ARA-290
Innate repair receptor agonist
Also known as: Cibinetide, Helix B surface peptide, HBSP
Studied in registered human trials with published pharmacokinetic data, but not approved. Dosing outside a trial protocol has no established safety margin.
No human plasma half-life value was located. Published analysis was expressed as AUC above a threshold: receptor activation requires concentrations of at least ~1 nmol/L, and AUC was calculated for the period during which plasma concentrations exceeded 1.3 ng/mL. That framing implies short plasma residence but does not constitute a reported half-life, and is not converted into one here.
Sourced human dose: 2 mg intravenously, three times weekly for 4 weeks, in a double-blind placebo-controlled exploratory trial in sarcoidosis patients with small fibre neuropathy. This is an investigational trial dose, not an approved dose.
Several small exploratory trials with a favourable safety signal, but none adequately powered to confirm efficacy. Positive pilot results in this size range routinely fail to replicate.
Cibinetide has shown a favourable safety profile across several small trials. Critically, it was engineered to activate the innate repair receptor WITHOUT erythropoietin's erythropoietic effect, thereby avoiding EPO's thrombotic and haematocrit-raising risks, that is the compound's central design rationale. Trials to date are small and exploratory; efficacy is not confirmed in adequately powered studies. Long-term safety unknown.