Educational reference only. Not medical advice. Consult a healthcare provider before starting any protocol.

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ARA-290

ARA-290 (Cibinetide / pHBSP / Helix B Surface Peptide)

NeuroprotectionAnti-inflammatoryTissue repairMetabolic11 amino acids

What it is

A synthetic 11-amino-acid peptide rationally designed from erythropoietin's helix-B domain by Araim Pharmaceuticals. ARA-290 selectively activates the Innate Repair Receptor (IRR), a heterodimer of the EPO receptor and CD131 (β-common receptor), which is upregulated at sites of tissue injury. Critically, it produces zero erythropoietic activity — no increase in hematocrit, hemoglobin, or thrombotic risk. It has been studied in multiple completed Phase 2 human trials for sarcoidosis-associated small fiber neuropathy, type 2 diabetic neuropathy, and diabetic macular edema, with consistent positive results. Holds FDA orphan drug and fast track designations.

Community-reported ranges

Dose ranges sourced from published Phase 2 clinical trial protocols and limited community forum data. Not dosing guidance.

Reported dose range

20004000 mcg

Estimated half-life

~20 minutes (subcutaneous terminal half-life)

Source: Human Phase 2 clinical trial data. Despite very short plasma half-life, biological effects persist for days to weeks due to durable intracellular signaling cascades.

Reported cycle length

46 weeks on

4 weeks off

Route

subcutaneous

Common vial sizes

10mg, 16mg

Reported timing

AM, daily

Reported frequency

1x daily

Frequently discussed alongside

Based on community forum discussions. Not a recommendation to combine compounds.

Published research

ARA-290 has the most robust human clinical dataset among niche tissue-repair peptides. A pilot trial in 22 sarcoidosis patients (Heij et al., 2012) showed significant improvement in neuropathic symptom scores with 2 mg IV 3x/week. A Phase 2 trial in 49 type 2 diabetes patients (Brines et al., 2015) demonstrated significant improvement in HbA1c (p=0.002) and neuropathic pain scores with 4 mg SC daily for 28 days. A Phase 2b dose-ranging study in 64 sarcoidosis patients (Culver et al., 2017) showed 4 mg SC daily produced a 23% increase in corneal nerve fiber area versus placebo (p=0.012). A diabetic macular edema pilot (Lois et al., 2020) confirmed safety over 12 weeks. Mechanism involves selective IRR activation, PI-3K/Akt signaling, NF-κB inhibition, and TRPV1 channel antagonism.

Reported side effects

From community self-reports. Not from controlled studies.

Clinical trials report an excellent safety profile across all published studies. Mild adverse events include transient fatigue, nausea, diarrhea, and injection site reactions. No serious adverse events, no dose-limiting toxicity, and no anti-cibinetide antibodies were detected in any study. No hematologic effects — no increases in hematocrit, hemoglobin, or thrombotic events.

Regulatory status

FDA (United States)

Not approved. Holds US Orphan Drug Designation for sarcoidosis and pancreatic islet transplantation survival. Holds US Fast Track Designation for neuropathic pain in sarcoidosis. Also holds EU Orphan Medicinal Product designations for both indications. Completed successful End-of-Phase 2 meeting with FDA.

Health Canada

Not authorized as a therapeutic product. No DIN assigned.

WADA (Competitive Athletes)

Not explicitly named on the 2024–2025 Prohibited List. Status is ambiguous: the S2 category covers 'Erythropoietin-Receptor agonists' and ARA-290 does act on the EPOR (in heterodimer with CD131), but it lacks any erythropoietic activity. The broad 'and mimetics' language could encompass it. Athletes should consult WADA/USADA directly.

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