Pioglitazone Hydrochloride 盐酸吡格列酮

盐酸吡格列酮由武田制药（Takeda）研发，于1999年7月15日获美国食品药品管理局（FDA）批准上市，之后于1999年9月22日获日本医药品医疗器械综合机构（PMDA）批准上市，后又于2000年10月13日获欧洲药物管理局（EMA）批准上市。盐酸吡格列酮由武田制药负责销售，商品名为Actos®。

盐酸吡格列酮为噻唑烷二酮类、过氧化物酶增殖激活受体（PPAR）γ激动剂，从转录水平促进胰岛素分泌、降低胰岛素抵抗，进而实现降低血糖的作用。适用于辅助饮食和运动改善II型糖尿病成年患者的血糖控制。

Actos®为口服片剂，每片含15 mg，30 mg或45 mg吡格列酮，推荐剂量为起始每日1次，每次15 mg或30 mg， 如不能有效控制血糖可增加至不超过每日1次，45 mg；对于出血性心衰患者（NYHA，一级或二级），起始剂量为每日1次，每次15 mg。

目录：

基本信息

更新时间：2017-02-16

药品名称：
Pioglitazone Hydrochloride 盐酸吡格列酮
研发代码：
AD-4833 AD-4833MET STR 001 STR001 thermogel SUB03834MIG  
商品名称：
Actos®  /  Glustin®  /  Actoplus Met®  /  Actoplus Met XR®  /  Competact®  /  Glubrava®  /  Metact®  /  瑞格临®  /  艾可拓®
作用机制：
Peroxisome proliferator-activated receptor γ (PPARγ) agonists Thiazolidinediones
适应症：
2型糖尿病
研发阶段：
批准上市
研发公司：
武田 (原研) 礼来
年销售额：
$336.5 Million (Y2014)
$489 Million (Y2013);
$2,143.7 Million (Y2012);
$4,381.3 Million (Y2011)
ATC号：
A10BG03
主要国家或地区批准情况

更新时间：2017-02-16

批准日期 NDA号 商品名 适应症 剂型 规格 公司 审查类别
1999-07-15 NDA 021073 Actos 2型糖尿病 片剂 Eq. 15 mg/30 mg/45 mg Pioglitazone 武田
展示更多
批准日期 NDA号 商品名 适应症 剂型 规格 公司 审查类别
2000-10-13 EMEA/H/C/000285 Actos 2型糖尿病 片剂 15 mg/30 mg/45 mg 武田
2000-10-11 EMEA/H/C/000286 Glustin 2型糖尿病 片剂 15 mg/30 mg/45 mg 武田
展示更多
批准日期 NDA号 商品名 适应症 剂型 规格 公司 审查类别
2010-01-15 OD15 mg: 22200AMX00046; OD 30 mg: 22200AMX00047 Actos 2型糖尿病 片剂，口腔崩解片 15 mg/30 mg 武田
1999-09-22 15 mg: 21100AMZ00642; 30 mg: 21100AMZ00643 Actos 2型糖尿病 片剂 15 mg/30 mg 武田
展示更多
批准日期 NDA号 商品名 适应症 剂型 规格 公司 审查类别
2014-04-30 H20140270; H20140271; H20140272; H20140267; H20140268; H20140269 艾可拓/Actos 2型糖尿病 片剂 15 mg/30 mg 武田
展示更多
化学信息

更新时间：2015-08-27

分子量 392.9
分子式 C19H20N2O3S • HCl
CAS号 111025-46-8 (Pioglitazone );
112529-15-4 (Pioglitazone HCl)
化学名称 [(±)-5-[[4-[2-(5-ethyl-2-pyridinyl) ethoxy] phenyl] methyl]-2,4-] thiazolidinedione monohydrochloride
Pioglitazone 药品（游离态）参数:
MW HD HA FRB* PSA* cLogP*
356.44 1 5 7 93.6 3.500±0.394
*：Calculated by ACD/Labs software V11.02.
专利信息 2016-02-03

