ARA-290 / Cibinetide
Evidence: B — Meaningful Human EvidenceRepair / Tissue Healing
Evidence Snapshot
What this grade covers
A for identity and current FDA category status; B/C for small indication-specific human trials and surrogate findings; D/E for established neuropathy treatment, broad tissue repair, metabolic treatment, approval, safety, or dosing.
Regulatory Context
Investigational erythropoietin-derived peptide; not FDA-approved.
Research Takeaway
ARA-290 and cibinetide are names for the same 11-amino-acid nonerythropoietic peptide derived from an erythropoietin helix and designed to engage tissue-protective innate-repair signaling without stimulating red-cell production.
Evidence boundary: This identity must not be conflated with erythropoietin itself.
See all 6 evidence claims →Quick Summary
ARA-290, later developed as cibinetide, is an erythropoietin-derived peptide engineered to activate tissue-protective signaling without stimulating red-blood-cell production. Several small phase 2 studies evaluated neuropathic symptoms, corneal nerve measures, metabolic endpoints, and diabetic macular edema.
Mechanism & Research Overview
ARA-290/cibinetide was designed from the helix-B surface of erythropoietin. It is studied as a selective agonist of the innate repair receptor, commonly described as a heteromer involving the erythropoietin receptor and beta-common receptor, with proposed anti-inflammatory and tissue-protective signaling that lacks conventional erythropoietic activity.
Evidence Claims
Individual scientific statements drawn from the sources cited below, each shown with the specific evidence boundary that statement does not establish.
Supported
ARA-290 and cibinetide are names for the same 11-amino-acid nonerythropoietic peptide derived from an erythropoietin helix and designed to engage tissue-protective innate-repair signaling without stimulating red-cell production.
Does not establish
Evidence boundary: This identity must not be conflated with erythropoietin itself.
Sources: ARA 290 improves symptoms in patients with sarcoidosis-associated small nerve fiber loss and increases corneal nerve fiber density; CIBINETIDE / ARA-290 substance record
Supported
Randomized human studies reported improvements in neuropathic symptoms and small-nerve-fiber measures in sarcoidosis-associated and diabetic small-fiber neuropathy populations.
Does not establish
Evidence boundary: These small studies do not establish broad neuroregenerative efficacy across unrelated disorders.
Sources: ARA 290 improves symptoms in patients with sarcoidosis-associated small nerve fiber loss and increases corneal nerve fiber density; ARA 290, a nonerythropoietic peptide engineered from erythropoietin, improves metabolic control and neuropathic symptoms in patients with type 2 diabetes; Cibinetide Improves Corneal Nerve Fiber Abundance in Patients With Sarcoidosis-Associated Small Nerve Fiber Loss and Neuropathic Pain
Supported
Cibinetide has been clinically investigated but is not established in this package as an FDA-approved therapeutic product; an FDA UNII identifies the substance but does not imply approval.
Does not establish
Evidence boundary: Clinical-trial registration and substance registration are not marketing authorization.
Sources: Study of Efficacy of ARA 290 on Corneal Nerve Fiber Density and Neuropathic Symptoms of Sarcoidosis Patients; CIBINETIDE / ARA-290 substance record
Supported
Short controlled studies did not identify the hematopoietic adverse effects characteristic of erythropoietin, but the trials are too small and short to define a complete long-term safety profile.
Does not establish
Evidence boundary: Absence of a major signal in small trials does not establish long-term safety.
Sources: ARA 290 improves symptoms in patients with sarcoidosis-associated small nerve fiber loss and increases corneal nerve fiber density; ARA 290, a nonerythropoietic peptide engineered from erythropoietin, improves metabolic control and neuropathic symptoms in patients with type 2 diabetes; Cibinetide Improves Corneal Nerve Fiber Abundance in Patients With Sarcoidosis-Associated Small Nerve Fiber Loss and Neuropathic Pain
Supported
The human evidence supports a neuropathy research signal but does not establish cibinetide as a proven treatment for generalized pain, anti-aging, athletic recovery, or systemic tissue repair.
Does not establish
Evidence boundary: Mechanistic tissue-protection language must not be converted into unsupported indications.
Sources: ARA 290 improves symptoms in patients with sarcoidosis-associated small nerve fiber loss and increases corneal nerve fiber density; ARA 290, a nonerythropoietic peptide engineered from erythropoietin, improves metabolic control and neuropathic symptoms in patients with type 2 diabetes; Cibinetide Improves Corneal Nerve Fiber Abundance in Patients With Sarcoidosis-Associated Small Nerve Fiber Loss and Neuropathic Pain
Supported
Only exact regimens from named clinical trials may appear as Study/Trial Dosing, with no consumer dosing or self-administration recommendations.
