEED studies of novel drugs approved by the FDA in 2022 and 2023. The male premating treatment duration was specified for 44 drugs. Only 16 % of these had a 2-week male premating treatment period. 52 % of drugs had a 4-week period. No examples were found in the literature of drugs for which male-mediated reproductive toxicity could have been detected using a 4-week, but not a 2-week, premating treatment period. Repeat dose studies in 2 species, with a duration of treatment at least equivalent to that in patients, are generally completed before the FEED study is planned. Providing no effects on male reproductive organs are detected in the repeat dose studies, a 2-week premating treatment period appears sufficient for the detection of effects on male mating performance. If toxic effects on spermatogenesis are detected in the repeat dose studies, a male FEED study serves little regulatory purpose. Even in the absence of effects on mating performance and fertility in the FEED study, a drug-related disruption of spermatogenesis would likely be considered pertinent to the human.

项与 Bexagliflozin 相关的新闻（医药）

2025-03-20

·蒲公英Ouryao

FDA审评：Bexagliflozin片上市后承诺

NDA序号 214373 申请人 Theracos Sub LLC 药物名 Brenzavvy (bexagliflozin) 片剂型片剂规格 20mg 给药途径口服 Rx/OTC分类 Rx 适应症成人2型糖尿病控制制剂性状蓝色、胶囊形、双凸、斜边、薄膜包衣片，一侧印有有“2”和倒置的“2”，另一侧没有印字。片剂包装在30ct或90ct高密度聚乙烯（HDPE）瓶中，带有（b）（4）封口（b）（4）。存储条件在20°C至25 °C下储存，允许在15°C至30°C之间短暂储存。上市后承诺1：对未来25批（至少）商业规模的Bexagliflozin片，规格20毫克，进行额外测试XX，并在完成暂定于2022年Q3至2024年Q2的每次生产活动后，在年度报告中向FDA提供数据。上市后承诺2：对未来至少在25个商业化批次，以适当的间隔执行全面的分层控制策略XX，并在完成暂定于2022年Q3至2024年Q2的每次生产活动后，在年度报告中向FDA提供数据。 Brenzavvy（Bexagliflozin）片剂，20毫克，每天口服一次。Bexagliflozin是一种新的化学实体。Bexagliflozin的化学名称是（2S,3R,4R,5S,6R)-2-（4-氯-3-（4-（2-环丙氧基）苄基）苯基）-6-（羟甲基）四氢-2H-吡喃-3,4,5-三醇。 Brenzavvy片是蓝色薄膜包衣片，一面印有“2”和倒置的“2”，另一面没有标记。片剂含有20毫克的Bexagliflozin以及胶态二氧化硅、二苯甲酸甘油酯、一水合乳糖、硬脂酸镁、微晶纤维素、聚乙烯氧化物和波洛沙聚糖188。薄膜包衣层含有FD&C Blue #1/Brilliant Blue FCF铝湖、FD&C Blue #2/Indigo carmine铝、macrogol 3350、聚乙烯醇、滑石粉和二氧化钛。