MedPath

Berberine

Generic Name
Berberine
Drug Type
Small Molecule
Chemical Formula
C20H18NO4
CAS Number
2086-83-1
Unique Ingredient Identifier
0I8Y3P32UF

Overview

An alkaloid from Hydrastis canadensis L., Berberidaceae. It is also found in many other plants. It is relatively toxic parenterally, but has been used orally for various parasitic and fungal infections and as antidiarrheal.

Background

An alkaloid from Hydrastis canadensis L., Berberidaceae. It is also found in many other plants. It is relatively toxic parenterally, but has been used orally for various parasitic and fungal infections and as antidiarrheal.

Indication

主要用于志贺菌属、霍乱弧菌等敏感病原菌所致的胃肠炎、细菌性痢疾等肠道感染。 外用用于治疗敏感细菌引起的宫颈糜烂。

Associated Conditions

No associated conditions information available.

Clinical Trials

Title
Posted
Study ID
Phase
Status
Sponsor
2025/01/20
Phase 2
ENROLLING_BY_INVITATION
2024/10/07
N/A
Recruiting
Shanghai Jiao Tong University School of Medicine
2024/09/19
Phase 4
Recruiting
Xijing Hospital of Digestive Diseases
2024/07/23
Phase 4
Completed
Xijing Hospital of Digestive Diseases
2023/07/17
Early Phase 1
Completed
Beijing Tongren Hospital
2023/03/01
Phase 4
Not yet recruiting
China National Center for Cardiovascular Diseases
2023/02/09
Not Applicable
Recruiting
Yu Chen
2022/12/13
Phase 4
Completed
China National Center for Cardiovascular Diseases
2021/11/03
Phase 4
Not yet recruiting
Tang Yida
2021/08/20
Phase 4
Completed
Xijing Hospital of Digestive Diseases

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
No FDA approvals found for this drug.

EMA Drug Approvals

Approved Product
Authorization Holder
Status
Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product
Manufacturer
Approval Number
Dosage Form
Strength
Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
Berberine Hydrochloride Capsules
国药准字H20023402
化学药品
胶囊剂
11/27/2020
Berberine Hydrochloride Capsules
国药准字H53021319
化学药品
胶囊剂
6/22/2020
Berberine Hydrochloride Capsules
国药准字H20045876
化学药品
胶囊剂
9/2/2020
Berberine Hydrochloride Capsules
国药准字H50020837
化学药品
胶囊剂
7/17/2020
Berberine Hydrochloride Capsules
国药准字H44023970
化学药品
胶囊剂
2/12/2020
Berberine Hydrochloride Capsules
国药准字H51020101
化学药品
胶囊剂
12/2/2019
Berberine Hydrochloride Capsules
国药准字H34021050
化学药品
胶囊剂
6/2/2020
Berberine Hydrochloride Capsules
国药准字H50020485
化学药品
胶囊剂
4/9/2020
Berberine Hydrochloride Capsules
国药准字H45020640
化学药品
胶囊剂
8/19/2020
Berberine Hydrochloride Tablets
国药准字H41023247
化学药品
片剂
7/6/2020

PPB Drug Approvals

Approved Product
Registration No.
Company
Licence No.
Strength
Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product
ARTG ID
Sponsor
Registration Type
Status
Registration Date
MURINE RELIEF berberine chloride 0.26mg/mL eye drops bottle
29660
Medicine
A
10/21/1991
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