ARA-290 — questions, answered plainly.

ARA-290 (cibinetide) is an 11-residue peptide derived from the helix B domain of erythropoietin. It activates the innate-repair receptor — a heterodimer of EPO-R and the β common receptor — without stimulating red-blood-cell production.

Erythropoietin has tissue-protective effects beyond erythropoiesis, but its hematopoietic activity introduces thrombotic and hypertensive risks at therapeutic doses. ARA-290 was engineered to retain the tissue-protective signalling via the innate-repair receptor while removing the hematopoietic action.

van Velzen et al. 2014 (Expert Opin Investig Drugs, PMID 24555851) reviewed Phase II clinical-trial data in which ARA-290 was associated with improvements in neuropathic pain, corneal nerve fibre density, and quality of life in adults with sarcoidosis-related small-fibre neuropathy.

Watanabe et al. 2016 (Transplantation, PMID 26683514) studied marginal pancreatic islet transplantation in diabetic mice (185 islets per animal). ARA-290 was associated with suppressed macrophage activation and reduced islet damage in the model used.

No. ARA-290 (cibinetide) is investigational at the time of writing. Late-phase clinical development has been limited; the available evidence is small Phase II trials and preclinical models.

Investigational. Primary published evidence is from small Phase II trials and preclinical models. Long-term safety and efficacy in humans have not been established in broad peer-reviewed databases.