Brenzavvy片装在30ct或90ct HDPE瓶中。包衣片由XX生产，最初生产过程控制策略缺少XX。根据FDA建议，申请人同意实施测试分层控制策略XX，并在完成暂定于2022年Q3至2024年Q2的每次生产活动后，在年度报告中向FDA提供数据。尽管该药物含有的辅料有助于在体外溶出条件下8小时内释放药物，但拟定剂型不被视为缓释片。制剂溶出接受标准申请人仅使用临床批次来确定溶出标准，验证批次信息仅供参考（附件2）。临床批次的溶出测试，根据两个接收标准的任一标准进行：5点（1、3、5、8和10小时）或3点（1、5和8小时）收集溶出曲线。临床批次B17217和B17218是根据3点（1、5和8小时）标准放行，而B09706、B10904、B11421、B13445和B13446是根据5点标准放行。验证批次B22329、B22331和B23014以4点标准（1、3、5和8小时）放行。如表6所示，申请人提供了所有测试数据，表7显示了仅临床批次的数据摘要，表8显示了过程验证批次的数据摘要。所有数据之间没有显著差异。来自4批临床批次片剂，20mg规格，包装于60ml HDPE瓶中，90片/瓶（4批次B09706, B10904, B11421, B13446），放置于稳定性箱中25 °C/60% RH, 30 °C/75% RH and 40 °C/75% RH条件下，申请人没有观察到稳定性样品的溶出变化。申请人使用表9数据，来设定溶出标准（见表10）。 FDA评估：虽然拟定制剂为速释片，但申请人提出了长期体外药物释放的多点接受标准。根据临床批次的溶出数据，拟定溶解接受标准是可以接受的。处方桥接：使用拟定20毫克片剂，（表11）进行了七项3期临床试验和6项临床药理学研究。片剂20毫克的临床处方与拟定产业化制剂相同，临床片剂的生产工艺与商业化产品的生产过程基本相同。生产工艺有轻微变化，例如XX。两者都被认为是不影响产品质量的轻微变化。因此，不需要桥接。解读：制剂控制策略稍有不足，但没有被延迟批准。FDA提出了两个要求，为上市后承诺。从两个承诺中看出，该制剂在商业化期间需要额外进行分析数据的收集，直至25批商业化产品后，再来判断是否可以不再进行控制。虽制剂中辅料可以延迟片剂的释放，但FDA仍认为制剂为速释制剂，非缓释制剂。这一点意见非常重要，缓释和速释对于后续溶出方法的开发与标准设定要求不完全相同。 Bexagliflozin制剂溶出缓慢，最终需要8个小时才能完全溶出，但FDA没有同意该制剂为缓释，仍认定为速释制剂。申请人拟定了4个不同时间点的接受标准，使用临床批次的数据支持溶出标准的制定，FDA同意。同时收集关键批次在稳定性条件下的溶出曲线数据，没有观察到溶出显著变化。处方工艺的微小变化，可以不进行额外的桥接，只需要溶出曲线对比即可。作者精彩原创集锦 1、创新药研发中原料药工艺与沟通交流常见难点 2、创新药研发中「制剂工」常见难点 3、创新药研发中「变更」相关难点 4、创新药研发中「质量分析控制」相关难点（1） 5、创新药研发中「质量分析控制」相关难点（2） 6、创新药研发难点分析与CMC研究策略探讨 7、《已上市化学药品药学变更研究技术指导原则（试行）原料药变更的问答》浅析 8、FDA：原料药中亚硝胺风险评估的最新观点 9、亚硝胺「传奇」：5年来监管和制药界的反思 10、【学习笔记】2023年度CDE审评报告 11、FDA审评：吡托布鲁替尼的药学变更桥接(完) 12、CDE：ICH指南在国内的实施概况 13、「解读」FDA审评：repotrectinib胶囊5次CMC会议内容 14、FDA：IND阶段CMC关注点 15、药品注册检验难点与建议 16、最新 FDA 人用药物亚硝胺杂质指南更新的「底层」参考 17、不同国家地区注册检验差异对比曾文亮博士近20年药物研发经验，擅长新药研发与注册申报，近5年积累了近十个小分子新药中美IND申报成功和两个1类抗肿瘤新药上市申报成功经验。先后任职于某大型CRO医药研发公司、USP大中华区研发中心和港资原料药厂等，主导过MNC质量研究项目、USP各论更新和药厂QC实验室通过国家GMP检查和WHO审计。受中国医药保健品进出口商会邀请在二十二届世界制药原料药中国展（CPHI）主导策划了“小分子创新药质量研究和注册策略”沙龙并发表主题演讲；同时受专业药学论坛邀请发表了《创新药质量研究要点和案例分析》、《中美新药申报沟通交流常见问题和案例分析》、《亚硝胺杂质的FDA和EMA控制策略》、《分析方法开发，验证和转移的统计学评价》和《FDA483中清洁验证的典型案例分析》等十余次主题演讲。更多精彩内容可关注： ▲ 关注文亮频道，探索未知世界

