AG-NPP709(AG-NPP709) - 在研适应症：哮喘，支气管炎，病毒感染_专利_临床

概要

基本信息

药物类型

中药

别名

Sinechura、Synatura

靶点-

作用机制-

治疗领域

免疫系统疾病感染呼吸系统疾病

在研适应症

哮喘支气管炎病毒感染

非在研适应症

急性上呼吸道感染急性上呼吸道炎症慢性支气管炎

原研机构

AHN-GOOK PHARMACEUTICAL Co., Ltd.

在研机构

AHN-GOOK PHARMACEUTICAL Co., Ltd.

非在研机构-

最高研发阶段批准上市

首次获批日期

韩国 (2011-03-01),

哮喘支气管炎病毒感染

最高研发阶段(中国)-

特殊审评-

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关联

2

项与 AG-NPP709 相关的临床试验

NCT03623282 / Completed临床4期

Study Regarding the Clinical Efficacy of Synatura® in Patients With Chronic Bronchitis Type COPD

This study aims to examine the clinical efficacy of synatura in patients with chronic bronchitis type COPD in Korea.

开始日期2017-04-17

申办/合作机构

AHN-GOOK PHARMACEUTICAL Co., Ltd.

NCT01151202 / Completed临床3期

Therapeutic Confirmatory Clinical Trial to Evaluate the Safety and Efficacy of "AG NPP709 Syrup" in Acute Upper Respiratory Tract Infection and Chronic Inflammatory Bronchitis Patients: Double Blinded, Randomized, Active Drug Comparative, Parallel Designed, Multi-centered, Phase III Study

The purpose of this study is to assess therapeutic confirmation of AG NPP709 syrup to evaluate the safety and efficacy in patients with acute upper respiratory tract infection and chronic inflammatory bronchitis.

开始日期2010-02-01

申办/合作机构

AHN-GOOK PHARMACEUTICAL Co., Ltd.

[+5]

100 项与 AG-NPP709 相关的临床结果

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100 项与 AG-NPP709 相关的转化医学

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100 项与 AG-NPP709 相关的专利（医药）

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6

项与 AG-NPP709 相关的文献（医药）

2023-12-01·Journal of Ethnopharmacology

Assessment of subchronic toxicity and toxicokinetics of AG NPP709 in Sprague-Dawley rats

Article

作者: Chang, Soo Im ; Ryu, Doug-Young

ETHNOPHARMACOLOGICAL RELEVANCEHedera helix L. (HH) leaves and Coptidis rhizoma (CR) have traditionally been used to treat respiratory conditions. AG NPP709, which is formulated using extracts of both these herbs, has been developed as an expectorant and antitussive.AIM OF THE STUDYThe objective was to evaluate the subchronic toxicity and toxicokinetic characteristics of AG NPP709 in laboratory rats.MATERIALS AND METHODSAG NPP709 was orally administered to rats at doses of up to 2.0 g/kg/day for a duration of 13 weeks. Various health parameters were measured throughout the treatment period. At the end of the treatment, a necropsy was conducted and additional parameters were analyzed. Toxicokinetic analyses were also performed on hederacoside C and berberine, the active components of HH leaves and CR, respectively, in the plasma of rats treated with AG NPP709.RESULTSAG NPP709-treated rats exhibited several health issues, such as reduced feed intake, altered differential white blood cell (WBC) count, increased plasma Alb/Glo ratio in females, and reduced kidney weight in males. However, these changes appeared to be incidental and fell within the typical range for healthy animals of this species. Additionally, toxicokinetic analysis of hederacoside C and berberine showed no accumulation in the plasma of rats during the repeated treatments with AG NPP709.CONCLUSIONSOur study demonstrates that AG NPP709 does not have any harmful effects on rats under experimental conditions. Based upon these findings, the no observed adverse effect level of AG NPP709 can be estimated to be 2.0 g/kg/day in rats.

2023-02-03·Medicine

The clinical efficacy of a mixture of ivy leaf extract and coptidis rhizome in patients with idiopathic pulmonary fibrosis

Article

作者: Choi, Hee Eun ; No, Tae-Hoon ; Kim, Ji Yeon ; Lee, Jae Ha ; Park, Jin Han ; Jung, So Young ; Ko, Junghae ; Kim, Seong-Ho ; Jang, Ji Hoon ; Lee, Sunggun ; Jang, Hang-Jea

