ARA-290: what it is, what the studies show and where it stands
ARA-290 (cibinetide) is a synthetic 11 amino acid peptide designed from the structure of erythropoietin. It acts on the innate repair receptor and was built to avoid erythropoietin's effect on red blood cells.
At a glance
US Not approved
Canada Not authorized
Group Healing and recovery
Sources 13
Checked 10 Oct 2026What is ARA-290?
ARA-290 (cibinetide) is a synthetic 11 amino acid peptide designed from the structure of erythropoietin. It acts on the innate repair receptor and was built to avoid erythropoietin's effect on red blood cells. [7]
Other names: ARA 290, ARA290, cibinetide.
How it has been given to people: injection under the skin in most trials; intravenous injection in the first pilot trial.
Looking for doses? ARA-290 dosage chart and vial math
Is ARA-290 approved in the US and Canada?
United States: Not FDA approved. It reached phase 2 trials; no approved product or label was found and no registered trial of it is listed as recruiting. [9]
Canada: No ARA-290 or cibinetide product is in Health Canada's Drug Product Database, and Health Canada lists ARA 290 among unauthorized injectable peptide drugs seized from an online seller. [12]
Both were checked on 10 Oct 2026 against the regulators' own product databases.
Which approved products contain ARA-290?
No approved medicine containing ARA-290 was found in the US or Canada. Anything sold under this name is not a regulated product, so there is no label to check a dose against.
What human studies of ARA-290 exist?
The 9 findings listed here: 8 from randomized human trials and 1 from smaller or observational human studies.
In 22 sarcoidosis patients, 2 mg into a vein three times a week for 4 weeks improved a small fiber neuropathy symptom score more than placebo. [1]
In the same trial, pain and fatigue scores improved by the same amount on placebo as on ARA 290. [1]
In a second sarcoidosis trial, 28 days of daily injections under the skin improved neuropathic symptoms compared with placebo. [2]
In type 2 diabetes, 4 mg a day for 28 days improved neuropathic symptoms on the PainDetect questionnaire. [3]
The same diabetes trial reported better hemoglobin A1c and lipid results in the treated group over 56 days. [3]
In the 64-subject dose-ranging trial, only the 4 mg group showed a significant gain in corneal nerve fiber area; the 1 mg and 8 mg groups did not. The authors read the result as a disease-modifying effect. [4]
In that trial pain improved in every group, placebo included, so the pain result does not separate the drug from placebo. [4]
In 36 healthy people a 2 mg dose changed some measures of emotional processing, but the authors did not find a clear antidepressant-like pattern. [6]
In 9 patients with diabetic macular edema, 12 weeks at 4 mg a day did not improve vision or retinal thickness on average. [5]
What are the side effects of ARA-290?
Reported in human studies or on a label:
- The 4-week intravenous pilot trial in sarcoidosis reported no safety concerns. [1]
- The abstract of the 28-day diabetes trial reports no safety issues. [3]
- The full text of the diabetes trial records four serious adverse events in the treated group. Two were judged unlikely to be related and two possibly related; one was worsening kidney function in a patient whose diuretic dose had been raised, and one patient died of a heart attack two weeks after the last dose, which the safety committee judged unrelated. [3]
- The 12-week trial in 9 patients with diabetic macular edema saw no serious adverse events and no antibodies to the peptide. [5]
What is the half-life of ARA-290?
About 20 minutes after injection under the skin and about 2 minutes after intravenous injection, as given in a 2016 review written by the trial group (full text). [7]
How does ARA-290 compare with others in its group?
These are the peptides filed under healing and recovery. The last column says whether a randomized human trial is on record for each.
| Peptide | US | Canada | Half-life | Randomized human trial |
|---|---|---|---|---|
| BPC-157 | Not approved | Not authorized | Not found | No |
| TB-500 | Not approved | Not authorized | Not found | Yes |
| KPV | Not approved | Not authorized | Not found | No |
| ARA-290 | Not approved | Not authorized | About 20 minutes after injection under the skin and about 2 minutes after intravenous injection, as given in a 2016 review written by the trial group (full text). | Yes |
| MGF | Not approved | Not authorized | Not found | No |
| Cartalax | Not approved | Not authorized | Not found | No |
What could not be found
These were searched for and did not turn up. They are listed so a missing number is not mistaken for a hidden one.