申请上市

2025-03-07

·蒲公英Ouryao

FDA审评：Bexagliflozin片溶出方法开发

NDA序号 214373 申请人 Theracos Sub LLC 药物名 Brenzavvy (bexagliflozin) 片剂型片剂规格 20mg 给药途径口服 Rx/OTC分类 Rx 适应症成人2型糖尿病控制制剂性状蓝色、胶囊形、双凸、斜边、薄膜包衣片，一侧印有有“2”和倒置的“2”，另一侧没有印字。片剂包装在30ct或90ct高密度聚乙烯（HDPE）瓶中，带有（b）（4）封口（b）（4）。存储条件在20°C至25 °C下储存，允许在15°C至30°C之间短暂储存。生物药剂学 Theracos Sub, LLC申请拟定的Bexagliflozin片，20毫克。为蓝色薄膜涂层速释片，在拟定的溶出方法中具有延长的体外药物释放特征。FDA重点审评了拟定的质量控制溶出方法和标准的可接受性。溶解方法和验收标准：根据所提供的信息，拟定溶出方法和溶解验收标准是可以接受。 BCS定义溶解度申请人确定了原料药Bexagliflozin在KCl/HCl缓冲液（pH 1.0）、NaOAc/HOAc缓冲液（pH 4.5）和NaOH/KH2PO4缓冲液（pH 7.6）中的饱和浓度。没有观察到溶解度随pH变化而显著变化。溶解度的平均值在37°C下16小时后为0.44、0.46和0.46mg/ml，在37°C条件下，24小时后为0.45、0.51和0.43mg/ml，pH值分别为1.0、4.5和7.6。拟定的商业化规格为20毫克，在上述任何缓冲液中很容易溶解在250ml中，因此申请人认为，根据BCS标准，Bexagliflozin原料药是一种高溶解性化合物。 FDA同意申请人对原料药的溶解度定性，其渗透性为低至中。制剂溶出方法区分力申请人使用拟定的溶出方法评估了Bexagliflozin片的溶出速率：20毫克规格含不同比例和等级的辅料。增加片剂重量申请人进行了一系列实验，以确定增加片剂总重量对溶出曲线的影响。片剂总重量的变化涉及添加影响片剂释放的辅料。具体见下表：申请人观察到，片剂重量增加，溶出会变慢，如下图。 SUPAC级别的辅料变化申请人进行了一系列研究，以确定SUPAC I级和II级变化对处方的影响（表4）。申请人观察到了辅料的比例变化，会影响到Bexagliflozin片的溶出速率，如下图。申请人对拟定商业化处方中的辅料数量变化进行了额外的确认性研究。处方中心点（表5中3、4和11代表商业化处方。其他（1、2、5、6、7、8、9和10）使用表5第一行所示的可变辅料用量。如表5和图5所示：申请人观察到XX辅料数量变化，与中心点处方对比，没有显著影响溶出曲线。同样，XX辅料数量的一致增加或减少（6和9），对中心点处方对比，没有显著影响溶出曲线。然而，XX辅料量的变化显著影响溶出速率（2、5、7和8）。溶出方法可以用于区分这些辅料比例变化得到的制剂。