Delving into the Latest Updates on Berberine Chloride Hydrate with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

Benberine Hydrochlor, Benberine Hydrochloride, Berber Hydrochlorde

+ [33]

Target-

Action-

Mechanism-

Therapeutic Areas

Infectious DiseasesOther DiseasesDigestive System Disorders

Active Indication

DiarrheaIntestinal infectionsInfectious Diseases+ [1]

Inactive Indication

Diabetes Mellitus, Type 2Familial Hyperchylomicronemia SyndromeHypercholesterolemia+ [6]

Originator Organization

Hubei Huazhong Pharmaceutical Co. Ltd.

Active Organization

Hubei Huazhong Pharmaceutical Co. Ltd.

Nichi-Iko Pharmaceutical Co., Ltd.

Kunming Bangyu Pharmaceutical Co., Ltd.

Inactive Organization

Northeast Pharmaceutical Group Co., Ltd.

Chinese Academy of Medical SciencesInstitute of Pharmaceutical Biotechnology, Chinese Academy of Medical Sciences

+ [1]

License Organization-

Drug Highest PhaseApproved

First Approval Date

China (01 Jan 1981),

Intestinal infections

Regulation-

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Structure/Sequence

Molecular FormulaC20H22ClNO6

InChIKeyNWMNHQUPWGJEKI-UHFFFAOYSA-M

CAS Registry5956-60-5

View All Structures (2)

This pilot 12-week randomized open-label study compares metformin and berberine in newly diagnosed type 2 diabetes patients stratified by the TCF7L2 (rs7903146) genotype (TT vs. CC). The primary goal is to assess changes in HbA1c between metformin and berberine treated groups within each genotype. Secondary outcomes include fasting and postprandial glucose, insulin levels, HOMA-IR, body weight/BMI, lipid profile and adverse events.
The central hypothesis is that berberine, through its additional effect on TCF7L2-linked pathways, will provide superior glycemic control in high-risk TT carriers compared to metformin, whereas both treatments will yield comparable results in CC carriers. By enrolling only TT and CC genotypes, this study aims to estimate effect sizes and feasibility, guiding a future, larger-scale trial on genotype-tailored diabetes therapies.

Start Date01 Jul 2025

Sponsor / Collaborator-

NCT05720299

/ RecruitingNot ApplicableIIT

A Randomized, Double-blind, Placebo-controlled Clinical Study to Evaluate the Effects of Akkermansia Muciniphila and Berberine on Prediabetes Among Obese Subjects.

The Akkermania muciniphila may play an important role in the occurrence and development of Prediabetes. The purpose of this study was to evaluate the safety and efficacy of AKK in the treatment of Prediabetes among obese patients. In this study, a single center, randomized, double-blind, placebo-controlled design is adopted. 90 obese subjects with Prediabetes are included in this study, and are allocated to AKK group, BBR group, and placebo group at a ratio of 1:1:1. The study treatment lasts for 12 weeks. The changes of body fat, glucose metabolism, lipid metabolism indicators compared with the baseline at the end of the treatment will be analyzed. In addition, glucagon like peptide-1 (GLP-1) and inflammatory markers (hsCRP、TNF-α、IL-6、IL-8、IL-1β) in blood will be analyzed before and after treatment. The changes in fecal flora structure and the AKK bacteria also will be analyzed.

Start Date12 Mar 2025

Sponsor / Collaborator-

CTR20244648

/ RecruitingPhase 1

小儿盐酸小檗碱无水吞服颗粒与盐酸小檗碱片在健康受试者中的相对生物利用度临床试验

[Translation] Clinical trial on the relative bioavailability of berberine hydrochloride anhydrous swallowable granules and berberine hydrochloride tablets in healthy subjects

主要目的：以昆明邦宇制药有限公司生产的小儿盐酸小檗碱无水吞服颗粒为受试制剂，以上海信谊天平药业有限公司持证，浙江前进药业有限公司生产的盐酸小檗碱片为对照药品，对比在中国健康成年受试者中空腹及餐后给药条件下人体内的吸收速度及吸收程度药代动力学特征，比较在健康成年人群中肠道排泄的差异。次要目的：观察评估空腹和餐后状态条件下单次口服受试制剂小儿盐酸小檗碱无水吞服颗粒和对照药品盐酸小檗碱片在中国健康受试者成年人群中的安全性。

[Translation]

Main purpose: Using berberine hydrochloride anhydrous swallowable granules produced by Kunming Bangyu Pharmaceutical Co., Ltd. as the test preparation, and berberine hydrochloride tablets certified by Shanghai Xinyi Tianping Pharmaceutical Co., Ltd. and produced by Zhejiang Qianjin Pharmaceutical Co., Ltd. as the control drug, the pharmacokinetic characteristics of absorption rate and degree of absorption in the human body under fasting and postprandial administration conditions in healthy adult subjects in China were compared, and the differences in intestinal excretion in healthy adult populations were compared. Secondary purpose: Observe and evaluate the safety of a single oral test preparation of berberine hydrochloride anhydrous swallowable granules for children and the control drug berberine hydrochloride tablets in healthy adult subjects in China under fasting and postprandial conditions.