Does not establish
Evidence boundary: Trial dosing does not imply an approved or advisable regimen outside the study.
Sources: ARA 290 improves symptoms in patients with sarcoidosis-associated small nerve fiber loss and increases corneal nerve fiber density; ARA 290, a nonerythropoietic peptide engineered from erythropoietin, improves metabolic control and neuropathic symptoms in patients with type 2 diabetes; Study of Efficacy of ARA 290 on Corneal Nerve Fiber Density and Neuropathic Symptoms of Sarcoidosis Patients
Safety & Evidence Limitations
Considerations reported in the sources cited on this page — not a complete list of every possible risk, and not medical advice.
Safety Consideration
Published human studies were small and short; long-term safety is not established.Safety Consideration
Improvements in corneal nerve-fiber density are surrogate or exploratory findings and do not automatically prove durable clinical benefit.Safety Consideration
The compound remains investigational and no approved indication has been established.Safety Consideration
Potential class or receptor-related effects and interactions have not been comprehensively characterized.Safety Consideration
Short-term small trials did not show the hematocrit-raising profile expected from erythropoietin, consistent with nonerythropoietic design, but this does not establish comprehensive safety. Important uncertainties include limited participant numbers and exposure duration; unknown long-term receptor effects; cardiovascular and hemodynamic effects; hematologic effects not detectable in small studies; immune and inflammatory pathway modulation; angiogenic or proliferative consequences; hepatic, renal, retinal, neurologic, reproductive, pregnancy, and developmental effects; interaction with erythropoietin, diabetes drugs, anticoagulants, immunomodulators, and cancer therapy; peptide aggregation, impurities, immunogenicity, sterility, and endotoxins; free-form versus salt/formulation differences; and absence of a completed confirmatory safety program. Lack of erythropoiesis does not eliminate all cardiovascular or cancer-related risk.
Research Areas Being Studied
Research areas discussed on this page reflect the Repair / Tissue Healing category and the sources cited below.
Findings Reported in Studies
Educational summary only — reported in cited studies, not a claim of proven benefit.
- A Phase 2 clinical trial on the use of cibinetide for the treatment of diabetic macular edema (2020):
- Cibinetide Improves Corneal Nerve Fiber Abundance in Patients With Sarcoidosis-Associated Small Nerve Fiber Loss and Neuropathic Pain (2017):
- ARA 290, a nonerythropoietic peptide engineered from erythropoietin, improves metabolic control and neuropathic symptoms in patients with type 2 diabetes (2015):
- ARA 290 for treatment of small fiber neuropathy in sarcoidosis (2014):
- ARA 290 improves symptoms in patients with sarcoidosis-associated small nerve fiber loss and increases corneal nerve fiber density (2013):
- Safety and efficacy of ARA 290 in sarcoidosis patients with symptoms of small fiber neuropathy (2012):
Study Tables by Evidence Type
Human Studies & Clinical Data
| Title | Year | Population / Model | Dose / Duration / Finding | Safety Notes | Source |
|---|---|---|---|---|---|
| A Phase 2 clinical trial on the use of cibinetide for the treatment of diabetic macular edema | 2020 | Treatment-naive patients with diabetic macular edema | Small phase 2 study evaluated ocular and systemic outcomes; it was exploratory and not definitive evidence of clinical efficacy.
| Small sample; systemic and long-term safety remain incompletely characterized. | |
| Cibinetide Improves Corneal Nerve Fiber Abundance in Patients With Sarcoidosis-Associated Small Nerve Fiber Loss and Neuropathic Pain | 2017 | Patients with sarcoidosis-associated small-fiber loss and neuropathic pain | Cibinetide increased corneal and cutaneous small-nerve-fiber abundance in patients with sarcoidosis-associated small-fiber loss. The findings support biological activity but do not constitute approval.
| Short-duration study; long-term safety and clinical relevance of surrogate endpoints remain uncertain. | |
| ARA 290, a nonerythropoietic peptide engineered from erythropoietin, improves metabolic control and neuropathic symptoms in patients with type 2 diabetes | 2015 | Adults with type 2 diabetes and painful neuropathy | In type 2 diabetes with painful neuropathy, ARA-290 was associated with improvement in neuropathic symptoms and selected metabolic measures over a short trial. No major safety issue was identified, but larger confirmatory studies were required.
| No major signal was identified in this small study, but sample size and duration were insufficient to establish long-term safety. | |
| ARA 290 for treatment of small fiber neuropathy in sarcoidosis | 2014 | Patients with sarcoidosis-associated small-fiber neuropathy | Clinical evaluation reported improvement in neuropathic-pain symptoms during ARA-290 treatment. | Limited sample size and investigational setting. | |
| ARA 290 improves symptoms in patients with sarcoidosis-associated small nerve fiber loss and increases corneal nerve fiber density | 2013 | Patients with sarcoidosis-associated small-fiber neuropathy | In patients with sarcoidosis-associated small-fiber neuropathy, 28 days of ARA-290 improved neuropathic symptoms and was associated with increased corneal nerve-fiber density. The trial was small and exploratory.
