A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Clinical Trial and Open-Label Extension Study to Evaluate the Efficacy and Safety of Add-On Therapy With Empagliflozin for Patients With Inadequately Controlled Type 2 DiabetesMellitus in the Combination Treatment With Metformin and Alogliptin

Phase 3 study to assess the Efficacy and Safety of CT-L02-301 in Type 2 Diabetes Patients with Insufficient Glycemic Control with Metformin and Alogliptin Combination Therapy.

开始日期2025-07-18

申办/合作机构

Celltrion, Inc.

CTR20250730

/ CompletedN/A

苯甲酸阿格列汀片（25mg）在中国健康受试者中空腹给药条件下随机、开放、单剂量、两序列、两周期、双交叉生物等效性试验

主要研究目的：按有关生物等效性试验的规定，选择Takeda Pharmaceutical Company Limited为持证商的苯甲酸阿格列汀片（商品名：尼欣那，规格：25mg）为参比制剂，对石家庄四药有限公司生产并提供的受试制剂苯甲酸阿格列汀片（规格：25mg）进行空腹给药人体生物等效性试验，比较受试制剂中药物的吸收速度和吸收程度与参比制剂的差异是否在可接受的范围内，评价两种制剂在空腹给药条件下的生物等效性。次要研究目的：观察健康受试者口服受试制剂苯甲酸阿格列汀片（规格：25mg）和参比制剂苯甲酸阿格列汀片（商品名：尼欣那，规格：25mg）的安全性。

开始日期2025-03-24

申办/合作机构

石家庄四药有限公司

CTR20250729

/ CompletedN/A

苯甲酸阿格列汀片（25mg）在中国健康受试者中餐后给药条件下随机、开放、单剂量、两序列、两周期、双交叉生物等效性试验

主要研究目的：按有关生物等效性试验的规定，选择Takeda Pharmaceutical Company Limited为持证商的苯甲酸阿格列汀片（商品名：尼欣那，规格：25mg）为参比制剂，对石家庄四药有限公司生产并提供的受试制剂苯甲酸阿格列汀片（规格：25mg）进行餐后给药人体生物等效性试验，比较受试制剂中药物的吸收速度和吸收程度与参比制剂的差异是否在可接受的范围内，评价两种制剂在餐后给药条件下的生物等效性。次要研究目的：观察健康受试者口服受试制剂苯甲酸阿格列汀片（规格：25mg）和参比制剂苯甲酸阿格列汀片（商品名：尼欣那，规格：25mg）的安全性。

开始日期2025-03-23

申办/合作机构

石家庄四药有限公司

100 项与苯甲酸阿格列汀相关的临床结果

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100 项与苯甲酸阿格列汀相关的转化医学

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100 项与苯甲酸阿格列汀相关的专利（医药）

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865

项与苯甲酸阿格列汀相关的文献（医药）

2025-12-01·American journal of medicine open

The Association of SGLT2i vs DPP4i on Fracture: A Cohort Study in Veterans with Diabetes

Article

作者: Hackstadt, Amber ; Griffin, Katherine ; Javid, Amir ; Hung, Adriana ; Roumie, Christianne L ; Snyder, Kathryn ; Greevy, Robert

Background:

Increased bone turnover is associated with use of SGLT2i. Patients with diabetes experience adverse effects on bone metabolism. Our aim was to evaluate if SGLT2i was associated with fractures vs DPP4i as add-on therapy to diabetes regimens.

Methods:

We assembled a retrospective cohort of Veterans with diabetes combining Veterans Administration, Medicare, and National Death Index databases. Using an active comparator new user design, patients starting on SGLT2i or DPP4i were followed from prescription fill until a fracture event, death, stopping medication, loss of follow-up, or study end. Fractures included: face/skull, spine, ribs, long bones, hand/feet/digits, or hip. Fractures were identified based on a validated algorithm with positive predictive value 91.3% (86.8, 94.4). Cox models compared the association of fractures between SGLT2i and DPP4i in a propensity score-weighted cohort that balanced 70+ covariates including comorbidities, vital signs, labs, vitamin D levels, smoking, and medications.

Results:

The unweighted sample included 115,124 SGLT2i episodes (104,086 Veterans; 94% empagliflozin; 4% canagliflozin; 2% dapagliflozin) and 213,095 DPP4i episodes (173,724 Veterans; 45% saxagliptin; 15% sitagliptin; 34% alogliptin; 6% Linagliptin). After propensity score calculation and matched weighting, the cohort included 76,072 SGLT2i and 75,833 DPP4i episodes. Median age was 69.3 years and diabetes duration 9.7 (6.1, 14.0) years. In the matched weighted analyses, there were 1431 and 1564 fractures among SGLT2i and DPP4i users, respectively. There were no clinical differences in fractures per 1000 person-years: 18.2 (17.4, 19.1) vs 19.8 (19.0, 20.6). The adjusted hazard ratio (adjusted hazard ratio 0.93 [0.87, 0.99]) excluded increased risk of fractures (adjusted hazard ratio > 1) in SGLT2i users.