Start Date05 Feb 2025

Sponsor / Collaborator

Kunming Bangyu Pharmaceutical Co., Ltd.

100 Clinical Results associated with Berberine Chloride Hydrate

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100 Translational Medicine associated with Berberine Chloride Hydrate

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100 Patents (Medical) associated with Berberine Chloride Hydrate

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13,102

Literatures (Medical) associated with Berberine Chloride Hydrate

31 Dec 2025·Gynecological Endocrinology

Study on the mechanism of action of berberine combined with Jianpi Yishen Huazhuo formulation in treating obese polycystic ovary syndrome by activating PI3K/AKT signaling pathway

Article

Author: Ji, Dejiang ; Ye, Gaxi ; Feng, Yahong ; Du, Cuizhong ; Ahmad, Aqsa ; Zhang, Xiaojing ; Zhang, Yan ; Liang, Lijun

OBJECTIVESThis study aims to investigate the effects and potential mechanisms of berberine in conjunction with Jianpi Yishen Huazhuo formulation (JPYSHZF) on obese rats that serve as a model for polycystic ovary syndrome (PCOS).METHODSLetrozole combined with high-fat diet (HFD) was used to establish an overweight PCOS rat model. After successful modeling, each intervention group was monitored for 28 d. An oral glucose tolerance test (OGTT) is performed to assess glucose metabolism. Enzyme-linked immunosorbent assay (ELISA) was used to determine the levels of sex hormones and serum levels of gastrointestinal hormones in rats. Biochemical analyzers were used to assess blood lipid levels. The protein expression levels of p38, PI3K, GLUT4, and AKT in ovarian tissue were demonstrated using Western Blotting (WB). Real-time fluorescence quantitative PCR (RT-qPCR) was used to measure the mRNA expression levels of p38, PI3K, GLUT4 and AKT in the same tissue. The morphological changes of ovarian tissue were observed using Hematoxylin-eosin (HE).RESULTSTreatment with berberine in conjunction with JPYSHZF has been shown to reduce serum testosterone T and luteinizing hormone (LH) levels while increasing serum follicle-stimulating hormone (FSH) and E2 levels. This combination therapy also decreases the LH/FSH ratio and ameliorates polycystic ovary-like pathological changes in the ovaries of rats with PCOS. Additionally, this treatment decreases serum TC, TG, and LDL-c levels while increasing HDL-c levels. It also reduces levels of GLU and Ghrelin while enhancing levels of CCK, PYY, and GLP-1. Furthermore, the relative 6 of PI3K and AKT proteins, as well as the mRNA levels of PI3K, GLUT4, and AKT, were found to be increased.CONCLUSIONSBerberine combined with JPYSHZF can improve the sex hormone levels, ovarian function, glucose and lipid metabolism levels, and gastrointestinal hormone levels in obese PCOS rats by activating the PI3K/AKT signaling pathway, thereby playing a role in treating obese PCOS.

01 Dec 2025·Molecular Biology Reports

Synergistic inhibitory effect of atmospheric pressure plasma and berberine on non‑small cell lung cancer cells via inducing apoptosis

Article

Author: Ming, Huiyun ; Song, Wencheng ; Zhou, Han ; Dai, Haiming ; Lu, Tingting

BACKGROUNDNon-small cell lung cancer (NSCLC) is a type of lung cancer, the incidence and mortality rate have been high, and the use of monotherapy is easy to make patients develop tolerance. Atmospheric pressure plasma (APP) is an emerging technology for killing cancer cells in recent years, and combination of berberine (BBR) mechanism has not been fully elucidated for NSCLC. The article's primary goal is to investigate the effect of combination on NSCLC and its associated characterization.METHODS AND RESULTSAntiproliferative effects were detected by cell viability assay and colony formation, and flow cytometry analysis of apoptosis and cycling showed that the combination synergistically induced apoptosis. Then, extracellular reactive oxygen species (ROS)levels and DCFH-DA-based kits examined intracellular ROS levels, and their effects on mitochondrial membrane potential were measured. Study reveals that co-induced apoptosis is associated with ROS accumulation. Subsequently, Western blotting (WB) detected the expression of epidermal growth factor receptor (EGFR), and the important signaling pathway proteins Ras/ERK and AKT/mTOR. Results showed that it could downregulation of EGFR protein expression and inhibit of activation of ERK/AKT signaling pathways. Simultaneous wound healing assay and epithelial-to-mesenchymal transition (EMT) marker detection were performed for the assessment of migration and EMT ability of NSCLC cells. Combination therapy inhibited migration and EMT of NSCLC cells.CONCLUSIONThe results of this study show that the combination can synergistically induce apoptosis of NSCLC by regulating ROS production. EGFR downregulation and AKT/ERK signaling pathway inhibition are linked to the synergistic effect.

