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ARA-290

ARA-290 is a synthetic 11-amino acid peptide derived from the tissue-protective domain of erythropoietin (EPO), specifically engineered to retain neuroprotective and tissue-protective properties while eliminating erythropoietic activity. This innovative therapeutic agent activates the innate repair receptor (IRR), also known as the common β-receptor (CD131), which plays a crucial role in tissue protection, repair, and regeneration processes.

Unlike native erythropoietin, ARA-290 does not stimulate red blood cell production, making it suitable for therapeutic applications without the cardiovascular risks associated with increased hematocrit. The peptide has gained significant attention in regenerative medicine and neurology due to its demonstrated efficacy in treating diabetic neuropathy, chronic neuropathic pain, and inflammatory conditions through its unique mechanism of promoting neural repair and reducing inflammation.

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Overview

ARA-290 was specifically designed through peptide engineering to isolate the tissue-protective properties of erythropoietin from its hematopoietic effects. The peptide maintains the critical binding domain necessary for IRR activation while eliminating sequences responsible for erythropoiesis. The peptide demonstrates high bioavailability (>85%) via subcutaneous injection and is metabolized primarily in the liver with renal elimination.

Patient consulting with Dr. Ched Garten at Paragon, symbolizing advanced non-surgical care for joint, tendon, muscle, and pain issues.

Chemical structure & Properties

  • Molecular Formula: C59H95N17O22
  • Molecular Weight: 1,382 Da
  • Sequence: 11 amino acids derived from erythropoietin's tissue-protective domain
  • Half-life: Approximately 6-8 hours following subcutaneous administration
  • Stability: Stable in lyophilized form, requires refrigeration when reconstituted

Mechanism of Action

ARA-290 exerts its therapeutic effects through multiple interconnected molecular pathways:

Innate Repair Receptor (IRR) Activation

ARA-290's primary mechanism involves selective binding to the IRR complex:

  • Selective binding to CD131 (common β-receptor) and EPO receptor
  • Activation of tissue-protective signaling without erythropoietic stimulation
  • Initiation of cellular repair and survival pathways
  • Enhanced tissue resilience against oxidative and inflammatory damage

Neuroprotection and Neural Repair

The peptide demonstrates significant neuroprotective properties through:

  • Prevention of neuronal apoptosis and oxidative damage
  • Enhancement of nerve growth factor expression and signaling
  • Promotion of axonal regeneration and remyelination processes
  • Improvement of neuronal survival under stress conditions

Anti-inflammatory Effects

ARA-290 exhibits potent anti-inflammatory properties through:

  • Suppression of pro-inflammatory cytokines (TNF-α, IL-1β, IL-6)
  • Reduction of nuclear factor-kappa B (NF-κB) activation
  • Enhancement of anti-inflammatory mediator expression
  • Modulation of microglial activation and neuroinflammation

Vascular Protection and Repair

The peptide promotes vascular health through:

  • Improvement of endothelial function and nitric oxide bioavailability
  • Enhancement of microvascular circulation, particularly in peripheral tissues
  • Protection against ischemia-reperfusion injury
  • Promotion of angiogenesis and vascular repair processes

Clinical Applications and

Research Evidence

Patient consulting with Dr. Ched Garten at Paragon, symbolizing advanced non-surgical care for joint, tendon, muscle, and pain issues.

Current Clinical Evidence

Safety Profile and Considerations

Clinical Safety Data

Common Adverse Events (Rare):

  • Injection site reactions: mild pain, redness, or swelling (<5% incidence)
  • Gastrointestinal effects: occasional nausea (<3% incidence)
  • Headaches: mild headaches in some patients (<2% incidence)
  • Fatigue: transient during treatment initiation (<2% incidence)

Potential Concerns

Theoretical Risks:

  • No evidence of erythropoietic effects or increased cardiovascular risk
  • Minimal drug interaction potential identified
  • No immunogenic responses or antibody formation observed
  • Excellent tolerability across clinical studies

Drug Interactions:

  • Limited data on interactions with other medications
  • Consultation with healthcare providers recommended for complex cases

Contraindications

ARA-290 should be avoided in:

  • Known hypersensitivity to ARA-290 or formulation components
  • Active malignancy (theoretical concern regarding tissue-protective effects)
  • Pregnancy and breastfeeding (insufficient safety data)
  • Severe cardiovascular disease without medical supervision