Conclusions:

SGLT2i use as add-on treatment for diabetes was not associated with increased fracture outcomes compared to DPP4i.

2025-09-01·Cureus Journal of Medical Science

Efficacy and Safety of Vildagliptin Versus Other Dipeptidyl Peptidase 4 (DPP-4) Inhibitors in the Management of Type 2 Diabetes Mellitus: A Systematic Review of Randomized Controlled Trials

Review

作者: Selvaraj, Vinodhini

Dipeptidyl peptidase 4 inhibitors (DPP-4 inhibitors) are used as second-line drugs in the treatment of type 2 diabetes mellitus (T2DM) patients. They act by preventing the breakdown of incretin hormones, which enhance insulin secretion and reduce glucagon secretion. Vildagliptin and sitagliptin are more commonly used DPP-4 inhibitors. In recent years, the use of DPP-4 inhibitors has been increasing; hence, it is important to evaluate the comparative efficacy and safety of this medication with available evidence. Moreover, this systematic review will evaluate to look for any specific superiority or safety advantage of using Vildagliptin over other DPP-4 inhibitors. In accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines, we conducted a systematic review search with Cochrane and PubMed databases. Two independent reviewers examined randomized controlled trial (RCT) studies against the inclusion criteria. Excluded studies involve type 1 diabetes, gestational diabetes, and severe acute diabetic complications. Finally, five RCT studies were chosen, involving 296 participants overall. Baseline and outcome values with p-values and intergroup differences with their p-value from original studies were gathered to evaluate the significance of using vildagliptin over DPP-4 inhibitors, and findings were provided in a narrative way with available evidence. All five RCT studies have demonstrated a significant reduction in HbA1c from baseline, ranging from -0.3 to -1.34 with p-value <0.05 in the vildagliptin group and -0.1 to -1.07 with p-value >0.05 in other DPP-4 inhibitors, with no significant intergroup differences indicating comparable efficacy between vildagliptin and other DPP-4 inhibitors. Similarly, no significant intergroup differences were observed between vildagliptin and comparator agents in reducing fasting plasma glucose and postprandial glucose. Notably, one study reported a significant reduction favoring vildagliptin, while another showed a greater reduction of FPG with alogliptin; however, intergroup comparisons were not statistically significant. In addition, vildagliptin did not show consistent improvement in lipid profile across the involved studies. Vildagliptin showed a low incidence of hypoglycemic events in comparison with other DPP-4 inhibitors. Overall, this systematic review found no significant superiority of vildagliptin over other DPP-4 inhibitors such as sitagliptin and alogliptin in the management of type 2 diabetes mellitus, whether used as monotherapy or in combination therapy.

2025-07-09·Current Reviews in Clinical and Experimental Pharmacology

Dipeptidyl Peptidase-4 Inhibitors and the Risk of Fractures in Type 2 Diabetes Mellitus Patients: A Bayesian Network Meta-Analysis

Article

作者: Azharuddin, Mohammad ; Vohora, Divya ; Adil, Mohammad ; Sharma, Manju ; Ansari, Shamsuzzaman ; Ahmad, Tufail

Background/Objective::

Type 2 diabetes mellitus (T2DM) increases the risk of fractures and its effects on bone health. The impact of dipeptidyl peptidase-4 inhibitors (DPP-4i) on bone fracture risk is unclear. We performed a network meta-analysis (NMA) to assess the impact of DPP-4i on fracture risk in patients with T2DM.

Methods::

A comprehensive systematic literature search was conducted on PubMed/Medline, Cochrane Library, and ClinicalTrials.gov until June 2024 to identify RCTs reporting fracture events with DPP-4i among T2DM patients. A Bayesian NMA has been performed to calculate the odds ratio (OR) and 95% credible intervals (CrI). Surface under the cumulative ranking analysis (SUCRA) was utilized to assess the rank probability of DPP-4i.

