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ARA-290 (Cibinetide): What It Is and What Trials Show

ARA-290 (cibinetide) explained: the EPO-derived peptide studied for small fiber neuropathy, what Phase 2 trials found, side effects, and FDA status.

PeptIQ Research Team
Editorial
ARA-290 (Cibinetide): What It Is and What Trials Show

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The Short Answer

ARA-290, also called cibinetide, is an investigational peptide designed from the structure of erythropoietin (EPO), the hormone that drives red blood cell production. Researchers describe it as a nonhematopoietic helix-B peptide of EPO: it was built to keep EPO's tissue-protective, anti-inflammatory signaling without stimulating red blood cell production.

It has been tested in small Phase 2 trials, mainly for small fiber neuropathy (nerve pain and nerve-fiber loss) in people with sarcoidosis and in people with type 2 diabetes. Results were encouraging but early.

ARA-290 is not FDA-approved for any use. This guide is educational. It doesn't give dosing advice. Talk with a licensed clinician about any treatment.

How It's Supposed to Work

EPO acts through two different receptor setups. The classic EPO receptor pair drives red blood cell production. Tissue protection is linked to a different complex: the EPO receptor paired with the β-common receptor (CD131) (Collino 2014; Joshi 2014). ARA-290's trial investigators describe it as acting selectively on the innate repair receptor, which mediates tissue protection (Brines 2015). That selectivity is why it isn't expected to behave like EPO on blood counts.

What the Human Trials Found

StudyWhoWhat was studiedMain findings
Heij 2012, Mol Med22 people with sarcoidosis and small fiber neuropathy symptoms2 mg IV three times weekly vs placebo for 4 weeksNeuropathy symptom score (SFNSL) improved more than placebo. General pain (BPI) and fatigue improved in both groups equally. No safety concerns reported
Dahan 2013, Mol MedPeople with sarcoidosis-associated small nerve fiber lossDaily subcutaneous ARA-290 vs placebo for 28 daysBetter neuropathic symptoms, higher corneal nerve fiber density, longer 6-minute walk
Brines 2015, Mol Med (Phase 2)People with type 2 diabetes and painful neuropathy4 mg subcutaneous daily vs placebo for 28 days, then 1 month offImproved HbA1c and lipids over 56 days, better PainDetect scores. No safety issues identified
Culver 2017, IOVS (Phase 2b)64 people with sarcoidosis-associated nerve fiber loss and pain1, 4 or 8 mg/day vs placebo for 28 daysCorneal nerve fiber area rose significantly only in the 4 mg group. Pain improved in all study groups, and the placebo-corrected pain drop at 4 mg (moderate-to-severe pain) wasn't statistically significant (P = 0.157)

Doses above are the amounts used in those research protocols, reported for context. They aren't recommendations.

How to Read These Results

  • Small and short. The trials ran about four weeks and enrolled dozens of people, not thousands.
  • Mixed on pain. Nerve-fiber measures moved in the right direction, but in the largest trial (Culver 2017) pain improved across all study groups and the placebo-corrected pain benefit wasn't statistically significant.
  • One research group. The trials share authors affiliated with Araim Pharmaceuticals (the sponsor of the Phase 2b study) and Leiden University Medical Center. Independent replication is limited.
  • No approval path yet. The Phase 2b sarcoidosis study (NCT02039687) is listed as completed on ClinicalTrials.gov, and a later diabetic macular edema study (NCT06626971) is listed as terminated after enrolling 9 people, with the reason given as expiry of the study drug and no replacement available.

ARA-290 Side Effects

In the published trials, investigators reported no safety concerns over roughly four weeks of treatment (Heij 2012; Brines 2015). That's reassuring for a short study, but it isn't the same as long-term safety data, and these were small groups. Products sold online outside of trials aren't checked by FDA for identity, purity or sterility. Our peptide certificate of analysis guide covers what a real test report should show.

If you have neuropathy symptoms, a licensed clinician can look for the cause (diabetes, B12 levels, thyroid, sarcoidosis and others) and discuss treatments with stronger evidence.

Tracking With Your Clinician

Neuropathy changes slowly, so consistent notes matter: pain scores, numbness, sleep, walking distance and anything you're taking. Save this in the PeptIQ app: PeptIQ keeps those notes on one timeline you can share with your care team.

Related reading: the ARA-290 research profile, KPV peptide benefits and the wellness peptide evidence gap.

Frequently Asked Questions

Q: What is ARA-290 peptide?

A: An investigational peptide (cibinetide) designed from erythropoietin to keep its tissue-protective effects without raising red blood cell production.

Q: What is ARA-290 used for?

A: In research, it's been studied mainly for small fiber neuropathy in sarcoidosis and in type 2 diabetes. It isn't approved for any use.

Q: Is ARA-290 FDA-approved?

A: No. It's investigational.

Q: What are ARA-290 side effects?

A: Short Phase 2 trials reported no safety concerns, but long-term human safety data hasn't been published.

Q: Is ARA-290 the same as EPO?

A: No. It's derived from part of EPO's structure but was designed not to stimulate red blood cell production.

Q: Does ARA-290 help nerve pain?

A: Small trials showed improvements in neuropathy symptom scores and nerve-fiber measures, but in the largest trial the placebo-corrected pain benefit wasn't statistically significant. Larger trials are needed.

Sources

This article is educational content from PeptIQ. It is not medical advice. Talk with a licensed clinician before starting, stopping, or changing any peptide, medication, or injection practice.

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