ARA-290
Cibinetide / Innate Repair Receptor agonist
ARA-290 (also known as cibinetide) is an 11-amino acid synthetic peptide derived from the structure of erythropoietin (EPO) that selectively activates the innate repair receptor (IRR) without stimulating erythropoiesis or promoting blood cell production. It was developed by Araim Pharmaceuticals to capture the tissue-protective and anti-inflammatory properties of EPO while eliminating the undesirable hematological effects. Clinical trials have focused primarily on painful neuropathies, including diabetic neuropathy and sarcoidosis-associated small fiber neuropathy.
Mechanism of Action
Synthetic 11-amino-acid peptide that selectively activates the innate repair receptor (IRR), a heterodimer of EPO receptor and beta common receptor. Promotes tissue protection and repair without erythropoietic effects. Anti-inflammatory via macrophage phenotype switching from M1 to M2.
Research Protocols
For research purposes only. Not medical advice.
Clinical trial protocols used 2-8mg subcutaneously or IV daily. Sarcoidosis studies used 5mg IV daily for 28 days. Small fiber neuropathy studies used 4mg subcutaneously 3 times weekly for 28 days.
Research Notes
Clinical Research Status
ARA-290 has completed multiple Phase II clinical trials for diabetic neuropathy and sarcoidosis-associated small fiber neuropathy, with results published in peer-reviewed journals showing improvements in corneal nerve fiber density and neuropathic pain scores. The compound received Orphan Drug Designation from the European Medicines Agency for sarcoidosis treatment. Despite promising results, development has progressed slowly, and Phase III trials have not been widely reported as of recent literature.
Key Published Findings
Clinical studies demonstrate that subcutaneous ARA-290 administration increases corneal nerve fiber density (a surrogate marker for small fiber neuropathy) and reduces neuropathic pain in diabetic patients. Research in sarcoidosis patients showed significant improvements in small nerve fiber density, pain scores, and quality of life measures compared to placebo over 28-day treatment periods. Mechanistic studies reveal that IRR activation promotes Schwann cell survival, reduces neuroinflammation, and stimulates axonal regeneration through JAK2/STAT5-independent pathways.
Safety Profile
ARA-290 has demonstrated an excellent safety profile across clinical trials, with no dose-limiting toxicities and adverse event rates comparable to placebo. Unlike EPO, it does not increase hemoglobin levels, platelet counts, or thromboembolic risk, confirming selective IRR activation without erythropoietic receptor engagement. The most common side effects reported include mild injection site reactions and transient headache, with no cardiovascular or hematological safety signals identified.
Comparison to Related Compounds
ARA-290 represents a fundamentally different approach from EPO-derived therapy by targeting the heterocomplex innate repair receptor (EPOR/betaCD131) rather than the homodimeric erythropoietic receptor. Unlike gabapentin or pregabalin which merely modulate pain perception, ARA-290 aims to repair damaged nerve fibers and address the underlying pathology of neuropathy. Compared to other neuroprotective peptides like Cerebrolysin or NGF, ARA-290 has a more defined single-target mechanism through the IRR pathway.
Community Observations
Interest in ARA-290 within research communities centers on its potential as a disease-modifying therapy for neuropathy rather than merely symptomatic treatment. Availability outside of clinical trials is extremely limited, and the compound is not widely accessible through typical peptide suppliers. Patients with small fiber neuropathy from various causes have expressed strong interest in the compound based on published trial results showing objective nerve regeneration.
Half-Life
~2-3 minutes
Reconstitution
Sterile saline
Storage
Lyophilized
Refrigerate 2-8C.
Reconstituted
Use within 24 hours of preparation.
US Legal Status
Also Known As
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