Delving into the Latest Updates on Albenatide with Synapse

Overview

Basic Info

Drug Type

Synthetic peptide

Synonyms

PC-DAC:Exendin-4, PCDAC, 阿贝那肽

+ [4]

Target

GLP-1R

Action

agonists

Mechanism

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

Therapeutic Areas

Endocrinology and Metabolic Disease

Active Indication

Diabetes Mellitus, Type 2Obesity

Inactive Indication-

Originator Organization

ConjuChem LLC

Active Organization

Hebei Changshan Biochemical Pharmaceutical Co., Ltd.

Inactive Organization

ConjuChem LLC

License Organization

ConjuChem LLCHebei Changshan Long Kang Biotechnology Co., Ltd.Albumedix A/S

+ [1]

Drug Highest PhaseNDA/BLA

First Approval Date-

Regulation-

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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]

NCT07057271

/ CompletedPhase 3

A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Trial Designed to Evaluate the Efficacy and Safety of CJC-1134-PC Injection Administered Once A Week in Patients With Type 2 Diabetes With Inadequately Controlled Blood Glucose Level After Metformin Monotherapy or Metformin in Combination With Insulin Secretagogues

This study is a Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Trial Designed to Evaluate the Efficacy and Safety of CJC-1134-PC Injection Administered Once A Week in Patients with Type 2 Diabetes with Inadequately Controlled Blood Glucose Level after Metformin Monotherapy or Metformin in Combination with Insulin Secretagogues.

Start Date27 May 2021

Sponsor / Collaborator

Changshan ConjuChem BioPharmaceutical Research and Development (Hebei) Co., Ltd.

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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2

Literatures (Medical) associated with Albenatide

02 Dec 2021·EXPERT OPINION ON INVESTIGATIONAL DRUGS

Safety, tolerability, pharmacodynamics, and pharmacokinetics of CJC-1134-PC in healthy Chinese subjects and type-2 diabetic subjects

Article

Author: Yang, Lizhi ; Ding, Yanhua ; Yao, Zhiwen ; Wu, Min ; Xie, Qiang ; Liu, Xiping ; Li, Cuiyun ; Zhu, Xiaoxue ; Zhang, Hong

BACKGROUND:

Glucagon-like peptide-1 (GLP-1) mimetics are widely used for treating type 2 diabetes (T2D) with pleiotropic effects on heart and kidneys. The safety/tolerability and pharmacokinetics/pharmacodynamics ((PK/PD) of CJC-1134-PC (a long-acting GLP-1) were investigated in Chinese.

METHOD:

Two randomized, double-blind, placebo-controlled phase I studies were conducted. Study A: 30 healthy subjects received (subcutaneously injected) a single dose (2 mg) or titrate doses (2 + 3 and 2 + 3 + 4 mg at weekly intervals) of CJC-1134-PC. Study B: 49 T2D subjects received 10 weekly doses (1, 2, 3, and 4 mg).

RESULT:

CJC-1134-PC was well tolerated with gastrointestinal (GI) side effects. Higher doses increased the adverse events risk. CJC-1134-PC was steadily absorbed, with maximum plasma concentrations(C_max) occurring at 36-72 h and 48 h after administration in healthy and T2D subjects, respectively. The steady-state exposures in T2D subjects increased more than the dose-proportionality(1-3 mg). The mean t_1/2 ranged from 111.6 to 127.6 h. After four- five weeks of targeting doses, steady state was reached in T2D subjects with apparent accumulation effect. At week 11 for T2D subjects, HbA1c mean baseline change was significantly different than that of the placebo, and the fasting plasma glucose (FPG) was not significantly altered.

CONCLUSION:

The safety and PK/PD profiles of weekly CJC-1134-PC doses support Phase II studies with guidance on optimal-dose selection. Clinical trial registration: ChiCTR-IPC-15007190.

01 Apr 2010·Current diabetes reportsQ2 · MEDICINE

Once-Weekly GLP-1 Agonists: How Do They Differ from Exenatide and Liraglutide?

Q2 · MEDICINE

Review

Author: Christensen, Mikkel ; Knop, Filip K.

Incretin mimetics offer a new modality in diabetes treatment. This modality is based on the effects of the naturally occurring glucoregulatory gut hormone glucagon-like peptide-1 (GLP-1), which counteracts several pathophysiologic traits in type 2 diabetes. GLP-1 receptor agonists with extended half-lives entailing fewer injections and presumably an improved throughout-the-day glycemic control are in clinical development. This article summarizes the physiologic effects of GLP-1; the effects of the already marketed GLP-1 analogues for daily dosing, exenatide and liraglutide; and reviews the presently published data (with emphasis on clinical pharmacokinetics, efficacy, and safety) on GLP-1 agonists, which currently are in development and intended for once-weekly dosing: albiglutide/albugon, CJC-1131, CJC-1134-PC, exenatide once weekly, and taspoglutide.

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	China	Hebei Changshan Biochemical Pharmaceutical Co., Ltd.	25 Apr 2024
Obesity	Phase 1	China	Hebei Changshan Biochemical Pharmaceutical Co., Ltd.	25 May 2026

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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)	zwgizxrlej(lqgweqegmt) = phrgmyhodb tfbnvjgzcc (ajhbrgbtbh, 0.597) View more	-	19 Jul 2017
				CJC-1134-PC Injection (Arm 2 - Weekly CJC-1134-PC)	zwgizxrlej(lqgweqegmt) = dlqemvkwer tfbnvjgzcc (ajhbrgbtbh, 0.627) View more
NCT00674466 (CTgov)	Phase 2	Diabetes Mellitus, Type 2	90	CJC-1134-PC (1.5 mg CJC-1134-PC)	fkxceezlso(npbebvlhoy) = lhqkvcxubl aqyhoayzcz (wsgcnjcmjb, 1.226) View more	-	02 Jun 2017
				CJC-1134-PC (1.5 mg or 2.0 mg CJC-1134-PC)	fkxceezlso(npbebvlhoy) = aoaoamqfmh aqyhoayzcz (wsgcnjcmjb, 0.672) View more
NCT00638716 (DM200-101, CTgov)	Phase 2	Diabetes Mellitus, Type 2	122	CJC-1134-PC (1.5 mg CJC-1134-PC)	ngzbxappnl(vixofrabix) = cpmcpyrwgx mwqmtkorij (opwlusbaqk, 0.883) View more	-	02 Jun 2017
				CJC-1134-PC (1.5 or 2.0 mg CJC-1134-PC)	ngzbxappnl(vixofrabix) = zghszuknks mwqmtkorij (opwlusbaqk, 0.827) View more

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Biosimilar

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