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Nerve Repair & InflammationGrade A

ARA-290 (Cibinetide)

Also known as Cibinetide

An 11-amino-acid peptide derived from the tissue-protective region of erythropoietin, investigated for anti-inflammatory, tissue-protective, and neuropathy-related effects.

Regulatory status
Investigational clinical compound

ARA-290 has been evaluated in registered clinical trials but is not an approved standard therapy.

Half-life
Rapid plasma clearance reported in human studies (minutes)

Reported pharmacokinetics come from limited clinical pharmacology work; values vary with route and assay.

Route
Subcutaneous and intravenous in clinical trials

Investigational clinical use only.

Evidence
Multiple randomized controlled trials in humans

Mechanism of action

ARA-290 was designed to engage the proposed innate repair receptor (a heteroreceptor complex of the EPO receptor and the beta-common receptor) that mediates the tissue-protective signaling of erythropoietin. It was engineered to retain tissue-protective and anti-inflammatory signaling while largely minimising classical erythropoietic activity; published human studies have generally not shown meaningful haemoglobin elevation, though absence of hematological effects should not be stated as absolute.

ARA-290Innate repair receptor (EPOR/βcR)Anti-inflammatory & repair signalingSmall nerve fibers

Studied and reported uses

  • Small-fiber neuropathy

    Human clinical research has investigated neuropathic symptoms and small-fiber outcomes, including symptom questionnaires and nerve-fiber measures.

  • Sarcoidosis-associated neuropathy

    Randomized clinical studies have evaluated ARA-290 in patients with sarcoidosis-associated small-fiber neuropathy.

  • Neuropathic pain

    Investigated for changes in pain intensity and sensory symptoms in controlled human studies.

  • Tissue protection

    Preclinical and translational studies evaluate cytoprotective and repair-related signaling across several tissues.

  • Corneal nerve research

    Human studies have investigated corneal nerve-fiber measures using confocal microscopy in selected patient populations.

Dosing information

Clinical research informationNo approved clinical dosing exists; ARA-290 remains investigational.
Trial protocolsPhase II trials administered daily subcutaneous injection over multiple weeks (dose used in those studies, not a recommended dose).

Ranges are reported from literature and clinical labeling for reference only. They are not a dosing recommendation.

Published research has used different experimental protocols depending on the compound, formulation, route, indication and study design. These study protocols should not be interpreted as established clinical dosing recommendations.

Important pharmacology

Separation from erythropoiesis

ARA-290 targets the tissue-protective receptor pathway rather than the classical homodimeric EPO receptor. Reported human studies have generally not observed clinically meaningful erythropoietic effects, but long-term hematological safety is not fully characterized.

Short plasma exposure, longer signaling

Plasma clearance is rapid relative to the duration of reported biological effects, consistent with receptor-mediated repair signaling rather than sustained plasma exposure.

Side effects

  • Injection-site reactions
  • Headache
  • Generally well tolerated in reported trials

Published human trials reported tolerability comparable to placebo over study durations of weeks. Long-term safety and safety in broader populations remain incompletely established.

Research evidence

Phase I clinical pharmacology

Human Clinical Trial: early-phase studies assessed safety, tolerability, and pharmacokinetics in healthy volunteers and patients.

Phase II sarcoidosis small-fiber neuropathy trial

Human RCT: randomized placebo-controlled study evaluating neuropathic symptom scores and corneal nerve-fiber measures over 28 days.

Neuropathic pain outcomes

Human Clinical Trial: reported improvements in pain and symptom scales in selected populations; sample sizes were modest.

Preclinical tissue protection

Animal: preclinical studies suggest cytoprotective and anti-inflammatory effects in nerve, kidney, and cardiac injury models.

Scientific references

  • ARA 290 improves symptoms in patients with sarcoidosis-associated small nerve fiber loss and increases corneal nerve fiber density

    Dahan A, et al. · Molecular Medicine · 2013

    Molecular Medicine (PubMed-indexed randomized study)

    Human RCTPubMed

  • Efficacy and safety of ARA 290 in sarcoidosis patients with symptoms of small fiber neuropathy

    Molecular Medicine / ClinicalTrials.gov · 2016

    Randomized double-blind placebo-controlled trial

    Human RCTPubMedClinicalTrials.gov

  • Cibinetide (ARA 290) and the innate repair receptor

    Brines M, Cerami A

    PubMed-indexed mechanistic reviews of tissue-protective erythropoietin signaling

    MechanisticPubMed

  • Nonerythropoietic, tissue-protective peptides derived from erythropoietin

    Brines M, et al. · 2008

    PNAS / Molecular Medicine (PubMed-indexed)

    AnimalPubMed

  • ARA 290 in type 2 diabetes with neuropathic pain

    Registered clinical trial records and published results

    Human Clinical TrialClinicalTrials.gov