Delving into the Latest Updates on Brivudine with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

(E)-5-(2-Bromovinyl)-deoxyuridine, BVdU, Brivudine (INN)

+ [7]

Target

DNA-directed DNA polymerase x TYMS

Mechanism

DNA-directed DNA polymerase inhibitors, TYMS inhibitors(Thymidylate synthase inhibitors)

Therapeutic Areas

Infectious DiseasesNeoplasmsDigestive System Disorders+ [1]

Active Indication

Varicella Zoster Virus InfectionHerpes ZosterPancreatic Cancer+ [1]

Inactive Indication

Eye InfectionsPancreatic adenocarcinoma metastaticPancreatic carcinoma non-resectable

Originator Organization-

Active Organization

RESprotect GmbHBERLIN-CHEMIE AG

Inactive Organization

SciClone Pharmaceuticals LLCMenarini Biotech SRL

Drug Highest PhaseApproved

First Approval Date

DE (05 Mar 2002),

Varicella Zoster Virus Infection

RegulationOrphan Drug (EU)

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Structure/Sequence

Molecular FormulaC11H13BrN2O5

InChIKeyODZBBRURCPAEIQ-PIXDULNESA-N

CAS Registry69304-47-8

主要研究目的：按有关生物等效性试验的规定，选择Berlin-Chemie AG生产的溴夫定片（商品名：Zostex（左代），规格：125mg/片）为参比制剂，对华润双鹤药业股份有限公司提供，华润双鹤利民药业（济南）有限公司生产的受试制剂溴夫定片（规格：125mg/片）进行空腹和餐后给药人体生物等效性试验，比较受试制剂中药物的吸收速度和吸收程度与参比制剂的差异是否在可接受的范围内，比较两种制剂在空腹和餐后给药条件下的生物等效性。次要研究目的：观察健康志愿受试者口服受试制剂溴夫定片（规格：125mg/片）和参比制剂溴夫定片（商品名：Zostex（左代），规格：125mg/片）的安全性。

[Translation]

Main research purpose: According to the relevant provisions of bioequivalence test, brivudine tablets (trade name: Zostex, specification: 125 mg/tablet) produced by Berlin-Chemie AG were selected as the reference preparation, and the test preparation brivudine tablets (specification: 125 mg/tablet) provided by China Resources Double Crane Pharmaceutical Co., Ltd. and produced by China Resources Double Crane Limin Pharmaceutical (Jinan) Co., Ltd. were subjected to human bioequivalence test for fasting and postprandial administration, to compare whether the absorption rate and degree of the drug in the test preparation were within the acceptable range with the reference preparation, and to compare the bioequivalence of the two preparations under fasting and postprandial administration conditions. Secondary research purpose: To observe the safety of oral administration of the test preparation brivudine tablets (specification: 125 mg/tablet) and the reference preparation brivudine tablets (trade name: Zostex, specification: 125 mg/tablet) in healthy volunteers.

Start Date02 Jun 2021

Sponsor / Collaborator

China Resources Double-Crane Pharmaceutical (Jinan) Co., Ltd.

CTR20210797

/ CompletedNot Applicable

溴夫定片在健康受试者空腹及餐后状态下，单中心、随机、开放、完全重复试验。

[Translation] This was a single-center, randomized, open, completely repeated trial of brivudine tablets in healthy subjects in the fasting and fed state.

考察健康受试者在空腹及餐后条件下单次口服湖南华纳大药厂股份有限公司生产的溴夫定片（受试制剂，规格：125mg）与Berlin-Chemie AG生产的溴夫定片（参比制剂，商品名：Zostex®，规格：125mg）的药动学特征，评价两制剂间的生物等效性，为该受试制剂注册申请提供依据。

[Translation]

To investigate the pharmacokinetic characteristics of brivudine tablets (test preparation, specification: 125 mg) produced by Hunan Warner Pharmaceutical Co., Ltd. and brivudine tablets (reference preparation, trade name: Zostex®, specification: 125 mg) produced by Berlin-Chemie AG after a single oral administration under fasting and postprandial conditions in healthy subjects, evaluate the bioequivalence between the two preparations, and provide a basis for the registration application of the test preparation.

Start Date10 May 2021

Sponsor / Collaborator

Hunan Warrant Pharmaceutical Co., Ltd.

CTR20171008

/ CompletedNot Applicable

一项评估中国健康成年受试者空腹/餐后口服溴夫定片后体内生物等效性的随机、开放、单剂量、交叉对照研究

[Translation] A randomized, open-label, single-dose, crossover study to evaluate the in vivo bioequivalence of oral brivudine tablets in healthy Chinese adult subjects after fasting or feeding

评价两种制剂空腹时生物利用度，获取参比制剂个体内变异度，用于计算和调整正式试验样本量，同时验证和确定正式试验流程、采血点和样本数，以确定是否采用参比制剂校正的平均生物等效性评价方法。计算餐后受试和参比制剂的总体变异系数，用于计算和调整正式试验样本量，并验证和完善正式试验流程、采血点和样本数。

[Translation]

Evaluate the fasting bioavailability of the two preparations, obtain the intra-individual variability of the reference preparation, which is used to calculate and adjust the sample size of the formal test, and verify and determine the formal test process, blood collection points and sample number to determine whether to use the average bioequivalence evaluation method corrected by the reference preparation. Calculate the overall coefficient of variation of the test and reference preparations after meals, which is used to calculate and adjust the sample size of the formal test, and verify and improve the formal test process, blood collection points and sample number.

Start Date11 Sep 2017

Sponsor / Collaborator

China Resources Double-Crane Pharmaceutical Co., Ltd.

