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Peptide engineered from erythropoietin

ARA-290

ARA-290 (cibinetide) is an experimental peptide engineered from erythropoietin, tested in small trials for nerve pain and never approved by the FDA.

Medical review in progressLast reviewed

US regulatory status

Not approved for human use in the US

Cibinetide (ARA-290) is an investigational peptide that has never been approved by the FDA. None of its registered trials on ClinicalTrials.gov is active, and no phase 3 trial has been registered. The FDA lists it in Category 3 for pharmacy compounding: nominated without adequate support. It is not on the FDA’s Category 2 safety-risk page, and it was not on the agenda of the July 2026 compounding advisory committee meeting or the one planned before the end of February 2027.

As of

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On this page
  1. US regulatory status
  2. At a glance
  3. What the research shows
  4. Side effects and safety
  5. Vial math
  6. Questions people ask
  7. Sources
  8. Related compounds

At a glance

Also known as
Cibinetide
Supplied as
Freeze-dried powder, mixed before use
Research
Limited human evidence
US status
US status: Not approvedchecked

What the research shows

Evidence grade

Limited human evidence

Some studies in people, but they are small, short, early-phase or uncontrolled.

ARA-290 has been tested in people only in small trials lasting about 4 weeks, mostly in sarcoidosis with small nerve fiber damage, and published between 2012 and 2017. In a 2012 pilot, 22 people received ARA-290 into a vein (12) or placebo (10) three times a week for 4 weeks: a small fiber neuropathy symptom score fell by 11.5 points with ARA-290 and 2.9 with placebo, but pain and fatigue scores improved equally in both groups. A 2013 placebo-controlled trial of 28 days of daily injections under the skin reported fewer neuropathic symptoms, more small nerve fibers in the cornea (the clear front of the eye) and a longer 6-minute walk. In the largest trial, a 28-day phase 2b study in 64 people, the primary measure, corneal nerve fiber area, rose significantly versus placebo in only one of three dose groups, and pain improved in every group including placebo, with no significant difference (P = 0.157). A 28-day phase 2 trial in type 2 diabetes reported better blood sugar control (HbA1c), blood lipids and neuropathic symptoms than placebo.

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How we grade evidence

  1. Strong human evidence

    Consistent results from large randomized controlled trials in people.

  2. Limited human evidence · this page

    Some studies in people, but they are small, short, early-phase or uncontrolled.

  3. Mixed evidence

    Studies in people disagree, or strong evidence for one use sits beside weak evidence for another.

  4. Animal or lab studies only

    Studied in cells or animals, not properly in people. Animal results may not apply to humans.

The grade describes how much research exists and in whom. It is not a judgment that a compound works or is safe.

Side effects and safety

The published trials found no safety concerns: the 2012 pilot raised none in clinical or laboratory checks, and the type 2 diabetes trial identified no potential safety issues. A 2014 review by the developers described “an excellent safety profile”. These trials were small and treated people for about 4 weeks, so they cannot show rare or long-term effects. No official label covers how unapproved vials are made, mixed or stored.

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Vial math

Pre-filled calculators turn your vial, water and prescribed dose into syringe units.

Calculator

These pages do the arithmetic for a vial you already have. They don’t suggest a dose.

This is arithmetic, not medical advice. Confirm with your prescriber or pharmacist.

Questions people ask

What is ARA-290?

A small peptide engineered from the structure of erythropoietin (EPO). Unlike EPO, it is nonerythropoietic: it is designed not to stimulate red blood cell production. It is described as working through the “innate repair receptor”, a complex of the EPO receptor and CD131 (the beta common receptor) that mediates tissue protection. Its generic name is cibinetide.

Sources

Is ARA-290 FDA approved?

No. Drugs@FDA lists no cibinetide product, and none of its registered trials on ClinicalTrials.gov is active. For pharmacy compounding, the FDA’s May 2026 lists put “Cibinetide (ARA-290)” in Category 3, nominated without adequate support. Unlike BPC-157 or LL-37, it was not on the agenda of the FDA’s compounding advisory committee in July 2026 or for the meeting planned before the end of February 2027.

Sources

What has ARA-290 been studied for?

