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Tissue & Regeneration
ARA-290 (Cibinetide)
Cibinetide · ARA290 · ARA 290 · pHBSP · Helix-B-Surface-Peptid
ARA-290 (Cibinetide) is an 11-amino-acid synthetic peptide derived from the helix-B surface of erythropoietin (EPO). It was developed by Araim Pharmaceuticals to harness the tissue-protective and anti-inflammatory properties of EPO without triggering its blood-forming (erythropoietic) effect. In small, early-phase clinical studies it has been investigated primarily in sarcoidosis-associated small-fiber neuropathy as well as in neuropathic symptoms in the context of type 2 diabetes. ARA-290 is a research/investigational agent and is not approved as a medicine in either the EU or the USA. The findings summarized here come predominantly from small pilot and phase-2 studies and should not be understood as proven therapeutic effects.
Regulatory status
In clinical trials only · not approved
In clinical investigation, not approved – ARA-290 is a research/investigational agent and is not approved as a medicine anywhere.
Drug class
Synthetic peptide; non-erythropoietic EPO derivative / agonist of the "innate repair receptor" (IRR). Research/investigational agent, not an approved medicine.
Half-life (informative)
As a short peptide, ARA-290 is described in the literature as having only a short residence time in the blood; concrete pharmacokinetic parameters are limited in the publicly available literature. No dosing or application information is deliberately given here.
Studied in the literature
In the clinical studies, ARA-290 was administered as an injection (subcutaneous or intravenous). This describes solely HOW the peptide was investigated in studies and does NOT constitute an instruction for use.
Mechanism of action
ARA-290 is an 11-amino-acid peptide modeled on the helix-B region of erythropoietin – that surface of the EPO molecule which faces away from the classical erythropoietic receptor. According to the model described in the literature, the peptide does not bind to the classical homodimeric EPO receptor (EPOR/EPOR), which governs the formation of red blood cells, but rather to a heterodimeric receptor complex composed of the EPO receptor and the beta-common receptor (CD131), referred to as the "innate repair receptor" (IRR). Via this pathway, anti-inflammatory and tissue-protective signaling pathways are thought to be addressed without stimulating blood formation. This mechanism of action is derived predominantly from preclinical (animal/cell models) and small clinical studies and is not regarded as conclusively proven in humans.
The available data come from small, early-phase studies. Pharmacological information is therefore incomplete and should not be regarded as established. It is an investigational agent without standardized, regulatory-reviewed use.
Research history
ARA-290 (Cibinetide) was derived from the erythropoietin research of Michael Brines and Anthony Cerami, who showed that the tissue-protective effects of EPO can be separated from its blood-forming effect. On this basis, Araim Pharmaceuticals developed a short peptide derived from the helix-B surface. From around 2012 onward, the first small, controlled clinical studies followed, in particular on sarcoidosis-associated small-fiber neuropathy as well as on neuropathic symptoms in type 2 diabetes. According to reports, the agent received orphan-drug and fast-track status in the USA for neuropathic pain in sarcoidosis; however, no regular approval as a medicine exists.
Regulatory status by region
No approval by the European Medicines Agency (EMA). ARA-290 is not an approved medicine in the EU; data come from clinical studies.
No regular FDA approval. According to reports, orphan-drug and fast-track designations existed for neuropathic pain in sarcoidosis; however, a designation is not an approval and does not prove efficacy.
Classified internationally as an investigational substance. Outside of controlled clinical studies, ARA-290 is not available as a tested medicine.
Research areas
- Sarcoidosis-associated small-fiber neuropathy (investigation of neuropathic symptoms and corneal nerve-fiber density)
- Neuropathic pain / small-fiber neuropathy in general
- Type 2 diabetes with neuropathic symptoms (exploratory investigation of metabolic parameters and pain scores)
- Diabetic macular edema (phase-2 study, but terminated early according to the registry entry)
- General: anti-inflammatory and tissue-protective mechanisms of action (predominantly preclinical)
Documented effects (from the literature)
- In small, controlled studies (e.g., in sarcoidosis patients), no relevant safety concerns were raised by clinical or laboratory investigations, according to the authors.
