Delving into the Latest Updates on Benapenem with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

Target

PBPs

Mechanism

PBPs inhibitors(Bacterial penicillin-binding protein inhibitors), Cell wall inhibitors

Therapeutic Areas

Infectious DiseasesUrogenital DiseasesRespiratory Diseases

Active Indication

Urinary Tract InfectionsHealthcare-Associated PneumoniaIntraabdominal Infections+ [1]

Inactive Indication

Bacterial InfectionsCommunity Acquired PneumoniaCommunity-Acquired Infections+ [3]

Originator Organization

Shandong Xuanzhu Pharmaceutical Technology Co., Ltd.

Active Organization

Shandong Xuanzhu Pharmaceutical Technology Co., Ltd.

Shanghai New Asiatic Pharmaceuticals Co., Ltd.

Inactive Organization

Shandong Hengli Medicine Science & Technology Co., Ltd.

Beijing Sihuan Pharmaceutical Co. Ltd.

Drug Highest PhasePhase 2/3

First Approval Date-

RegulationSpecial Review Project (CN)

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Structure

Molecular FormulaC22H28N4O7S2

InChIKeyJNSMRGMLNPEWLR-PDCLSYJBSA-N

CAS Registry1312953-83-5

主要目的：评价注射用百纳培南在轻、中度肾功能损害受试者中的药物代谢动力学特征，并与肾功能正常的健康受试者的药代动力学特征进行比较分析，为在肾功能损害患者中制定百纳培南的给药方案提供依据；评价注射用百纳培南在肾功能损害受试者中的安全性。

[Translation]

Main objective: To evaluate the pharmacokinetic characteristics of Benapenem for injection in subjects with mild and moderate renal impairment, and to compare and analyze the pharmacokinetic characteristics with those of healthy subjects with normal renal function, so as to provide a basis for formulating the dosing regimen of Benapenem in patients with renal impairment; to evaluate the safety of Benapenem for injection in subjects with renal impairment.

Start Date15 Jun 2019

Sponsor / Collaborator

Beijing Sihuan Pharmaceutical Co. Ltd.

[+1]

NCT04476407 / CompletedPhase 1

"Pharmacokinetics of Benapenem in Subjects With Mild or Moderate Renal Impairment "

This is an open-label, multiple center, parallel-group Study to compare the pharmacokinetics and safety of single-dose benapenem (1.0mg) in subjects with mild or moderate Renal Impairment(RI) and healthy subjects. Subjects were enrolled with defined degrees of RI based on eGFR(estimated Glomerular Filtration Rate) calculated by MDRD (Modification of Diet in Renal Disease)formular as follows: nomal renal function(≥90ml/min/1.73m2 ; N=6); mild RI (60-89mL/min/1.73 m2 ; N=6), moderate RI (30-59 mL/min/1.73m2 ; N=6)

Start Date15 Jun 2019

Sponsor / Collaborator

Sihuan Pharmaceutical Holdings Group Ltd.

100 Clinical Results associated with Benapenem

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100 Translational Medicine associated with Benapenem

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100 Patents (Medical) associated with Benapenem

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4

Literatures (Medical) associated with Benapenem

16 Apr 2023·Antibiotics (Basel, Switzerland)

Novel Antimicrobial Agents for Gram-Negative Pathogens

Review

Author: Koulenti, Despoina ; Abdul-Aziz, Mohd Hafiz ; Paramythiotou, Elisabeth ; Tsigou, Evdoxia ; Almyroudi, Maria Panagiota ; Blot, Stijn ; Karvouniaris, Marios

Gram-negative bacterial resistance to antimicrobials has had an exponential increase at a global level during the last decades and represent an everyday challenge, especially for the hospital practice of our era. Concerted efforts from the researchers and the industry have recently provided several novel promising antimicrobials, resilient to various bacterial resistance mechanisms. There are new antimicrobials that became commercially available during the last five years, namely, cefiderocol, imipenem-cilastatin-relebactam, eravacycline, omadacycline, and plazomicin. Furthermore, other agents are in advanced development, having reached phase 3 clinical trials, namely, aztreonam-avibactam, cefepime-enmetazobactam, cefepime-taniborbactam, cefepime-zidebactam, sulopenem, tebipenem, and benapenem. In this present review, we critically discuss the characteristics of the above-mentioned antimicrobials, their pharmacokinetic/pharmacodynamic properties and the current clinical data.

