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Investigational / not FDA-approved

ARA-290

Cibinetide (non-erythropoietic EPO helix-B peptide) — ≠ EPO; exploratory SFN/DME pilots.

Editorial review:
What evidence says

Evidence snapshot

This drawer marks papers. It is not a plan, a dose, or a source. A paper is a bounded report. It is not a protocol. Grades name the object. They are not a safety rating.

Identity lock. ARA-290 (INN cibinetide; also pHBSP / pyroGlu helix-B surface peptide) is an 11-amino-acid non-erythropoietic peptide engineered from erythropoietin’s helix B / innate repair receptor (EPOR–βc / CD131) pathway. PubChem CID 91810664; formula C51H84N16O21 / MW 1257.3; CAS 1208243-50-8. ≠ recombinant EPO / epoetin (separate drawer — hematologic biologic). It is designed to avoid erythropoiesis while engaging tissue-protective signaling. This drawer marks papers. It is not use advice.

Bottom line

Human exploratory / Phase 2-class work exists mainly in sarcoidosis-associated small-fiber neuropathy (symptoms, corneal nerve fiber metrics) and limited metabolic/neuropathic or diabetic macular edema pilots. These are not the same as approved EPO anemia biologics, and they do not establish broad neuropathy or “repair peptide” consumer claims. Preclinical pain/inflammation models are not human grades.

Papers

Human — sarcoidosis small-fiber neuropathy / corneal nerves

PMID 24136731 — Dahan 2013

Tested: ARA 290 on symptoms in patients with sarcoidosis-associated small nerve fiber loss and corneal nerve fiber density (clinical exploratory framing).

Does not show: a large confirmatory Phase 3 approval package for all neuropathies, or EPO-equivalent anemia treatment.

PMID 28475703 — Culver 2017

Tested: cibinetide improving corneal nerve fiber abundance in sarcoidosis-associated small nerve fiber loss and neuropathic pain (clinical framing).

Does not show: approved indication for unlabeled “ARA-290” vials outside trial/regulated contexts.

PMID 24555851 — van Velzen 2014

Tested: ARA 290 for treatment of small fiber neuropathy in sarcoidosis (clinical commentary/series framing).

Does not show: broad SFN approval across etiologies.

PMID 29549285 — Brines 2018

Tested: corneal nerve fiber size utility in diagnosing/assessing therapeutic response in small fiber neuropathy (includes cibinetide-context assessment methods).

Does not show: a new primary efficacy RCT by itself.

Human — metabolic / neuropathic / ocular pilots

PMID 25387363 — Brines 2015

Tested: ARA 290 effects on metabolic control and neuropathic symptoms in patients with type 2 diabetes (clinical exploratory).

Does not show: diabetes disease-modification approval or interchangeability with EPO.

PMID 32674280 — Lois 2020

Tested: Phase 2 clinical trial of cibinetide for diabetic macular edema.

Does not show: completed Phase 3 ocular approval from this pack’s set.

Mechanism / preclinical (not human grades)

PMID 21873879 — Swartjes 2011

Tested: ARA290 producing long-term relief of neuropathic pain in experimental (animal) studies.

Does not show: human chronic-pain approval.

PMID 29026145 — Nairz 2017

Tested: cibinetide dampening innate immune cell functions and ameliorating experimental colitis (preclinical).

Does not show: a human IBD indication.

PMID 29392190 — Dahan 2016

Tested: narrative on targeting the innate repair receptor to treat neuropathy (includes ARA-290/cibinetide framing).

Does not show: new primary trial data.

What is not established

Approved broad neuropathy, anti-aging, or “EPO without blood” consumer claims. Equivalence to labeled recombinant EPO anemia biologics. That small sarcoidosis / DME exploratory programs equal general efficacy. Product identity of unlabeled research chemicals vs clinical cibinetide. This drawer does not provide use advice, schedules, or sourcing.

Selected sources

24136731 28475703 24555851 29549285 25387363 32674280 21873879 29026145 29392190

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