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ARA-290 (Cibinetide)

Human clinical Neuroprotection In 1 protocol 3 sources

ARA-290, also known as Cibinetide, is an engineered peptide derived from erythropoietin (EPO) that selectively activates the innate repair receptor (IRR) without stimulating red blood cell production. Research has primarily focused on its potential to reduce inflammation, promote tissue repair, and alleviate neuropathic pain, particularly in conditions like sarcoidosis and diabetic neuropathy.

01Dosing reference

Amount
4 mg/day
Frequency
Once daily
Cycle
28-day cycle (4 weeks)
Reference figures, not a recommendationThese values reflect amounts described in the literature and vendor documentation this database indexes. Use the reconstitution calculator to convert them into syringe units.

02Mechanism of action

01

Innate Repair Receptor (IRR) activation

ARA-290 binds specifically to the IRR, a heteromeric receptor composed of EPO receptor and beta-common receptor subunits.

02

Anti-inflammatory signaling

Activation of the IRR downregulates pro-inflammatory cytokines and prevents apoptosis in stressed or damaged cells.

03

Neuroprotection and repair

By reducing inflammation and promoting nerve fiber regeneration, it helps restore function and alleviate neuropathic pain.

03Human evidence

Improved symptoms in sarcoidosis-associated small nerve fiber loss.

Phase 2 clinical trials demonstrated that ARA-290 improved neuropathic pain and increased corneal nerve fiber density in patients with sarcoidosis.

Potential benefits in diabetic neuropathy.

Early clinical studies suggest it may improve metabolic control and neuropathic symptoms in type 2 diabetes patients, though larger trials are needed.

04Preclinical evidence

Accelerated wound healing and reduced scarring.

Animal models of injury showed that ARA-290 administration promoted faster tissue repair and reduced fibrosis.

Protection against ischemic injury.

In rodent models of myocardial infarction and stroke, ARA-290 reduced infarct size and preserved organ function.

05What is known vs. unknown

Reasonably established
  • ARA-290 is a non-erythropoietic derivative of EPO, meaning it does not increase red blood cell counts.
  • It specifically targets the innate repair receptor (IRR) to modulate inflammation and promote healing.
  • Clinical research has heavily focused on its use for small fiber neuropathy, particularly in sarcoidosis patients.
  • It has been granted Orphan Drug Designation by the FDA for the treatment of sarcoidosis.
Unknowns & limits
  • Long-term safety and efficacy data in large-scale Phase 3 human trials are still lacking.
  • The optimal dosing protocol and duration of treatment for various neuropathic conditions remain under investigation.
  • Its effectiveness compared to standard neuropathic pain medications is not fully established.

06Safety & regulatory context

Regulatory statusARA-290 has generally been well-tolerated in Phase 2 clinical trials, with a safety profile comparable to placebo. Unlike traditional EPO, it does not carry the risk of cardiovascular events associated with increased red blood cell production and thrombosis. However, it is not an FDA-approved medication and remains an investigational compound. Common side effects reported in studies are mild and include injection site reactions. It is currently restricted to research and clinical trial settings.

07Compared with Erythropoietin (EPO)

ARA-290 (Cibinetide) vs. Erythropoietin (EPO)
Key difference
EPO stimulates red blood cell production (erythropoiesis) and can increase cardiovascular risk, whereas ARA-290 is engineered to only activate tissue repair pathways without affecting blood cell counts.
When researchers discuss each
EPO is discussed for treating anemia, while ARA-290 is discussed for neuroprotection, anti-inflammation, and neuropathic pain without hematological side effects.

08Appears in protocols

09Glossary

Innate Repair Receptor (IRR)
A specialized cell surface receptor that, when activated, triggers anti-inflammatory and tissue-healing processes.
Small Fiber Neuropathy
A condition characterized by damage to the small unmyelinated nerve fibers, leading to pain, burning sensations, and autonomic dysfunction.
Erythropoietic
Relating to the production of red blood cells. ARA-290 is specifically designed to be non-erythropoietic.

10Knowledge check

Q1What is the primary advantage of ARA-290 over traditional Erythropoietin (EPO) in tissue repair research?
Q2Which condition has been a primary focus of clinical trials investigating ARA-290?
Q3Which of the following is a documented limitation in interpreting the current clinical evidence for ARA-290 (Cibinetide)?
Q4When researchers contrast ARA-290 with erythropoietin (EPO), for which research context is ARA-290 most commonly discussed according to the dossier?
Q5Which statement correctly reflects ARA-290’s safety or regulatory status as described in the dossier?

11Sources

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Research and educational use onlyNothing on this site is medical advice, a prescription, or a recommendation for human use. Compounds documented here are research chemicals. Consult a qualified clinician before making any health decision.