Results::

A total of 85 RCTs were identified, including 89,965 T2DM patients with 1,083 fracture events. In the direct meta-analysis, DPP-4i did not elevate fracture risk compared to placebo or other oral anti-diabetics (OADs) (OR (95%CI): 1.04 (0.91-1.18); p=0.57 and 1.18 (0.79-1.74); p=0.96, respectively). Alogliptin and sitagliptin indicated a non-significant trend towards reducing fracture risk compared to placebo (OR (95%CI): 0.59 (0.31-1.15); p=0.12) and OADs (OR (95%CI): 0.73 (0.41-1.30); p=0.28), respectively. In the NMA, alogliptin significantly reduced fracture risk compared to linagliptin and SGLT2i (OR (95%CrI): 0.41 (0.16-0.93) and 0.16 (0.017-0.83), respectively). Conversely, linagliptin increased fracture risk compared to sulfonylurea (OR (95%CrI): 2.3 (1.1-5.2)). According to SUCRA, alogliptin (84%) ranked as the preferred treatment for reducing fracture risk in T2DM patients.

Conclusion::

Overall, DPP-4i was not associated with an increased risk of fractures in patients with T2DM. However, alogliptin demonstrated a reduced risk of fractures when compared to both linagliptin and SGLT2i. Further long-term clinical studies are needed to confirm the present findings.

164

项与苯甲酸阿格列汀相关的新闻（医药）

2025-09-02

·国家药品监督管理局

2025年09月02日药品批准证明文件送达信息

2022年11月1日起，行政相对人可登录国家药品监督管理局政务服务门户的法人空间查看电子证照，按照相关提示自行打印。序号受理号药品名称申请人批准文号批准日期1CYHB2400169盐酸莫西沙星氯化钠注射液石药集团欧意药业有限公司————2025年09月01日2CYHB2401192坎地沙坦酯片浙江诺得药业有限公司国药准字H202581762025年09月01日3CYHB2401822中长链脂肪乳/氨基酸（16）/葡萄糖（30%）注射液四川科伦药业股份有限公司————2025年09月01日4CYHB2401823中长链脂肪乳/氨基酸（16）/葡萄糖（30%）注射液四川科伦药业股份有限公司————2025年09月01日5CYHB2450370非那雄胺分散片恒昌（广州）新药研究有限公司————2025年09月01日6CYHB2450599克拉霉素片浙江京新药业股份有限公司————2025年09月01日7CYHB2501182硫酸羟氯喹片重庆博腾药业有限公司国药准字H202581752025年09月01日8CYHB2501335盐酸特比萘芬乳膏武汉华灵生物医药有限公司————2025年09月01日9CYHB2501552酚氨咖敏颗粒四川巴中普瑞制药有限公司————2025年09月01日10CYHB2501553酚氨咖敏颗粒四川巴中普瑞制药有限公司————2025年09月01日11CYHB2501575氯化钠注射液沈药合泽药业（山东）有限公司————2025年09月01日12CYHB2501576氯化钠注射液沈药合泽药业（山东）有限公司————2025年09月01日13CYHB2501577氯化钠注射液沈药合泽药业（山东）有限公司————2025年09月01日14CYHB2501584葡萄糖氯化钠注射液沈药合泽药业（山东）有限公司————2025年09月01日15CYHB2501585葡萄糖氯化钠注射液沈药合泽药业（山东）有限公司————2025年09月01日16CYHB2501586葡萄糖氯化钠注射液沈药合泽药业（山东）有限公司————2025年09月01日17CYHB2501617米力农注射液湖南赛隆药业（长沙）有限公司————2025年09月01日18CYHB2501618米力农注射液湖南赛隆药业（长沙）有限公司————2025年09月01日19CYHB2501626左氧氟沙星片天津柏海药业有限责任公司————2025年09月01日20CYHB2501633脂肪乳(10%)/氨基酸(15)/葡萄糖(20%)注射液山东科伦药业有限公司————2025年09月01日21CYHB2501634脂肪乳(10%)/氨基酸(15)/葡萄糖(20%)注射液山东科伦药业有限公司————2025年09月01日22CYHB2501637硫酸阿米卡星注射液海南爱科制药有限公司————2025年09月01日23CYHB2501638硫酸阿米卡星注射液海南爱科制药有限公司————2025年09月01日24CYHB2501656萘敏维滴眼液安徽艾珂尔制药有限公司————2025年09月01日25CYSB2400165四价流感病毒亚单位疫苗江苏中慧元通生物科技股份有限公司————2025年09月01日26CYSB2400283Sabin株脊髓灰质炎灭活疫苗(Vero细胞)中国医学科学院医学生物学研究所————2025年09月01日27CYSB2400284Sabin株脊髓灰质炎灭活疫苗（Vero细胞）中国医学科学院医学生物学研究所————2025年09月01日28CYZB2402198香砂平胃颗粒云南白药集团股份有限公司————2025年08月29日29CYZB2501012风湿二十五味丸（琪素-25）乌兰浩特中蒙制药有限公司————2025年08月29日30CYZB2501101苏合香丸贵州德昌祥医药股份有限公司————2025年08月29日31CYZB2501149阿胶益寿口服液江西半边天药业有限公司————2025年09月01日32CYZB2501153麝雄至宝丸山西广誉远国药有限公司————2025年08月29日33CYZB2501184麦味地黄胶囊贵州益佰制药股份有限公司————2025年09月01日34CYZB2501277宁神丸重庆希尔安药业有限公司————2025年08月29日35CYZB2501280银翘解毒片雷允上药业集团有限公司————2025年08月29日36CYZB2501301中华跌打酒广西梧州制药（集团）股份有限公司————2025年08月29日37CYZB2501310西黄丸龙晖药业有限公司————2025年08月29日38CYZB2501339复方一枝蒿颗粒新疆银朵兰药业股份有限公司————2025年09月01日39CYZB2501356灵芝滴丸包头中药有限责任公司————2025年08月29日40CYZB2501359痔血丸津药达仁堂集团股份有限公司达仁堂制药厂————2025年08月29日41JTH2500120磷酸泊沃昔替尼海南德镁医药科技有限责任公司————2025年09月01日42JTH2500126尼古丁树脂酸盐北京金城泰尔制药有限公司————2025年09月01日43JTH2500129维立西呱片拜耳医药保健有限公司————2025年09月01日44JTH2500130维立西呱片拜耳医药保健有限公司————2025年09月01日45JTH2500131维立西呱片拜耳医药保健有限公司————2025年09月01日46JTH2500132美罗培南泊诺（天津）创新医药研究有限公司————2025年09月01日47JTS2500063Ziltivekimab二级对照品诺和诺德（中国）制药有限公司————2025年09月01日48JTS2500064Ziltivekimab原液诺和诺德（中国）制药有限公司————2025年09月01日49JYHB2500338拉米夫定多替拉韦片葛兰素史克（中国）投资有限公司————2025年09月01日50JYHB2500415水飞蓟素胶囊晖致医药有限公司————2025年09月01日51JYHB2500426苯甲酸阿格列汀片杭州中美华东制药有限公司————2025年09月01日52JYHB2500427苯甲酸阿格列汀片杭州中美华东制药有限公司————2025年09月01日

