Delving into the Latest Updates on Albenatide with Synapse

Overview

Basic Info

Drug Type

Synthetic peptide

Synonyms

PC-DAC:Exendin-4, PCDAC

+ [3]

Target

GLP-1R

Mechanism

GLP-1R agonists(Glucagon-like peptide 1 receptor agonists)

Therapeutic Areas

Endocrinology and Metabolic Disease

Active Indication

Diabetes Mellitus, Type 2

Inactive Indication-

Originator Organization

ConjuChem LLC

Active Organization

Hebei Changshan Biochemical Pharmaceutical Co., Ltd.

Inactive Organization

ConjuChem LLC

Drug Highest PhaseNDA/BLA

First Approval Date-

RegulationSpecial Review Project (CN)

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Structure/Sequence

Sequence Code 3958

Source: *****

Sequence Code 37437

Source: *****

主要目的：评价在健康受试者中皮下注射CJC-1134-PC注射液分别对二甲双胍、阿托伐他汀、华法林的药代动力学的影响，为CJC-1134-PC注射液临床合并用药提供科学依据。次要目的：1、评价在健康受试者中皮下注射CJC-1134-PC注射液对华法林的药效学的影响；2、评价在健康受试者中皮下注射CJC-1134-PC注射液分别与二甲双胍、阿托伐他汀、华法林联合给药的安全性。

[Translation]

Primary objective: To evaluate the effect of subcutaneous injection of CJC-1134-PC injection on the pharmacokinetics of metformin, atorvastatin, and warfarin in healthy subjects, and to provide a scientific basis for the clinical combination of CJC-1134-PC injection. Secondary objectives: 1. To evaluate the effect of subcutaneous injection of CJC-1134-PC injection on the pharmacodynamics of warfarin in healthy subjects; 2. To evaluate the safety of subcutaneous injection of CJC-1134-PC injection in combination with metformin, atorvastatin, and warfarin in healthy subjects.

Start Date21 Oct 2022

Sponsor / Collaborator

Hebei Changshan Biochemical Pharmaceutical Co., Ltd.

[+1]

CTR20202678

/ CompletedPhase 3

一项多中心、随机、双盲、安慰剂对照III期临床研究以评价在接受二甲双胍单药或二甲双胍联合胰岛素促泌剂治疗后血糖控制不佳的2型糖尿病患者中CJC-1134-PC注射液每周给药1次的有效性和安全性

[Translation] A multicenter, randomized, double-blind, placebo-controlled Phase III clinical study to evaluate the efficacy and safety of CJC-1134-PC injection once weekly in patients with type 2 diabetes who have poor glycemic control after treatment with metformin alone or metformin combined with insulin secretagogues

主要目的：在二甲双胍单药或二甲双胍联合胰岛素促泌剂治疗后血糖控制不佳的2型糖尿病患者中评价CJC-1134-PC注射液每周给药1次、连续给药24周对比安慰剂的有效性。次要目的：在二甲双胍单药或二甲双胍联合胰岛素促泌剂治疗后血糖控制不佳的2型糖尿病患者中评价CJC-1134-PC注射液每周给药1次： 1.与安慰剂对比，连续给药24周的安全性； 2.连续给药28周和52周的有效性； 3.连续给药28周和52周的安全性。

[Translation]

Primary objective: To evaluate the efficacy of CJC-1134-PC injection once a week for 24 weeks compared with placebo in patients with type 2 diabetes who have poor glycemic control after treatment with metformin alone or metformin combined with insulin secretagogues. Secondary objective: To evaluate the efficacy of CJC-1134-PC injection once a week for 24 weeks compared with placebo in patients with type 2 diabetes who have poor glycemic control after treatment with metformin alone or metformin combined with insulin secretagogues: 1. Safety of continuous administration for 24 weeks compared with placebo; 2. Efficacy of continuous administration for 28 and 52 weeks; 3. Safety of continuous administration for 28 and 52 weeks.

Start Date15 Apr 2021

Sponsor / Collaborator

Hebei Changshan Biochemical Pharmaceutical Co., Ltd.

