5-盐酸氨基戊酮酸/琥珀酸亚铁钠(5-aminolevulinic acid hydrochloride/Sodium ferrous citrate)

概要

基本信息

药物类型

小分子化药

别名

Aminolevulinic acid/sodium ferrous citrate、Sodium ferrous citrate/aminolevulinic acid

+ [1]

靶点-

作用机制

Erythropoiesis刺激剂(红细胞生成刺激剂)、光敏剂

治疗领域

血液及淋巴系统疾病

在研适应症

贫血

非在研适应症

自闭症2型糖尿病疟疾+ [1]

原研机构

The National Institute For Medical Research

在研机构

The National Institute For Medical ResearchThe University of Tokyo Hospital

非在研机构

SBI Pharmaceuticals Co., Ltd.

最高研发阶段临床2期

首次获批日期-

最高研发阶段(中国)-

特殊审评-

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结构

分子式C5H10ClNO3

InChIKeyZLHFONARZHCSET-UHFFFAOYSA-N

CAS号5451-09-2

查看全部结构式(2)

序列信息

Sequence Code 178207

当前序列信息引自: *****

关联

5

项与 5-盐酸氨基戊酮酸/琥珀酸亚铁钠相关的临床试验

NCT05234346 / CompletedN/A

An Open-Label, Pilot Study to Evaluate the Safety, Tolerability, and Efficacy of 5-ALA-Phosphate + SFC as an Immune System Enhancer Along With Vaccination Against SARS-CoV-2 Virus Infection

In this study, it is hypothesized that administration of 5-ALA-Phosphate + SFC in subjects vaccinated against Covid-19 could contribute in enhancing the targeted function of the immune system, which might lead to re-activation and/or increase of the vaccination response. Thus, in the present study, we will be evaluating the safety and efficacy of 5-ALA-Phosphate + SFC in subjects receiving the Covid-19 vaccine.

开始日期2022-03-15

申办/合作机构

Vedic Lifesciences Pvt Ltd

NCT05228483 / RecruitingN/AIIT

Safety and Efficacy of Carbon Dioxide（CO2）Fractional Laser Combined With Photodynamic Therapy in the Treatment of Female Vulvar Lichen Sclerosus

The objective of this study is to evaluate the safety and efficacy of CO2 fractional laser combined with photodynamic therapy in female patients with vulvar lichen sclerosus.

开始日期2021-11-23

申办/合作机构

西京医院第四军医大学

JPRN-JapicCTI-184159 / Completed临床2期

A Phase II Study of SPP-003 for Nephrotoxicity Induced by Cisplatin-based Chemotherapy

开始日期2018-11-13

申办/合作机构

SBI Pharmaceuticals Co., Ltd.

100 项与 5-盐酸氨基戊酮酸/琥珀酸亚铁钠相关的临床结果

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100 项与 5-盐酸氨基戊酮酸/琥珀酸亚铁钠相关的转化医学

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100 项与 5-盐酸氨基戊酮酸/琥珀酸亚铁钠相关的专利（医药）

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2

项与 5-盐酸氨基戊酮酸/琥珀酸亚铁钠相关的文献（医药）

2022-01-01·Oncology

A Randomized Phase 2 Study of 5-Aminolevulinic Acid Hydrochloride and Sodium Ferrous Citrate for the Prevention of Nephrotoxicity Induced by Cisplatin-Based Chemotherapy of Lung Cancer

Article

作者: Natsume, Ichiro ; Sato, Kazuhiro ; Mitsuishi, Yoichiro ; Nakamura, Sukeyuki ; Takahashi, Kazuhisa ; Nakajima, Motowo ; Nishi, Koichi ; Iwanaga, Kentaro ; Sasaki, Takaaki ; Iwashima, Akira ; Sakai, Hiroshi ; Taniguchi, Hirokazu ; Kawamura, Kodai ; Yamauchi, Mitsugu ; Ohsaki, Yoshinobu ; Matsushima, Hidekazu ; Shigenaga, Takehiko ; Sasaki, Shinichi ; Kojima, Tohru

