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ARA-290 (Cibinetide)

D

lead outcome

Sarcoidosis-associated small-fibre…

grades vary by outcome ↓

Peptide

also called — ARA-290 · Cibinetide · pyroglutamate helix B surface peptide (pHBSP) · innate repair receptor agonist. INCI: none

tissue-protective / anti-inflammatory(studied:) neuropathic pain, sarcoidosis neuropathy — research context

Reference entry — not sold here. A non-erythropoietic EPO fragment with a legitimate tissue-protective rationale and encouraging but small Phase 2 data in neuropathy. Investigational, approved nowhere. No dosing published here.

In brief

ARA-290 (cibinetide) is an 11-amino-acid peptide copied from the helix-B surface of erythropoietin. Its clever design is to keep EPO's tissue-protective, anti-inflammatory signalling — via the innate-repair receptor — while dropping the red-blood-cell stimulation that makes EPO risky (clots, raised hematocrit). Phase 2 trials in sarcoidosis-associated small-fibre neuropathy and in neuropathic pain reported encouraging signals, and it was generally well tolerated. But it remains investigational: the human trials are small and Phase 2, it is approved nowhere, and the headline uses are suggestive rather than proven. A well-designed candidate with a real signal, not a finished drug.

Legal standing, by region

European Union

Not approved

Not approved; no EMA marketing authorisation. Investigational only.

United States

Not FDA-approved (investigational)

Not FDA-approved. Has held orphan-drug designation for sarcoidosis neuropathy but no approval. Sold research-use-only.

International

Approved nowhere

Approved nowhere; investigational research peptide.

Evidence, by outcome

How we grade →

An honest grade per outcome — drawn from the evidence, not any catalogue. Hype and undemonstrated marketing claims grade low.

OutcomeEvidence base · effectGrade

Sarcoidosis-associated small-fibre neuropathy (lead human indication)

Small Phase 2 endpoints; never reached an approved indication. Promising is not proven.

Phase 2 trials reported improved neuropathic symptoms / corneal nerve-fibre measures · Suggestive positive signal

D

Tissue-protective / anti-inflammatory signalling (mechanism)

Strong mechanistic and animal basis; the point of the design is protection without EPO's clotting/hematocrit risk.

Derived from the helix-B surface of erythropoietin; activates the innate-repair receptor (EPOR/CD131 heterocomplex) without stimulating red-cell production — well-characterised preclinically · Consistent tissue-protective effect in animal models

C

Diabetic / neuropathic pain, other inflammatory conditions

Early-stage; not replicated to approval standard.

Early trials + preclinical · Suggestive

D

Safety

The design intent — no erythropoietic effect, so no hematocrit/thrombosis driver like EPO — held up in trials, but long-term human safety is not established.

Phase 1/2 exposure · Generally well tolerated in trials

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Disclosure

Vallydia sells its own cosmetic serums, and some ingredients graded here belong to the same categories as those products. Grades are drawn from the published evidence by the method we publish, and applied to our own ingredients on the same terms — our copper-peptide serum is graded no more kindly than the peptides it competes with. We disclose the interest so you can weigh it.

Trade names shown here (for example Matrixyl, Argireline, Syn-Ake) are the property of their respective owners and are used only to identify the ingredient under discussion. Their appearance implies no affiliation with, or endorsement by, the proprietor.

Evidence changes

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We track new research and update these grades as the evidence moves. Leave your email and we'll tell you if the evidence for ARA-290 (Cibinetide) changes - nothing else.

The honest part

ARA-290 is a genuinely elegant design — EPO's repair signalling without EPO's clotting risk — and unlike some register entries it has real, if small, human Phase 2 data with positive signals. The honest limit is stage, not plausibility: no Phase 3, no approval, small endpoints. Credit the signal; don't upgrade it to a treatment.

Identity

ARA-290, or cibinetide, is an 11-amino-acid peptide (< 40 aa → peptide) whose sequence is copied from the helix-B surface of erythropoietin (EPO). It is also written pHBSP (pyroglutamate helix-B surface peptide). The design goal is unusual and worth stating plainly: to isolate one half of EPO's biology and leave the other behind.

Mechanism (as proposed)

EPO does two very different things. Through the classic EPO receptor homodimer it drives red-blood-cell production — useful in anemia, but the source of EPO's danger (raised hematocrit, thrombosis). Through a separate innate-repair receptor — a heterocomplex of the EPO receptor with CD131 (the β-common receptor) — it delivers tissue-protective, anti-inflammatory signalling. ARA-290 is engineered to bind only the second receptor. It switches on repair and anti-inflammatory pathways without touching erythropoiesis, which is exactly why it does not carry EPO's clotting risk. The peptide is essentially EPO with the dangerous half deleted.

What the human data shows

The lead human work is in sarcoidosis-associated small-fibre neuropathy, where Phase 2 trials reported improved neuropathic symptoms and better corneal small-nerve-fibre measures, and in neuropathic / diabetic pain. The signals were positive and the peptide was generally well tolerated — consistent with the design. But these are small Phase 2 studies, it has never reached an approved indication, and the broader anti-inflammatory claims rest on preclinical work. The rationale is strong and the early signal is real; the stage is early and the finish line unreached.

Chemical identifiers

Cross-reference identifiers for the authoritative external databases — not a recipe, and nothing about how to use it.

CAS1208243-50-8

PubChem CID91810664

InChIKeyWZTIQQBMSJTRBR-WYKNNRPVSA-N

via PubChem (CID verified) · high confidence

Sources — 3 cited

01Brines M, Cerami A, et al. (Non-erythropoietic, tissue-protective peptides derived from the helix-B of erythropoietin; innate-repair-receptor concept.)

02Dahan A, et al. (ARA-290/cibinetide Phase 2 in sarcoidosis-associated small- fibre neuropathy — symptom and corneal-nerve outcomes.)

03Reviews of cibinetide across neuropathic-pain and inflammatory indications; orphan-designation records.

Updated 2026-08-07 (Investigational — watch for any Phase 3 or approval decision, which would move the neuropathy grades.)

Grades reflect the published evidence, not our interest. No dosing, reconstitution, or administration is published for research compounds — that restraint is deliberate.

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