申请上市临床申请

2025-08-29

·EINPresswire

July - September 2021 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)

Ajovy (fremanezumab-vfrm) Emgality (galcanezumab-gnlm) Nurtec ODT (rimegepant) Ubrelvy (ubrogepant) Vyepti (eptinezumab-jjmr) Hypertension The "Warnings and Precautions", "Adverse Reactions", "Patient Counseling Information", and "Patient Information" sections of the labeling were updated in March 2025 to include information about the risk of hypertension. Example: Ajovy labeling Apriso (mesalamine) Asacol (mesalamine) Asacol HD (mesalamine) Azulfidine (sulfasalazine) Azulfidine EN-Tabs (sulfasalazine) Canasa (mesalamine) Colazal (balsalazide disodium) Delzicol (mesalamine) Dipentum (osalazine sodium) Giazo (balsalazide disodium) Lialda (mesalamine) Rowasa (mesalamine) Pentasa (mesalamine) Severe cutaneous adverse reactions The Warnings and Precautions section of the labeling was updated November 2021 to include severe cutaneous adverse reactions. Example: Delzicol labeling Avastin (bevacizumab) Mvasi (bevacizumab-awwb) Zirabev (bevacizumab-bvzr) Pancreatitis FDA determined that no action is necessary at the time based on available information. Avastin (bevacizumab) Mvasi (bevacizumab-awwb) Zirabev (bevacizumab-bvzr) Anaphylactic shock The "Warnings and Precautions" section of the labeling was updated between September 2022 and February 2023 to include anaphylactoid/anaphylactic reactions. Example: Avastin labeling Ayvakit (avapritinib) Photosensitivity reaction The "Warnings and Precautions", "Adverse Reactions", "Patient Counseling Information", and "Patient Information" sections of the labeling were updated in March 2023 to include information about photosensitivity. Ayvakit labeling Azacitidine Onureg (azacitidine) Vidaza (azacitidine) Generic products containing azacitidine Pericarditis The "Adverse Reactions" section of the labeling was updated between September 2022 and June 2023 to include pericarditis. Example: Vidaza labeling FDA determined that no action is necessary at the time based on available information for Onureg. Bavencio (avelumab) Imfinzi (durvalumab) Libtayo (cemiplimab-rwlc) Keytruda (pembrolizumab) Opdivo (nivolumab) Tecentriq (atezolizumab) Yervoy (ipilimumab) Tumour lysis syndrome FDA determined that no action is necessary at the time based on available information. Cymbalta (duloxetine hydrochloride) Drizalma Sprinkle (duloxetine hydrochloride) Generic products containing duloxetine hydrochloride Anosmia, Hyposmia This issue is posted as two individual newly identified safety signal (NISS) entries in the January-March 2022 quarter, to reflect the focus on the potential signals of anosmia and hyposmia, separately. Darzalex (daratumumab) Darzalex Faspro (daratumumab and hyaluronidase-fihj) Blood stem cell transplant failure FDA determined that no action is necessary at the time based on available information. Dipeptidyl peptidase-4 (DPP-4) inhibitors Glyxambi (empagliflozin and linagliptin) Janumet (metformin hydrochloride and sitagliptin phosphate) Janumet XR (metformin hydrochloride and sitagliptin phosphate) Jentadueto (linagliptin and metformin hydrochloride) Jentadueto XR (linagliptin and metformin hydrochloride) Kazano (alogliptin and metformin hydrochloride) Kombiglyze XR (metformin hydrochloride and saxagliptin) Nesina (alogliptin) Onglyza (saxagliptin) Oseni (alogliptin and pioglitazone) Steglujan (ertugliflozin and sitagliptin) Tradjenta (linagliptin) Trijardy XR (empagliflozin, linagliptin and metformin hydrochloride) Qtern (saxagliptin and dapagliflozin) Generic products containing dipeptidyl peptidase-4 inhibitors Tubulointerstitial nephritis The "Adverse Reactions" section of the labeling was updated between March 2022 and June 2022 for products containing alogliptin and sitagliptin to include tubulointerstitial nephritis. Example: Janumet labeling FDA determined that no action is necessary for products containing linagliptin and saxagliptin at the time based on available information. *An administrative error resulted in the omission of Januvia from the list of product names after the initial quarterly report was posted. Dupixent (dupilumab) Angioedema The "Warnings and Precautions" and "Adverse Reactions" sections of the labeling were updated in December 2021 to include angioedema. Dupixent labeling Glucagon-like peptide-1 (GLP-1) analogues Adlyxin (lixisenatide) Bydureon (exenatide) Bydureon BCise (exenatide) Byetta (exenatide) Ozempic (semaglutide) Rybelsus (semaglutide) Saxenda (liraglutide) Soliqua 100/33 (insulin glargine and lixisenatide injection) Trulicity (dulaglutide) Victoza (liraglutide) Wegovy (semaglutide) Xultophy 100/3.6 (insulin degludec and liraglutide injection) Generic products containing glucagon-like peptide-1 analogues Gallbladder related disorders The "Warnings and Precautions", "Adverse Reactions", and "Patient Counseling Information" sections of the GLP-1 analogues labeling were updated between March 