Delving into the Latest Updates on Cefcamate Pivoxil Hydrochloride with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

CFPN-PI, Cefcapene Pivoxil Hydrochloride, Cefcapene Pivoxil Hydrochloride Hydrate

+ [6]

Target

PBPs

Action

inhibitors

Mechanism

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

Therapeutic Areas

Infectious DiseasesDigestive System DisordersEye Diseases+ [7]

Active Indication

Bacterial InfectionsAcute BronchitisCholangitis+ [28]

Inactive Indication-

Originator Organization

Shionogi & Co., Ltd.

Active Organization

Shionogi & Co., Ltd.

Jiangsu Hansoh Pharmaceutical Co., Ltd.

Inactive Organization-

Drug Highest PhaseApproved

First Approval Date

Japan (22 Apr 1997),

Acute BronchitisCholangitisCholecystitis+ [27]

RegulationPriority Review (China)

Login to view timeline

Structure/Sequence

Molecular FormulaC23H32ClN5O9S2

InChIKeyLUXIJPQYUCFVAL-XRLCNELCSA-N

CAS Registry147816-24-8

View All Structures (2)

主要目的：评估盐酸头孢卡品酯颗粒治疗儿童急性呼吸系统细菌感染中的临床疗效；次要目的：评估盐酸头孢卡品酯颗粒治疗儿童急性呼吸系统细菌感染的安全性；评估盐酸头孢卡品酯颗粒治疗儿童急性呼吸系统细菌感染的微生物学疗效；分析盐酸头孢卡品酯颗粒的药物敏感性。

[Translation]

Primary purpose: To evaluate the clinical efficacy of cefuroxime hydrochloride granules in the treatment of acute respiratory bacterial infections in children; Secondary purpose: To evaluate the safety of cefuroxime hydrochloride granules in the treatment of acute respiratory bacterial infections in children; To evaluate the microbiological efficacy of cefuroxime hydrochloride granules in the treatment of acute respiratory bacterial infections in children; To analyze the drug sensitivity of cefuroxime hydrochloride granules.

Start Date24 Jan 2025

Sponsor / Collaborator

Shionogi Pharma Chemicals Co., Ltd.

[+2]

CTR20242385

/ CompletedNot Applicable

盐酸头孢卡品酯颗粒在健康受试者中单中心、随机、开放、两制剂、单次给药、两周期、双交叉空腹/餐后生物等效性试验研究

[Translation] A single-center, randomized, open-label, two-formulation, single-dose, two-period, double-crossover fasting/fed bioequivalence study of cefcapone hydrochloride granules in healthy subjects

以药代动力学参数作为主要终点评价指标，分别比较在空腹/餐后状态下口服受试制剂盐酸头孢卡品酯颗粒（规格：50mg（按C17H19N5O6S2计），持证商：苏州盛达药业有限公司）与参比制剂盐酸头孢卡品酯颗粒（规格：50mg（按C17H19N5O6S2计），持证商：SHIONOGI & Co., LTD.）后在健康受试者体内的药代动力学行为，评价两种制剂的生物等效性。

[Translation]

Pharmacokinetic parameters were used as the primary endpoint evaluation indicators. The pharmacokinetic behaviors of the test preparation Cefcapone Hydrochloride Granules (Specification: 50 mg (calculated as C17H19N5O6S2), license holder: Suzhou Shengda Pharmaceutical Co., Ltd.) and the reference preparation Cefcapone Hydrochloride Granules (Specification: 50 mg (calculated as C17H19N5O6S2), license holder: SHIONOGI & Co., LTD.) in healthy subjects after oral administration in the fasting/postprandial state were compared to evaluate the bioequivalence of the two preparations.

Start Date31 Jul 2024

Sponsor / Collaborator

China Union Chempharma (Suzhou) Co., Ltd.

CTR20192349

/ RecruitingNot Applicable

盐酸头孢卡品酯颗粒在中国健康受试者中随机、开放、空腹及餐后、单剂量、两周期、双交叉的生物等效性试验

[Translation] A randomized, open-label, fasting and fed, single-dose, two-period, double-crossover bioequivalence study of cefcapone hydrochloride granules in Chinese healthy subjects

①主要目的：通过随机、开放、空腹及餐后、单剂量、两周期、双交叉的生物等效性试验以药代动力学参数为终点评价指标，评估受试制剂和参比制剂在空腹/餐后条件下给药时的相对生物利用度和生物等效性。 ②次要目的：观察受试制剂和参比制剂在健康受试者中的安全性。

[Translation]

①Main purpose: To evaluate the relative bioavailability and bioequivalence of the test preparation and the reference preparation under fasting/postprandial conditions through a randomized, open, fasting and postprandial, single-dose, two-period, double-crossover bioequivalence study with pharmacokinetic parameters as the endpoint evaluation indicators. ②Secondary purpose: To observe the safety of the test preparation and the reference preparation in healthy subjects.