Regulatory Status and

Legal Considerations

FDA Status

  • Classification: Investigational drug under clinical development
  • Approval Status: Not approved for commercial therapeutic use
  • Research Status: Available for clinical trials and expanded access programs
  • Regulatory Position: Phase II completed, Phase III studies needed for approval

International Status

  • EMA: Orphan drug designation potential for rare neuropathic conditions
  • Other Regions: Early-stage regulatory interactions initiated
  • Clinical Access: Limited to research protocols and compassionate use cases

Legal Availability

  • Commercial Status: Not legally available as prescription medication
  • Market Presence: Limited to clinical trial participants
  • Quality Control: Clinical-grade material produced under GMP conditions
  • Clinical Use: Restricted to research settings and experimental protocols

Administration and Dosing

Considerations

The Paragon Method: Step-by-Step

Clinical Considerations

Important Notes:

  • No FDA-approved dosing guidelines exist for human use
  • Individual response may vary significantly
  • Medical supervision required for any therapeutic application
  • Quality and purity limited to clinical-grade preparations

Priority Research Areas

  • Large-scale Phase III clinical trials for regulatory approval
  • Long-term safety studies with extended follow-up periods
  • Comparative effectiveness research against standard therapies
  • Optimal dosing regimens for different neuropathic conditions
  • Biomarker development for treatment response prediction

Emerging Applications

Research is investigating potential applications in:

  • Central nervous system neuroprotection
  • Stroke recovery and traumatic brain injury
  • Age-related neurodegenerative diseases
  • Inflammatory bowel disease and tissue protection
  • Athletic performance and cognitive optimization
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Conclusion

ARA-290 represents a promising therapeutic peptide with demonstrated benefits in clinical studies of diabetic neuropathy and chronic neuropathic pain. Its unique mechanism of action through innate repair receptor activation offers distinct advantages in neurological applications without the cardiovascular risks associated with traditional erythropoietin therapy.

The current evidence base includes positive Phase II clinical trial results with excellent safety profiles. However, the investigational status and need for Phase III studies necessitate careful consideration and medical supervision for any therapeutic application. Patients interested in ARA-290 therapy should engage in thorough discussions with qualified healthcare providers and explore participation in clinical trials or expanded access programs.

Future research will be critical in establishing the full therapeutic potential of ARA-290 across various neurological and inflammatory conditions. The peptide's novel approach to activating endogenous repair mechanisms positions it as a potentially transformative therapeutic tool in neurology and regenerative medicine.

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ARA-290 SCIENTIFIC

DATA SUMMARY

MOLECULAR CHARACTERISTICS
PRECLINICAL EFFICACY DATA
CLINICAL EVIDENCE SUMMARY
SAFETY PROFILE
REGULATORY STATUS
Parameter
Molecular Weight
Amino Acid Length
Half-Life
Bioavailability
Detection Window
Value
1,382 Da
11 residues
6-8 hours (hepatic)
High via subcutaneous (>85%)
Up to weeks (immune effects)
Application
Diabetic Neuropathy
Neuropathic Pain
Neural Protection
Anti-inflammatory
Studies
Phase II trials
Clinical studies
Preclinical
Multiple studies
Dose Range
0.1-0.2 mg daily
2-6 mg cycles
0.1-1.0 mg local
Variable dosing
Outcome
Significant pain reduction, improved nerve function
40% average pain reduction
Enhanced axonal regeneration
Reduced cytokines, tissue protection
Study Type
Phase II Trial
Sarcoidosis Study
Safety Studies
Population
Diabetic neuropathy patients
Chronic pain patients
Various populations
Results
Positive efficacy results
40% pain improvement
Excellent tolerability
Limitations
Phase III studies needed
Limited sample size
Long-term data needed
Parameter
Acute Toxicity
Organ Toxicity
Adverse Events
Long-term Safety
Finding
No adverse effects (up to 1000x therapeutic dose)
No hematocrit changes or cardiovascular effects
Minimal reported in clinical studies
Excellent profile in extended studies
Authority
FDA
WADA
DEA
Classification
Investigational Drug
S0 Non-approved Substance
Unscheduled
Status
Phase II completed, Phase III needed
Status unclear
Not controlled substance

Disclaimer: This information is provided for educational purposes only and does not constitute medical advice. ARA-290 is currently investigational and not approved by the FDA for routine therapeutic use. Access is limited to clinical trials and expanded access programs. Patients should consult with qualified healthcare providers before considering any experimental peptide therapy.

The content reflects current scientific literature and regulatory status as of 2025.