2022 and June 2022 to include information about acute gallbladder disease. Example: Adlyxin labeling FDA has determined that the last approved labeling for Saxenda and Wegovy is adequately labeled for acute gallbladder disease, and that no further regulatory action is needed at this time. Gonadotropin releasing hormone (GnRH) analogues Fensolvi (leuprolide acetate) Lupron Depot-PED (leuprolide acetate) Supprelin LA (histrelin acetate) Synarel (nafarelin acetate) Triptodur (triptorelin) Idiopathic intracranial hypertension The "Warnings", "Precautions", and "Adverse Reactions" sections of the labeling were updated in April 2022 to include idiopathic intracranial hypertension. Example: Fensolvi labeling Jakafi (ruxolitinib phosphate) Herpes simplex virus (HSV) reactivation and/or disseminated HSV The "Dosage and Administration", "Warnings and Precautions", and "Adverse Reactions" sections of the labeling were updated in January 2023 to include information about herpes simplex and herpes zoster infections. Jakafi labeling Ibrance (palbociclib) Kisqali (ribociclib) Kisqali Femara Co-Pack (letrozole and ribociclib) Embolic and thrombotic events, venous The "Adverse Reactions" section of the Ibrance labeling was updated in December 2024 to include venous thromboembolism. Ibrance labeling FDA determined that no action is necessary at the time for Kisqali and Kisqali Femara Co-Pack based on available information. Ocrevus (ocrelizumab) Myocardial infarction FDA determined that no action is necessary at the time based on available information. Potassium Chloride Product preparation error The “Warnings” section of the labeling was updated in December 2022 to include information about fatal cardiac adverse reactions with intravenous administration of undiluted potassium chloride. Praxbind (idarucizumab) Wrong dose errors The carton labeling and "Dosage and Administration" sections of the labeling were revised in February 2022 to clarify the number of vials included in each carton and the recommended dosing. Praxbind labeling Qbrexza (glycopyrronium tosylate) Accidental exposure to product The container label, carton labeling, "Dosage and Administration", "Warnings and Precautions", "Patient Counseling Information", and "Patient Information" sections of the labeling were updated in October 2022 to include information about accidental exposure. Qbrexza labeling Qbrexza (glycopyrronium tosylate) Urinary retention The “Warnings and Precautions”, “Adverse Reactions”, and “Patient Counseling Information” sections of the labeling were updated in October 2022 to include information about new or worsening urinary retention. Qbrexza labeling Sodium-glucose cotransporter-2 (SGLT-2) inhibitors Farxiga (dapagliflozin) Glyxambi (empagliflozin and linagliptin) Invokamet (canagliflozin and metformin hydrochloride) Invokamet XR (canagliflozin and metformin hydrochloride) Invokana (canagliflozin) Jardiance (empagliflozin) Qtern (saxagliptin and dapagliflozin) Steglatro (ertugliflozin) Steglujan (ertugliflozin and sitagliptin) Segluromet (ertugliflozin and metformin hydrochloride) Synjardy (empagliflozin and metformin hydrochloride) Synjardy XR (empagliflozin and metformin hydrochloride) Trijardy XR (empagliflozin, linagliptin and metformin hydrochloride) Xigduo XR (dapagliflozin and metformin) Generic products containing sodium-glucose cotransporter-2 (SGLT-2) inhibitors Tubulointerstitial nephritis FDA determined that no action is necessary at the time based on available information. Somatostatin Receptor Imaging Agents Detectnet (copper Cu-64 dotatate injection) Gallium Dotatoc (GA 68) Octreoscan (Indium In 111 Pentetreotide) Netspot (Gallium GA 68 Dotatate) Hypersensitivity The "Warnings and Precautions" and "Adverse Reactions" sections of the labeling were updated in December 2021 to include hypersensitivity reactions. Example: Netspot labeling Stromectol (ivermectin) Generic products containing ivermectin Off label use FDA determined that no action is necessary at the time based on available information. Stromectol (ivermectin) Generic products containing ivermectin Neurotoxicity The "Warnings", "Adverse Reactions", and "Overdosage" sections of the labeling were updated in March 2022 to include neurotoxicity. Example: Stromectol labeling Sunosi (solriamfetol hydrochloride) Hypersensitivity FDA determined that no action is necessary at the time based on available information. Vivitrol (naltrexone) Incorrect route of product administration The container label (vial), carton labeling, "Dosage and Administration", "Warnings and Precautions", and "Description", sections of the labeling were revised in September 2022 to emphasize the appropriate route and site of administration. Vivitrol labeling Xcopri (cenobamate) Psychiatric disorders The "Adverse Reactions" section of the labeling was updated in June 2022 to include psychiatric disorders. Xcopri labeling Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.