Start Date30 Dec 2019

Sponsor / Collaborator

Zhongshan Bailing Biotechnology Co., Ltd.

100 Clinical Results associated with Cefcamate Pivoxil Hydrochloride

Login to view more data

100 Translational Medicine associated with Cefcamate Pivoxil Hydrochloride

Login to view more data

100 Patents (Medical) associated with Cefcamate Pivoxil Hydrochloride

Login to view more data

211

Literatures (Medical) associated with Cefcamate Pivoxil Hydrochloride

01 Jan 2025·Biomedicine & Pharmacotherapy

Oral administration of Bifidobacterium longum and Bifidobacterium infantis ameliorates cefcapene pivoxil-induced attenuation of anti-programmed cell death protein-1 antibody action in mice

Article

Author: Wada, Satoshi ; Udaka, Yuko ; Uchiyama, Jun ; Nakano, Ryota ; Tsunoda, Takuya ; Tajima, Kohei ; Nobe, Koji ; Kuramasu, Atsuo ; Maruyama, Yuki ; Oguchi, Tatsunori ; Yoshimura, Kiyoshi ; Amari, Yasunobu ; Yamazaki, Yoshitaka ; Akiyama, Masahiro ; Hosonuma, Masahiro ; Sasaki, Akiko ; Toyoda, Hitoshi ; Shida, Midori ; Funayama, Eiji ; Kiuchi, Yuji ; Sasaki, Aya ; Kim, Yun-Gi ; Tsuji, Mayumi ; Sambe, Takehiko ; Baba, Yuta ; Murayama, Masakazu ; Tsurui, Toshiaki ; Nakashima, Rie ; Kobayashi, Shinichi ; Isobe, Junya ; Narikawa, Yoichiro

Gut bacteria play pivotal roles in the antitumor effects of immune checkpoint inhibitors (ICIs). However, antimicrobial therapy, often necessary for infections in cancer patients, can reduce the efficacy of ICIs. The potential of probiotics to restore ICI efficacy remains uncertain. This study evaluated the effects of Bifidobacterium longum and Bifidobacterium infantis (BLBI) in a CT-26 subcutaneous tumor mouse model treated with anti-programmed cell death protein 1 antibody (αPD-1) and cefcapene pivoxil (CFPN-PI). BALB/c mice received daily oral gavage of CFPN-PI for 5 days before tumor inoculation, followed by weekly αPD-1 administration and tumor growth monitoring. BLBI was administered via ad libitum feeding, mixed in powdered feed. Gut microbiota composition and fecal short-chain fatty acid concentrations were assessed, along with gene expression and immune cell populations in the tumor microenvironment, using quantitative RT-PCR and flow cytometry, respectively. CFPN-PI alone increased tumor growth and attenuated the antitumor effect of αPD-1. In contrast, BLBI inhibited CFPN-PI-induced tumor growth and improved the efficacy of αPD-1. Probiotic treatment increased the stool propionic acid concentration and the number of tumor-infiltrating conventional type 1 dendritic cells. Relative decreases in Bacteroides and Lachnospiraceae _NK4A136_group species and relative increases in Muribaculaceae and Unclassified_f_Oscillospiraceae species correlated with an improved αPD-1 response. These results suggest that probiotic administration may be a new therapeutic strategy to rescue the attenuated efficacy of ICIs in patients with cancer who require antimicrobial therapy.

01 Dec 2024·European Journal of Medicinal Chemistry

Sensitive quantification of fibroblast activation protein and high-throughput screening for inhibition by FDA-approved compounds

Article

Author: Šácha, Pavel ; Šimková, Adéla ; Konvalinka, Jan ; Staňurová, Jana ; Čermáková, Kateřina ; Wichterle, Filip ; Bušek, Petr ; Kryštůfek, Robin ; Vaníčková, Zdislava

Fibroblast activation protein (FAP) has been extensively studied as a cancer biomarker for decades. Recently, small-molecule FAP inhibitors have been widely adopted as a targeting moiety of experimental theranostic radiotracers. Here we present a fast qPCR-based analytical method allowing FAP inhibition screening in a high-throughput regime. To identify clinically relevant compounds that might interfere with FAP-targeted approaches, we focused on a library of FDA-approved drugs. Using the DNA-linked Inhibitor Antibody Assay (DIANA), we tested a library of 2667 compounds within just a few hours and identified numerous FDA-approved drugs as novel FAP inhibitors. Among these, prodrugs of cephalosporin antibiotics and reverse transcriptase inhibitors, along with one elastase inhibitor, were the most potent FAP inhibitors in our dataset. In addition, by employing FAP DIANA in the quantification mode, we were able to determine FAP concentrations in human plasma samples. Together, our work expands the repertoire of FAP inhibitors, analyzes the potential interference of co-administered drugs with FAP-targeting strategies, and presents a sensitive and low-consumption ELISA alternative for FAP quantification with a detection limit of 50 pg/ml.

