Emerging evidence · Grade B
ARA-290
Cibinetide (ARA-290)
Score
66 / 100
Origin
EPO-derived
Target
Innate repair receptor
Status
Investigational (phase 2)
TL;DR
01
An 11-amino-acid peptide (cibinetide) derived from erythropoietin, designed to activate the 'innate repair receptor' — the tissue-protective side of EPO — without EPO's blood-thickening effects.
02
It is the best-evidenced peptide in this group: a phase 2b randomized trial in sarcoidosis-associated small-fiber neuropathy showed it regenerated nerve fibers and reduced pain.
03
That trial used objective surrogate endpoints (corneal nerve fiber imaging), which strengthens the signal — but it was small and used surrogate rather than hard clinical outcomes.
04
It is still investigational: no approval, and larger confirmatory trials are needed.
05
Consumer supply is research-grade and unregulated.
Phase 2b trial
Positive (surrogate)
sarcoidosis neuropathy, n=64
Corneal nerve fibers
Increased
4 mg dose · p=0.012
No RBC effect
Yes
non-hematopoietic EPO derivative
Hard outcomes
Not yet
surrogate endpoints only
Approval
None
research-grade supply
Part 01 · How it works
Mechanism.
Erythropoietin (EPO) does two jobs: it makes red blood cells, and it protects and repairs injured tissue. ARA-290 (cibinetide) was engineered to keep only the tissue-repair job, activating the 'innate repair receptor' without thickening the blood. In a well-designed phase 2 trial in people with sarcoidosis-related nerve damage, it actually regrew small nerve fibers (measured objectively in the cornea) and eased neuropathic pain. That's a genuinely encouraging human result — the caveats are that the trial was small and used surrogate markers, and it hasn't yet been confirmed in larger studies.
The 'healing half' of EPO, split off from the 'thicken the blood' half — and in a real trial it measurably regrew damaged nerves.
Innate repair receptor
Selectively activates the heteromeric EPO/CD131 innate repair receptor, mediating tissue protection/repair.
Non-hematopoietic
Does not stimulate red-cell production, avoiding EPO's thrombotic risk.
Nerve regeneration
Increased corneal nerve fiber area and regenerating intraepidermal (GAP-43+) fibers in a phase 2b trial.
Evidence stage
Phase 2 with surrogate endpoints; no approval; confirmatory trials needed.
Part 02 · Dosing & administration
How it's taken.
Clinical · trial-validatedValues below describe how ARA-290 has been administered in human clinical trials and/or approved labeling. Provided for educational purposes only — this is not medical advice and not instructions for self-administration. Consult your healthcare provider before making any health decision.
Trial
4 mg/day
The most effective dose in the phase 2b trial; not an approved regimen.
·
Doses below are from a clinical trial, not instructions.
·
Given subcutaneously in the trial program.
·
No approved regimen; consumer supply is research-grade.
Need help with reconstitution?
Use the free peptide calculator for dilution, unit conversion, and injection volume.
Part 03 · Safety
Side effects, rare serious events, who shouldn't.
Common
Injection-site reactions
Generally mild in trials.
Reported
Serious · rare
No red-cell/thrombotic effect
Non-hematopoietic — avoids EPO's clotting risk (a safety advantage).
By design
Long-term safety
Short trials; long-term human data limited.
Limited data
Product-quality risk
Research-grade supply may not match labeled purity/dose.
Source-dependent
Absolute · do not use
×
Pregnancy or breastfeeding
×
Children under 18
×
Known hypersensitivity to cibinetide or any component
×
Active systemic infection (may modulate immune response)
×
Uncontrolled autoimmune disease
Relative · discuss first
!
Reliance on it as a proven neuropathy therapy — evidence is phase 2 only
!
Pregnancy or breastfeeding — insufficient data
!
