Reviewed & approved by Dr. Nova Reyes · Last checked 2026-10-15. ← Back to Evidence Library
ARA-290 (cibinetide): what the evidence says
At a glance
What it is: a lab-made 11-amino-acid peptide designed from part of erythropoietin (EPO, the hormone that makes red blood cells). It is meant to switch on the "innate repair receptor" (EPO receptor plus a partner unit called CD131) without raising red blood cell counts. Its official name is cibinetide. It was developed by Araim Pharmaceuticals. Gray-market "ARA-290" vials are sold for nerve pain, inflammation, healing and recovery. R1, R2
What the evidence says: three small placebo-controlled trials in sarcoidosis nerve damage (22 to 64 people, 28 days each), all run with the company, reported better symptom questionnaires and more nerve fibers in the eye. Pain scores themselves were not clearly better than placebo. One phase 2 trial in type 2 diabetes and a 9-person eye study round out the patient record. No phase 3 trial (large studies confirming benefit and safety before approval) has been published. R3–R7
Biggest risks: no serious drug-related problems were reported in the small trials, but only about 220 people have been studied in published trials, for at most 12 weeks. The bigger risk for gray-market users is not knowing what's in the vial. R3–R6
| Claim | Rating |
|---|---|
| Human Nerve symptoms in sarcoidosis (small fiber neuropathy) | Very limited (mixed results): three small 28-day placebo-controlled trials, all company-linked; symptom questionnaires and eye nerve fibers improved, but pain intensity did not clearly beat placebo R3–R5 |
| Human Nerve symptoms and blood sugar in type 2 diabetes | Very limited: one 28-day phase 2 placebo-controlled trial, company-run; HbA1c and nerve-fiber changes are lab changes R6 |
| Human Diabetic macular edema (eye swelling) | Very limited: one 9-person study with no placebo; no improvement in vision or retinal thickness R7 |
| Human Mood / depression | Very limited: one 36-person study in healthy volunteers; no effect on mood R8 |
| Animal "Healing," inflammation, injury recovery, anti-aging in healthy people (gray-market use) | No human data (animal/lab only) R9 |
| Regulatory | Not approved anywhere · FDA orphan designation (sarcoidosis neuropathic pain, 2011) · EU orphan designations (sarcoidosis 2013; islet transplantation 2016) · 503A: Category 3 · 503B: not nominated · WADA 2026: not named; The Open Peptide Project's reading is that it falls under S2.1.5 "innate repair receptor agonists" (banned at all times), not a WADA ruling R10–R15 |
| Established human dose | Unknown None |
Evidence verdict: Sarcoidosis nerve symptoms: Very limited (mixed results) · Type 2 diabetes: Very limited · Diabetic macular edema: Very limited · Mood: Very limited · Healing, inflammation and recovery in healthy people: No human data (animal/lab only) Card verdict: Very limited (sarcoidosis nerve symptoms, type 2 diabetes, macular edema) · Healing & recovery in healthy people: No human data Card note: Varies by use, see page
This page reports what studies used. It is not dosing advice.
Legend: HUMAN data · ANIMAL / LAB data · UNKNOWN · UNVERIFIED: not yet confirmed against a primary source
What "No human data" means here: for healing, inflammation, recovery or anti-aging in healthy people, there are animal and lab studies only, and no human trials.
What is it?
EPO protects tissues in lab studies, but it also raises red blood cell counts, which can cause clots. ARA-290 was designed to keep the protective effect without the blood effect, by acting on a receptor that appears mainly in injured tissue. A change in nerve-fiber counts, HbA1c or other markers is not a health benefit by itself. What matters is whether people feel and function better, which is what the trials below test. R1, R4
Does it work?
Human Sarcoidosis nerve damage (small fiber neuropathy): - Heij 2012: 22 patients, IV ARA-290 or placebo for 4 weeks, double-blind. Three patients (1 ARA-290, 2 placebo) dropped out because of the IV visits and were replaced. A neuropathy symptom questionnaire improved more on ARA-290. Pain scores and fatigue improved equally in both groups. R3 - Dahan 2013: 38 patients (21 ARA-290, 17 placebo), injections under the skin for 28 days. Symptom questionnaire scores, nerve fibers in the cornea (the clear front of the eye) and the 6-minute walk improved more on ARA-290. Pain intensity improved about 9% in both groups, with no difference. Skin nerve fibers did not change significantly. R4 - Culver 2017: a phase 2b trial (mid-size studies testing doses and early effects) of 64 patients, three dose groups vs placebo for 28 days. The main measure, corneal nerve fiber area, rose significantly only in the middle dose group. Pain improved in all groups, including placebo. In the middle dose, the drop in pain beyond placebo was not statistically significant (P = 0.157), so it could have been chance. R5
Human Type 2 diabetes: a phase 2 placebo-controlled trial of injections for 28 days (49 enrolled, 48 analyzed, 24 per group) reported better HbA1c (average blood sugar), cholesterol profiles and a nerve-pain questionnaire. These are lab and questionnaire changes. R6
Human Diabetic macular edema: 9 patients used it for 12 weeks with no placebo group. Vision, retinal thickness and retinal sensitivity did not improve. A vision questionnaire score did. R7
Human Mood: 36 healthy volunteers got ARA-290 or placebo. There was no effect on mood. Some emotion-processing tests changed in mixed directions. R8
Animal Animals and lab: nerve injury, stroke, kidney, heart and other models in rodents and cells. Not reviewed in detail for this page. R9
Who paid / conflicts: Araim Pharmaceuticals officers or employees (including Michael Brines and Anthony Cerami) are authors of all the patient trials. In Heij 2012, Dahan 2013, Brines 2015 and Lois 2020 they declared that they own stock or stock options in the company. Dahan 2013 and Brines 2015 were also partly funded by a Dutch government grant to the Netherlands Institute for Regenerative Medicine; Brines 2015 also lists Swedish research funders. Caution [UNVERIFIED: Culver 2017 disclosure statement not read (no free full text)] R3–R7
Development status: a 2014 company press release said phase 3 trials were "slated to begin 4Q 2015." We found no published phase 3 trial. Caution [UNVERIFIED: current development status; trial registries not fully searched] R16
Is it safe?
