Peptide education

ARA-290

Cibinetide · ARA 290 · PHBSP

ARA-290, properly called cibinetide, is an 11-amino-acid peptide engineered from erythropoietin to trigger EPO's tissue-protective signaling without making red blood cells. That is a real drug-design idea, and unlike most compounds on this site it produced real human trials: small randomized studies in sarcoidosis-associated small-fiber neuropathy that reported symptom and nerve-fiber signals, plus a small study in early type 2 diabetes. Then the story stalls: no phase 3, no approval, orphan designations that never converted. What survives is a gray market of research vials and clinic nerve-regeneration programs selling 12-week courses that no trial ever ran.

ARA-290 has genuine randomized human data, rare for this market, but only in one narrow neuropathy and one small diabetes study, all short. Development stopped before phase 3, and the clinic programs being sold were never part of the trials.

Main interestSmall-fiber neuropathy research
EvidenceSmall phase 2 human studies
Regulatory statusInvestigational
Common study routeSubcutaneous in later trials
Product issueResearch-use vial uncertainty

Overview

Quick answer

The product used in clinical studies is not the same thing as a research-use ARA-290 vial sold online. Human papers describe controlled investigational use; vendor labels, COAs, and clinic marketing do not verify identity, sterility, potency, endotoxin control, storage, or clinical suitability.

What is ARA-290?

Cibinetide: an 11-amino-acid peptide (sequence pEQLERALNSS) built from erythropoietin's helix-B surface. It activates the innate repair receptor, an EPOR-CD131 complex, without engaging the red-blood-cell pathway, which was the entire point of the design.

Why do people talk about it?

Because the small human studies actually reported signals: improved neuropathic symptoms and corneal nerve-fiber measures in sarcoidosis small-fiber neuropathy, and metabolic plus neuropathic-symptom signals in a small type 2 diabetes study. Narrow, short, early data, but real, which is more than most forum peptides have.

What did studies actually use?

Short courses, mostly subcutaneous: 2 mg IV three times weekly for four weeks in the first sarcoidosis pilot, daily subcutaneous dosing for 28 days in later sarcoidosis work, 1, 4, or 8 mg daily for 28 days in the phase 2b, 4 mg daily for 28 days in the diabetes study, and 4 mg daily for 12 weeks in a tiny diabetic macular edema pilot. A healthy-volunteer mood study used a single 2 mg dose.

Where do claims overreach?

At the jump from "signals in two narrow neuropathy populations" to broad nerve repair, pain, inflammation, long COVID, autoimmune disease, anti-aging, and recovery. One clinic sells a staged 12-week regeneration program; the longest controlled exposure in the literature is 28 days. Forum reports are mixed too, including a pain flare that ended one self-experiment and a 60-day run with no benefit.

What is the product-quality issue?

FDA places cibinetide in 503A Category 3: the compounding nomination did not contain enough support to even evaluate it. A research-use vial with a purity claim says nothing about identity, sterility, endotoxin, fill accuracy, or whether it matches the investigational material the trials used.

Reported practice

Commonly reported protocol

ARA-290 community-reported use
Route
Subcutaneous injection
Typical amount
Community protocols commonly mirror the 4 mg per day schedule used in the sarcoid neuropathy trials
Frequency
Once daily in trial-mirroring descriptions
Duration
Commonly described as 28-day runs, matching the cited trial duration

Trial-mirroring community protocols. Community-reported patterns, not verified by controlled human trials and not a use recommendation. Full use-pattern detail

Evidence

Evidence snapshot

Best-supported human settingSarcoidosis small-fiber neuropathy

The clearest human evidence comes from sarcoidosis-associated small-fiber neuropathy studies, including randomized or blinded work with symptom, corneal nerve, skin-fiber, temperature-sensitivity, and walking-test endpoints.

Secondary human settingType 2 diabetes neuropathic symptoms

A small phase 2 diabetes study reported metabolic and neuropathic-symptom signals after 28 days of daily subcutaneous ARA-290, with follow-up after treatment stopped.

Exploratory eye studyDiabetic macular edema pilot

A very small open-label pilot used 4 mg/day subcutaneously for 12 weeks. It reported safety over that short course and exploratory signals, but no controlled efficacy conclusion.

Regulatory statusOrphan designations, not approval

FDA identity and orphan-designation records connect the cibinetide name to the sarcoidosis-neuropathic-pain designation. They do not create an FDA approval label.

Compounding and product statusCompounding review warning

The cited FDA 503A material did not give enough support to evaluate cibinetide as a compounded bulk substance. A clinic or pharmacy claim still has to answer identity, sterility, dose, and safety questions.