辅料PSD变化申请人使用不同PSD大小的辅料制备得到的制剂溶出如下，发现使用大PSD的辅料得到的制剂溶出速率更快。申请人同时使用不同级别辅料生产的制剂，溶出曲线结果表明，不同级别辅料得到的制剂溶出没有明显区别。原料药粒度大小变化申请人使用不同PSD原料药批次制备得到的制剂，发现溶出速率的系统性变化很小。 FDA评估：申请人充分证明了拟定溶出方法对商业化Bexagliflozin片的批次释放和稳定性测试的适用性。拟定溶出方法显示了对制剂中辅料比例和不同粒度辅料变化的区分能力。拟定溶出方法（900毫升0.1 N HCl，USP方法I，50转/分）可以满足用于商业化制剂的质量控制。解读：虽原料药在不同pH值溶液中的溶解度不高，但基于商业化规格20mg，在250ml的缓冲液中很易溶解，因此原料药被定义为高溶化合物。 Bexagliflozin制剂溶出方法开发，考察了不同辅料比例的制剂，不同粒度辅料的制剂，拟定溶出方法具有一定区分能力。对于不同级别辅料，不同粒度原料药的制剂，拟定溶出方法不具有区分力。FDA认可了申请人拟定的溶出方法。作者精彩原创集锦 1、创新药研发中原料药工艺与沟通交流常见难点 2、创新药研发中「制剂工」常见难点 3、创新药研发中「变更」相关难点 4、创新药研发中「质量分析控制」相关难点（1） 5、创新药研发中「质量分析控制」相关难点（2） 6、创新药研发难点分析与CMC研究策略探讨 7、《已上市化学药品药学变更研究技术指导原则（试行）原料药变更的问答》浅析 8、FDA：原料药中亚硝胺风险评估的最新观点 9、亚硝胺「传奇」：5年来监管和制药界的反思 10、【学习笔记】2023年度CDE审评报告 11、FDA审评：吡托布鲁替尼的药学变更桥接(完) 12、CDE：ICH指南在国内的实施概况 13、「解读」FDA审评：repotrectinib胶囊5次CMC会议内容 14、FDA：IND阶段CMC关注点 15、药品注册检验难点与建议 16、最新 FDA 人用药物亚硝胺杂质指南更新的「底层」参考 17、不同国家地区注册检验差异对比曾文亮博士近20年药物研发经验，擅长新药研发与注册申报，近5年积累了近十个小分子新药中美IND申报成功和两个1类抗肿瘤新药上市申报成功经验。先后任职于某大型CRO医药研发公司、USP大中华区研发中心和港资原料药厂等，主导过MNC质量研究项目、USP各论更新和药厂QC实验室通过国家GMP检查和WHO审计。受中国医药保健品进出口商会邀请在二十二届世界制药原料药中国展（CPHI）主导策划了“小分子创新药质量研究和注册策略”沙龙并发表主题演讲；同时受专业药学论坛邀请发表了《创新药质量研究要点和案例分析》、《中美新药申报沟通交流常见问题和案例分析》、《亚硝胺杂质的FDA和EMA控制策略》、《分析方法开发，验证和转移的统计学评价》和《FDA483中清洁验证的典型案例分析》等十余次主题演讲。更多精彩内容可关注： ▲ 关注文亮频道，探索未知世界