- No approved product or label in the US or Canada, so no label dose, contraindications, interaction list or storage instructions.
- No phase 3 trial: PubMed and ClinicalTrials.gov searches for ARA 290 and cibinetide returned phase 2 work only.
- No published trial dosed it for longer than 12 weeks. The neuropathy trials all ran 28 days.
- The primary pharmacokinetic paper was not read. The half-life comes from a review by the trial group [7]; the diabetes trial's full text gives the same figure of about 20 minutes after 4 mg under the skin [3].
- The number enrolled in the 2015 diabetes trial is not in its abstract. The 2016 review by the same group gives 48 patients [7].
- Not named on the WADA Prohibited List (page checked 2026-10-11, [13]). The list has an open class, S0, for substances with no current approval by any governmental health authority; whether it applies to this compound was not determined here.
ARA-290 questions
Is ARA-290 approved in the US?
Not FDA approved. It reached phase 2 trials; no approved product or label was found and no registered trial of it is listed as recruiting.
Is ARA-290 authorized in Canada?
No ARA-290 or cibinetide product is in Health Canada's Drug Product Database, and Health Canada lists ARA 290 among unauthorized injectable peptide drugs seized from an online seller.
What is the half-life of ARA-290?
About 20 minutes after injection under the skin and about 2 minutes after intravenous injection, as given in a 2016 review written by the trial group (full text).
Has ARA-290 been tested in a randomized human trial?
Yes. At least one randomized human trial is listed on this page.
Sources
Each one was opened on 10 Oct 2026 and matched to the line it supports.
- 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. PubMed 23168581.
- Dahan A et al. ARA 290 improves symptoms in patients with sarcoidosis-associated small nerve fiber loss and increases corneal nerve fiber density. Mol Med 2013. PubMed 24136731.
- Brines 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 2015. PubMed 25387363.
- Culver DA et al. Cibinetide Improves Corneal Nerve Fiber Abundance in Patients With Sarcoidosis-Associated Small Nerve Fiber Loss and Neuropathic Pain. Invest Ophthalmol Vis Sci 2017. PubMed 28475703.
- Lois N et al. A Phase 2 Clinical Trial on the Use of Cibinetide for the Treatment of Diabetic Macular Edema. J Clin Med 2020. PubMed 32674280.
- Cerit H et al. Testing the antidepressant properties of the peptide ARA290 in a human neuropsychological model of drug action. Eur Neuropsychopharmacol 2015. PubMed 26431906.
- Dahan A et al. Targeting the innate repair receptor to treat neuropathy. Pain Rep 2016. PubMed 29392190.
- Araim Pharmaceuticals, Inc. A Double Blind, Placebo Controlled Phase 2 Dose Ranging Study of the Effects of ARA 290 on Corneal Nerve Fiber Density and Neuropathic Symptoms of Subjects With Sarcoidosis ClinicalTrials.gov 2014. clinicaltrials.gov. Trial NCT02039687.
- US Food and Drug Administration Drugs@FDA and drug label searches via openFDA for cibinetide and ARA 290 (no match) 2026. api.fda.gov.
- Health Canada Health Canada Drug Product Database, active ingredient searches: ara 290 and cibinetide (0 records) 2026. health-products.canada.ca.
- US Food and Drug Administration Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks 2026. fda.gov.
- Health Canada Unauthorized injectable peptide drugs seized and sold by Canada Peptide may pose serious health risks 2025. recalls-rappels.canada.ca.
- World Anti-Doping Agency The Prohibited List 2026. wada-ama.org.
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ARA-290 dosage10 mg vialHealing and recoveryStatus in Canada
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