ARA-290 (cibinetide): what the evidence shows

What the human research shows

Genuinely interesting biology with a genuinely small evidence base. A surrogate endpoint moved in one trial; the symptom people care about did not separate from placebo.

Evidence profile0–5

Metabolic & weightC0.7
Cardiovascular—0.0
Muscle & growth—0.0
Healing & repairC0.0
Neuro & sleep—0.0
Immune & inflammationD0.0
Sexual & hormonal—0.0
Skin & appearance—0.0
Ageing & longevity—0.0

Each score is confidence × effect size, taken from the best-evidenced benefit in that domain: the grade (A–D) sets the confidence, the measured effect sets the size. Hover a domain to see the outcomes behind it. Adverse effects are excluded and listed separately below.

Outcome	Grade	Effect size	Human studies	Where the evidence comes from
Nerve fibre regeneration (sarcoidosis small-fibre neuropathy)	CWeak	Small	1 phase 2b RCT (n=64, 28 days)	Corneal nerve fibre area rose significantly on the 4 mg dose but not on 1 mg or 8 mg, and regenerating skin fibres increased at 4 mg — a surrogate signal, in a short trial, with a non-monotonic dose response.1
Neuropathic pain	CWeak	Not measurable	Same trial + earlier phase 2	Pain improved in every arm including placebo; the placebo-corrected difference in the 4 mg group did not reach significance.1
Diabetic neuropathy and metabolic control	CWeak	Small	1 small phase 2	A 28-day trial in type 2 diabetes with neuropathy reported improved HbA1c and neuropathic symptoms; small, short, not replicated.2
Healing, recovery, inflammation (grey-market uses)	DNo human evidence	Not measurable	None	Extrapolated from the mechanism and from animal work. No human trial.
Adverse effectsadverse	CWeak	Not measurable	Phase 2 trials	Well tolerated in the short trials, with no effect on haemoglobin — the point of the design. No long-term data.1

AMultiple good human trials, consistentBSome human trials, mostly consistentCFew or weak human studiesDAnimal or anecdotal onlyeffect size · red = adverse

Literature searched to 10 September 2026. Human studies only; animal and cell work informs the mechanism section and nothing else.

Registered trials

ClinicalTrials.gov lists 4 interventional studies naming ARA-290 (cibinetide) as an intervention — 2 completed, and 1 with results posted to the registry.

A registration is not a result. Anyone can register a study, and many never report — so this list shows what has been attempted, not what has been shown. The graded evidence above is the answer to whether something works.

Study	Phase	Status	Participants	Sponsor	Results
Study of Efficacy of ARA 290 on Corneal Nerve Fiber Density and Neuropathic Symptoms of Subjects With SarcoidosisNCT02039687 · started Jan 2014	Phase 2	Completed	64	Araim Pharmaceuticals, Inc.	Posted
ARA290 in T2D (Effects of ARA 290, an Erythropoietin Analogue) in Prediabetes and Type 2 Diabetes)NCT01933529 · started Oct 2013	Phase 2	Unknown	24*	Claes-Göran Östenson	None
The Use of ARA290 for the Treatment of Diabetic Macular OedemaNCT06626971 · started Apr 2016	Phase 2	Terminated	9	Belfast Health and Social Care Trust	None
Cognitive and Neural Effects of ARA290NCT02070783 · started Feb 2012	Phase 1	Completed	36	Leiden University Medical Center	None

Participant counts marked * are the sponsor's estimate, not a final enrolment. Source: ClinicalTrials.gov, read directly from the registry and refreshed weekly.

What it is

Erythropoietin does two things: it makes red cells through the classical receptor, and it protects injured tissue through a different receptor complex. ARA-290 is an 11-amino-acid piece of EPO's helix B, the part that touches the second receptor and not the first — protection without the clotting and blood-pressure risks of EPO. Araim Pharmaceuticals developed it as cibinetide.

It has orphan designation for sarcoidosis-associated small-fibre neuropathy and a decade of phase 2 work without a phase 3 result. Online it is sold as a general repair and anti-inflammatory peptide.

How it is thought to work

It activates the innate repair receptor — a heteromer of the EPO receptor and the β-common receptor that appears on injured cells — triggering anti-inflammatory and pro-survival signalling. Its half-life is minutes; the effect is proposed to come from a brief trigger rather than sustained exposure.

What is still unknown

Whether the nerve-fibre signal turns into a clinical benefit over months; no trial has been long enough.
Why the 8 mg dose did less than 4 mg.

The molecule and how long it lasts

Identity

Formula: C51H84N16O21
Molecular weight: 1257.3 g/mol
CAS number: 1208243-50-8
PubChem: CID 91810664

PubChem record, read 23 September 2026.

Pharmacokinetics

Route: Intravenous and subcutaneous in the trials, which report no PK
Half-life: No human pharmacokinetic data located

No pharmacokinetic study in people: Heij L, et al. Safety and efficacy of ARA 290 in sarcoidosis patients with symptoms of small fiber neuropathy: a randomized, double-blind pilot study. Mol Med 2012

Regulatory status

European Union

Unauthorised medicinal product

Investigational only; orphan designation. Supplying it for human use outside a trial is an offence.

United States

Not approved

Investigational; orphan designation for sarcoidosis neuropathy. Sold as a 'research chemical'.

United Kingdom

Unlicensed medicine

No MHRA licence.

Australia

Prescription-only / unapproved

Not on the ARTG.

Canada

Not authorised

No Drug Identification Number.

Sport (WADA)

Prohibited at all times

A non-approved substance under the non-approved-substances class; it is designed not to stimulate red cells, but that does not exempt it.

Questions people actually ask

Does ARA-290 help nerve pain?

In the largest trial, pain improved on placebo as much as on the drug. What improved on the drug — at one dose — was the number of nerve fibres measured in the cornea and skin, which is a surrogate that may or may not matter to how a person feels.

Is ARA-290 like EPO?

It is a fragment of EPO chosen to keep the tissue-protective signal and drop the red-cell signal. In trials it did not raise haemoglobin, which was the design goal.

Is it approved?

No. It has orphan designations and phase 2 data, and no phase 3 result. It is not approved anywhere and is prohibited in sport as a non-approved substance.

One page per claimed effect

CDoes ARA-290 (cibinetide) help with nerve fibre regeneration?1 phase 2b RCT (n=64, 28 days)
CDoes ARA-290 (cibinetide) help with neuropathic pain?Same trial + earlier phase 2
CDoes ARA-290 (cibinetide) help with diabetic neuropathy and metabolic control?1 small phase 2
DDoes ARA-290 (cibinetide) help with healing, recovery, inflammation?None
CHow common is adverse effects with ARA-290 (cibinetide)?Phase 2 trials

References

1
Culver DA, Dahan A, Bajorunas D, et al. Cibinetide improves corneal nerve fiber abundance in patients with sarcoidosis-associated small nerve fiber loss and neuropathic pain.Invest Ophthalmol Vis Sci, 2017Phase 2b; 64 patients; 28 days.
2
Brines M, Dunne AN, van Velzen M, et al. ARA 290, a nonerythropoietic peptide engineered from erythropoietin, improves metabolic control and neuropathic symptoms in patients with type 2 diabetes.Mol Med, 2015Small 28-day phase 2.

Change log

2026-09-10Initial publication. Grade C on phase 2 surrogate data; pain did not separate from placebo.