申请上市

2024-12-12

·Business Wire

A Study in the New Issue of JAMA Network Open Reveals Income-Related Disparities in Type 2 Diabetes Outcomes Despite Equivalent Access to Healthcare

MARLBOROUGH, Mass.--( BUSINESS WIRE )--A new study published in JAMA Network Open titled “ Income-Related Disparities in Mortality Among Young Adults With Type 2 Diabetes ” underscores the need for addressing disparities in care and improving access to important therapies for type 2 diabetes. This study further underscores recent data compiled by the American Diabetes Association which states that diabetes is the most expensive chronic condition in the United States, and millions of Americans struggle to afford effective treatment of their type 2 diabetes and associated complications. Seeking to address this critical health issue, BRENZAVVY ® (bexagliflozin) is a safe, effective and affordable option for adults with type 2 diabetes. In the United States, BRENZAVVY is sold at around $50 per month through a network of online and independent pharmacies. BRENZAVVY's low price point makes sodium-glucose cotransporter 2 (SGLT2) inhibitor therapy a more affordable option for uninsured, underinsured, and Medicare patients. This increased affordability can help ensure that patients can initiate and maintain a safe and effective therapy, improving their ability to manage their type 2 diabetes. Adults with type 2 diabetes can easily determine if BRENZAVVY is right for them by visiting www.brenzavvydirect.com and speaking to a doctor quickly and affordably. For healthcare providers, BRENZAVVY can easily be prescribed without insurance plan headaches, such as prior authorizations or step therapy hurdles, that the SGLT2 inhibitor class traditionally faces. “ The findings of this study reinforce that many adults living with type 2 diabetes simply cannot afford to start and stay on their therapy ,” said the TheracosBio CEO, Brian Connelly. “ With BRENZAVVY, TheracosBio is fulfilling our mission to address financial barriers to care. By unlocking wider access to an important class of therapy, more and more people with type 2 diabetes have better access to a safe, affordable and effective treatment option,” Mr. Connelly added. BRENZAVVY is available as 20 mg oral tablets to be taken once daily, in the morning, with or without food. Phase 3 clinical studies have shown BRENZAVVY significantly reduces hemoglobin A1c and fasting blood sugar after 24 weeks, either as a monotherapy, in combination with metformin, or as an add-on to standard-of-care treatment consisting of a variety of regimens, including metformin, sulfonylureas, insulin, DPP4 inhibitors or combinations of these agents. Although BRENZAVVY is not approved for weight loss or blood pressure reduction, modest decreases in both weight and blood pressure have been observed in the clinical program. To learn more about BRENZAVVY , please visit https://www.brenzavvy.com . To learn more about TheracosBio, please visit https://theracosbio.com . BRENZAVVY Important Safety Information BRENZAVVY ® (bexagliflozin) is a prescription medicine used along with diet and exercise to improve blood sugar in adults with type 2 diabetes. BRENZAVVY is not recommended to decrease blood sugar in people with type 1 diabetes. Do not take BRENZAVVY if you are allergic to bexagliflozin or any of the ingredients in BRENZAVVY. BRENZAVVY can cause serious side effects including diabetic ketoacidosis that may be fatal. Signs and symptoms of ketoacidosis include nausea, vomiting, stomach pains, tiredness, trouble breathing, and ketones in urine or blood. Ketoacidosis can happen even if your blood sugar is less than 250 mg/dL. BRENZAVVY may increase the risk of lower limb amputations. Call your doctor if you notice signs or symptoms. Amputations mainly involve removal of the toe or part of the foot, however, amputations involving the leg, below and above the knee, have also occurred. Some people had more than one amputation. BRENZAVVY may cause dehydration, urinary tract or genital yeast infections, and low blood sugar. Symptoms of dehydration include feeling dizzy, faint, lightheaded, or weak upon standing. Yeast infections can occur in women and men. Signs of low blood sugar may include headache, confusion, drowsiness, dizziness, sweating, irritability, hunger, shaking, fast heartbeat, or weakness. A rare life-threatening bacterial infection in the skin of the perineum could occur. Stop taking BRENZAVVY and call your doctor right away if you have symptoms of this infection The perineum is the area between the anus and genitals. Symptoms of this infection include fever, weakness and pain tenderness, redness, or swelling of the genital area. The most common side effects of BRENZAVVY are vaginal yeast infections, urinary tract infections, and changes in urination, including an urgent need to urinate more often, in large amounts, and at night. For additional important safety information about BRENZAVVY, visit www.brenzavvy.com . About TheracosBio TheracosBio was founded in 2000 and develops affordably priced novel therapeutics for diseases with significant societal impact. The mission of TheracosBio is to expand access to new medications for patients with common diseases. COM-23118-01

临床3期上市批准

100 项与 Bexagliflozin 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D10865	-	-	DB12236

研发状态

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适应症	国家/地区	公司	日期
2型糖尿病	美国	Theracos, Inc.	2023-01-20

