What Is ARA-290? Benefits, Research & Safety
An 11-amino-acid peptide derived from erythropoietin (EPO) that selectively activates the innate repair receptor (IRR) without stimulating red blood cell production, researched for neuroprotection, tissue repair, and anti-inflammatory effects.
UK summary: Investigational peptide derived from EPO (innate-repair-receptor agonist; lacks EPO's erythropoietic activity). Studied for small-fibre neuropathy and sarcoidosis-related pain; not currently a licensed UK medicine.
Quick Facts
Overview
ARA-290 — evidence and risk at a glance
Twenty standard modules scored against the Peptide Authority evidence grading methodology. Missing modules indicate the field has not yet been characterised editorially — treat absences as uncertainty rather than reassurance.
01Evidence snapshot
Investigational peptide derived from EPO (innate-repair-receptor agonist; lacks EPO's erythropoietic activity). Studied for small-fibre neuropathy and sarcoidosis-related pain; not currently a licensed UK medicine.
02Human evidence grade
03Preclinical evidence grade
04Regulatory status
- UK: Investigational compound. Not licensed by the MHRA for any therapeutic indication.
- EU: Not authorised by the EMA. Has received orphan medicinal product designation for sarcoidosis in the EU.
- Notes: ARA-290 (cibinetide) has been evaluated in multiple clinical trials and received orphan drug designation for sarcoidosis. Despite promising Phase II results, it has not yet achieved regulatory approval from any major authority. It is not available as a research chemical in the same manner as many research peptides — access has been primarily through clinical trial participation.
05Approved medical uses
None in the UK or EU as a finished medicine. (Or: not yet documented; treat as absence rather than approval.)
06Unapproved / promotional claims
- Cures neuropathy.
- Available for UK private prescription.
07Common internet claims
- Marketed by some chronic-pain communities ahead of licensing.
08Claim vs evidence
| Claim | Evidence | Human evidence? | Regulatory concern | Safer wording |
|---|---|---|---|---|
| “Approved for neuropathy” | E | No | High | ARA-290 is investigational with some encouraging Phase 2 data; not approved for any indication. |
09Safety uncertainty score
Safety profile partly characterised; some signals from observational or preclinical data.
10Known adverse signals
- Phase 2 trial profile: generally well tolerated short-term.
- Lacks EPO's erythropoietic activity (designed advantage).
- Long-term safety beyond trial timeframes unstudied.
11Drug-interaction uncertainty
Some interaction data published; check with a prescriber for your specific medicines.
12Anti-doping status
13UK legal position
Investigational compound. Not licensed by the MHRA for any therapeutic indication.
14EU legal position
Not authorised by the EMA. Has received orphan medicinal product designation for sarcoidosis in the EU.
15What this page cannot tell you
- Whether grey-market 'ARA-290' contains the labelled compound.
- Whether Phase 3 will confirm Phase 2 neuropathy signal.
16Last reviewed
17Citation quality score
18Research gaps
- Phase 3 not completed; UK regulatory submission not active.
19Safer alternatives / established care pathways
- NICE NG193 / CG173 neuropathic pain pathway via NHS.
- Clinical trial enrolment via ClinicalTrials.gov for genuinely refractory cases.
20Doctor discussion prompts
Questions to ask a qualified clinician
These are starter questions you can adapt for a GP, specialist, pharmacist, or anti-doping advisor. The aim is to help you have a better-informed conversation — not to replace one.
- Are there UK trials of ARA-290 for my situation?
- What licensed neuropathy treatments should I consider?
Discovery & History
Mechanism of Action
Researched Benefits
Based on preclinical and clinical research findings:
- 1Increased intraepidermal nerve fibre density in sarcoidosis patients with small fibre neuropathy in Phase II trials
- 2Reduction in neuropathic pain scores in clinical studies of sarcoidosis-related neuropathy
- 3Anti-inflammatory effects through macrophage phenotype modulation without immunosuppression
- 4Tissue-protective properties equivalent to EPO without haematopoietic stimulation or blood thickening
- 5Potential cardioprotective effects observed in preclinical models of myocardial ischaemia
- 6Improved metabolic parameters including glucose handling in research models
- 7Neuroprotective effects in models of traumatic brain injury and stroke
- 8Promotion of wound healing in diabetic ulcer models
Claim vs Evidence
How popular claims about ARA-290 stack up against the current research, graded using our public evidence grading methodology.