01 Sep 2025·Talanta

A novel quality evaluation strategy for natural medicines integrated with HPLC Euclidean quantitative fingerprinting, UV total fingerprint dissolution and in vitro antioxidant activity: A case study of Gegen Qinlian tablet

Article

Author: Hu, Yanlei ; Sun, Guoxiang ; Zhang, Liuwei ; Zhai, Manhuayun

A reliable quality control system is essential for ensuring the clinical efficacy and safety of medicines. However, past work on quality control of natural medicines has been focused mainly on the quantification of indicator components and the characteristic chemical fingerprint which provide qualitative information only and rarely provide quantitative information. Herein, a fusion of the Comprehensive Euclidean quantitative fingerprinting method (CEQFM) and multi-component quantification, on-line UV total dissolution methods based on the Dissolution-systematically quantitative fingerprint method (DSQFM) were developed for quality control of Gegen Qinlian tablets (GQTs). Furthermore, DPPH• was used to evaluate the antioxidant activity of GQTs and construct the spectrum-effect relationship. Based on these strategies, the 22 batches of GQTs were classified into six grades by CEQFM (0.898 ≤ S_m ≤ 0.986, 74.4 % ≤ P_E ≤ 149.7 %) and seven grades by DSQFM (0.978 ≤ S_m ≤ 1.000, 50.64 % ≤ P_m ≤ 142.3 %), and 8 active ingredients were quantified simultaneously, with the total contents of all the 8 components spanned from 66.47 to 120.40 mg/g. In the in vitro dissolution test, the dissolution curves of 10 batches of GQTs were very similar (S_m > 0.9, 70 %< P_m<130 %, f2>50). Furthermore, the spectrum-effect relationship was applied to screen out the potential antioxidant active components, such as puerarin, baicalein, baicalin, berberine hydrochloride, palmatine chloride, etc. This method can quickly evaluate the quality of GQTs from the aspects of quantitative fingerprinting, dissolution, multi-component, and antioxidant efficacy. The study provides a new approach to quality control and quality consistency evaluation of natural medicines.

100 Deals associated with Berberine Chloride Hydrate

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External Link

KEGG	Wiki	ATC	Drug Bank
D01250	Berberine Chloride Hydrate	J	-

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Diarrhea	Japan	Nichi-Iko Pharmaceutical Co., Ltd.	01 Jul 1994
Intestinal infections	China	Hubei Huazhong Pharmaceutical Co. Ltd.	01 Jan 1981
Infectious Diseases	-	-	-

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Diabetes Mellitus, Type 2	Phase 2	China	Institute of Pharmaceutical Biotechnology, Chinese Academy of Medical Sciences	22 Mar 2017
Diabetes Mellitus, Type 2	Phase 2	China	Northeast Pharmaceutical Group Co., Ltd.	22 Mar 2017
Diabetes Mellitus, Type 2	Phase 2	China	Chinese Academy of Medical Sciences	22 Mar 2017
Familial Hyperchylomicronemia Syndrome	Phase 2	China	Northeast Pharmaceutical Group Co., Ltd.	22 Mar 2017
Familial Hyperchylomicronemia Syndrome	Phase 2	China	Institute of Pharmaceutical Biotechnology, Chinese Academy of Medical Sciences	22 Mar 2017
Hyperlipidemias	Phase 2	China	Chinese Academy of Medical Sciences	22 Mar 2017
Hyperlipoproteinemia Type IV	Phase 2	China	Northeast Pharmaceutical Group Co., Ltd.	22 Mar 2017
Hyperlipoproteinemia Type IV	Phase 2	China	Institute of Pharmaceutical Biotechnology, Chinese Academy of Medical Sciences	22 Mar 2017
Primary Hyperlipidemia	Phase 2	China	Institute of Pharmaceutical Biotechnology, Chinese Academy of Medical Sciences	22 Mar 2017
Primary Hyperlipidemia	Phase 2	China	Northeast Pharmaceutical Group Co., Ltd.	22 Mar 2017

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03909763 (CTgov)	Phase 2	Purpura, Thrombocytopenic, Idiopathic	55	Berberine+danazol	jchfoyvqbh(hwndlxhdgh) = hpbrseycmb otfbkrjnga (nhcoytaels, uxtmcclxnh - icjnyewaby) View more	-	25 Sep 2020