PeptideTrace
Research CompoundInnate Repair Receptor AgonistTissue Repair & Healing

ARA-290 (Cibinetide)

C

Evidence Grade C — Moderate human evidence. 23 published studies, 14 human. 4 registered clinical trials.

4 trials23 studiesUSEUCA

Medically reviewed by a licensed medical professional

Overview

ARA-290 (cibinetide) is a synthetic peptide designed to promote tissue repair without stimulating red blood cell production — separating the protective effects of erythropoietin from its blood-thickening risks. It has been studied in Phase II trials for nerve damage caused by sarcoidosis and diabetes, and received FDA Fast Track designation for sarcoidosis neuropathy.

Also Known As

ARA-290 is also known by these brand and alternate names:

Research Activity

23studies
Human 14
Animal 6
In-vitro 7
Reviews 3

23 published studies: 14 human, 6 animal, 7 in-vitro, 3 reviews

Regulatory Status

US
Not approved by FDA(FDA)
EU
Not authorised by EMA(EMA)
CA
Not approved by Health Canada(Health Canada)

Legal Status

USNot applicable (not approved)
EUNot applicable (not authorised)
CANot applicable (not approved)

Summary

ARA-290 (cibinetide) has no marketing authorisation. Phase II trials in sarcoidosis neuropathy showed improvements in corneal nerve fibre density, and a Phase II trial in diabetic neuropathy reported improved metabolic parameters and pain scores. The FDA granted Fast Track designation for sarcoidosis neuropathy.

No Phase III trials have been completed. The compound represents an investigational approach to tissue repair that is distinct from existing erythropoietin-based therapies, but its clinical development remains at an early stage.

Mechanism of Action

Research suggests ARA-290 activates a specific receptor complex (the innate repair receptor) that is distinct from the classical erythropoietin receptor used in red blood cell production. This receptor is proposed to mediate tissue protection and repair without affecting blood cell counts. The compound is derived from erythropoietin's structure but engineered to avoid erythropoietic activity. These mechanisms are based on preclinical and early clinical data.

Research Summary

Research suggests Phase II trials showed improvements in corneal nerve fibre density (a measure of nerve repair) in sarcoidosis patients and improved metabolic parameters and pain scores in diabetic neuropathy. The concept of an innate repair receptor distinct from the red blood cell receptor is scientifically interesting, though debated. No Phase III trials have been completed. The compound is developed by a small biotech company, and the uncertain commercial path is a practical limitation. Good tolerability has been demonstrated, with no stimulation of red blood cell production confirmed.

Clinical Trials

PeptideTrace tracks 4 registered clinical trials for ARA-290 sourced from ClinicalTrials.gov.

NCT06626971Phase IITerminated

The Use of ARA290 for the Treatment of Diabetic Macular Oedema

Belfast Health and Social Care TrustEndpoint: Primary Outcome - Best corrected distance visual acuity.Completion: 2017-08-01
NCT02039687Phase IICompleted

Study of Efficacy of ARA 290 on Corneal Nerve Fiber Density and Neuropathic Symptoms of Subjects With Sarcoidosis

Araim Pharmaceuticals, Inc.Endpoint: Change in Corneal Nerve Fiber AreaCompletion: 2015-02-01
NCT01933529Phase IIUnknown

ARA290 in T2D (Effects of ARA 290, an Erythropoietin Analogue) in Prediabetes and Type 2 Diabetes)

Claes-Göran ÖstensonEndpoint: oral glucose toleranceCompletion: 2015-12-01
NCT02070783Phase IICompleted

Cognitive and Neural Effects of ARA290

Leiden University Medical CenterEndpoint: performance on information processing test battery, particularly emotion recognitionCompletion: 2014-02-01
View all 4 trials on ClinicalTrials.gov →

Scientific Detail

Overview (Scientific)

ARA-290 (cibinetide) is a synthetic 11-amino-acid linear peptide (pyroGlu-Glu-Arg-Leu-Glu-Arg-Phe-Leu-Glu-Ala-Leu-NH2), MW ~1,419 Da. Selectively activates innate repair receptor (IRR), heterodimer of EPOR and betacR/CD131, without classical EPOR erythropoiesis. Derived from EPO helix B. SC 4 mg daily. Half-life ~10-30 minutes. Developed by Araim Pharmaceuticals.

Mechanism of Action (Scientific)

Research suggests selective IRR activation (EPOR/betacR heterodimer) on damaged tissues, neurons, immune cells — not erythroid progenitors. Triggers JAK2/STAT5 and PI3K/AKT: cell survival, reduced apoptosis, NF-kappaB inhibition, M1-to-M2 macrophage polarization, tissue repair. Restores corneal nerve fiber density in diabetic neuropathy models. No thrombotic/tumor risks of EPO.

Summary (Scientific)

No marketing authorization. Phase II sarcoidosis neuropathy (N=22 crossover): corneal nerve fiber density +0.31 vs. -0.15 fibers/mm2 (P=0.02). Phase II diabetic neuropathy (N=48): improved metabolic parameters and pain scores. FDA Fast Track for sarcoidosis neuropathy. No Phase III completed.

The information on this page is provided for educational and research reference purposes only. This is not medical advice. Always consult a qualified healthcare professional before making any health-related decisions.

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Related Compounds

Pentadecapeptide BPC

Research Compound
Gastric Pentadecapeptide (Alternate Designation)

This entry reflects historical nomenclature for the compound more commonly known as BPC-157. The evidence base, regulatory status, and limitations described for BPC-157 (#81) apply identically to this compound. See compound #81 for the full assessment. No marketing authorisation. No human Phase III trials. No established human dosing or safety profile.

BPC-157

Research Compound
Gastric Pentadecapeptide (Unregulated)

BPC-157 has no marketing authorisation from any major regulatory agency. No human Phase III clinical trials have been completed. The preclinical evidence base consists of over 100 animal studies, predominantly conducted at the University of Zagreb. A small pilot study in ulcerative colitis (4 patients) has been reported but was uncontrolled. No established human dosing, safety profile, or efficacy data from rigorous clinical trials exist. Products available through unregulated channels are not subject to pharmaceutical manufacturing standards, and their composition, purity, and sterility cannot be assured. The gap between the extensive animal literature and the near-complete absence of human clinical data is the defining feature of this compound's evidence base.

Palovarotene

Approved
RARγ Agonist (Small Molecule, Approved)

Palovarotene (Sohonos) is approved for FOP. The Phase III MOVE trial (107 patients — representing approximately 12% of the global FOP population) initially did not meet statistical significance on its pre-specified primary analysis. However, a post-hoc re-analysis with corrected placebo data showed a 54% reduction in new heterotopic ossification volume. The approval pathway was complex given the ultra-rare nature of FOP. Palovarotene is not a peptide. Important safety considerations include premature growth plate closure in growing children, requiring monitoring. FOP has no other approved treatment.

This content is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional before making decisions about your health.