Mainly nerve pain and small nerve fiber loss in people with sarcoidosis, and neuropathic symptoms in type 2 diabetes. The trials measured symptom scores and small nerve fibers in the cornea, at the front of the eye. Findings were mixed: symptom scores improved in the first pilot, but pain also improved with placebo, with no significant difference, in the pilot and in the 64-person phase 2b trial, where only one of three dose groups showed a significant nerve fiber increase.

Sources

What are the side effects of ARA-290?

The small published trials reported no safety concerns, and the developers describe its safety profile as excellent. That evidence comes from a few small trials that treated people for about 4 weeks, so rare or long-term effects are unknown. No FDA label exists, and the contents of unapproved vials are not verified.

Sources

How do you reconstitute ARA-290?

No FDA label or official source says what liquid to mix ARA-290 with or how much to add, so we can’t tell you which one to use. What we can do is the arithmetic: the strength in mg per mL is the mg printed on the vial divided by the mL of liquid added, and more liquid means each syringe unit holds less. The reconstitution calculator works this out for your vial and shows the units on a U-100 syringe. Because ARA-290 is not FDA-approved, the contents of its vials are not verified. Talk to a licensed prescriber or pharmacist before using any unapproved product.

Is ARA-290 banned in sport?

Cibinetide is not named on WADA’s 2026 Prohibited List. But the list bans innate repair receptor agonists as a class (S2.1.5), which is how researchers describe cibinetide, and its S0 rule bans unapproved substances in general. Athletes should check with their anti-doping organization.

Sources

Sources

  1. Drugs@FDA: FDA-Approved DrugsU.S. Food and Drug Administration · Accessed Oct 16, 2026 (opens in a new tab)
  2. Cibinetide Improves Corneal Nerve Fiber Abundance in Patients With Sarcoidosis-Associated Small Nerve Fiber Loss and Neuropathic PainInvest Ophthalmol Vis Sci, 2017 · Accessed Oct 16, 2026 (opens in a new tab)
  3. ARA 290 phase 2 trial in sarcoidosis-associated small nerve fiber loss, NCT02039687ClinicalTrials.gov · Accessed Oct 16, 2026 (opens in a new tab)
  4. Bulk Drug Substances Nominated for Use in Compounding Under Section 503A of the FD&C Act (updated May 14, 2026)U.S. Food and Drug Administration, 2026 · Accessed Oct 15, 2026 (opens in a new tab)
  5. Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety RisksU.S. Food and Drug Administration, 2026 · Accessed Oct 15, 2026 (opens in a new tab)
  6. July 23-24, 2026: Meeting of the Pharmacy Compounding Advisory CommitteeU.S. Food and Drug Administration, 2026 · Accessed Oct 15, 2026 (opens in a new tab)
  7. Meeting of the Pharmacy Compounding Advisory Committee (to be held before the end of February 2027)U.S. Food and Drug Administration, 2026 · Accessed Oct 15, 2026 (opens in a new tab)
  8. Safety and efficacy of ARA 290 in sarcoidosis patients with symptoms of small fiber neuropathy: a randomized, double-blind pilot studyMol Med, 2012 · Accessed Oct 16, 2026 (opens in a new tab)
  9. ARA 290 improves symptoms in patients with sarcoidosis-associated small nerve fiber loss and increases corneal nerve fiber densityMol Med, 2013 · Accessed Oct 16, 2026 (opens in a new tab)
  10. ARA 290, a nonerythropoietic peptide engineered from erythropoietin, improves metabolic control and neuropathic symptoms in patients with type 2 diabetesMol Med, 2015 · Accessed Oct 16, 2026 (opens in a new tab)
  11. ARA 290 for treatment of small fiber neuropathy in sarcoidosisExpert Opin Investig Drugs, 2014 · Accessed Oct 16, 2026 (opens in a new tab)
  12. Nonerythropoietic, tissue-protective peptides derived from the tertiary structure of erythropoietinProc Natl Acad Sci U S A, 2008 · Accessed Oct 16, 2026 (opens in a new tab)
  13. World Anti-Doping Code International Standard: Prohibited List 2026World Anti-Doping Agency, 2026 · Accessed Oct 16, 2026 (opens in a new tab)

Related compounds

Guides

Medical review in progressLast reviewed

Every medical and regulatory statement on this page links to a checkable source, listed above. Peptinote does arithmetic and education, not medical advice, and never sells or links to sellers of peptides.

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