01 Oct 2024·Journal of Infection and Chemotherapy

Homology of Escherichia coli isolated from urine and vagina and their antimicrobial susceptibility in postmenopausal women with recurrent cystitis

Article

Author: Wada, Koichiro ; Sadahira, Takuya ; Hirakawa, Hidetada ; Araki, Motoo ; Ishii, Ayano ; Sekito, Takanori

Uropathogenic Escherichia coli (UPEC) is a typical cystitis-causing organism that can migrate from the vagina to the bladder and cause recurrent cystitis (RC). Few reports have compared the characteristics of urinary and vaginal UPEC in patients with RC. We carried out molecular biological analyses of Escherichia coli (E. coli) strains and their antimicrobial susceptibility to assess the association between urinary and vaginally UPEC. We included E. coli isolated from urinary and vaginal samples at the onset of cystitis in postmenopausal women with RC between 2014 and 2019 in our hospital. Pulsed-field gel electrophoresis (PFGE) was performed using a restriction enzyme (Xba I). These sequences were compared with 17 antimicrobial susceptibilities determined by a micro-liquid dilution method. Multilocus sequence typing (MLST) and classification of extended-spectrum β-lactamase (ESBL) genotypes by multiplex polymerase chain reaction (PCR) were performed on ESBL-producing E. coli. We analyzed 14 specimens (each seven urine and vaginal) from seven patients in total. On PFGE, the similarity of urinary and vaginal E. coli per patient ranged from 89.5 to 100 %, including four patients with 100 % matches. MLST demonstrated that 29 % (4/14 specimens) were strain sequence type 131. Two specimens contained ESBL-producing strains and identified the CTX-M-27 genotype for each specimen. For each patient, antimicrobial susceptibilities between urinary and vaginal E. coli were mostly identical. Thus, urinary- and vaginally-derived E. coli were identical in postmenopausal women with RC. Management targeting both urinary and vaginal UPEC is essential for RC, indicating the importance of a vagina-targeted approach.

100 Deals associated with Cefcamate Pivoxil Hydrochloride

Login to view more data

External Link

KEGG	Wiki	ATC	Drug Bank
-	-	J01DD17	-

R&D Status

10 top approved records.

Login

to view more data

Indication	Country/Location	Organization	Date
Acute Bronchitis	Japan	Shionogi & Co., Ltd.	22 Apr 1997
Cholecystitis	Japan	Shionogi & Co., Ltd.	22 Apr 1997
Cystitis	Japan	Shionogi & Co., Ltd.	22 Apr 1997
Dacryocystitis	Japan	Shionogi & Co., Ltd.	22 Apr 1997
Hordeolum	Japan	Shionogi & Co., Ltd.	22 Apr 1997
Jaw osteitis	Japan	Shionogi & Co., Ltd.	22 Apr 1997
Laryngitis	Japan	Shionogi & Co., Ltd.	22 Apr 1997
Mastitis	Japan	Shionogi & Co., Ltd.	22 Apr 1997
Meibomianitis	Japan	Shionogi & Co., Ltd.	22 Apr 1997
Otitis Externa	Japan	Shionogi & Co., Ltd.	22 Apr 1997
Otitis Media	Japan	Shionogi & Co., Ltd.	22 Apr 1997
Pelvic Inflammatory Disease	Japan	Shionogi & Co., Ltd.	22 Apr 1997
Pharyngitis	Japan	Shionogi & Co., Ltd.	22 Apr 1997
Pneumonia	Japan	Shionogi & Co., Ltd.	22 Apr 1997
Pyelonephritis	Japan	Shionogi & Co., Ltd.	22 Apr 1997
Pyoderma	Japan	Shionogi & Co., Ltd.	22 Apr 1997
Skin Diseases, Infectious	Japan	Shionogi & Co., Ltd.	22 Apr 1997
Suppuration	Japan	Shionogi & Co., Ltd.	22 Apr 1997
Urethritis	Japan	Shionogi & Co., Ltd.	22 Apr 1997
Vulvitis	Japan	Shionogi & Co., Ltd.	22 Apr 1997