- Reported observations from these studies concern an improvement in pain scores on questionnaires as well as an increase in corneal nerve-fiber density – these findings come from small samples and should be regarded as preliminary.
- Because ARA-290 is specifically designed to be non-erythropoietic, relevant stimulation of blood formation was not the primary aim in the studies; this, however, does not replace a comprehensive long-term safety assessment.
Safety concerns & caution
- The body of data rests on a few, small pilot and phase-2 studies with low participant numbers; no established efficacy or safety statements can be derived from this.
- There is no pharmaceutical-regulatory approval; purity, dosing, and use outside of studies are not regulatory-reviewed.
- Long-term safety and rare side effects have not been sufficiently studied.
- A trial registered as phase 2 in diabetic macular edema was terminated early according to the study registry (expiry of the study medication), which underscores the limited and unfinished body of evidence.
Risks of gray-market purchase
- ARA-290 is in part offered on the gray market as a "research chemical" without pharmaceutical quality control; identity, purity, and sterility are not assured in this case.
- Advertising claims such as "nerve regeneration," "anti-aging," or "organ protection" are to be classified as assertions – unproven and not substantiated by the small studies available.
- Products from unregulated sources may contain impurities, incorrect ingredients, or endotoxins; regulatory oversight as for approved medicines is entirely lacking.
- Obtaining and using it outside of controlled clinical studies operates in a legal gray area and is associated with incalculable risks.
Frequently asked questions
Is ARA-290 (Cibinetide) an approved medicine?
No. ARA-290 is a research or investigational agent and is not approved as a medicine in either the EU (EMA) or the USA (FDA). It has been investigated in small clinical studies. Reported "orphan-drug" or "fast-track" status in the USA are funding categories for development and do not mean approval and do not provide proof of efficacy.
How is ARA-290 supposed to work?
According to the model described in the literature, ARA-290 is derived from the helix-B surface of erythropoietin and binds to the so-called "innate repair receptor" (a complex of the EPO receptor and CD131) without stimulating blood formation. Through this, anti-inflammatory and tissue-protective effects are thought to be mediated. This mechanism comes predominantly from animal, cell, and small clinical studies and is not regarded as conclusively proven in humans.
What was ARA-290 investigated against?
Mainly against neuropathic symptoms in small-fiber neuropathy – in particular in connection with sarcoidosis – as well as in type 2 diabetes. In small, controlled studies, pain scores and corneal nerve-fiber density, among other things, were examined. These investigations only describe that and how the peptide was studied; they do not prove established efficacy and do not constitute a recommendation for use.
Is the efficacy of ARA-290 proven?
No, not in the sense of established proof of efficacy. The available studies are small and early-phase (pilot and phase-2 studies). Positive observations from such studies are preliminary and would need to be confirmed in larger, independent studies. Statements such as "regenerates nerves" are therefore to be classified as assertions – unproven.
Is ARA-290 safe?
In the few, small studies, no relevant safety concerns were reported according to the authors. However, this does not allow a general safety statement: long-term and rare risks have barely been studied, and gray-market products are not subject to any quality control. PeptidLotse expressly makes no statements on use or dosing; this page serves exclusively for neutral information.
Sources
Primary and reference sources for your own reading.
- Molecular Medicine (PubMed, PMID 23168581)Safety and efficacy of ARA 290 in sarcoidosis patients with symptoms of small fiber neuropathy: a randomized, double-blind pilot study
- Molecular Medicine (PubMed, PMID 24136731)ARA 290 improves symptoms in patients with sarcoidosis-associated small nerve fiber loss and increases corneal nerve fiber density
- Molecular Medicine (PubMed, PMID 25387363)ARA 290, a nonerythropoietic peptide engineered from erythropoietin, improves metabolic control and neuropathic symptoms in patients with type 2 diabetes
- ClinicalTrials.govA 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 (NCT02039687)
Related substances
Unfamiliar terms? Look them up in the glossary or read the fundamentals.
This profile is for information and education only. It is not medical advice and deliberately contains no dosing or usage details. Decisions about use belong in a doctor’s hands.