序号 NDA号 技术分类 授权公告号 预计专利失效日 化合物专利 产品专利 专利用途代码
（代码说明）
1 N021073 制剂 5965584 2016-06-19 U - 753
2 N021073 适应症 6150383 2016-06-19 U - 418
3 N021073 适应症 6150384 2016-06-19 U - 419
4 N021073 适应症 6166042 2016-06-19 U - 414
5 N021073 适应症 6166043 2016-06-19 U - 415
6 N021073 适应症 6172090 2016-06-19 U - 416
7 N021073 适应症 6211205 2016-06-19 U - 410
8 N021073 适应症 6271243 2016-06-19 U - 411
9 N021073 适应症 6303640 2016-08-09 U - 425
10 N021073 制剂 6329404 2016-06-19 U - 753
展示更多
化学合成路线及相关杂质

更新时间：2017-06-02


1. US4687777A.


1. Chem Pharm Bull 1991, 39, 1440-1445.


1. Org. Process. Res. Dev. 2009, 13, 1190-1194.

2. Org. Process. Res. Dev. 2004, 8, 157-162.


1. WO2004007490A2.


1. US20140088127A1.

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Coronary Artery Disease/Type 2...MoreCoronary Artery Disease/Type 2 Diabetes Mellitus
Completed
Phase Ⅱ/Ⅲ
NCT00681733
Pentoxifylline Versus Pioglitazone In Non-Alcoholic Steatohepatiti (NASH)
Metabolic Parameters and Liver...MoreMetabolic Parameters and Liver Histology
Recruiting
N/A
NCT00639457
Exercise and Pioglitazone for HIV-Metabolic Syndromes
HIV Infections/Type 2 Diabetes...MoreHIV Infections/Type 2 Diabetes/Obesity/HIV/AIDS/Cardiovascular Disease/Lipodystrophy
Completed
N/A
NCT00531882
Pilot Mouthwash Study of Pioglitazone and Simvastatin in Healthy Volunteers
Cystic Fibrosis/Anti Inflammat...MoreCystic Fibrosis/Anti Inflammatory Non-Steroidal/Neutrophils
Recruiting
N/A
NCT00722371
MK0431 and Pioglitazone Co-Administration Factorial Study in Patients With Type 2 Diabetes Mellitus ...MoreMK0431 and Pioglitazone Co-Administration Factorial Study in Patients With Type 2 Diabetes Mellitus (0431-102 AM2)
Type 2 Diabetes Mellitus
Completed
Phase Ⅲ
NCT00437970
Medication in Early Diabetes (MED) Study
Diabetes Mellitus, Type 2
Withdrawn
Phase Ⅳ
NCT00507494
Influence of Pioglitazone for Renal Transplant Function in Diabetics
Diabetes Mellitus/Kidney Trans...MoreDiabetes Mellitus/Kidney Transplantation/Proteinuria
Completed
Phase Ⅲ
NCT00742326
Pioglitazone to Treat Fatty Liver in Patients With HIV and Hepatitis C Infections
HIV/Hepatitis C/Liver Disease/...MoreHIV/Hepatitis C/Liver Disease/Fatty Liver/Steatosis
Terminated
Phase Ⅳ
NCT00780715
Response To Oral Agents in Diabetes (ROAD)- Pilot Study
Diabetes Mellitus, Type 2
Completed
Phase Ⅳ
NCT00470262
Effects of PPAR Ligands on Ectopic Fat Accumulation and Inflammation
Metabolic Syndrome X/Prediabet...MoreMetabolic Syndrome X/Prediabetic State
Active not recruiting
N/A
NCT00441272
Pioglitazone to Treat Fatty Liver in People With HIV Infection
HIV Infections/Hepatic Steatos...MoreHIV Infections/Hepatic Steatosis/Insulin Resistance
Completed
Phase Ⅱ
NCT00521742
Efficacy of Pioglitazone Compared to Glyburide in Treating Subjects With Type 2 Diabetes Mellitus an...MoreEfficacy of Pioglitazone Compared to Glyburide in Treating Subjects With Type 2 Diabetes Mellitus and Mild Cardiac Disease
Diabetes Mellitus
Completed
Phase Ⅲ
NCT00782795
Chronic Pancreatitis. Effect of Pioglitazone on Endocrine Function, Exocrine Function & Structure, P...MoreChronic Pancreatitis. Effect of Pioglitazone on Endocrine Function, Exocrine Function & Structure, Pain & Life Quality