上市批准

2025-08-19

·药圈头条

刚刚，华东医药2025上半年业绩公布，营收216.75亿！

刚刚，华东医药发布2025年半年度报告，2025年上半年华东医药合计实现营业收入216.75亿元，同比增长3.39%；实现归属于上市公司股东的净利润18.15亿元，同比增长7.01%；实现归属于上市公司股东的扣除非经常性损益的净利润17.62亿元，同比增长8.40%。报告期内，其核心子公司中美华东整体经营继续保持良好增长趋势，实现营业收入73.17亿元（含CSO业务），同比增长9.24%，实现归母净利润15.80亿元，同比增长14.09%，净资产收益率12.16%。目前，华东医药工业商业化创新产品梯队已覆盖肿瘤、内分泌、自身免疫等多个重点治疗领域，代表性产品包括尼欣那®（苯甲酸阿格列汀片）、利鲁平®（利拉鲁肽注射液）、惠优静®（脯氨酸加格列净片）、赛乐信®（乌司奴单抗注射液），以及爱拉赫®（索米妥昔单抗注射液）、CAR-T产品赛恺泽®（泽沃基奥仑赛注射液）等。受益于新产品陆续获批上市带来的增量释放，华东医药创新产品业务收入贡献持续攀升，当期实现销售及代理服务收入合计10.84亿元，同比增幅达59%，已进入高速增长通道。 2025上半年，华东医药医美板块合计营业收入达到11.12亿元（剔除内部抵消因素），同比出现一定下降。其中，华东医药全资子公司英国Sinclair报告期内实现销售收入约5.24亿元，同比下降7.99%，国内医美全资子公司欣可丽美学实现营业收入5.43亿元，同比下降12.15%。报告期内华东医药医药工业研发投入（不含股权投资）14.84亿元，同比增长33.75%，其中直接研发支出11.74亿元，同比增长54.21%，直接研发支出占医药工业营收比例为15.97%。欢迎加入群聊

免疫疗法财报细胞疗法上市批准

100 项与苯甲酸阿格列汀相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D06553	苯甲酸阿格列汀	A10BH04	DB06203