Idiopathic pulmonary fibrosis (IPF) is a progressive fibrotic lung disease with poor prognosis and cough is the one of most common and major symptoms in IPF. The aim of this study was to evaluate the clinical efficacy of a Mixture of Ivy Leaf Extract and Coptidis rhizome (Synatura®) in patients with IPF. This was a prospective, open-label, single-center, and single-arm study in Korea from October 2019 to September 2020. IPF patients with chronic bronchitis were enrolled. Between baseline and eight weeks after use of Synatura®, clinical measures regarding cough and health-related quality of life, and the systemic inflammatory markers was prospectively collected. Thirty patients were enrolled. Median age was 73 years and 86.7% were men. The median gender-age-pulmonary function stage of IPF was 3. Baseline total score of Leicester cough questionnaire (LCQ) and St. George respiratory questionnaire (SGRQ) were 104.5 and 30.59 respectively. After eight weeks, there was no significant improvement in LCQ (16.8 [15.6–19.1] vs 17.5 [15.2–18.9], P = .772) and SGRQ (30.6 [19.4–37.8] vs 29.9 [19.6–41.8], P = .194) scores. Also, there was no significant difference of systemic inflammatory markers. In analysis of minimal clinically important differences (MCID), one third (33.3%) patients fulfilled the criteria of MCID (1.3) in LCQ scores and median differences was 14 (range: 10–18). In terms of SGRQ, 6 patients (20%) reached MCID (4.0) without significant predictive factors. In our study, use of Synatura® during 8 weeks improved cough-specific life quality in one third patients with IPF. Large-scale, randomized, double-blind, and placebo-controlled clinical trials are needed.

2021-01-01·Journal of Thoracic Disease4区 · 医学

The safety and efficacy of CKD-497 in patients with acute upper respiratory tract infection and bronchitis symptoms: a multicenter, double-blind, double-dummy, randomized, controlled, phase II clinical trial

4区 · 医学

Article

作者: Ra, Seung Won ; Park, Yong Bum ; Yoo, Kwang Ha ; Lee, Chang Youl ; Park, Shin Jung ; Rhee, Chin Kook ; Yoon, Hyoung Kyu ; Kim, Sun Young ; Park, Jeong-Woong ; Kim, Deog Kyeom ; Lim, Yun Young

BACKGROUNDAcute upper respiratory tract infection (AURI) together with acute bronchitis is the most common illness worldwide. Botanical medicines used as expectorants and antitussives have proven to be effective while also having excellent safety margins. We aimed at evaluating the efficacy and safety of a new botanical drug, CKD-497, in patients with AURI and acute bronchitis.METHODSIn this phase 2 study, 225 patients were enrolled and randomly assigned to one of four treatment groups: placebo (n=55), Synatura^® (n=49), CKD-497 200 mg (n=68), or CKD-497 300 mg (n=53). The study drugs were administered three times daily over the course of 7 days. Primary endpoint was the change in the bronchitis severity score (BSS) from baseline to day 7. Secondary endpoint was evaluated based on clinical response rates on days 4 and 7. A safety analysis was also performed.RESULTSBetween baseline and day 7, the mean BSS scores decreased significantly in each group (P<0.001): -4.04±1.85, -4.31±1.47, -4.09±1.48, and -4.28±1.69. However, neither the CKD-497 nor Synatura^® group showed any significant effect on the difference in BSS change (P=0.75). The rate of clinical response was higher in the CKD-497 300 mg group as compared to the placebo only on day 4 (36% vs. 18%; P<0.05) and those having more severe bronchitis (phlegm score ≥3) showed a significant reduction of total BSS in the Synatura^® and CKD-497 groups (P=0.042). No significant adverse events were observed in either of the CKD-497 groups.CONCLUSIONSCKD-497 and even the positive control drug had no significant effect on BSS change in this phase 2 clinical trial. However, CKD-497 300 mg had a mild but significant clinical improvement in early bronchitis patients with more severe phlegm. Considering both efficacy and safety, a future study using 300 mg of CKD-497 with a shorter-term endpoint is warranted in patients with more severe bronchitis symptoms.

100 项与 AG-NPP709 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	R07AX	-

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
哮喘	韩国	AHN-GOOK PHARMACEUTICAL Co., Ltd.	2011-03-01
支气管炎	韩国	AHN-GOOK PHARMACEUTICAL Co., Ltd.	2011-03-01
病毒感染	韩国	AHN-GOOK PHARMACEUTICAL Co., Ltd.	2011-03-01

未上市

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适应症	最高研发状态	国家/地区	公司	日期
急性上呼吸道感染	临床1期	韩国	AHN-GOOK PHARMACEUTICAL Co., Ltd.	2010-02-01
急性上呼吸道炎症	临床1期	韩国	AHN-GOOK PHARMACEUTICAL Co., Ltd.	2010-02-01
慢性支气管炎	临床1期	韩国	AHN-GOOK PHARMACEUTICAL Co., Ltd.	2010-02-01