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-

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]

Drug Highest PhaseApproved

First Approval Date

CN (01 Jan 1981),

Intestinal infections

Regulation-

Login to view timeline

Structure/Sequence

Molecular FormulaC20H22ClNO6

InChIKeyNWMNHQUPWGJEKI-UHFFFAOYSA-M

CAS Registry5956-60-5

View All Structures (2)

Colorectal cancer (CRC) is a common malignancy of the digestive tract, which constitutes a major public health burden. Almost 90% of CRC cases progress from precursor adenomatous polyps through adenoma-carcinoma sequence. Endoscopic detection and removal of colorectal adenoma (CRA) could reduce the incidence and mortality risk of CRC, but the recurrence rate is still high. Therefore, chemoprevention is quite important, not only solve the urgent public health problem, but also be cost-effective.
In 2020, the investigators published a multicenter, randomized, double-blind, placebo-controlled clinical study (NCT02226185) in the Lancet Gastroenterology & Hepatology. The result concluded that oral BBR for 2 years significantly reduced recurrence after endoscopic removal of CRA (RR 0.77, 95%CI 0.66-0.91; p=0.001). BBR also has a significant preventive effect on all polypoid lesions, including adenomas and serrated lesions (adjusted RR 0.78, 95%CI 0.66-0.91; p=0.002) . Does BBR still have a long-term protective effect on the recurrence of CRA after discontinuation? That's what the investigators concerned.
The present study is performed to observe and compare retrospectively the recurrence rate of CRAs in patients of the original BBR RCT study (NCT02226185) within 6 years after discontinuation of medication, including the overall recurrence rate of traditional adenomas within the first year, 1-3 years, 3-6 years, and the entire follow-up period of 6 years. The aim is to evaluate the long-term efficacy of BBR in preventing recurrence and carcinogenesis after endoscopic resection of CRAs.

Start Date04 Oct 2024

Sponsor / Collaborator

Shanghai Jiao Tong University School of Medicine

[+4]

NCT04918667

/ Not yet recruitingPhase 1

A Phase I, Randomized, Crossover, Double-blind, Pharmacokinetic Study of Berberine Released From Cyclodextrin in Healthy Volunteers

In this study, we will evaluate the relative bioavailability of Berberine (BB) from capsules containing Indian Barberry (Berberis aristate DC.) Bark and Root Extract in the blood plasma of healthy subjects after oral administration of:
A. Capsules containing Berberine and GCD (BBA Berberine MetX™ Ultra Absorption, 250 mg) B. Capsules containing Berberine (BB, Berberine MetX™, 500 mg) - (reference product).

Start Date01 Sep 2024

Sponsor / Collaborator

Europharma AS

[+2]

ChiCTR2400083889

/ SuspendedEarly Phase 1IIT

Curative effect of berberine hydrochloride on diabetic nephropathy

Start Date15 May 2024

Sponsor / Collaborator

The First Hospital of Jilin University

100 Clinical Results associated with Berberine Chloride Hydrate

Login to view more data

100 Translational Medicine associated with Berberine Chloride Hydrate

Login to view more data

100 Patents (Medical) associated with Berberine Chloride Hydrate

Login to view more data

450

Literatures (Medical) associated with Berberine Chloride Hydrate

01 Jun 2025·Biomaterials

Herbal micelles-loaded ROS-responsive hydrogel with immunomodulation and microenvironment reconstruction for diabetic wound healing

Article

Author: Zhang, Guo ; Liang, Xiaoyang ; Zhang, Rui ; Zhang, Lei ; Chen, Honggui ; Xu, Zhixuan ; Xu, Fu-Jian ; Li, Yang ; Xu, Chen

Persistent inflammation is a major cause of diabetic wounds that are difficult to heal. This is manifested in diabetic wounds with excessive reactive oxygen clusters (ROS), advanced glycation end products (AGE) and other inflammatory factors, and difficulty in polarizing macrophages toward inhibiting inflammation. Berberine is a natural plant molecule that inhibits inflammation; however, its low solubility limits its biological function through cytosis. In this study, we designed F127 micelles to encapsulate berberine with the aim of improving its solubility and bioavailability. Meanwhile, in order to achieve effective drug delivery at the wound site, we designed an injectable ferrocene-cyclodextrin self-assembled oxidation-reactive supramolecular hydrogel drug delivery system. Cellular experiments have shown that the hydrogel can reduce intracellular ROS and AGE production, attenuate cellular damage, promote macrophage polarization toward inhibition of inflammation, and reduce the secretion of inflammatory factors. In an animal model of diabetic mice, this hydrogel dressing reduces the level of inflammation in diabetic wounds, optimizes collagen deposition in diabetic wounds, and ultimately achieves high-quality diabetic wound healing. The work offers a straightforward and effective solution to the challenge of administering hydrophobic anti-inflammatory agents in the context of diabetic wound therapy.

