Delving into the Latest Updates on Cibinetide with Synapse

Overview

Basic Info

Drug Type

Synthetic peptide

Synonyms

Cibinetide (USAN/INN), pHBSP

+ [2]

Target

EPO receptor

Action

agonists

Mechanism

EPO receptor agonists(Erythropoietin receptor agonists)

Therapeutic Areas

Immune System DiseasesNervous System DiseasesCardiovascular Diseases+ [4]

Active Indication-

Inactive Indication

Diabetes Mellitus, Type 2Diabetic macular oedemaGlucose Intolerance+ [3]

Originator Organization

Araim Pharmaceuticals, Inc.

Active Organization-

Inactive Organization

Araim Pharmaceuticals, Inc.

License Organization-

Drug Highest PhaseDiscontinuedPhase 2

First Approval Date-

Regulation-

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Structure/Sequence

Molecular FormulaC51H84N16O21

InChIKeyWZTIQQBMSJTRBR-WYKNNRPVSA-N

CAS Registry1208243-50-8

Sequence Code 148592

Source: *****

ARA 290-DMO is a prospective, open label, interventional, single centre, investigator led, phase II trial to examine the effect of ARA 290 on diabetic macular oedema in patients with type 1 or 2 diabetes.
The aim or primary objective of the study was to determine whether ARA 290 administered at a daily dose of 4mg subcutaneously for 12 weeks to patients with diabetes mellitus (DM) and DMO would have a beneficial effect on mean change in best corrected visual acuity (BCVA) from baseline values to week 12.

Start Date01 Apr 2016

Sponsor / Collaborator

Belfast Health & Social Care Trust

[+1]

EUCTR2015-001940-12-GB

/ Not yet recruitingPhase 2IIT

A phase II Clinical Trial on the use of ARA 290 for the treatment of diabetic macular oedema (ARA 290-DMO) - The use of ARA 290 for the treatment of DMO (ARA 290-DMO) v1

Start Date10 Nov 2015

Sponsor / Collaborator

Belfast Health & Social Care Trust

NCT02039687

/ CompletedPhase 2

A Double Blind, Placebo Controlled Phase 2 Dose Ranging Study of the Effects of ARA 290 on Corneal Nerve Fiber Density and Neuropathic Symptoms of Subjects With Sarcoidosis

The purpose of this study is to determine whether ARA 290, a new class of compound, is effective in the treatment of the neuropathic symptoms of sarcoidosis. Brief interaction of ARA 290 with the innate repair receptor results in anti-apoptotic and anti-inflammatory activities in myriad of cells, tissues and organs throughout the body to activate repair mechanisms and accelerate healing, including the nerve damage that can be associated with sarcoidosis. In this study, subjects with sarcoidosis and symptoms of small fiber neuropathy will administered ARA 290 or placebo by subcutaneous injection daily for 28 days. In addition to monitoring the safety of the treatment, the symptoms of the subjects will be assessed with several questionnaires, function tests, and measurement of nerve fibers in their cornea and skin (via a non-invasive test and a biopsy, respectively). The total participation time for each patient will be 16 weeks.

Start Date01 Jan 2014

Sponsor / Collaborator

Araim Pharmaceuticals, Inc.

100 Clinical Results associated with Cibinetide

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100 Translational Medicine associated with Cibinetide

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100 Patents (Medical) associated with Cibinetide

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95

Literatures (Medical) associated with Cibinetide

01 Jun 2025·European Journal of Pharmacology

ARA290, an alternative of erythropoietin, inhibits activation of NLRP3 inflammasome in schwann cells after sciatic nerve injury

Article

Author: Wang, Xiao ; Liang, Jie ; Li, Wei ; Wang, Luoyang ; Liu, Xiaoli ; Song, Meiying ; Jiang, Suli ; Zhang, Bei ; Liu, Guixian ; Yang, Zijie ; Zhang, Li ; Yang, Yanyan

The challenge of repairing peripheral nerve injury is a critical issue that needs to be addressed urgently. Previous research has shown that erythropoietin (EPO) and its prolonged peptides exhibit beneficial effects in neurological disorders. In our study, we demonstrated that both EPO and pyroglutamic acid helix B surface peptide (pHBSP, also known as ARA290) inhibit the early inflammatory response and promote functional recovery after sciatic nerve crush injury in rat models. Our experimental results demonstrate that significant inflammatory response occurred in Schwann cells after sciatic nerve injury, and that the activation of NLRP3 inflammasome in Schwann cells is inhibited after EPO and ARA290 treatment. Our study further demonstrated that EPO and ARA290 inhibit the activation of NLRP3 inflammasome in Schwann cells by inhibiting NF-κB phosphorylation and reducing reactive oxygen species (ROS) production. In summary, EPO and ARA290 promote repair and regeneration by inhibiting the activation of NLRP3 inflammasome after sciatic nerve injury.

