DW-1029M(DW-1029M) - 药物靶点：Advanced glycation end product x TGF-β1_专利_临床

概要

基本信息

药物类型

小分子化药

别名

靶点

Advanced glycation end product x TGF-β1

作用机制

晚期糖基化终末产物抑制剂、TGF-β1抑制剂(转化生长因子β1抑制剂)

治疗领域

内分泌与代谢疾病泌尿生殖系统疾病

在研适应症-

非在研适应症

糖尿病肾病

原研机构

DONG WHA PHARM Co., Ltd.

在研机构-

非在研机构

DONG WHA PHARM Co., Ltd.

最高研发阶段无进展临床2期

首次获批日期-

最高研发阶段(中国)-

特殊审评-

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关联

5

项与 DW-1029M 相关的临床试验

NCT02212782 / Completed临床1期

A Randomized, Open-label, Multiple-dose, Crossover Phase I Clinical Study to Evaluate DW1029M Influence the Pharmacokinetic Profiles of Linagliptin After Oral Administration in Healthy Male Volunteer

Phase I clinical study to evaluate DW1029M influence the pharmacokinetic profiles of Linagliptin after oral administration in healthy male volunteer.

开始日期2014-09-01

申办/合作机构

DONG WHA PHARM Co., Ltd.

NCT02212756 / Completed临床1期

A Randomized, Open-label, Multiple-dose, Crossover Phase I Clinical Study to Evaluate DW1029M Influence the Pharmacokinetic Profiles of Metformin After Oral Administration in Healthy Male Volunteer

Phase I clinical study to evaluate DW1029M influence the pharmacokinetic profiles of Metformin after oral administration in healthy male volunteer

开始日期2014-08-01

申办/合作机构

DONG WHA PHARM Co., Ltd.

NCT02212769 / Completed临床1期

A Randomized, Open-label, Multiple-dose, Crossover Phase I Clinical Study to Evaluate DW1029M Influence the Pharmacokinetic Profiles of Losartan After Oral Administration in Healthy Male Volunteer

Phase I clinical study to evaluate DW1029M influence the pharmacokinetic profiles of Losartan after oral administration in healthy male volunteer

开始日期2014-08-01

申办/合作机构

DONG WHA PHARM Co., Ltd.

100 项与 DW-1029M 相关的临床结果

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100 项与 DW-1029M 相关的转化医学

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100 项与 DW-1029M 相关的专利（医药）

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3

项与 DW-1029M 相关的文献（医药）

2017-09-01·Clinical Pharmacology in Drug Development

Pharmacokinetics and Safety of DW1029M, a Botanical Drug for the Treatment of Diabetic Nephropathy, Following Single Doses in Healthy Subjects

Article

作者: Lim, Cheol‐Hee ; Jeon, Ji‐Young ; Jang, Hwan Bong ; Kim, Min‐Gul ; Kim, Yunjeong ; Kim, Eun‐Young

AbstractDW1029M is a botanical extract of Morus albalinne root bark and Puerariae radix that is used for the treatment of diabetic nephropathy. This study evaluated the safety and pharmacokinetics of DW1029M following its administration in healthy Korean subjects. We conducted a randomized, open‐label, single‐dose, crossover phase 1 clinical study. During each period, subjects received 300, 600, or 1200 mg oral doses of DW1029M. Plasma concentrations of puerarin, daidzin, and daidzein were analyzed using a liquid chromatography–tandem mass spectrometry. Six healthy male subjects completed the study. The maximum concentration of the drug in the plasma (Cmax) and area under the plasma drug concentration–time curve to the last measurable concentration (AUClast) for puerarin, daidzin, and daidzein were assessed after oral administration of DW1029M. No serious adverse events or clinically or statistically significant adverse events associated with any of the drug levels were observed. The results of the measurement of vital signs, electrocardiogram, laboratory tests, and physical examinations indicated that no clinically significant changes occurred during this study. The DW1029M tablet was safe and well tolerated over a single dose range of 300–1200 mg. This pharmacokinetic study of a botanical drug may aid in the development of DW1029M.

2017-07-01·Clinical Pharmacology in Drug Development

Phase 1 and Pharmacokinetic Drug–Drug Interaction Study of Metformin, Losartan, and Linagliptin Coadministered With DW1029M in Healthy Volunteers

Article

作者: Lim, Cheol‐Hee ; Jang, Hwan Bong ; Kim, Sun‐Young ; Jeon, Ji‐Young ; Kim, Min‐Gul ; Moon, Seol Ju

AbstractWe investigated botanical drug–pharmaceutical drug interactions between DW1029M (a botanical extract of Morus alba linne root bark and Puerariae radix) and metformin, losartan, and linagliptin in the steady state. Three studies were conducted as randomized, open‐label, 2‐period, 2‐treatment, multiple‐dose, 2‐way crossover designs. Eligible subjects received metformin (500 mg twice daily), losartan (50 mg once daily), or linagliptin (5 mg once daily) with DW1029M (300 mg × 2T twice daily) every 12 hours on days 1 through 6 and a single dose on the morning of day 7. Coadministration of DW1029M with metformin, losartan, or linagliptin had no clinically relevant effects based on the area under the plasma concentration–time curve (AUCτ) geometric least‐squares mean ratio (GMR) — AUCτ GMR, 89.7; 90% confidence interval (CI), 81.0–99.4 for metformin; AUCτ GMR, 96.2; 90%CI, 86.3–107.1 for losartan; and AUCτ GMR, 89.7; 90%CI, 83.2–96.6 for linagliptin. In addition, coadministration of DW1029M did not have any clinically meaningful effect on the maximum plasma concentration (Cmax,ss) — Cmax,ss GMR, 87.3; 90%CI, 76.2–100.0 for metformin; Cmax,ss GMR, 90.5; 90%CI, 78.3–104.6 for losartan; and Cmax,ss GMR, 81.4; 90%CI, 69.5–95.3 for linagliptin. Coadministration of DW1029M with metformin, losartan, or linagliptin was well tolerated.

2014-05-15·American Journal of Physiology-Renal Physiology3区 · 医学

DW1029M, a novel botanical drug candidate, inhibits advanced glycation end-product formation, rat lens aldose reductase activity, and TGF-β₁signaling

3区 · 医学

Article

作者: Seong, Seungkyoo ; Choi, Hyunsik ; Park, Dongeun ; Choi, Dong Hwa ; Lee, Hyunyong ; Kim, Yong Sung ; Rho, Yang Kook ; Chang, Hwan Bong ; Yoon, Joobyoung ; Ku, Bonchul

DW1029M is a botanical extract consisting of Morus bark and Puerariae radix, produced by Dong-Wha Pharmaceutical, for nephroprotective drug development; it has been in phase II clinical trials in Korea. In our mechanistic investigations, we found that DW1029M inhibits advanced glycation end products (AGEs), rat lens aldose reductase (RLAR), and transforming growth factor (TGF)-β1signaling, all of which are implicated in diabetic complications such as diabetic nephropathy and diabetic retinopathy. DW1029M inhibits AGE formation via Fe2+chelation. The extract contains 13 active constituents that inhibit AGE formation, 8 active constituents that inhibit RLAR activity, and 1 inhibitor of TGF-β1signaling. Our results suggest DW1029M protects against diabetic nephropathy via blockade of AGE formation, RLAR activity, and TGF-β1signaling.

100 项与 DW-1029M 相关的药物交易

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