研发状态

批准上市

10 条最早获批的记录,

后查看更多信息

适应症	国家/地区	公司	日期
2型糖尿病	日本	Takeda Pharmaceutical Co., Ltd.	2010-04-06
2型糖尿病	日本	Teijin Pharma Ltd.	2010-04-06

未上市

10 条进展最快的记录,

后查看更多信息

适应症	最高研发状态	国家/地区	公司	日期
急性冠状动脉综合征	临床3期	美国	Takeda Pharmaceutical Co., Ltd.	2009-09-01
急性冠状动脉综合征	临床3期	日本	Takeda Pharmaceutical Co., Ltd.	2009-09-01
急性冠状动脉综合征	临床3期	阿根廷	Takeda Pharmaceutical Co., Ltd.	2009-09-01
急性冠状动脉综合征	临床3期	澳大利亚	Takeda Pharmaceutical Co., Ltd.	2009-09-01
急性冠状动脉综合征	临床3期	奥地利	Takeda Pharmaceutical Co., Ltd.	2009-09-01
急性冠状动脉综合征	临床3期	比利时	Takeda Pharmaceutical Co., Ltd.	2009-09-01
急性冠状动脉综合征	临床3期	巴西	Takeda Pharmaceutical Co., Ltd.	2009-09-01
急性冠状动脉综合征	临床3期	保加利亚	Takeda Pharmaceutical Co., Ltd.	2009-09-01
急性冠状动脉综合征	临床3期	加拿大	Takeda Pharmaceutical Co., Ltd.	2009-09-01
急性冠状动脉综合征	临床3期	智利	Takeda Pharmaceutical Co., Ltd.	2009-09-01