01 Apr 2025·Neuropharmacology

Berberine ameliorates seizure activity and cardiac dysfunction in pentylenetetrazol-kindling seizures in rats: Modulation of sigma1 receptor, Akt/eNOS signaling, and ferroptosis

Article

Author: Elshazly, Shimaa M ; Mohamed, Ahmed F ; Basiouny, Shrouk M ; Zaki, Hala F

Seizures can lead to cardiac dysfunction. Multiple pathways contribute to this phenomenon, of which the chaperone sigma-1 receptor (S1R) signaling represents a promising nexus between the abnormalities seen in both epilepsy and ensuing cardiac complications. The study explored the potential of Berberine (BER), a promising S1R agonist, in treating epilepsy and associated cardiac abnormalities in a pentylenetetrazol (PTZ) kindling rat model of epilepsy. Male Wistar albino rats received PTZ (35 mg/kg) every other day alone, with BER, with phenytoin (PHT), with both BER and PHT and with both BER and an S1R blocker (NE-100) over 27 days. BER decreased seizure severity and improved hemodynamic parameters. Histopathological abnormalities were more pronounced in the PTZ, and blocker group than in other groups, in heart tissue. In cardiac tissue, BER enhanced the AKT/eNOS signaling pathway and mitigated ferroptosis by boosting the cystine/glutamate transporter/Glutathione/Glutathione Peroxidase 4 (XCT/GSH/GPX4) system and ferritin heavy chain-1 (FTH-1) expression, while reducing iron and Transferrin receptor protein 1 (TFR1) levels. Such effects were largely negated by NE-100 pretreatment. In conclusion, BER shows protective effects on cardiac dysfunction induced by the PTZ kindling model by acting as an S1R agonist and influencing the AKT/eNOS signaling pathway and ferroptosis.

01 Feb 2025·Mini-Reviews in Medicinal Chemistry

A Review of the Protective Effects of Alkaloids against Alpha-synuclein Toxicity in Parkinson's Disease

Article

Author: Javadi, Behjat ; Khodadadi, Mahdi

Background:Alpha-synuclein (α-syn) aggregation products may cause neural injury and several neurodegenerative disorders (NDs) known as α-synucleinopathies. Alkaloids are secondary metabolites present in a variety of plant species and may positively affect human health, particularly α-synucleinopathy-associated NDs.Aim:To summarize the latest scientific data on the inhibitory properties of alkaloids in α- synucleinopathies, especially in Parkinson’s disease.Methods:Literature search was performed using web-based databases including Web of Science, PubMed, and Scopus up to January 2024, in the English language.Results:Harmala alkaloids, caffein, lycorine, piperin, acetylcorynoline, berberin, papaverine, squalamine, trodusquemine and nicotin have been found to be the most active natural alkaloids against synucleinopathy. The underlying mechanisms that contribute to this effect would be the inhibition of α-syn aggregation; elimination of formed aggregates; improvement in autophagy activation; promotion of the activity and expression of antioxidative enzymes; and prevention of oxidative injury and apoptosis in dopaminergic neurons.Conclusion:The findings of the present study highlight the inhibitory activities of alkaloids against synucleinopathy. However, no clinical data supports the reported activities in humans, which calls attention to the need for conducting clinical trials to elucidate the efficacy, safety, proper dosage, unwanted effects and pharmacokinetics aspects of alkaloids in humans.

100 Deals associated with Berberine Chloride Hydrate

Login to view more data

External Link

KEGG	Wiki	ATC	Drug Bank
D01250	Berberine Chloride Hydrate	J	-

R&D Status

Approved

10 top approved records.

Login

to view more data

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

Developing

10 top R&D records.

Login

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Hypercholesterolemia	Phase 2	CN	Northeast Pharmaceutical Group Co., Ltd.	22 Mar 2017
Hypercholesterolemia	Phase 2	CN	Institute of Pharmaceutical Biotechnology, Chinese Academy of Medical Sciences	22 Mar 2017
Hyperlipidemias	Phase 2	CN	Chinese Academy of Medical Sciences	22 Mar 2017
Hyperlipoproteinemia Type IIb	Phase 2	CN	Institute of Pharmaceutical Biotechnology, Chinese Academy of Medical Sciences	22 Mar 2017
Hyperlipoproteinemia Type IIb	Phase 2	CN	Northeast Pharmaceutical Group Co., Ltd.	22 Mar 2017
Hyperlipoproteinemia Type III	Phase 2	CN	Institute of Pharmaceutical Biotechnology, Chinese Academy of Medical Sciences	22 Mar 2017
Hyperlipoproteinemia Type III	Phase 2	CN	Northeast Pharmaceutical Group Co., Ltd.	22 Mar 2017
Secondary hyperlipidemia	Phase 2	CN	Northeast Pharmaceutical Group Co., Ltd.	22 Mar 2017
Secondary hyperlipidemia	Phase 2	CN	Institute of Pharmaceutical Biotechnology, Chinese Academy of Medical Sciences	22 Mar 2017
Primary Hyperlipidemia	Discovery	CN	Northeast Pharmaceutical Group Co., Ltd.	22 Mar 2017

Login to view more data

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03909763 (CTgov)	Phase 2	Purpura, Thrombocytopenic, Idiopathic	55	Berberine+danazol	aktganhgnc(ggcnvnvrsi) = eoegfcwsbo iermtlwhki (zxlgupzlwh, wxrhjzggwj - mxblinvgnz) View more	-	25 Sep 2020