31 Dec 2024·Toxicology Research

Mechanisms of ARA290 in counteracting cadmium-triggered neurotoxicity in PC12 cells

Article

Author: Ghassemi Barghi, Nasrin ; Fakhri B, Maryam S ; Motafeghi, Farzaneh

Abstract Erythropoietin (EPO) is known for its role in hematopoiesis and also exhibits anti-inflammatory, anti-apoptotic, antioxidant, and cytoprotective properties. However, its clinical application is limited by hematopoietic side effects. ARA290, a non-hematopoietic derivative of EPO, selectively activates the innate repair receptor (IRR) and replicates these protective effects without the associated hematopoietic complications. Cadmium (Cd), a prevalent environmental toxin, causes neurotoxic damage through mechanisms such as oxidative stress, genotoxicity, apoptosis, and inflammation. This study explored ARA290’s neuroprotective effects against cadmium-induced toxicity in PC12 cells, an in vitro model for neuronal health. PC12 cells pretreated with ARA290 showed significantly improved cell viability in the MTT assay, indicating reduced cytotoxicity. The comet assay revealed decreased DNA damage, suggesting reduced genotoxicity. ARA290 also alleviated oxidative stress, as evidenced by reduced levels of reactive oxygen species (ROS) and malondialdehyde (MDA), alongside increased glutathione (GSH), total antioxidant capacity (TAC), and superoxide dismutase (SOD) activities. A marker of apoptosis, TUNEL-positive cells, was significantly reduced. Additionally, ARA290 decreased inflammatory markers such as TNF alpha, IL1ß and IL 6. These findings demonstrate that ARA290, via IRR activation, provides robust neuroprotection against cadmium-induced toxicity, suggesting a multi-faceted protective mechanism. This highlights ARA290’s potential therapeutic role in managing heavy metal-induced neurotoxicity and supports further research into its long-term effects and applications in other neurodegenerative diseases or conditions involving environmental toxins.Highlights

01 Dec 2024·Neuroscience Bulletin

Microglial EPOR Contribute to Sevoflurane-induced Developmental Fine Motor Deficits Through Synaptic Pruning in Mice

Article

Author: Shi, Xiaotong ; Kuang, Fang ; Zhao, Youyi ; Cao, Shuhui ; He, Danyi ; Liu, Bing ; Zhang, Xiao ; Liang, Lirong ; Gao, Zhenzhen ; Fan, Ze ; Ma, Sanxing ; Zhang, Hui

AbstractClinical researches including the Mayo Anesthesia Safety in Kids (MASK) study have found that children undergoing multiple anesthesia may have a higher risk of fine motor control difficulties. However, the underlying mechanisms remain elusive. Here, we report that erythropoietin receptor (EPOR), a microglial receptor associated with phagocytic activity, was significantly downregulated in the medial prefrontal cortex of young mice after multiple sevoflurane anesthesia exposure. Importantly, we found that the inhibited erythropoietin (EPO)/EPOR signaling axis led to microglial polarization, excessive excitatory synaptic pruning, and abnormal fine motor control skills in mice with multiple anesthesia exposure, and those above-mentioned situations were fully reversed by supplementing EPO-derived peptide ARA290 by intraperitoneal injection. Together, the microglial EPOR was identified as a key mediator regulating early synaptic development in this study, which impacted sevoflurane-induced fine motor dysfunction. Moreover, ARA290 might serve as a new treatment against neurotoxicity induced by general anesthesia in clinical practice by targeting the EPO/EPOR signaling pathway.

100 Deals associated with Cibinetide

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External Link

KEGG	Wiki	ATC	Drug Bank
D11218	-	-	DB13006

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Diabetic macular oedema	Phase 2	United Kingdom	Araim Pharmaceuticals, Inc.	01 Apr 2016
Neurosarcoidosis	Phase 2	United States	Araim Pharmaceuticals, Inc.	01 Jan 2014
Neurosarcoidosis	Phase 2	Netherlands	Araim Pharmaceuticals, Inc.	01 Jan 2014
Pain	Phase 2	United States	Araim Pharmaceuticals, Inc.	01 Jan 2014
Pain	Phase 2	Netherlands	Araim Pharmaceuticals, Inc.	01 Jan 2014
Diabetes Mellitus, Type 2	Phase 2	Sweden	Araim Pharmaceuticals, Inc.	01 Oct 2013
Glucose Intolerance	Phase 2	Sweden	Araim Pharmaceuticals, Inc.	01 Oct 2013
Prediabetic State	Phase 2	Sweden	Araim Pharmaceuticals, Inc.	01 Oct 2013

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02039687 (CTgov)	Phase 2	Pain \| Neurosarcoidosis	64	ARA 290 (1 mg Per Day ARA 290)	ciezdeoqos(iewglrdhoz) = nmvelsyywq pusmpbunxx (mduuxjodfu, eiwgokbdyx - akmsasebpy) View more	-	18 Jan 2017
				ARA 290 (4 mg Per Day ARA 290)	ciezdeoqos(iewglrdhoz) = nlscupqlaw pusmpbunxx (mduuxjodfu, ssmdmdzmwf - xzdzsigtzr) View more
PS 045 (EASD2013)	Not Applicable	Diabetes Mellitus, Type 2	-	ARA290	rkjtaxiuqw(resbytlyty) = ijegfhijof rmycpikbeu (vyhfhhmwgg ) View more	Positive	25 Sep 2013
				Placebo	rkjtaxiuqw(resbytlyty) = iyxyfzncgb rmycpikbeu (vyhfhhmwgg ) View more

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Translational Medicine

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Clinical Trial

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Approval

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Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

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Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

Regulation

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Cibinetide

Overview

Basic Info

Structure/Sequence

Related

External Link

R&D Status

Clinical Result

Translational Medicine

Deal

Core Patent

Clinical Trial

Approval

Biosimilar

Regulation