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适应症	最高研发状态	国家/地区	公司	日期
原发性高血压	临床3期	美国	Theracos, Inc.	2017-10-18

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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


NCT03259789 (Biospace) 人工标引	临床3期	2型糖尿病	317	Brenzavvy+Metformin	鏇壓淵醖蓋遞簾選鑰願(襯憲鏇顧憲鏇鹽衊壓壓) = 製製鹹範製憲鏇窪遞醖願積遞齋廠積壓襯憲齋 (憲積獵網鏇鬱夢蓋選蓋 ) 更多	积极	2023-08-04
				placebo+Metformin	鏇壓淵醖蓋遞簾選鑰願(襯憲鏇顧憲鏇鹽衊壓壓) = 鑰醖繭網憲餘獵網蓋醖願積遞齋廠積壓襯憲齋 (憲積獵網鏇鬱夢蓋選蓋 ) 更多
NCT02558296 (FDA) 人工标引	临床3期	2型糖尿病	1,701	Placebo	鑰艱積鏇壓簾鑰夢繭壓(願鏇窪簾憲艱衊窪窪鏇) = 餘鑰遞淵顧網衊繭艱製夢願壓網餘繭憲遞獵蓋 (醖廠築糧餘壓襯衊膚壓, 0.04) 更多	积极	2023-01-20
				BRENZAVVY	鑰艱積鏇壓簾鑰夢繭壓(願鏇窪簾憲艱衊窪窪鏇) = 遞膚鹹鏇淵構艱繭壓憲夢願壓網餘繭憲遞獵蓋 (醖廠築糧餘壓襯衊膚壓, 0.03) 更多
NCT03259789 (FDA) 人工标引	临床3期	糖尿病	317	BRENZAVVY+ Metformin	獵齋夢醖憲觸鹽蓋觸糧(鑰積艱醖餘齋繭齋壓積) = 鹹醖網淵膚衊艱壓鏇膚廠積積遞鏇憲膚窪餘獵 (簾齋鑰觸艱觸衊蓋廠夢, 0.1) 更多	积极	2023-01-20
				Placebo+ Metformin	獵齋夢醖憲觸鹽蓋觸糧(鑰積艱醖餘齋繭齋壓積) = 壓淵繭衊觸範窪鏇選構廠積積遞鏇憲膚窪餘獵 (簾齋鑰觸艱觸衊蓋廠夢, 0.1) 更多
NCT02769481 (FDA) 人工标引	临床3期	2型糖尿病	426	BRENZAVVY+Metformin	壓選築糧鹽壓壓網築鹽(簾築壓遞齋築鏇構廠衊) = 鑰鏇膚鏇齋鏇積膚醖鏇製鹹鏇顧廠繭艱艱遞衊 (壓憲範鑰選餘鏇鬱襯積, 0.1) 更多	积极	2023-01-20
				Glimepiride+Metformin	壓選築糧鹽壓壓網築鹽(簾築壓遞齋築鏇構廠衊) = 醖鹹獵夢鑰鑰憲鑰鑰鏇製鹹鏇顧廠繭艱艱遞衊 (壓憲範鑰選餘鏇鬱襯積, 0.1) 更多
NCT02836873 (FDA) 人工标引	临床3期	2型糖尿病	312	Placebo	積鹹壓積鬱衊憲鹽製獵(遞鏇齋蓋膚廠膚遞窪鏇) = 壓繭夢製膚鹹簾顧觸膚遞餘襯蓋淵簾鏇壓膚遞 (糧餘鬱壓鹽鹹願繭築築, 0.1) 更多	积极	2023-01-20