- Human In trials: Heij 2012 raised "no safety concerns." In Dahan 2013 there were no serious adverse events (problems reported after use, which may or may not have been caused by the drug), no injection-site pain and no antibodies against the drug. One person on ARA-290 had ongoing weight loss that began before the study. The eye study saw no serious adverse events and no antibodies. R3, R4, R7
- Dropouts vs placebo: in Dahan 2013, every ARA-290 dose was given; one placebo patient stopped dosing for the last week (diarrhea). In Heij 2012, 1 of the ARA-290 group and 2 of the placebo group withdrew (IV visits too inconvenient) and were replaced. In Brines 2015, 1 person stopped at day 15 because of worsening kidney function and was left out of the analysis. In the eye study, 8 of 9 finished. Caution [UNVERIFIED: dropouts for Culver 2017 not checked] R3, R4, R6, R7
- Unknown Nothing is known about use longer than 12 weeks, in healthy people, or with repeated cycles.
Is it legal?
- FDA: not approved. Orphan designation (a status that gives incentives to develop drugs for rare diseases; it is not an approval) for "treatment of neuropathic pain in patients with sarcoidosis," designated Sept 13, 2011, sponsor Araim Pharmaceuticals, "Not FDA Approved for Orphan Indication." R10 The company also announced a US orphan designation for sarcoidosis (2016) and Fast Track status (2014). Caution [UNVERIFIED: these two are company statements only; not checked in FDA's database] R16, R17
- EU: not authorised. Orphan designations EU/3/13/1191 (sarcoidosis, Oct 7, 2013) and EU/3/16/1721 (preventing graft loss in pancreatic islet transplantation, Aug 29, 2016), both "positive," sponsor now Araim Pharmaceuticals Europe Limited, Ireland. R11, R12
- Compounding (503A): "Cibinetide (ARA-290)" is in Category 3, "nominated without adequate support" (list updated May 14, 2026). Pharmacies have no approved basis to compound it. R13
- Compounding (503B): not on FDA's 503B nominations list (updated Mar 21, 2025). R14
- Athletes: WADA's 2026 list bans "innate repair receptor agonists, e.g. asialo EPO; carbamylated EPO (CEPO)" at all times (S2.1.5). ARA-290 is not named. Unknown The Open Peptide Project's reading (not a WADA ruling): because ARA-290 was designed to activate the innate repair receptor, we think it falls under S2.1.5, and as an unapproved substance it would also fall under S0. Athletes should ask their anti-doping organization. R15
What's in the vial?
Gray-market "ARA-290" vials have no quality control and no guarantee of identity. It could contain the wrong compound, the wrong amount, impurities or bacterial toxins, or be fake (counterfeit). The trial results above don't transfer to it. We test retail vials blind under the Open Peptide Standard. See results at /tests/. A passing test covers one batch, tested on one date. It does not mean the compound itself is safe.
What do users report?
Self-report, not evidence.
We haven't summarized user reports for this peptide yet.
