ARA-290 Reconstitution Calculator

No. ARA-290 (cibinetide, pyroglutamate helix B surface peptide) is investigational. The highest human data are phase 2 trials in diabetic macular edema and sarcoidosis-associated small fiber neuropathy; no regulatory approval exists for any indication.

ARA-290 selectively activates the innate repair receptor (IRR), a heterodimer of the erythropoietin receptor (EPOR) and β common receptor (CD131), without binding the classical EPOR homodimer. This biases signaling toward anti-inflammatory, anti-apoptotic, and tissue-repair pathways while avoiding erythropoiesis. Plasma half-life is ~2 min, but downstream anti-inflammatory effects are prolonged.

Parenteral. ARA-290 is an 11-amino-acid peptide with negligible oral bioavailability; clinical trials used injection. Subcutaneous bolus is the standard community route, typically 4 mg once daily, because of the short half-life and need for consistent systemic exposure (community protocol).

No long-term safety data exist. Clinical trials used courses of 4–12 weeks (community protocol). Community protocols commonly cycle 4–6 weeks on followed by 2–4 weeks off, based on the sustained tissue effect after short exposure (community protocol). Continuous use beyond available trial durations is unsupported.

No. ARA-290 does not activate the EPOR homodimer required for erythropoiesis and avoids the thrombotic liability of recombinant EPO. In cerebral ischemia models, neuroprotection occurred without erythropoiesis.

Evidence is strongest for sarcoidosis-associated small fiber neuropathy, where cibinetide improved corneal nerve fiber abundance and neuropathic pain in a clinical study. Preclinical work shows reduced NLRP3 inflammasome activation, neuroinflammation, and improved functional recovery after sciatic nerve injury, and neuroprotection in cerebral ischemia. Other neuropathic pain etiologies lack robust human data.

Human data are limited but no serious safety signal emerged in phase 2 trials. Animal and in-vitro studies consistently demonstrate anti-inflammatory and anti-apoptotic effects without hematological changes. Injection-site reactions are possible; long-term immunogenicity and chronic-use risks are uncharacterized (community protocol).

Yes. Store lyophilized ARA-290 at −20 °C for long-term stability. After reconstitution with bacteriostatic water, keep at 2–8 °C and use within 30 days; avoid repeated freeze-thaw cycles (community protocol).