Cibinetide

Erythropoietin Derived Tissue Protective Peptide (non Hematopoietic EPO Mimetic)Rx: InvestigationalCompound: Investigational

Also known as: ARA 290, ARA-290, HBSP, Helix B surface peptide

Educational Only — Not medical advice. Consult a qualified clinician before using any peptide.

Summary

Cibinetide (ARA 290) is a 11-amino acid peptide derived from the three-dimensional structure of erythropoietin that mimics the tissue-protective but not the hematopoietic actions of EPO. It has been investigated primarily for painful small fiber neuropathy, sarcoidosis-associated neuropathy, and other conditions involving neuroinflammation, ischemia-reperfusion injury, and organ protection. It does not stimulate red blood cell production.

Mechanism of Action

Selectively activates the tissue-protective heterodimeric receptor complex (composed of the EPO receptor and the beta common receptor, βcR/CD131) without activating the classical homodimeric EPOR responsible for erythropoiesis. This triggers cytoprotective, anti-inflammatory, and anti-apoptotic signaling pathways (JAK2, STAT3, PI3K/Akt, NF-κB modulation) in non-hematopoietic tissues including neurons, endothelium, and kidney.

Routes of Administration

IntravenousSubcutaneous

Goals & Uses

  • Metabolic improvement in type 2 diabetes-associated neuropathyMetabolic / EndocrineLow
  • Reduction of painful small fiber neuropathy symptomsNeurological / PainModerate
  • Neuroprotection and nerve fiber regenerationNeurologicalModerate
  • Anti-inflammatory effects in sarcoidosisInflammatory / AutoimmuneModerate
  • Ischemia-reperfusion organ protectionOrgan ProtectionLow

Contraindications

  • Active malignancyOncologyModerateUse caution or avoid depending on agent and context
  • Known hypersensitivity to cibinetide or excipientsAllergy / HypersensitivityHigh

Adverse Effects

  • Injection site reactionsLocalCommon
  • HeadacheNeurologicUncommonPain in the head or upper neck
  • NauseaGastrointestinalUncommonFeeling of sickness or urge to vomit
  • FatigueGeneralUncommonLow energy or tiredness

Drug Interactions

  • Immunosuppressants (e.g., corticosteroids, methotrexate)Low
  • Erythropoiesis-stimulating agents (ESAs)Low

Population Constraints

  • PregnancyReproductive SafetyRelative
  • Severe renal impairmentOrgan ImpairmentRelative
  • Pediatric patientsAgeRelative
  • Patients with known thromboembolic riskCardiovascularRelative

Regulatory Status

  • European UnionInvestigationalEMA Orphan Medicinal Product Designation granted for sarcoidosis. Not approved for commercial use.
  • United StatesInvestigationalFDA Orphan Drug Designation granted for sarcoidosis-associated small fiber neuropathy. No approved indication as of knowledge cutoff.
  • United KingdomUnknownNo confirmed regulatory designation or approval in the UK post-Brexit; status follows EMA precedent historically.

Cibinetide received Orphan Drug Designation from the FDA and EMA for sarcoidosis-associated small fiber neuropathy. It has not received full market approval in any jurisdiction as of the knowledge cutoff. Clinical development has been led by Araim Pharmaceuticals.

Evidence & Sources

No sources recorded yet.

Browse All PeptidesBuild My Stack