ARA-290 (cibinetide) is a synthetic 11-amino-acid peptide derived from the helix B surface of erythropoietin (EPO). It was engineered to retain EPO’s reported tissue-protective signalling while removing the erythropoietic (red-blood-cell-stimulating) activity of the parent hormone4. It is supplied strictly for laboratory research use only and is not an approved drug in Canada, the United States, the EU, or any other jurisdiction; it carries orphan-drug and fast-track designations for sarcoidosis-associated neuropathic pain, which support investigation but do not constitute approval5. The human evidence base is limited to small early-phase trials in sarcoidosis and type 2 diabetes small-fiber neuropathy123. Nothing here is medical guidance.
Sequence & identity
Mechanisms studied
ARA-290 was designed as a selective agonist of the so-called innate repair receptor (IRR). Researchers reported that the IRR is a heterocomplex of the EPO receptor (EPOR) and the β-common receptor (CD131), distinct from the EPOR homodimer that drives red-cell production4. In immune and other cell models, investigators observed that cibinetide engagement of this heteroreceptor was associated with anti-inflammatory and anti-apoptotic signalling without stimulating erythropoiesis4. The peptide is cleared rapidly from plasma (reported intravenous half-life on the order of a few minutes), and researchers have attributed any longer-lasting effects to downstream signalling rather than sustained circulating levels4.
Dosing in the research literature
The figures below summarise regimens as reported in published research — they are not recommendations or directions for use.
| Source / model | Regimen reported | Notes |
|---|---|---|
| Heij et al. 2012, Molecular Medicine (sarcoidosis pilot)1 | 2 mg intravenously, three times weekly, for 4 weeks (n=22) | Randomized, double-blind, placebo-controlled pilot. Reported as study-administered regimen only — not a usage recommendation. |
| Culver et al. 2017, IOVS (Phase 2b, sarcoidosis)2 | 1, 4, or 8 mg subcutaneously once daily for 28 days vs placebo (n=64) | The 4 mg arm met the primary corneal-nerve-fiber endpoint. Dose explored in a controlled trial; not a directive. |
| Brines et al. 2015, Molecular Medicine (type 2 diabetes)3 | 4 mg subcutaneously once daily for 28 days, then 28 days off (49 enrolled, 48 analyzed) | Phase 2 randomized study with a 56-day observation window. Reported regimen only. |
Effects observed in research
In a randomized double-blind pilot in sarcoidosis patients with small-fiber neuropathy symptoms, investigators reported that ARA-290 significantly improved a neuropathy symptom screening score versus placebo, with improvements in pain and physical-functioning measures and no safety concerns raised by clinical or laboratory assessment1. In a larger Phase 2b trial, researchers observed that the 4 mg dose met the pre-specified primary endpoint of increased corneal nerve fiber area measured by corneal confocal microscopy, alongside a significant increase in intra-epidermal GAP-43-positive fibers; a clinically meaningful pain reduction in the moderate-to-severe subgroup did not reach statistical significance2. In a Phase 2 study in type 2 diabetes, researchers reported improvements in PainDetect neuropathic-symptom scores, increased corneal nerve fiber density in those with low baseline values, and improved HbA1c and lipid measures over the observation period3. Across these trials no significant safety issues were reported, though sample sizes were small123.
Strength of evidence
Graded B. Human data come from a handful of small early-phase, single-program trials (sarcoidosis pilot n=22; Phase 2b n=64; diabetes Phase 2 n=49, 48 analyzed), supported by anti-inflammatory and tissue-protective findings in animal and in-vitro models1234. There are no large, multi-center confirmatory or long-term safety trials, and outcomes beyond small-fiber neuropathy (for example general “recovery” or tissue healing in healthy subjects) are not established in humans. The compound remains investigational and unapproved; following the closure of the original sponsor, no active development program is publicly documented5. Treat all reported effects as preliminary.
Reconstitution & storage
Reconstitute with bacteriostatic water for laboratory handling. Store lyophilised material frozen and reconstituted material refrigerated. Use Peptigo’s reconstitution calculator and storage cheat sheet for working figures.
References
- Heij L, Niesters M, Swartjes M, 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;18(1):1430-1436. PMID 23168581. doi:10.2119/molmed.2012.00332
- Culver DA, Dahan A, Bajorunas D, 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;58(6):BIO52-BIO60. PMID 28475703. doi:10.1167/iovs.16-21291
- Brines M, Dunne AN, van Velzen 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;20(1):658-666. PMID 25387363. doi:10.2119/molmed.2014.00215
- Nairz M, Haschka D, Dichtl S, et al. Cibinetide dampens innate immune cell functions thus ameliorating the course of experimental colitis. Sci Rep. 2017;7:13012. PMID 29026145. doi:10.1038/s41598-017-13046-3
- Araim Pharmaceuticals. Cibinetide (ARA 290) Regenerates Small Nerve Fibers and Improves Neuropathic Clinical Symptoms in the Orphan Disease of Sarcoidosis (press release / orphan and fast-track designation, FDA/EMA). 2017.
- National Center for Biotechnology Information. PubChem Compound Summary for CID 91810664, Cibinetide (ARA-290). Accessed 2026.