| Small, short-duration study; findings require confirmation. | |
| Safety and efficacy of ARA 290 in sarcoidosis patients with symptoms of small fiber neuropathy | 2012 | 22 patients with sarcoidosis and small-fiber-neuropathy symptoms | Pilot randomized data reported improvement in neuropathic symptoms and supported further evaluation.
| Small sample and short exposure limit safety conclusions. |
Animal / Cell / Preclinical Data
| Title | Year | Population / Model | Dose / Duration / Finding | Safety Notes | Source |
|---|---|---|---|---|---|
| ARA290, a peptide derived from the tertiary structure of erythropoietin, produces long-term relief of neuropathic pain in rats | 2011 | Rat peripheral-nerve-injury model | Preclinical work reported prolonged antiallodynic effects associated with innate-repair-receptor signaling. | Preclinical result; translation to humans is uncertain. | |
| Effect of insulin and an erythropoietin-derived peptide on diabetic neuropathy in rats | 2011 | Diabetic rat neuropathy model | ARA-290 was evaluated for tissue-protective effects in diabetic neuropathy models. | Animal evidence does not establish human efficacy or safety. |
Regulatory Documents & Official Trial Registries
| Title | Year | Population / Model | Dose / Duration / Finding | Safety Notes | Source |
|---|---|---|---|---|---|
| 503A Bulk Drug Substances Categories, Updated May 14, 2026 | 2026 | Thymalin was not identified on the reviewed current FDA 503A or 503B bulk-substance category lists or FDA peptide safety table; Cibinetide (ARA-290) is listed in Category 3, meaning it was nominated without adequate support for FDA evaluation. Absence from those lists, or Category 3 status, is not approval, a safety determination, or authorization to compound, and Category 3 is not the Category 1 pathway under which FDA described interim enforcement discretion. | |||
| CIBINETIDE / ARA-290 substance record | 2026 | FDA GSRS identifies ARA-290 and cibinetide as synonyms for the same 11-amino-acid peptide. FDA states that UNII availability does not imply regulatory review or approval. | FDA UNII: 9W5677JKDA. FDA URL: https://precision.fda.gov/uniisearch/srs/unii/9W5677JKDA | ||
| The use of ARA290 for the treatment of diabetic macular edema | 2024 | Participants with diabetic macular edema | Current registry record; a registry listing is not evidence of completed efficacy results. | ||
| Study of Efficacy of ARA 290 on Corneal Nerve Fiber Density and Neuropathic Symptoms of Sarcoidosis Patients | 2014 | Adults with sarcoidosis-associated neuropathy | The registry documents clinical investigation of ARA-290 in sarcoidosis-associated neuropathy. Registration and completion do not imply FDA approval. | ||
| Effects of ARA 290 in type 2 diabetes | 2013 | Adults with type 2 diabetes and neuropathy | Official registry for the controlled type 2 diabetes study. | ||
| PubChem Cibinetide Record | PubChem's Cibinetide compound record establishes the identity of the 11-amino-acid synthetic peptide derived from the three-dimensional structure of erythropoietin. Used for identity verification only, not efficacy evidence. |
Anecdotal Reported Patterns — Not Medical Advice
Anecdotal Reported Patterns — Not Medical Advice
Reported dosing patterns are included for educational context only. They are self-reported, unverified, not medical advice, and not instructions for human use. Community-submitted patterns are not yet available in this Phase 1 prototype; this section is a placeholder reserved for moderated, aggregated community data.
Lab Markers to Discuss With a Clinician
Educational topics only — not self-monitoring instructions.
FAQ
Disclaimer
Educational information only. This page summarizes published and official research and does not provide medical advice, a recommendation, or instructions for human use.
Educational use only. This content is provided for informational and research-summary purposes only. It is not medical advice, not a treatment recommendation, not a dosing guide, and not a substitute for care from a licensed medical professional. Nothing here is intended to diagnose, treat, cure, prevent, or mitigate disease. Reported dosing patterns, when shown elsewhere on the site, must be labeled either as Study / Trial Dosing or Anecdotal Reported Patterns — Not Medical Advice. Community reports are self-reported, unverified, and not scientific proof.
Community-reported experiences, once enabled, must be displayed only as moderated, anonymized, or aggregated data. They are anecdotal, self-reported, unverified, and should never be presented as proof of safety, efficacy, or expected results.
Content status: Content pending review. Last updated 2026-07-30.
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