Anyone expecting confirmed hard-outcome benefit — not yet established
Interactions
Immunosuppressants (tacrolimus, cyclosporine)
Cibinetide modulates innate immune repair pathways; may alter immunosuppressive efficacy
Moderate
Erythropoiesis-stimulating agents (EPO)
Cibinetide acts on EPO receptor heterodimer; theoretical interaction with EPO therapy
Moderate
Inflammation-modulating biologics (TNF inhibitors)
Additive inflammation-modulating effects; theoretical risk of excessive immune suppression
Moderate
Labs to monitor
CBC with Differential
Baseline and monthly
Monitor hematologic parameters given EPO receptor interaction
CMP (Comprehensive Metabolic Panel)
Baseline and every 3 months
Liver and kidney function
HbA1c
Baseline and every 3 months
Track glycemic control in diabetic neuropathy patients
CRP / ESR
Baseline and monthly
Track inflammatory markers
Part 04 · Evidence
How strong is the evidence?
66
Grade B
Grade B, Emerging — the strongest in this immune/tissue group. A well-designed phase 2b RCT showed objective nerve regeneration and pain relief, with a clean non-hematopoietic mechanism. Held here by small size, surrogate endpoints, and lack of confirmatory/approval-level data.
Mechanistic plausibility
Well-defined innate-repair-receptor mechanism; rational EPO-derivative design.
82
Human evidence
A positive phase 2b RCT with objective surrogates; small and unconfirmed.
64
Safety & tolerability
Non-hematopoietic (avoids EPO's clotting risk); well tolerated in trials; long-term data limited.
72
Durability
28-day trial; durability and hard-outcome benefit not established.
58
Independence
Sponsor-involved (Araim) but with independent academic investigators and objective endpoints.
62
Part 05 · Research log
Every study we cite.
We list each study with its methodology, funding source, and our quality grade. Flagged studies aren't dismissed — they're tagged so you can weigh them.
01
2017
Invest Ophthalmol Vis Sci Flagged
Cibinetide improves corneal nerve fiber abundance in sarcoidosis small-fiber neuropathy
Cibinetide 4 mg/day significantly increased corneal nerve fiber area (p=0.012) and regenerating skin fibers, with pain improvement — consistent with a disease-modifying effect.
Phase 2b, 28-day, randomized, placebo-controlled · n = 64 · Objective surrogate endpoints strengthen it; small and needs confirmation in hard outcomes.
PMID 28475703 ↗
Moderate-High
Evidence against
What didn't work, and where the evidence is thin.
Every publication is incentivized to tell you a peptide works. We catalogue the null results, failed trials, and mechanism limits we found in the same literature — so you can weigh them against the upside, with your provider.
01
Positive but small, surrogate-endpoint, and unconfirmed
Mechanism limit Invest Ophthalmol Vis Sci · 2017
The encouraging result is a single phase 2b trial (n=64) using surrogate nerve-imaging endpoints over 28 days, not hard clinical outcomes over the long term, and it has not been confirmed in larger trials or led to approval.
What this means: A promising signal, not an established therapy. It deserves confirmatory trials before anyone treats it as proven.
PMID 28475703 ↗
Part 06 · Cost & access
Where it's available, at what price.
United States
Investigational
Not approved; studied in trials. Consumer supply is research-grade.
Grey-market; unregulated
European Union
Investigational
Not approved; research use.
N/A
United Kingdom
Investigational
Not approved.
N/A
Canada
Investigational
Not approved.
N/A
The Peptide Column takes no affiliate commission from any source. ARA-290 (cibinetide) is investigational with promising phase 2 data but no approval; consumer supply is research-grade and unregulated. We link only to clinician-directed care, never to sellers.
Part 07 · Your appointment
Questions to bring.
01
Has cibinetide shown benefits for my specific type of neuropathy in clinical trials?
02
How does ARA-290 differ from erythropoietin in terms of safety and blood clot risk?
03
What is the current regulatory pathway for cibinetide, and are there ongoing trials I could join?
04
Are there any interactions between ARA-290 and my current medications?
References
Every citation, numbered.
Citation list. For our editorial read of each study — including bias flags and quality grades — see the Research log above.
- 01. Cibinetide improves corneal nerve fiber abundance in sarcoidosis small-fiber neuropathy · Invest Ophthalmol Vis Sci, 2017 · PMID 28475703 ↗
- 02. Araim Pharmaceuticals / ClinicalTrials.gov. Cibinetide sarcoidosis neuropathy program