Chronic Pancreatitis/Insulin R...MoreChronic Pancreatitis/Insulin Resistance/Normal Stool Fat Levels
Completed
Phase Ⅱ
NCT00554853
PPAR-gamma Agonists, Rheumatoid Arthritis and Cardiovascular Disease
Rheumatoid Arthritis
Completed
Phase Ⅲ
NCT00727857
Efficacy and Safety of Pioglitazone and Metformin Combination Therapy in Treating Type 2 Diabetes Me...MoreEfficacy and Safety of Pioglitazone and Metformin Combination Therapy in Treating Type 2 Diabetes Mellitus.
Diabetes Mellitus
Completed
Phase Ⅲ
NCT00775164
Pioglitazone Therapy in Obese Children With Insulin Resistance: A Randomized, Controlled Pilot Study
Obesity/Insulin Resistance
Withdrawn
Phase Ⅳ
NCT00571506
Effect of Thiazolidinedione Treatment Vascular Risk Markers
Diabetes Mellitus, Type 2/Vasc...MoreDiabetes Mellitus, Type 2/Vascular Diseases
Completed
Phase Ⅳ
NCT00770497
Efficacy Study of Pioglitazone and Ramipril Combination Therapy in Treating Non-diabetic Hypertensiv...MoreEfficacy Study of Pioglitazone and Ramipril Combination Therapy in Treating Non-diabetic Hypertensive Patients.
Inflammation/Hypertension
Completed
Phase Ⅱ
NCT00521820
Safety Comparison of Pioglitazone and Glyburide in Type 2 Diabetes Subjects With Mild to Moderate Co...MoreSafety Comparison of Pioglitazone and Glyburide in Type 2 Diabetes Subjects With Mild to Moderate Congestive Heart Failure
Diabetes Mellitus
Terminated
Phase Ⅲ
NCT00286494
Study of Alogliptin Combined With Pioglitazone in Subjects With Type 2 Diabetes Mellitus
Diabetes Mellitus
Completed
Phase Ⅲ
NCT00364988
Pioglitazone and Losartan Provides Additional Renoprotection
Type 2 Diabetes/Diabetic Nephr...MoreType 2 Diabetes/Diabetic Nephropathy
Completed
N/A
NCT00308373
Effects of Fats on Blood Glucose in People With and Without Type 2 Diabetes Mellitus
Diabetes Mellitus, Type 2
Completed
N/A
NCT00352287
Study to Determine the Effects of Human Growth Hormone and Pioglitazone in Overweight, Prediabetic A...MoreStudy to Determine the Effects of Human Growth Hormone and Pioglitazone in Overweight, Prediabetic Adults
Obesity/Metabolic Syndrome/Imp...MoreObesity/Metabolic Syndrome/Impaired Glucose Tolerance
Completed
Phase Ⅳ
NCT00154037
Investigation of Vascular Relaxing Effects of Candesartan and Pioglitazone.
Healthy Subjects
Completed
N/A
NCT00322868
Safety and Efficacy of Pioglitazone as an Anti-Inflammatory for the Treatment of CF Lung Disease
Cystic Fibrosis
Completed
N/A
NCT00155350
Treatment of Coronary Atherosclerosis by Insulin Sensitizers in Insulin-Resistant Patients
Coronary Atherosclerosis/Infla...MoreCoronary Atherosclerosis/Inflammation/Coronary Heart Disease
Recruiting
Phase Ⅳ
NCT00145340
Pioglitazone Treatment in Polycystic Ovary Syndrome
Polycystic Ovary Syndrome
Completed
Phase Ⅳ
NCT00189163
Pioglitazone in Hepatitis C
Chronic Hepatitis C
Recruiting
Phase Ⅳ
NCT00395941
Efficacy and Safety of Acitretin Plus Pioglitazone in Patients With Psoriasis
Psoriasis
Not yet recruiting
Phase Ⅱ
NCT00314561
The Effect of Pioglitazone and Rosiglitazone on Atherosclerotic and Inflammatory Markers in Patients...MoreThe Effect of Pioglitazone and Rosiglitazone on Atherosclerotic and Inflammatory Markers in Patients With Metabolic Syndrome
Metabolic Syndrome
Completed
Phase Ⅳ
NCT00362440