Study details
R3–R8 Human Human studies
| Study | People | Route | Dose used (study arm, not a recommendation) | Follow-up | Reported | Limitations | Citation |
|---|---|---|---|---|---|---|---|
| Heij 2012 | 22 sarcoidosis + SFN (12 vs 10 placebo), Netherlands | IV, 3×/wk, 4 wk | 2 mg | 4 wk | SFNSL −11.5 vs −2.9 (p<0.05); pain (BPI) and fatigue improved equally | Pilot; company co-authors | PMID 23168581 |
| Dahan 2013 | 38 sarcoidosis + SFN (21 vs 17), Leiden | Subcutaneous daily, 28 d | 4 mg | 16 wk (+9 mo questionnaire) | SFNSL −12.2 vs −3.8 (p=0.005); corneal nerve area +14.5%; 6MWT +18.7 vs −15.1 m; BPI pain no difference | Single site; company co-authors | PMID 24136731 |
| Culver 2017 (phase 2b) | 64 sarcoidosis + SFN, multicenter | Subcutaneous daily, 28 d | 1, 4 or 8 mg vs placebo | 28 d | Corneal nerve area significant in middle dose group only (p=0.012); pain placebo-corrected p=0.157 | Surrogate primary endpoint; company-run | PMID 28475703 |
| Brines 2015 (phase 2) | 48 analyzed (24 vs 24) with type 2 diabetes and painful neuropathy | Subcutaneous daily, 28 d | 4 mg | 56 d | HbA1c, lipids, PainDetect improved | Company-run; lab markers | PMID 25387363 |
| Lois 2020 (phase 2) | 9 with diabetic macular edema, Belfast | Subcutaneous daily, 12 wk | 4 mg | 12 wk | No change in BCVA, CRT; NEI VFQ-25 +2.7 | No control group; tiny | PMID 32674280 |
| Cerit 2015 | 36 healthy volunteers | Single dose | 2 mg vs placebo | 1 wk | No mood effect; mixed emotion-processing changes | Healthy people; surrogate tests | PMID 26431906 |
R10–R17 Regulatory sources (as of Oct 15, 2026)
- R10 FDA Orphan Drug Designations database, cibinetide (listed by amino-acid sequence), designated 09/13/2011: https://www.accessdata.fda.gov/scripts/opdlisting/oopd/detailedIndex.cfm?cfgridkey=349111
- R11 EMA, EU/3/13/1191, orphan designation for treatment of sarcoidosis: https://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-13-1191
- R12 EMA, EU/3/16/1721, orphan designation for prevention of graft loss in pancreatic islet transplantation: https://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-16-1721
- R13 FDA 503A nominations list (May 14, 2026), Category 3: https://www.fda.gov/media/94155/download
- R14 FDA 503B nominations list (Mar 21, 2025): https://www.fda.gov/media/94164/download
- R15 WADA 2026 Prohibited List (S2.1.5): https://www.wada-ama.org/en/resources/world-anti-doping-code-and-international-standards/prohibited-list
- R16 Araim Pharmaceuticals press release, Fast Track designation, Oct 28, 2014 (company source, used only for the company's own claims): https://www.prnewswire.com/news-releases/araim-pharmaceuticals-given-fda-fast-track-designation-to-ara-290-for-the-treatment-of-sarcoidosis-associated-small-fiber-neuropathy-280635872.html
- R17 Araim Pharmaceuticals press release, US orphan designation for sarcoidosis, July 5, 2016 (company source): https://www.prnewswire.com/news-releases/araim-pharmaceuticals-receives-orphan-drug-designation-from-the-us-fda-for-ara-290-for-the-treatment-of-sarcoidosis-300293773.html
Full reference list (PMIDs verified on PubMed, Oct 15, 2026)
- R1 van Velzen M, et al. Expert Opin Investig Drugs. 2014. doi:10.1517/13543784.2014.892072. PMID 24555851 (review; authors from the trial group).
- R2 Dahan A, et al. Pain Rep. 2016. doi:10.1097/PR9.0000000000000566. PMID 29392190 (review).
- R3 Heij L, et al. Mol Med. 2012;18:1430-6. doi:10.2119/molmed.2012.00332. PMID 23168581. Dunne, Brines and Cerami are Araim employees and officers who own stock and/or options.
- R4 Dahan A, et al. Mol Med. 2013;19:334-45. doi:10.2119/molmed.2013.00122. PMID 24136731. Partly funded by Dutch government grant (NIRM FES0908); Dunne, Cerami and Brines are Araim employees with stock or options. Erratum 2016.
- R5 Culver DA, et al. Invest Ophthalmol Vis Sci. 2017;58(6):BIO52-60. doi:10.1167/iovs.16-21291. PMID 28475703. Araim co-authors Caution [UNVERIFIED: disclosure text not read].
- R6 Brines M, et al. Mol Med. 2015;20:658-66. doi:10.2119/molmed.2014.00215. PMID 25387363. Brines, Dunne and Cerami are Araim officers who own stock and/or options; partly funded by NIRM (Dutch government) and Swedish funders.
- R7 Lois N, et al. J Clin Med. 2020;9(7):2225. doi:10.3390/jcm9072225. PMID 32674280. Kirk, Dunne, Cerami and Brines are Araim officers and own stock; Bajorunas consults for Araim.
- R8 Cerit H, et al. Eur Neuropsychopharmacol. 2015;25(12):2289-99. doi:10.1016/j.euroneuro.2015.09.005. PMID 26431906.
- R9 Examples of animal/lab work: Swartjes M, et al. Mol Pain. 2014. doi:10.1186/1744-8069-10-13. PMID 24529189; Wang RL, et al. CNS Neurosci Ther. 2024. doi:10.1111/cns.14676. PMID 38488446.
Disclaimer
This page is for education and harm reduction. It is not medical advice and not a recommendation to use ARA-290. Please talk to a clinician you trust, especially if you have sarcoidosis, diabetes, nerve pain or are pregnant, or are a tested athlete. Seek care right away for a serious reaction, and report it to FDA MedWatch (https://www.fda.gov/safety/medwatch) or your national regulator.