[+1]

100 Clinical Results associated with Albenatide

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100 Translational Medicine associated with Albenatide

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100 Patents (Medical) associated with Albenatide

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19

Literatures (Medical) associated with Albenatide

01 Jun 2024·European Journal of Surgical Oncology

Staging laparoscopy with peritoneal lavage to identify peritoneal metastases and free intraperitoneal cancer cells in the management of locally advanced gastric cancer

Article

Author: Rouvelas, I ; Huang, B ; Ri, M ; Rampulla, V ; Nilsson, M ; Klevebro, F ; Lindblad, M

INTRODUCTIONGastric cancer often presents in advanced stage with a significant risk for peritoneal dissemination. Staging laparoscopy can be used to detect peritoneal carcinomatosis (PC+) and free cancer cells in peritoneal lavage cytology (CY+). The current study aimed to present the outcomes of staging laparoscopy and the prognosis of PC+ and CY+ in a Swedish high-volume center.MATERIALS AND METHODSA cohort study including all consecutive patients with locally advanced gastric cancer who underwent staging laparoscopy between February 2008 and October 2022. The laparoscopy findings were categorized as PC+, PC-CY+ (positive cytology without peritoneal carcinomatosis) or negative laparoscopy (PC-CY-). The primary endpoint was overall survival (OS) stratified by laparoscopy findings. The secondary endpoint was OS within each laparoscopy finding group stratified by subsequent treatment.RESULTSAmong 168 patients who underwent staging laparoscopy, 78 patients (46%) had PC-CY-, 29 patients (17%) had PC-CY+ and 61 patients (36%) had PC+. Decreased OS was observed for both PC-CY+ patients (aHR 2.14, 95% CI 1.13-4.06) and PC+ patients (aHR 5.36, 95% CI 3.21-8.93), compared to PC-CY-. Patients with PC-CY+ who converted to PC-CY- after chemotherapy and underwent tumor resection seemed to have a better prognosis compared to patients with persisting PC-CY+.CONCLUSIONSStaging laparoscopy is an important tool in the staging of locally advanced gastric cancer. Tumor resection for patients with PC-CY+ who convert to PC-CY- may lead to improved survival for these patients.

01 Jan 2024·Japanese Journal of Ophthalmology

Corneal refractive error and astigmatism in patients aged 6 to 18 years with a history of retinopathy of prematurity and birth weight of <1500 g

Article

Author: Ueno, Ritsuko ; Noda, Toru ; Tachikawa, Takako ; Mita, Tetsuko ; Yuzurihara, Daisuke

PURPOSETo investigate corneal refractive power (CR) and astigmatism (AS) in 6- to 18-year-old children with a history of retinopathy of prematurity (ROP) and birth weight of <1500 g who either did or did not undergo retinal photocoagulation (PC).STUDY DESIGNRetrospective study.METHODSWe examined 143 eyes of 77 children in 2021. The children were divided into three groups for evaluation of CR and AS: those with a birth weight of ≥2500 g (normal birth weight [NBW] group, 13 eyes) as controls, those with spontaneously resolved ROP (sr-ROP group, 27 eyes), and those who underwent PC for treatment of ROP (PC-ROP group, 103 eyes). Swept-source anterior segment optical coherence tomography was used to analyze the cornea.RESULTSThe median CR in the NBW, sr-ROP, and PC-ROP groups was 42.2 (41.3, 42.8) diopters (D), 44.5 (43.2, 45.5) D, and 45.2 (43.8, 46.6) D, respectively. The median AS in the NBW, sr-ROP, and PC-ROP groups was 1.2 (1.0, 1.5) D, 1.1 (0.8, 1.6) D, and 2.1 (1.4, 2.7) D. In the PC-ROP group, the with-the-rule astigmatic axis was 97%. In all three groups, a strong positive correlation was found between the mean anterior and posterior CR (NBW: r=0.795, sr-ROP: r=0.842, PC-ROP: r=0.890) and AS (NBW: r=0.883, sr-ROP: r=0.841, PC-ROP: r=0.860).CONCLUSIONCR was significantly higher in the sr-ROP (p=0.013) and PC-ROP (p<0.001) groups than in the NBW group. The PC-ROP group had significantly more AS than the sr-ROP group. There was a strong correlation between the anterior and posterior CR and AS.

