At a glance

Small nerve fiber repair
Neuropathic pain relief
Anti-inflammatory / tissue protection
No blood-thickening (vs EPO)
Unknown long-term safety (investigational)
Cancer / cell-survival caution
Injection-site reactions
BenefitSide effectHealth risk· more & brighter bars = stronger

Effects

  • Small nerve fiber repair: In a Phase 2b sarcoidosis trial, daily subcutaneous cibinetide increased corneal nerve fiber area (~23% from baseline at the 4 mg dose) and skin nerve fiber length.[7][8]
  • Neuropathic pain reduction: Patients with moderate-to-severe pain at baseline reported clinically meaningful, placebo-corrected decreases in pain intensity.[7][8]
  • Anti-inflammatory / tissue protection: Activates cytoprotective, anti-apoptotic signaling in stressed tissue; preclinical data span myocardial ischemia, retinopathy and traumatic brain injury.[1][6]
  • Metabolic effects (diabetes): A Phase 2 trial in type 2 diabetes reported improvements in HbA1c and lipid profiles over the observation period.[9]
  • No hematopoietic effect: Hemoglobin, reticulocyte and platelet levels remained stable in trials, confirming separation from EPO's blood-thickening pathway.[2][6]
Classification

Non-erythropoietic EPO-derived peptide; innate repair receptor (IRR) agonist

Active half-life

~20 min terminal (4 mg SC, human PK)

Route

Subcutaneous injection

Regulatory status

Investigational; not FDA-approved (Orphan Drug status only)

Onset

Symptom changes over weeks, not days