				BRENZAVVY	積鹹壓積鬱衊憲鹽製獵(遞鏇齋蓋膚廠膚遞窪鏇) = 艱鬱築壓鑰艱餘範製繭遞餘襯蓋淵簾鏇壓膚遞 (糧餘鬱壓鹽鹹願繭築築, 0.1) 更多
NCT03115112 (FDA) 人工标引	临床3期	2型糖尿病	384	BRENZAVVY+Metformin	築廠顧顧鑰顧簾製鏇製(選製鏇範積築襯糧繭齋) = 壓齋簾壓觸餘廠製壓餘鬱鏇選獵窪淵膚觸鏇獵 (壓簾製窪遞選醖襯憲醖, 0.1) 更多	积极	2023-01-20
				Sitagliptin+Metformin	築廠顧顧鑰顧簾製鏇製(選製鏇範積築襯糧繭齋) = 淵壓築衊構網顧艱積鏇鬱鏇選獵窪淵膚觸鏇獵 (壓簾製窪遞選醖襯憲醖, 0.1) 更多
NCT02715258 (FDA) 人工标引	临床3期	2型糖尿病	207	BRENZAVVY 20 mg	醖觸壓網顧鬱廠糧醖鬱(衊鹹糧壓簾襯鏇鏇選選) = 膚夢鬱壓鹹製糧選鏇遞鬱壓膚鏇醖鹽廠築範鹹 (淵壓願憲鏇蓋簾壓糧鹽, 0.1) 更多	积极	2023-01-20
				Placebo	醖觸壓網顧鬱廠糧醖鬱(衊鹹糧壓簾襯鏇鏇選選) = 壓廠觸糧糧簾醖獵衊網鬱壓膚鏇醖鹽廠築範鹹 (淵壓願憲鏇蓋簾壓糧鹽, 0.1) 更多
NCT03514641 (CTgov)	临床2/3期	原发性高血压	673	Bexagliflozin (Bexagliflozin Tablets, 20 mg)	顧鹽顧繭鑰願鏇窪簾衊(醖繭膚網觸簾獵選壓鑰) = 糧膚觸鹹蓋醖醖淵廠艱醖鹽顧糧齋繭築構鑰簾 (製夢憲鬱鬱膚壓蓋繭製, 0.642) 更多	-	2021-09-21
				Placebo (Placebo Tablets)	顧鹽顧繭鑰願鏇窪簾衊(醖繭膚網觸簾獵選壓鑰) = 夢築構鬱憲遞膚襯鹽壓醖鹽顧糧齋繭築構鑰簾 (製夢憲鬱鬱膚壓蓋繭製, 0.622) 更多
NCT02956044 (CTgov)	临床1期	2型糖尿病	54	Bexagliflozin (Group 1: Bexagliflozin Alone)	築顧鏇範淵鹹醖鏇醖齋(蓋鏇醖憲憲築選壓齋積) = 醖鏇蓋膚顧繭願製夢鑰壓構繭觸觸簾餘衊餘蓋 (艱淵醖選衊壓鏇襯網遞, 43.7) 更多	-	2021-07-22
				Metformin (Group 1: Metformin Alone)	壓製顧範淵鹽鹹憲糧簾(網鑰願遞壓夢鏇網廠蓋) = 顧範廠壓憲醖鏇膚蓋築艱鹹鹹鏇製繭廠選齋獵 (鑰齋憲獵鏇範願憲獵積, 27.2) 更多
NCT03197324 (CTgov)	临床1期	2型糖尿病	20	Digoxin (Digoxin Alone)	糧願壓觸壓醖範廠顧願(憲鏇觸繭遞鏇範網醖淵) = 鹹壓醖製糧繭淵獵鹽壓艱鹹獵齋製蓋鬱繭蓋顧 (鏇襯選醖鏇衊醖餘艱網, 28.8) 更多	-	2021-07-16
				Digoxin+Bexagliflozin (Digoxin With Bexagliflozin)	糧願壓觸壓醖範廠顧願(憲鏇觸繭遞鏇範網醖淵) = 範餘襯窪淵憲憲顧鹹鬱艱鹹獵齋製蓋鬱繭蓋顧 (鏇襯選醖鏇衊醖餘艱網, 40.9) 更多