ARA-290

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Snapshot

Chemistry and make-up

ARA-290, generic name cibinetide, is an 11-amino-acid linear peptide that reproduces a short stretch of the outer face of the B-helix of erythropoietin (EPO) [A]. The design idea is precise: EPO has two separable activities. One, driven by the classic homodimeric EPO receptor, stimulates red-blood-cell production. The other, tissue protection and dampening of inflammation, is mediated by a different receptor assembly, the innate repair receptor (a heterocomplex of the EPO receptor and the beta-common receptor, CD131). ARA-290 was engineered to reproduce only the second, protective face, so it engages the innate repair receptor without stimulating erythropoiesis and without raising haematocrit [A].

The N-terminus is a pyroglutamate (a cyclised glutamine), which blocks aminopeptidase attack; the molecule has no cysteine and so no disulfide bridge. It is a small, water-soluble peptide with a short plasma half-life, normally supplied as the acetate salt. Because “ARA-290” and “cibinetide” are used interchangeably and the counterion adds mass, the identity checks that matter are the observed mass and the sequence (including the pyroglutamate cap), which a proper mass-spec identity assay should confirm.

What it is studied for (evidence)

• Mechanism [A]: selective agonism of the innate repair receptor (EPOR / CD131). In preclinical models this pathway is anti-apoptotic, anti-inflammatory and pro-repair, and ARA-290 reproduces EPO’s tissue-protection in nerve, kidney and other tissues without the erythropoietic effect (Brines et al., PNAS 2008).
• Emerging (early clinical): the most developed human work is in small fibre neuropathy, especially sarcoidosis-associated neuropathic pain. A randomised, double-blind pilot reported improvements in neuropathic symptoms and quality-of-life measures (Heij et al., Mol Med 2012) [A], and later work reported increases in corneal nerve fibre abundance, a marker of small-fibre regeneration (Culver et al., 2017) [A]. ARA-290 / cibinetide has also been studied in painful diabetic neuropathy and in metabolic-control endpoints in type 2 diabetes [C].
• Established / thin: trials so far are small, early-phase and indication-specific. There is no completed, published, confirmatory Phase III trial and no marketing authorisation for ARA-290 anywhere. The tissue-protective and anti-inflammatory mechanism is well characterised preclinically; the human efficacy signal is promising but early.
• Marketing claims vs data: vendor pages sometimes present ARA-290 as an established anti-inflammatory, nerve-repair or anti-aging agent. The controlled human evidence is limited to early-phase neuropathy studies; anything beyond that, and any dosing protocol, is unsupported extrapolation and outside our scope.
• Human clinical status: investigational only. Reached early-phase (Phase II) clinical testing; no approval for any indication.

Handling, format and stability

Supplied lyophilised as a white to off-white powder, typically as the acetate salt, and reconstituted with water for research handling only (no dosing or human-use guidance here). Store the lyophilised powder cold and protected from light; reconstituted peptide is less stable and cold-chain dependent. The pyroglutamate cap gives resistance to aminopeptidase clipping but not to hydrolysis or oxidation in solution over time, so reconstituted material should be treated as short-dated. Because the name covers both “ARA-290” and “cibinetide”, a CoA should confirm sequence, salt form and observed mass.

Regulatory and trade status

• UK / EU RUO: research use only; not an authorised medicine. Because it has no marketing authorisation, any listing or email describing human benefits (nerve repair, pain relief, anti-inflammatory use) risks pulling it into “medicinal product by presentation” territory under UK medicines law. Keep all copy strictly RUO.
• US: not FDA-approved. Investigational peptide; not a lawful active in approved drugs.
• WADA (sport): ARA-290 is non-erythropoietic, so it does not act as an erythropoiesis-stimulating agent. It is not named on the Prohibited List, but as a non-approved substance with no current marketing authorisation for human therapeutic use it falls under S0 (non-approved substances), prohibited at all times. Its derivation from erythropoietin also warrants caution; athletes should treat it as banned and seek guidance [B].
• Customs: lower profile than the GLP-1 class; the main trade risk is identity and labelling (ARA-290 vs cibinetide, salt form) rather than scheduling.

Sources

• [A] Brines M. et al., “Nonerythropoietic, tissue-protective peptides derived from the tertiary structure of erythropoietin”, *PNAS* 2008 — https://www.pnas.org/doi/10.1073/pnas.0805594105
• [A] Heij L. et al., ARA 290 in sarcoidosis small fibre neuropathy (randomised pilot), *Mol Med* 2012 — https://pubmed.ncbi.nlm.nih.gov/?term=ARA+290+sarcoidosis+small+fiber+neuropathy
• [A] Culver D.A. et al., cibinetide and corneal nerve fibre regeneration in sarcoidosis, 2017 — https://pubmed.ncbi.nlm.nih.gov/?term=cibinetide+corneal+nerve+fiber+sarcoidosis
• [C] ClinicalTrials.gov, ARA-290 / cibinetide trial registrations — https://clinicaltrials.gov/search?term=ARA-290
• [B] WADA Prohibited List (S0 non-approved substances) — https://www.wada-ama.org/en/prohibited-list
• [B] PubChem, Cibinetide (CAS 1208243-50-8) — https://pubchem.ncbi.nlm.nih.gov/#query=cibinetide
• [D] Araim Pharmaceuticals (developer background) and vendor pages — commercial; used for identity/format norms only, not for efficacy

Plain summary

ARA-290 (cibinetide) is an 11-amino-acid peptide copied from the protective face of erythropoietin. It was deliberately engineered to trigger EPO’s tissue-protective, anti-inflammatory signalling through the innate repair receptor without making red blood cells, so it does not raise haematocrit. The most developed human research is early-phase work in small fibre neuropathy (notably sarcoidosis), with promising but limited results; there is no approved medicine and no large confirmatory trial. It is strictly research-use-only, is caught by WADA S0 as a non-approved substance, and commercially the main trap is identity, since “ARA-290” and “cibinetide” label the same peptide and the CoA must state sequence, salt form and observed mass.

For laboratory and research use only (RUO). Not for human or veterinary use, not for consumption, and not a medicine. Information is a research summary, not medical advice, and contains no dosing guidance.

For laboratory research use only. Not for human or veterinary use, not for consumption, and not a medicine. This is a research summary, not medical advice, and contains no dosing guidance.