Combination of Insulin Sensitizer and Leptin as Treatment for the HAART -Induced Metabolic Syndrome
HIV Lipodystrophy
Completed
Phase Ⅱ
NCT00402012
"TAKE TIME" Pioglitazone Reverses Defects in Mitochondrial Biogenesis in Patients With T2DM
Diabetes Mellitus, Type 2
Completed
Phase Ⅳ
NCT00331487
Study to Compare Pioglitazone and Rosiglitazone in Subjects With Type 2 Diabetes Mellitus and Dyslip...MoreStudy to Compare Pioglitazone and Rosiglitazone in Subjects With Type 2 Diabetes Mellitus and Dyslipidemia
Diabetes Mellitus
Completed
Phase Ⅲ
NCT00220961
Actos Now for Prevention of Diabetes (ACT NOW)
Impaired Glucose Tolerance/Typ...MoreImpaired Glucose Tolerance/Type 2 Diabetes
Completed
Phase Ⅲ
NCT00159211
Abdominal Adipose Tissue Distribution in Type 2 Diabetic Patients Treated During 6 Months With Piogl...MoreAbdominal Adipose Tissue Distribution in Type 2 Diabetic Patients Treated During 6 Months With Pioglitazone or Insulin
Type 2 Diabetes
Terminated
N/A
NCT00306826
Pioglitazone in Impaired Glucose Tolerance
Glucose Metabolism Disorders
Withdrawn
Phase Ⅳ
NCT00148850
Effect of Pioglitazone on HIV-1 Related Lipoatrophy: a Randomized, Double Blind, Placebo-Controlled ...MoreEffect of Pioglitazone on HIV-1 Related Lipoatrophy: a Randomized, Double Blind, Placebo-Controlled Trial in 130 Patients
HIV-Associated Lipodystrophy S...MoreHIV-Associated Lipodystrophy Syndrome/HIV Infections
Terminated
Phase Ⅲ
NCT00399204
Comparison of Cardiovascular Outcomes of Pioglitazone and Metformin in Type 2 Diabetes Patients
Type 2 Diabetes
Recruiting
Phase Ⅳ
NCT00408850
Effects of Pioglitazone Treatment on Sympathetic Nervous System Function in Metabolic Syndrome Obesi...MoreEffects of Pioglitazone Treatment on Sympathetic Nervous System Function in Metabolic Syndrome Obesity
Metabolic Syndrome
Recruiting
Phase Ⅲ
NCT00151710
Effects of Pioglitazone in Congenital Adrenal Hyperplasia
Congenital Adrenal Hyperplasia
Completed
N/A
NCT00269061
Study In Patients With Type 2 Diabetes Who Are Taking Metformin And Sulfonylurea, Metformin And Insu...MoreStudy In Patients With Type 2 Diabetes Who Are Taking Metformin And Sulfonylurea, Metformin And Insulin, Or Insulin
Non-Insulin-Dependent Diabetes...MoreNon-Insulin-Dependent Diabetes Mellitus
Completed
Phase Ⅰ
NCT00179400
Insulin Action in Individuals With Type 2 Diabetes by Natural Fatty Acids or the Medication Pioglita...MoreInsulin Action in Individuals With Type 2 Diabetes by Natural Fatty Acids or the Medication Pioglitazone
Type 2 Diabetes Mellitus
Active not recruiting
N/A
NCT00276497
Role of Pioglitazone in Preventing Diabetes
Diabetes
Completed
Phase Ⅰ
NCT00013598
Treatment of Nonalcoholic Steatohepatitis With Pioglitazone
Fatty Liver/Nonalcoholic Steat...MoreFatty Liver/Nonalcoholic Steatohepatitis
Completed
Phase Ⅱ
NCT00099021
Pioglitazone Hydrochloride in Preventing Head and Neck Cancer in Patients With Oral Leukoplakia
Head and Neck Cancer/Oral Leuk...MoreHead and Neck Cancer/Oral Leukoplakia
Completed
Phase Ⅱ
NCT00015626
A Clinical Trial to Prevent the Complications of Insulin Resistance (Including Type-2 Diabetes)
Insulin Resistance/Diabetes Me...MoreInsulin Resistance/Diabetes Mellitus
Completed
Phase Ⅱ
Clinical Trial 信息