01 Dec 2023·International Journal of Biological Macromolecules

Antimicrobial and anti-SARS-CoV-2 activities of smart daclatasvir-chitosan/gelatin nanoparticles-in-PLLA nanofibrous medical textiles; in vitro, and in vivo study

Article

Author: Hamdi, Mohamed ; Hammad, Mohamed A ; Elkashlan, Akram M ; Ali, Isra H

This study aims at the development of electrospun polylactic acid nanofibers (PLLA NFs) incorporating smart daclatasvir-loaded chitosan gelatin nanoparticles to be used as medical textiles. First, smart nanoparticles were prepared through ionic gelation and optimized using Design Expert® software where daclatasvir (DAC), chitosan (CS), and gelatin (GL) amounts were selected to be the independent variables. DAC was used owing to its reported Anti-SARS-CoV-2 activity, CS was chosen due to its antimicrobial activity and GL was used owing to its sensitivity to be hydrolyzed upon exposure to Papain-like protease enzyme (PLpro). The optimum DAC-CS/TAN NPs possessed 109 nm size and 94.44 % entrapment efficiency in addition to sustained drug release for 14 days. Furthermore, upon exposure to PLpro, smart DAC-CS/GL NPs released the whole DAC amount within 3 h. Then, DAC-CS/GL NPs were incorporated within PLLA NFs through electrospinning. Swellability was found to increase gradually reflecting the controlled release of DAC from nanofibers within 3 weeks. Cell viability assessments using human fibroblasts showed that the developed nanofibers possess high biocompatibility. An in-vivo animal model for skin irritation was carried out for two weeks where visual inspection and histopathological investigations showed that neither edema nor erythema were observed.

100 Deals associated with Albenatide

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Diabetes Mellitus, Type 2	NDA/BLA	CN	Hebei Changshan Biochemical Pharmaceutical Co., Ltd.	25 Apr 2024

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01514149 (CTgov)	Phase 2	Diabetes Mellitus, Type 2	73	CJC-1134-PC Injection (Arm 1 - Weekly CJC-1134-PC)	dosvbqlkeu(cxtdyajlnu) = tavkgipddd wifqtzrcvi (nowzvxnnlt, vufsykygjs - qyewclgysu) View more	-	19 Jul 2017
				CJC-1134-PC Injection (Arm 2 - Weekly CJC-1134-PC)	dosvbqlkeu(cxtdyajlnu) = mtlazvveeu wifqtzrcvi (nowzvxnnlt, rmmzdfnlfu - wgebicezbo) View more
NCT00638716 (DM200-101, CTgov)	Phase 2	Diabetes Mellitus, Type 2	122	CJC-1134-PC (1.5 mg CJC-1134-PC)	wwnaeidbus(ysehrlcpqr) = ddssamdwyj jculbyjuop (zciwdewkmy, tkjwypnnfq - zcrgearqdq) View more	-	02 Jun 2017
				CJC-1134-PC (1.5 or 2.0 mg CJC-1134-PC)	wwnaeidbus(ysehrlcpqr) = tbyrzsxtix jculbyjuop (zciwdewkmy, dkuieasnpc - xuqcdxctxk) View more
NCT00674466 (CTgov)	Phase 2	Diabetes Mellitus, Type 2	90	CJC-1134-PC (1.5 mg CJC-1134-PC)	udvshafxos(lyvfaznmft) = kmjosadnqx ddwnxqqzte (uaqaasugik, iwsijdgmfk - mdmlfrrphq) View more	-	02 Jun 2017
				CJC-1134-PC (1.5 mg or 2.0 mg CJC-1134-PC)	udvshafxos(lyvfaznmft) = ppfhlboxkj ddwnxqqzte (uaqaasugik, vnnmxgjtmc - lyekkeqsqd) View more