| Claim | Evidence | Human evidence? | Regulatory concern | Safer wording |
|---|---|---|---|---|
| “Approved for neuropathy” | E | No | High | ARA-290 is investigational with some encouraging Phase 2 data; not approved for any indication. |
Theoretical Dosing & Protocols
| Theoretical Dosage | 2–4 mg per injection (based on clinical trial dosing, typically 2 mg in sarcoidosis studies) |
| Frequency | Daily subcutaneous injection for 28 days (as per clinical trial protocols) |
| Duration | 28 days in published clinical trials; optimal duration for various conditions not yet established |
| Notes | ARA-290/cibinetide is an investigational compound that has been tested in controlled clinical trials. These protocols reflect trial designs and are not therapeutic recommendations. The peptide is not approved for any clinical use. Consult a qualified healthcare professional for guidance. |
Administration Routes
Routes studied in research settings (educational only):
- Subcutaneous injection (used in clinical trials)
- Intravenous injection (used in some early-phase studies)
| Half-Life | Stability |
|---|---|
| Approximately 10–15 minutes (short plasma half-life, but biological effects persist for hours due to sustained intracellular signalling following receptor activation) | Lyophilised powder stored at -20°C; reconstituted solution requires refrigeration at 2–8°C; relatively stable linear peptide structure |
Safety Profile & Known Risks
Commonly Reported Side Effects
- Injection site reactions (redness, mild discomfort)
- Headache reported in some clinical trial participants
- Mild gastrointestinal symptoms (nausea, abdominal discomfort)
- Fatigue (uncommon but reported)
Rare Risks & Concerns
- Unknown long-term effects as clinical trial durations have been relatively short
- Theoretical risk of immune modulation affecting responses to infection
- Potential interactions with other immunomodulatory therapies not fully characterised
- Allergic or hypersensitivity reactions (theoretical risk with any peptide)
Contraindications
- Known hypersensitivity to ARA-290 or any component of the formulation
- Pregnancy and breastfeeding (insufficient safety data)
- Active systemic infections (theoretical concern due to immune modulation)
- Children and adolescents (no paediatric safety data established)
- Concurrent use of erythropoiesis-stimulating agents (potential receptor interactions)
UK & EU Regulatory Context
🇬🇧 United Kingdom
Investigational compound. Not licensed by the MHRA for any therapeutic indication.
🇪🇺 European Union
Not authorised by the EMA. Has received orphan medicinal product designation for sarcoidosis in the EU.
Clinical Studies Summary
A Randomised Double-Blind Placebo-Controlled Trial of ARA 290 in Sarcoidosis Patients with Small Fibre Neuropathy
Phase II trial in 22 sarcoidosis patients demonstrating that 28 days of ARA-290 (2 mg daily SC) significantly increased intraepidermal nerve fibre density and improved neuropathic symptoms compared to placebo. The treatment was well tolerated with no serious adverse events.
Managing fatigue in sarcoidosis - A systematic review of the evidence.
Anti-TNF-α therapies may be beneficial in patients with organ-threatening disease. Neurostimulants have some trial evidence supporting improvements in fatigue but further investigation is needed before they can be recommended.
ARA 290 improves symptoms in patients with sarcoidosis-associated small nerve fiber loss and increases corneal nerve fiber density.
To improved patient-reported symptom-based outcomes, ARA 290 administration was also associated with a significant increase in corneal small nerve fiber density, changes in cutaneous temperature sensitivity, and an increased exercise capacity as assessed by the 6-minute walk test.
Safety and efficacy of ARA 290 in sarcoidosis patients with symptoms of small fiber neuropathy: a randomized, double-blind pilot study.
No change was observed in the IDS. ARA 290 appears to be safe in patients with sarcoidosis and can reduce neuropathic symptoms.
ARA 290, a nonerythropoietic peptide engineered from erythropoietin, improves metabolic control and neuropathic symptoms in patients with type 2 diabetes.
Mean corneal nerve fiber density (CNFD) was reduced significantly compared with normal controls and subjects with a mean CNFD >1 standard deviation from normal showed a significant increase in CNFD compared with no change in the placebo group. These observations suggest that ARA 290 may benefit both metabolic control and neuropathy in subjects with type 2 diabetes and deserves continued clinical evaluation.
Flipping the molecular switch for innate protection and repair of tissues: Long-lasting effects of a non-erythropoietic small peptide engineered from erythropoietin.
Despite a short plasma half-life (~2min), pHBSP activates a molecular switch that triggers sustained biological effects that have been observed in a number of experimental animal models of disease and in clinical trials. This review summarizes pharmacokinetic and pharmacodynamic data and discusses the molecular mechanisms underlying the long-lasting effects of this short-lived peptide.
Registered Trials & Regulatory Status
1 of 2 completed trials have never posted results. Unreported trials are not neutral: results that go unpublished are more often negative ones.
The Use of ARA290 for the Treatment of Diabetic Macular Oedema
Status: Terminated · 9 participants · Belfast Health and Social Care Trust
Conditions: Diabetic Macular Oedema
Study of Efficacy of ARA 290 on Corneal Nerve Fiber Density and Neuropathic Symptoms of Subjects With Sarcoidosis
Status: Completed · 64 participants · Araim Pharmaceuticals, Inc.
Conditions: Neuropathy of Sarcoidosis
ARA290 in T2D (Effects of ARA 290, an Erythropoietin Analogue) in Prediabetes and Type 2 Diabetes)
Status: Unknown · 24 participants · Claes-Göran Östenson
Conditions: Diabetes Type 2, Impaired Glucose Tolerance, Impaired Fasting Glucose
Cognitive and Neural Effects of ARA290
Status: Completed · 36 participants · Leiden University Medical Center
Conditions: Depression
Adverse event reports (FDA FAERS)
Not applicable: no licensed product contains this peptide, so it is not reported through FAERS. This is an absence of surveillance, not evidence of safety.
Source: ClinicalTrials.gov and openFDA. Updated automatically.
Looking for ARA-290?
Source research-grade ARA-290 from a trusted UK supplier — third-party tested with certificate of analysis.
View at SupplierFrequently Asked Questions
Questions to ask a qualified clinician about ARA-290
These are starter questions you can adapt for a GP, specialist, pharmacist, or anti-doping advisor. The aim is to help you have a better-informed conversation — not to replace one.
- Are there UK trials of ARA-290 for my situation?
- What licensed neuropathy treatments should I consider?
UK regulatory & safety context
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