更新时间：2016-10-15

NCT号
试验标题
适应症
阶段
状态
NCT02917629
ACTOplus Met XR in Treating Patients With Stage I-IV Oral Cavity or Oropharynx Cancer Undergoing Def...MoreACTOplus Met XR in Treating Patients With Stage I-IV Oral Cavity or Oropharynx Cancer Undergoing Definitive Treatment
Oral Cavity Neoplasm/Oropharyn...MoreOral Cavity Neoplasm/Oropharyngeal Neoplasm/Stage I Oral Cavity Squamous Cell Carcinoma/Stage I Oropharyngeal Squamous Cell Carcinoma/Stage II Oral Cavity Squamous Cell Carcinoma/Stage II Oropharyngeal Squamous Cell Carcinoma/Stage III Oral Cavity Squamous Cell Carcinoma/Stage III Oropharyngeal Squamous Cell Carcinoma/Stage IVA Oral Cavity Squamous Cell Carcinoma/Stage IVA Oropharyngeal Squamous Cell Carcinoma/Stage IVB Oral Cavity Squamous Cell Carcinoma/Stage IVB Oropharyngeal Squamous Cell Carcinoma/Stage IVC Oral Cavity Squamous Cell Carcinoma/Stage IVC Oropharyngeal Squamous Cell Carcinoma
Not yet recruiting
Phase Ⅱ
NCT02879409
HbA1c Variability in Type II Diabetes
Diabetes Mellitus Type 2
Not yet recruiting
N/A
NCT02733679
Response of Individuals With Ataxia-Telangiectasia to Metformin and Pioglitazone
Ataxia-Telangiectasia
Not yet recruiting
Phase Ⅳ
NCT02730195
Pioglitazone and Tyrosine Kinase Inhibitor in Treating Patients With Relapsed Chronic Myeloid Leukem...MorePioglitazone and Tyrosine Kinase Inhibitor in Treating Patients With Relapsed Chronic Myeloid Leukemia
Chronic Myelogenous Leukemia, ...MoreChronic Myelogenous Leukemia, BCR-ABL1 Positive/Recurrent Chronic Myelogenous Leukemia, BCR-ABL1 Positive
Recruiting
Phase Ⅱ
NCT02347813
Preventing Squamous Cell Skin Cancer
Squamous Cell Carcinoma of the...MoreSquamous Cell Carcinoma of the Skin
Enrolling by invitation
Phase Ⅱ
Data from http://clinicaltrials.gov查看更多