01 Jul 2022·European Journal of Clinical Pharmacology

Pharmacokinetics of benapenem for injection in subjects with mild to moderate renal impairment

Article

Author: Yu, Jicheng ; Yu, Chen ; Chen, Yuancheng ; Ren, Hong ; Zhang, Min ; You, Li ; Liang, Hong ; Wu, Jufang ; Lu, Jianda ; Xiao, Cuilan ; Yang, Haijing ; Zhang, Jing ; Zhang, Hong ; Xue, Jun ; He, Zishuang

OBJECTIVEThis study evaluated the pharmacokinetic (PK) characteristics of benapenem in subjects with mild to moderate renal impairment to provide a reference for benapenem dosing regimens in this patient population.METHODSEighteen subjects were enrolled in this study. Each subject received a single dose of benapenem intravenously (1.0 g in 100 ml of 0.9% saline) followed by blood and urine collection to measure the concentrations of benapenem and its major metabolite. PK analysis was performed to evaluate the effect of varying degrees of renal impairment on the PK characteristics of benapenem. The safety of benapenem was also evaluated.RESULTSIn subjects with normal renal function, mild renal impairment, and moderate renal impairment, the maximum plasma benapenem concentrations were 163 ± 6.58 mg/L, 138 ± 17.4 mg/L, and 134 ± 0.11 mg/L, respectively (15.3% and 17.8% lower in subjects with mild and moderate renal impairment, respectively, than in subjects with normal renal function). The areas under the plasma concentration-time curve (AUC_0-inf) were 1153.67 ± 143.2 mg·h/L, 1129.17 ± 241.41 mg·h/L, and 1316.46 ± 229.83 mg·h/L, respectively (P > 0.05); the cumulative urinary excretion rates at 72 h after dosing were 52.61 ± 8.58%, 39.42 ± 8.35%, and 29.84 ± 9.15%, respectively; and the metabolic ratio (AUC_0-inf__KBP-3331/AUC_0-inf__benapenem) were 3.96 ± 0.35%, 5.56 ± 0.82%, and 8.24 ± 0.85%, respectively. No drug-related adverse events (AEs), serious AEs, or AEs leading to withdrawal occurred in this study.CONCLUSIONNo adjustment to benapenem dosing is needed in patients with mild to moderate renal impairment.CLINICAL TRIAL REGISTRATIONDrug clinical trial registration and information publicity platform: http://www.chinadrugtrials.org.cn/index.html .REGISTRATION NUMBERCTR20190760.

21 Feb 2020·Antimicrobial Agents and ChemotherapyQ2 · MEDICINE

Model-Informed Drug Development, Pharmacokinetic/Pharmacodynamic Cutoff Value Determination, and Antibacterial Efficacy of Benapenem against Enterobacteriaceae

Q2 · MEDICINE

Article

Author: Yang, Xi-ping ; Ji, Xi-wei ; Zhong, Wei ; Kang, Zi-sheng ; Zhu, Xiao ; Kuan, Isabelle Hui-san ; Lv, Yuan ; Li, Yun ; Xue, Feng

Benapenem is a novel carbapenem. The objective of this study was to determine the pharmacokinetic (PK)/pharmacodynamic (PD) cutoff values and evaluate the optimal administration regimens of benapenem for the treatment of bacterial infections via PK/PD modeling and simulation. Ertapenem was used as a control. Infected mice received an intravenous (i.v.) injection of benapenem or ertapenem of 14.6, 58.4, or 233.6 mg/kg of body weight, and the PK/PD profiles were evaluated.

100 Deals associated with Benapenem

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Urinary Tract Infections	Phase 3	CN	Shanghai New Asiatic Pharmaceuticals Co., Ltd.	17 Jun 2022
Healthcare-Associated Pneumonia	Phase 2	CN	Shandong Xuanzhu Pharmaceutical Technology Co., Ltd.	-
Intraabdominal Infections	Phase 2	CN	Shandong Xuanzhu Pharmaceutical Technology Co., Ltd.	-
Pelvic Inflammatory Disease	Phase 2	CN	Shandong Xuanzhu Pharmaceutical Technology Co., Ltd.	-
Complicated urinary tract infection	Phase 1	CN	Shandong Xuanzhu Pharmaceutical Technology Co., Ltd.	13 Dec 2018
Complicated urinary tract infection	Phase 1	CN	Beijing Sihuan Pharmaceutical Co. Ltd.	13 Dec 2018
Pyelonephritis	Phase 1	CN	Beijing Sihuan Pharmaceutical Co. Ltd.	13 Dec 2018
Pyelonephritis	Phase 1	CN	Shandong Xuanzhu Pharmaceutical Technology Co., Ltd.	13 Dec 2018
Bacterial Infections	Phase 1	CN	Shandong Hengli Medicine Science & Technology Co., Ltd.	-
Community-Acquired Infections	Preclinical	CN	Shandong Xuanzhu Pharmaceutical Technology Co., Ltd.	-