ARA-290 (cibinetide)
Also called Cibinetide, ARA 290, ARA290
Research and education only. Not medical advice. Talk to a doctor.
In 30 seconds
A small peptide designed from the structure of EPO that doesn't raise red blood cells.[1]
Small phase 2 trials, up to 64 people, in nerve-pain conditions.[3][4]
Not FDA-approved.[6]
How far has the research gotten?
People in its biggest studies
How many people each study enrolled, as reported.Research over time
Papers on PubMed each year that mention ARA-290 (cibinetide).7 papers in 2025Most of the human studies here were co-written by the company developing it.[1][4][5]
What studies used
What each paper reports. A record of published research, not a recommendation.Safety and changes in pain intensity, small fiber neuropathy screening list score, quality of life (SF-36), depressive symptoms and fatigue.
Mol Med · 2012 · PubMed 23168581What the paper reports
2 mg intravenously three times weekly for 4 weeks (n = 12) vs placebo (n = 10)
Who: Humans (22 adults with sarcoidosis and small fiber neuropathy symptoms)Phase 2 study of HbA1c, lipid profiles, neuropathic symptoms (PainDetect) and corneal nerve fiber density.
Mol Med · 2015 · PubMed 25387363What the paper reports
4 mg self-administered subcutaneously daily for 28 days (vs placebo), then 1 month of follow-up without treatment
Who: Humans (adults with type 2 diabetes and painful neuropathy)Phase 2b randomized trial with change in corneal nerve fiber area at day 28 as primary endpoint, plus intraepidermal GAP-43+ fibers, pain and 6-minute walk test.
Invest Ophthalmol Vis Sci · 2017 · PubMed 28475703What the paper reports
1, 4, or 8 mg/day for 28 days vs placebo (route not stated in abstract)
Who: Humans (64 adults with sarcoidosis-associated small nerve fiber loss and neuropathic pain)Changes in best corrected visual acuity, central retinal thickness, retinal sensitivity, tear production, patient-reported outcomes, adverse events and anti-cibinetide antibodies.
J Clin Med · 2020 · PubMed 32674280What the paper reports
4 mg/day self-administered subcutaneously for 12 weeks
Who: Humans (9 adults with diabetic macular edema; 8 completed)What it is, in full 4
ARA-290, also called cibinetide, is a small peptide designed from the structure of erythropoietin (EPO) that does not stimulate red blood cell production and is described as acting selectively on the so-called innate repair receptor.[1]
In rats with a nerve injury, repeated injections reduced pain-like sensitivity to touch and cold for weeks, while mice lacking the beta-common receptor showed no effect; these are animal findings.[2]
Small placebo-controlled phase 2 trials in people with sarcoidosis-related small nerve fiber loss and in people with type 2 diabetes and painful neuropathy reported changes in symptom questionnaires and corneal nerve fiber measures.[3][4][1]
A nine-patient phase 2 study in diabetic macular edema found no mean improvement in visual acuity or retinal thickness after 12 weeks.[5]
Regulatory details 3
A search of FDA's Drugs@FDA data (openFDA) for 'cibinetide' and 'ARA-290' returned no matching application or product.[6]
Checked 2026-10-06'Cibinetide (ARA-290)' is listed in 503A category 3 on FDA's list updated May 14, 2026.[7]
Checked 2026-10-06ARA-290/cibinetide is not named in the 2026 List. Section S2.1.5 (prohibited at all times) covers 'innate repair receptor agonists, e.g. asialo EPO; carbamylated EPO (CEPO)', and S2 also covers substances with similar chemical structure or biological effect; whether this applies to ARA-290 is for anti-doping authorities to determine.[8]
Checked 2026-10-06Human trials on ClinicalTrials.gov
A ClinicalTrials.gov search for 'cibinetide' on 2026-10-06 returned 4 records: NCT01933529 (phase 2, type 2 diabetes, status unknown), NCT02039687 (phase 2, sarcoidosis, completed), NCT06626971 (phase 2, diabetic macular edema, terminated) and NCT02070783 (phase 1/2, cognitive and neural effects, completed).[9]
All sources 9
- 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. PMID 25387363PubMed (U.S. National Library of Medicine)
- Swartjes M et al. ARA290, a peptide derived from the tertiary structure of erythropoietin, produces long-term relief of neuropathic pain: an experimental study in rats and β-common receptor knockout mice. Anesthesiology. 2011. PMID 21873879PubMed (U.S. National Library of Medicine)
- 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. PMID 23168581PubMed (U.S. National Library of Medicine)
- 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. PMID 28475703PubMed (U.S. National Library of Medicine)
- 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. PMID 32674280PubMed (U.S. National Library of Medicine)
- openFDA Drugs@FDA API query for 'cibinetide' (no matches; same result for 'ARA-290')U.S. Food and Drug Administration
- FDA: Bulk Drug Substances Nominated for Use in Compounding Under Section 503A (category lists, updated May 14, 2026)U.S. Food and Drug Administration
- WADA: World Anti-Doping Code International Standard, Prohibited List 2026 (in effect 1 January 2026)World Anti-Doping Agency
- ClinicalTrials.gov API search, all fields = cibinetide (the same 4 records were returned for 'ARA-290')ClinicalTrials.gov (U.S. National Library of Medicine)
Tap any purple number to open the source it came from.
Written from the sources above and checked on the date shown. Sources can be incomplete or out of date, and summaries can contain mistakes: read the source. See the terms.