📚 Wiki Tissue Repair ARA-290

ARA-290

◎ Phase II (sarcoidosis neuropathy, diabetic neuropathy); FDA Orphan Drug designation
ARA-290 (Cibinetide, Helix B Surface Peptide of EPO)
Also known as: Cibinetide, HBSP, Helix B Surface Peptide, Innate Repair Receptor agonist
Brand names: Cibinetide
Page last reviewed

Quick Summary

ARA-290 (Cibinetide) is an 11-amino acid peptide corresponding to the helix B surface of erythropoietin (EPO), the glycoprotein hormone that regulates red blood cell production. Critically, ARA-290 binds the Tissue Protective Receptor (TPR), a distinct EPO receptor heterodimer expressed in non-hematopoietic tissues - without activating the classical EPO receptor that drives erythropoiesis.

Neuroprotection & Repair Extensively Studied
ARA-290 (Cibinetide) is an 11-amino acid peptide corresponding to the helix B surface of erythropoietin (EPO), the glycoprotein hormone that regulates red blood cell production. Critically, ARA-290 binds the Tissue Protective Receptor (TPR), a distinct EPO receptor heterodimer expressed in non-hematopoietic tissues - without activating the classical EPO receptor that drives erythropoiesis. This separation of tissue protection from erythropoiesis eliminates the red blood cell elevation, hypertension, and thrombosis risks associated with systemic EPO. ARA-290 has received FDA Orphan Drug designation for small fiber neuropathy and has shown nerve fiber regeneration in sarcoidosis patients in Phase II trials.
Storage Stability
Lyophilized
1–2 years (-20°C)
Reconstituted
~30 days (2–8°C)
Room temp
Avoid

Mechanism of Action

ARA-290 acts through the Tissue Protective Receptor (TPR), a heterodimer distinct from the classical EPO receptor.

Tissue Protective Receptor (TPR) Activation

The TPR is composed of the EPO receptor (EPOR) and CD131 (beta common receptor). ARA-290 binds this heterodimer with high affinity. Unlike the classical EPOR homodimer that drives erythropoiesis, the EPOR/CD131 heterodimer mediates cytoprotection in neurons, cardiac cells, and epithelial cells via anti-apoptotic (Akt/PI3K) and anti-inflammatory (reduced NF-kB) signaling.[1]

Small Nerve Fiber Regeneration

ARA-290 promotes regrowth of small unmyelinated C-fiber and Adelta nerve fibers, the fibers responsible for pain, temperature sensation, and autonomic function that are specifically damaged in small fiber neuropathy, sarcoidosis, and diabetes. It increases intraepidermal nerve fiber density (IENFD) - a measurable biomarker used as a primary endpoint in Phase II trials.[2]

Anti-inflammatory and Metabolic Protection

ARA-290 reduces macrophage-driven inflammation, protects pancreatic beta cells from cytokine-induced apoptosis, and improves insulin secretion in diabetic models. The combination of neuroprotection and metabolic protection makes it relevant for diabetic complications including both peripheral neuropathy and beta cell preservation.[3]

Research Overview

Sarcoidosis Small Fiber Neuropathy

Phase II Clinical

Phase II trial in sarcoidosis-associated small fiber neuropathy (28 days, 4 mg SC daily): statistically significant improvement in corneal nerve fiber length, intraepidermal nerve fiber density, and autonomic function scores. Pain and fatigue scores also improved. These are the most direct human data showing ARA-290 promotes peripheral nerve regeneration.[2]

Diabetic Neuropathy and Beta Cell Protection

Phase II Clinical

ARA-290 reduces pain scores in diabetic peripheral neuropathy in Phase II trials. Preclinical data shows preservation of pancreatic beta cell mass under cytokine stress, potentially relevant for both Type 1 and Type 2 diabetes neuropathic complications.[3]

Cardiac and Renal Ischemia Protection

Strong Evidence

ARA-290 reduces infarct size and improves cardiac function in ischemia-reperfusion models. In renal ischemia models, it reduces acute kidney injury markers. The TPR is expressed in heart, kidney, and brain, making ARA-290 a broad-spectrum organ protector in ischemic conditions.[1]

Long COVID and Autonomic Dysfunction

Emerging

Post-viral small fiber neuropathy is a documented feature of long COVID. ARA-290's Phase II sarcoidosis data (which also involves small fiber neuropathy) has generated interest in ARA-290 for long COVID autonomic symptoms. Research is in early stages.[2]


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Research Protocols

GoalDoseFrequencyRoute
Neuropathy / nerve repair4 mgOnce daily × 28 daysSubcutaneous
Metabolic / beta cell support4 mgOnce dailySubcutaneous
Cardiac / organ protection2–4 mgOnce dailySubcutaneous

No specific meal timing required. The Phase II trial protocol used 4 mg SC once daily for 28 consecutive days. Longer courses have been studied in chronic neuropathy. No fasting requirement.

Research protocols only. Not medical advice.


Peptide Interactions

compatible
BPC-157 local repair + ARA-290 nerve protection. Complementary for peripheral neuropathy and tissue repair protocols.
compatible
Both show cardiac and organ protection in ischemia models via different mechanisms. SS-31 (mitochondrial) + ARA-290 (TPR) could be complementary.
compatible
VIP
VIP and ARA-290 both show neuroprotection and anti-inflammatory effects via different receptors. Relevant for inflammatory neuropathy protocols.

Safety Profile

ARA-290 has a favorable Phase II safety profile.

No erythropoiesis: The key safety advantage, unlike EPO itself, ARA-290 does not raise hematocrit, does not cause hypertension, and does not increase thrombosis risk. This eliminates the primary safety concerns of EPO use.

FDA Orphan Drug designation: Granted for small fiber neuropathy, confirming the regulatory safety review pathway.

Well tolerated in Phase II: No dose-limiting toxicities identified in sarcoidosis neuropathy or diabetic neuropathy trials. Mild injection site reactions are the most common adverse event.

No FDA approval for treatment: Orphan Drug designation only; not yet approved for any therapeutic indication.


References

  • [1]Brines M, Cerami A. "Discovering erythropoietin's extra-hematopoietic functions: biology and clinical promise." Kidney Int. 2006;70(2):246-250.
  • [2]Brines M, et al. "ARA 290, a novel erythropoietin receptor ligand, improves metabolic control and neuropathic symptoms in patients with type 2 diabetes." Mol Med. 2015;20:658-666.
  • [3]van Velzen M, et al. "ARA 290, a non-erythropoietic EPO analogue, improves small fiber neuropathy in sarcoidosis." Sarcoidosis Vasc Diffuse Lung Dis. 2014;31(3):188-196.
Key Terms
Reconstitution is the process of dissolving lyophilized (freeze-dried) peptide powder with a sterile diluent to create a…
Bacteriostatic water (BAC water) is sterile water for injection containing 0.9% benzyl alcohol as a preservative. It is …
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Verified Scientific Data Last audited:
Data Sources & External References
Source: peer-reviewed literature  ·  Domain: ascendpeptide.org
ARA-290
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