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临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT02856113 (2015-000208-25, Pubmed \| Diabetes Ther)	临床3期	2型糖尿病	152	Alogliptin 25 mg QD	製繭遞範襯鹽鏇鏇壓醖(壓夢糧鬱艱餘壓築範壓) = 遞願襯蓋願網壓壓襯範網構築構淵築窪簾餘鏇 (鹽襯獵淵艱鬱範糧窪憲, -0.63 ~ 0.83)	不佳	2025-03-04
1340-P (ADA2024)	N/A	糖尿病	-	SGLT2i	艱鏇製築鏇獵構廠簾願(壓衊醖淵顧選鏇獵築鹽) = 鹹遞夢願鑰窪膚壓艱憲憲觸簾網淵淵糧鑰艱鹽 (繭簾餘築廠獵鹹網蓋構, 16.6 ~ 19.7)	积极	2024-06-14
				DPP4i	艱鏇製築鏇獵構廠簾願(壓衊醖淵顧選鏇獵築鹽) = 餘艱襯廠蓋醖觸窪窪鑰憲觸簾網淵淵糧鑰艱鹽 (繭簾餘築廠獵鹹網蓋構, 19.1 ~ 21.4)
NCT05782192 (Pubmed)	临床3期	2型糖尿病	-	Fotagliptin	簾夢襯獵廠餘鏇窪膚構(積夢鹹範顧醖鏇蓋顧獵) = 糧獵窪製鹽積製艱構膚觸廠顧醖網醖襯簾艱積 (壓壓顧遞夢構簾蓋鑰願 ) 更多	积极	2023-10-09
				Alogliptin	簾夢襯獵廠餘鏇窪膚構(積夢鹹範顧醖鏇蓋顧獵) = 願鏇膚鬱選顧觸積淵範觸廠顧醖網醖襯簾艱積 (壓壓顧遞夢構簾蓋鑰願 ) 更多
NCT02856113 (2015-000208-25, CTgov)	临床3期	2型糖尿病	152	Placebo (Placebo)	醖鑰鏇艱鹽鏇廠構衊壓(鹽蓋鏇繭艱顧膚遞鑰襯) = 積醖繭選簾遞觸製構齋衊選構範壓鬱蓋積蓋壓 (鬱鏇齋製顧獵觸憲鹽鑰, 0.2809) 更多	-	2022-10-19
				Alogliptin Benzoate (Alogliptin 25 mg)	醖鑰鏇艱鹽鏇廠構衊壓(鹽蓋鏇繭艱顧膚遞鑰襯) = 夢積餘壓壓遞壓夢願壓衊選構範壓鬱蓋積蓋壓 (鬱鏇齋製顧獵觸憲鹽鑰, 0.2879) 更多
NCT03794336 (ACADEMIC, Pubmed \| Diabetes Obes Metab) 人工标引	临床4期	2型糖尿病 \| 冠状动脉疾病	1,088	aspirin+alogliptin	蓋遞夢遞遞艱網鑰簾齋(願醖壓繭鑰範遞艱築鹽) = 衊壓鏇糧齋選廠壓窪鬱襯鑰鹹遞簾壓鬱鹽製糧 (顧願鑰齋衊醖鹹蓋壓鹽, 0.4) 更多	积极	2022-02-03
				aspirin+acarbose	蓋遞夢遞遞艱網鑰簾齋(願醖壓繭鑰範遞艱築鹽) = 夢艱齋鹹憲觸願窪鹽憲襯鑰鹹遞簾壓鬱鹽製糧 (顧願鑰齋衊醖鹹蓋壓鹽, 0.5) 更多
NCT03794336 (EASD2021)	临床4期	心血管疾病 \| 2型糖尿病 \| 冠状动脉疾病	-	Alogliptin 25 mg q.d.	鹹襯艱衊鏇獵構壓壓齋(鹹鹹遞憲艱壓餘齋鹹選) = Significantly lesser GI adverse events were observed with alogliptin than acarbose (8.9% vs 33.6%, P <0.0001) 廠構選網齋衊淵餘顧蓋 (鹹艱淵膚壓鏇築夢襯蓋 ) 更多	积极	2021-09-29
				Acarbose 100 mg t.i.d.
NCT03231709 (TRINITY, Pubmed \| Curr Med Res Opin)	临床4期	2型糖尿病	-	Trelagliptin	餘糧繭廠齋淵範繭窪鹽(齋鹹觸夢艱鏇鏇壓窪蓋) = 廠鏇獵窪觸糧艱網糧鏇餘憲築鬱糧襯齋鑰鹹鹹 (鏇艱鹽壓鏇選壓鏇淵獵 )	-	2019-12-02
				Alogliptin	餘糧繭廠齋淵範繭窪鹽(齋鹹觸夢艱鏇鏇壓窪蓋) = 願獵壓鬱網衊壓網糧製餘憲築鬱糧襯齋鑰鹹鹹 (鏇艱鹽壓鏇選壓鏇淵獵 )
NCT03501277 (CTgov)	临床1期	-	72	alogliptin+pioglitazone+SYR-322-4833 BL (Regimen A)	醖範齋艱範願廠範鹽選(鬱衊構壓鹽鑰壓夢艱餘) = 壓獵構醖積窪衊顧網鏇夢選醖願糧積鬱齋鹽觸 (鹽製製鏇願衊憲淵製繭, 42.87) 更多	-	2019-08-08
				Alogliptin+pioglitazone (Regimen B)	醖範齋艱範願廠範鹽選(鬱衊構壓鹽鑰壓夢艱餘) = 艱遞淵襯構鑰範糧鹹鑰夢選醖願糧積鬱齋鹽觸 (鹽製製鏇願衊憲淵製繭, 44.71) 更多
NCT03231709 (TRINITY, CTgov)	临床4期	2型糖尿病	60	Trelagliptin+Alogliptin (Trelagliptin 100 mg + Alogliptin 25 mg)	簾壓構壓醖蓋糧觸繭鹽 = 選鹽選鏇醖積窪鏇網範積願淵築鬱膚夢獵蓋窪 (願糧願積壓鑰糧鑰網積, 壓願選膚鬱膚糧廠網夢 ~ 壓淵蓋窪繭觸觸醖餘淵) 更多	-	2019-05-10
				Trelagliptin+Alogliptin (Alogliptin 25 mg + Trelagliptin 100 mg)	簾壓構壓醖蓋糧觸繭鹽 = 簾積醖餘網顧觸襯糧淵積願淵築鬱膚夢獵蓋窪 (願糧願積壓鑰糧鑰網積, 鬱鹽願糧繭網獵觸衊鹽 ~ 膚繭壓觸顧積壓糧膚衊) 更多
NCT02771093 (TRACK, CTgov)	临床4期	2型糖尿病	27	Trelagliptin (Trelagliptin 100 mg)	築淵艱襯鹹淵遞齋窪遞(構蓋鏇網鹹醖製襯觸齋) = 繭願築築夢繭選範夢網夢淵壓艱壓積壓鑰襯遞 (壓膚觸衊獵鑰夢鏇窪糧, 願餘簾鏇衊顧齋餘繭繭 ~ 衊窪齋廠襯襯觸遞窪鬱) 更多	-	2018-12-10
				Alogliptin (Alogliptin 25 mg)	築淵艱襯鹹淵遞齋窪遞(構蓋鏇網鹹醖製襯觸齋) = 願壓獵夢構網鬱觸網範夢淵壓艱壓積壓鑰襯遞 (壓膚觸衊獵鑰夢鏇窪糧, 淵鑰蓋衊壓糧簾簾簾選 ~ 網範衊製範艱壓選鏇鬱) 更多