Introduction: Cisplatin-based chemotherapy was established in the 1980s, and it has been improved by the development of a short hydration protocol in lung cancer therapy. However, cisplatin-based chemotherapy is still associated with renal toxicity. Because 5-aminolevulinic acid (5-ALA) with sodium ferrous citrate (SFC) is known to be a mitochondrial activator and a heme oxygenase-1 (HO-1) inducer, 5-ALA with SFC is speculated to mitigate cisplatin-induced renal inflammation. Methods: We investigated the effects of oral administration of 5-ALA with SFC for preventing cisplatin-based nephrotoxicity in patients with lung cancer and evaluated its benefits for patients who received cisplatin-based chemotherapy. The primary endpoint was the significance of the difference between the serum creatinine (sCr) levels of the patients administered 5-ALA with SFC and those given placebo after course 1 of chemotherapy. The difference in the estimated glomerular filtration rate (eGFR) between the two groups was also evaluated as the secondary endpoint. Results: The double-blind, randomized two-arm studies were conducted at 15 medical facilities in Japan; 54 male and 20 female patients with lung cancer who received cisplatin-based chemotherapy between the ages of 42 and 75 years were included in the study. The compliance rate was greater than 94% in the primary assessment and subsequent drug administration periods. All enrolled patients completed the four cycles of cisplatin-based chemotherapy with short hydration. The average level of sCr on day 22 of course 1 was 0.707 mg/dL in the group treated with 5-ALA and SFC and 0.735 mg/dL in the placebo group, respectively, and the sCr in the test group was significantly lower than that in the placebo group (p = 0.038). In addition, the eGFR was significantly higher in the SPP-003 group than in the placebo group up to day 1 of course 3 (84.66 and 75.68 mL/min/1.73 m2, respectively, p = 0.02) and kept better even after the last administration of the study drug (82.37 and 73.49 mL/min/1.73 m2, respectively, p = 0.013). Conclusions: The oral administration of 5-ALA with SFC is beneficial to patients undergoing cisplatin-based chemotherapy for lung cancer with short hydration.

2016-01-01·Journal of Diabetes Research3区 · 医学

The Safety and Tolerability of 5-Aminolevulinic Acid Phosphate with Sodium Ferrous Citrate in Patients with Type 2 Diabetes Mellitus in Bahrain

3区 · 医学

ArticleOA

作者: Aldosari, Waleed ; Nakajima, Motowo ; Darwish, Abdulla ; Khalfan, Hesham ; Al-Saber, Feryal ; Kudo, Sizuka ; Khan, Ghulam ; Alselaiti, Mariam ; Tanaka, Tohru ; Kaladari, Ahmed ; Rehani, Riyadh ; Harb, George ; Koda, Aya

Type 2 diabetes mellitus is prevalent especially in Gulf countries and poses serious long-term risks to patients. A multifaceted treatment approach can include nutritional supplements with antioxidant properties such as 5-aminolevulinic acid (5-ALA) with sodium ferrous citrate (SFC). This prospective, randomized, single-blind, placebo-controlled, dose escalating pilot clinical trial assessed the safety of 5-ALA with SFC at doses up to 200 mg 5-ALA/229.42 mg SFC per day in patients living in Bahrain with type 2 diabetes mellitus that was uncontrolled despite the use of one or more antidiabetic drugs. Fifty-three patients (n=53) from 3 sites at one center were enrolled by Dr. Feryal (Site #01), Dr. Hesham (Site #02), and Dr. Waleed (Site #03) (n=35, 5-ALA-SFC;n=18, placebo). There was no significant difference in incidence of adverse events reported, and the most frequent events reported were gastrointestinal in nature, consistent with the known safety profile of 5-ALA in patients with diabetes. No significant changes in laboratory values and no difference in hypoglycemia between patients receiving 5-ALA and placebo were noted. Overall, the current results support that use of 5-ALA-SFC up to 200 mg per day taken as 2 divided doses is safe in patients taking concomitant oral antidiabetic medications and may offer benefits in the diabetic population. This trial is registered with ClinicalTrials.govNCT02481141.

1

项与 5-盐酸氨基戊酮酸/琥珀酸亚铁钠相关的新闻（医药）

2022-06-14

·药通社

40个受理号获批，包括1品规注射用药品！

导读：2022年06月14日药品批准证明文件待领取信息发布，共40个受理号获批。其中，共有2个一致性受理号获批，包括1品规注射用药品。过评药品分别为：琥珀酸亚铁片（湖南九典制药股份有限公司）、乳酸环丙沙星氯化钠注射液（四川科伦药业股份有限公司）。其中，湖南九典制药股份有限公司的琥珀酸亚铁片为第二家过评，第一家过评的是：金陵药业股份有限公司。四川科伦药业股份有限公司的乳酸环丙沙星氯化钠注射液为第三家过评，此前已有广州南新制药有限公司、石家庄四药有限公司两家过评。

100 项与 5-盐酸氨基戊酮酸/琥珀酸亚铁钠相关的药物交易

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研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
贫血	临床2期	-	The University of Tokyo Hospital	-
贫血	临床2期	-	The National Institute For Medical Research	-
线粒体病	药物发现	日本	SBI Pharmaceuticals Co., Ltd.	2019-07-27
自闭症	药物发现	日本	-	2018-06-29
2型糖尿病	药物发现	巴林	SBI Pharmaceuticals Co., Ltd.	-
疟疾	药物发现	日本	-	-