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Core Molecular & Physical Traits
| Item | Details |
|---|---|
| Full Name | Pyroglutamate Helix B Surface Peptide (PHBSP), Cibinetide (ARA290) |
| Amino Acid Sequence | 11 amino acids (pGlu‑Glu‑Gln‑Leu‑Glu‑Arg‑Ala‑Leu‑Asn‑Ser‑Ser) |
| Molecular Weight | 1257.32 Da (C₅₁H₈₄N₁₆O₂₁) |
| CAS No. | 1208243-50-8 (free base) |
| Purity | ≥98% (HPLC), endotoxin < 0.01 EU/μg (research grade) |
| Formulation | Lyophilized acetate salt; reconstitute with sterile water/buffer for subcutaneous/intraperitoneal injection |
| Pharmacokinetics | Half‑life: 2–4 hours (human); low immunogenicity, rapid tissue distribution |
Mechanism of Action
ARA290 selectively binds to the innate repair receptor (IRR)-a heteromer of erythropoietin receptor (EPOR) and β‑common receptor (CD131)-avoiding EPOR homodimers that drive erythropoiesis. Key signaling pathways activated:
- JAK2/STAT5: Suppresses pro‑inflammatory cytokines (TNF‑α, IL‑1β) and reduces oxidative stress.
- PI3K/Akt: Inhibits apoptosis, enhances cell survival, and promotes small nerve fiber regeneration.
- MAPK/ERK: Boosts tissue repair, angiogenesis, and wound healing.
Its receptor selectivity eliminates erythropoietic side effects of native EPO, focusing on tissue protection and repair.
Key Biological Effects & Research Applications
Core Effects (Preclinical & Clinical)
Neuroprotection/Regeneration: Promotes small nerve fiber regrowth, reduces neuropathic pain (diabetic/sarcoidosis‑related), and improves corneal nerve density.
Anti‑Inflammatory: Attenuates pro‑inflammatory mediator expression, mitigating organ damage from ischemia‑reperfusion and autoimmune conditions.
Organ Protection: Preserves renal, myocardial, retinal, and pancreatic islet function in injury/disease models.
Wound Healing: Accelerates closure of dermal ulcers and biopsy wounds.
Metabolic Support: Improves insulin sensitivity and protects against high glucose‑induced cell damage.
Research & Clinical Focus Areas
| Area | Applications |
|---|---|
| Neuropathy | Diabetic neuropathy, small fiber neuropathy, traumatic brain injury (TBI) |
| Inflammatory Diseases | Sarcoidosis, autoimmune disorders, ischemic organ injury |
| Organ Transplantation | Pancreatic islet protection and engraftment enhancement |
| Metabolic Disorders | Insulin resistance, diabetic retinopathy |
| Wound Care | Decubitus ulcers, dermal injury repair |
Dosing & Administration (Research/Clinical)
| Model/Setting | Route | Dose Range | Frequency | Cycle |
|---|---|---|---|---|
| Rodents | IP/SC | 0.8–8 nmol/kg (renal injury); 30 μg/kg (TBI) | Daily | 2–4 weeks |
| Humans (Clinical) | SC | 2–4 mg | Once daily/every other day | 4–12 weeks (neuropathy trials) |
Note: Higher doses may increase injection site reactions; dose adjustment for renal/hepatic impairment is recommended.
Safety & Precautions
Common Side Effects (Clinical)
Mild injection site erythema/edema.
Transient fatigue or headache (rare, dose‑related).
No significant erythropoiesis stimulation or hypertension (vs. EPO).
Critical Warnings
For research/clinical development only; not approved for human therapeutic use outside trials.
Store at -20°C; reconstituted solution stable for 72 hours at 2–8°C.
Avoid use in patients with hypersensitivity to peptide components.
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