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Active Pharma Ingredients / 22 Sep 2026

CIBINETIDE

Generic Name: CIBINETIDE

ABSTRACT -

Cibinetide (ARA 290) is a synthetic 11-amino acid peptide derived from a non-erythropoietic helix-B surface region of erythropoietin (EPO). It selectively activates the tissue-protective innate repair receptor (IRR, a heterodimer of EPOR and βCR) without haematopoietic EPO effects. It has been investigated for small fibre neuropathy in sarcoidosis, diabetic neuropathy, and as a cytoprotective agent. Phase II trials showed improvements in corneal nerve fibre density and neuropathic symptom scores.

DOSAGE -

4 mg subcutaneously once daily for 28 days in Phase II trials for sarcoidosis-associated small fibre neuropathy.

SIDE EEFECTS -

  • Injection site reactions
  • Headache
  • Fatigue
  • Mild dizziness
  • Nausea

ALLERGIC REACTIONS -

These symptoms may indicate an allergic reaction and require immediate medical attention.

  • Injection site hypersensitivity
  • Urticaria
  • Angioedema
  • Anaphylaxis (rare)

DRUG INTERACTIONS-

  • No significant CYP-mediated interactions expected for peptides
  • Erythropoiesis-stimulating agents: cibinetide does not have haematopoietic activity — no direct PD interaction
  • No established clinically significant drug interactions

PREAUTONS–

  • Not haematopoietically active — does not replace EPO therapy in anaemia
  • Pregnancy safety not established
  • Long-term safety data in development
  • Use in clinical trial setting only

WARNINGS –

  • Not a substitute for erythropoietin in anaemia management
  • Investigational agent — therapeutic role remains under evaluation
  • Report all adverse events through clinical trial pharmacovigilance

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