100 Clinical Results associated with Brivudine

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100 Translational Medicine associated with Brivudine

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100 Patents (Medical) associated with Brivudine

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356

Literatures (Medical) associated with Brivudine

31 Dec 2024·Journal of Dermatological Treatment

Efficacy and safety of brivudine for the treatment of herpes zoster: a systematic review and meta-analysis

Review

Author: Zhang, Litao ; Cao, Peng ; Chen, Jiaxing ; He, Junchen ; Lei, Dongyun

BACKGROUND AND OBJECTIVEBrivudine has been used in herpes zoster (HZ) treatment for years, but the safety and efficacy of brivudine are inconclusive. Here we perform a meta-analysis to assess the efficacy, safety, incidence of postherpetic neuralgia of brivudine.METHODSData of randomized controlled Trials (RCTS) were obtained from the databases of both English (PubMed, Embase, and Cochrane Library) and Chinese (China National Knowledge Infrastructure, China Science Journal Database, and WanFang Database) literatures from inception to 12 September 2022. Meta-analyses of efficacy and safety of Brivudine for the treatment of herpes zoster for RCTS were conducted.RESULTSThe analyses included seven RCTS (2095 patients in experimental group and 2076 patients in control group) in the treatment of HZ with brivudine. It suggested that the brivudine group was superior to the control group in terms of efficacy (p = .0002) and incidence of postherpetic neuralgia (p = .04). But the incidence of adverse reactions has no significant difference between the brivudine and the control groups (p = .22). In addition, subgroup analysis of adverse events also showed that brivudine was about the same safety as other modalities in the treatment of HZ (p > .05).CONCLUSIONSBrivudine is effective for HZ. However, the evidence on the safety of brivudine is insufficient.

01 Dec 2024·Indian Journal of Ophthalmology

Primary treatment failure in acute retinal necrosis – A comprehensive review

Review

Author: Kawali, Ankush ; Khanum, Aayesha ; Mahendradas, Padmamalini ; Mishra, Sai B ; Sanjay, Srinivasan

Acute retinal necrosis (ARN) is a sight-threatening ophthalmic emergency that requires aggressive treatment to prevent irreversible vision loss. However, primary treatment failure (PTF), where the initial antiviral therapy is ineffective, is a common challenge in ARN management. This comprehensive review examines PTF in ARN, drawing insights from a systematic literature search spanning 1997 to 2022, which identified 35 relevant cases from 23 reports. The analysis focuses on drug resistance patterns, alternative antiviral agents, combination therapies, and emerging treatments. Potential causes of drug resistance, including host factors, viral mutations, and drug-related considerations, are elucidated. Alternative agents such as foscarnet, cidofovir, and brivudine, as well as combination approaches involving systemic and intravitreal administration, high-dose therapy, judicious use of steroids, and potential treatment-related complications, are discussed. The review also highlights emerging therapies, including vaccines, monoclonal antibodies, and natural compounds, offering insights into future directions for addressing this challenging condition.

24 Oct 2024·Cureus

Genital Herpes Zoster: A Report of a Rare Case

Article

Author: Anagnostaki, Ismini ; Alexakis, Chalent ; Anagnostaki, Maria Emmanouela ; Kalantzi, Sofia ; Zacharis, Konstantinos

Herpes zoster (HZ), caused by the reactivation of the varicella-zoster virus (VZV), typically presents as a unilateral vesicular rash in a dermatomal pattern. Its occurrence in the genital area is rare and often misdiagnosed. We report the case of a 51-year-old woman who presented with sudden vulvar pain and burning, without a history of immunodeficiency or sexually transmitted infections. Examination revealed unilateral vesicular lesions on the left labium majus, perianal area, medial thigh, and gluteal region along the second sacral (S2) and third sacral (S3) dermatomes. Polymerase chain reaction (PCR) confirmed VZV and ruled out herpes simplex virus (HSV). The patient was treated with brivudine, mupirocin, and analgesics, resulting in a complete resolution of symptoms. This case highlights the need to consider HZ in the differential diagnosis of genital lesions. Early recognition and treatment of atypical presentations can prevent complications and improve patient outcomes.

100 Deals associated with Brivudine

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External Link

KEGG	Wiki	ATC	Drug Bank
D07249	Brivudine	J05AB15	DB03312

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Varicella Zoster Virus Infection	DE	BERLIN-CHEMIE AG	05 Mar 2002
Herpes Zoster	-	-	-

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Pancreatic Cancer	Phase 3	-	RESprotect GmbH	-
Pancreatic carcinoma non-resectable	Phase 2	HU	SciClone Pharmaceuticals LLC	01 Sep 2007
Pancreatic carcinoma non-resectable	Phase 2	PE	SciClone Pharmaceuticals LLC	01 Sep 2007
Pancreatic carcinoma non-resectable	Phase 2	AR	SciClone Pharmaceuticals LLC	01 Sep 2007
Pancreatic carcinoma non-resectable	Phase 2	DE	SciClone Pharmaceuticals LLC	01 Sep 2007
Pancreatic carcinoma non-resectable	Phase 2	ES	SciClone Pharmaceuticals LLC	01 Sep 2007
Pancreatic carcinoma non-resectable	Phase 2	NL	SciClone Pharmaceuticals LLC	01 Sep 2007
Pancreatic carcinoma non-resectable	Phase 2	GB	SciClone Pharmaceuticals LLC	01 Sep 2007
Pancreatic carcinoma non-resectable	Phase 2	CL	SciClone Pharmaceuticals LLC	01 Sep 2007
Pancreatic carcinoma non-resectable	Phase 2	RO	SciClone Pharmaceuticals LLC	01 Sep 2007