Claims

Common claims vs evidence

ClaimHuman evidenceMechanistic evidenceAnecdotal evidenceVerdict
ARA-290 may help sarcoidosis-associated small-fiber neuropathy.The human evidence is early and narrow. Sarcoidosis studies reported improvements in neuropathic symptom measures and small-fiber markers, but the studies were small and short. The mechanism fits an injury-resolution idea: ARA-290 was designed to engage tissue-protective EPOR/CD131 signaling rather than classic erythropoietic signaling. One clinic page turns the 28-day sarcoidosis work into a 12-week regeneration program. A direct forum report planned to copy the 4 mg/28-day trial pattern but stopped after painful tingling during a gradual increase from 0.5 mg to 4 mg. Reasonable to discuss as a narrow sarcoidosis small-fiber-neuropathy research finding. Too early to describe as a settled treatment.
ARA-290 improves diabetic neuropathy or metabolic markers.A small type 2 diabetes phase 2 publication reported improvements in HbA1c, lipid-profile signals, PainDetect scores, and corneal nerve fiber density in a reduced-density subgroup after 4 mg subcutaneously once daily for 28 days. The tissue-protective and anti-inflammatory receptor rationale is compatible with neuropathy research, but receptor theory cannot stand in for diabetes treatment data. Online discussion often treats diabetic neuropathy, glucose effects, and general nerve repair as the same claim. The human study was much narrower. Early human data, not a diabetes-care standard and not a general neuropathy claim.
ARA-290 is a nerve-regeneration peptide.Human studies reported changes in corneal nerve fiber measures and related small-fiber endpoints in specific disease settings. They do not answer broad nerve regeneration throughout the body. The EPOR/CD131 tissue-protective model makes small-fiber repair plausible enough to study. A clinic page advertises a 12-week nerve-regeneration program. Direct forum reports are mixed: one user stopped after a pain flare, while another neuropathy thread includes both no-benefit reports and uncertain stacked-use improvement reports. Read this as disease-specific small-fiber research, not as a general nerve-regrowth product.
ARA-290 is safer than erythropoietin.Short studies did not report the erythropoietic drug profile that would be expected from classic EPO biology, and some short-course studies were reassuring. The safety database is still small. The molecule was designed to avoid the hematopoietic pathway. Design intent is useful, but it is not a long-term safety database. Marketing often says "non-EPO" or "nonerythropoietic" as if that answers all safety questions. That wording still leaves immunogenicity, repeated-course, pregnancy, malignancy, and product-contamination questions open. The design rationale is real. Blanket safety claims are too broad.
ARA-290 works for long COVID, chronic fatigue, autoimmune disease, anti-aging, or general recovery.Human studies have not tested ARA-290 as a long COVID, ME/CFS, autoimmune-disease, longevity, healthy-aging, training-recovery, or general injury-recovery drug. Anti-inflammatory and tissue-protective biology can explain why those claims appear online, but mechanism alone is weak support for a condition claim. The direct clinic and market pages found here broaden ARA-290 into inflammation, sleep, and generic nerve-repair programs. They do not establish a representative long-COVID, ME/CFS, longevity, or training-recovery use pattern. Human studies in sarcoidosis, diabetes, eye disease, and healthy-volunteer settings do not provide enough support for that claim.
A research-use vial is equivalent to clinical-study cibinetide.No human trial verifies that products sold online as ARA-290 match the identity, assay, sterility, endotoxin, storage, or handling controls used for investigational study material. Receptor biology says little about vial quality. Injectable products still need identity, sterility, endotoxin, and handling evidence. Online listings may show vial size, purity, or a COA, while still leaving the exact material, fill amount, impurity profile, sterility, and storage history uncertain. The molecule name alone is not product evidence.

Bottom line

Main takeaway

If you just heard the name

ARA-290 is an engineered repair-signaling peptide with small but real human trials in one kind of neuropathy. It is investigational, unapproved, and the clinic programs sold under its name were never studied.

If you are comparing nerve or inflammation peptides

It has more human data than most compounds here, and it is still two narrow indications, short exposures, and surrogate-heavy endpoints. Separate the trial molecule from the vial before using the literature to justify anything.

Where the evidence is strongest

Core record: the 2012 IV sarcoidosis pilot, the 2013 subcutaneous sarcoidosis corneal-nerve study, the phase 2b dose-ranging paper, the 2015 type 2 diabetes phase 2, and the 2020 macular edema pilot, plus FDA orphan and 503A Category 3 records for the regulatory picture.

Identity

What it is

Cibinetide is the formal name; ARA-290 is the one that stuck. It is an 11-amino-acid peptide derived from erythropoietin's helix-B surface, sequence pEQLERALNSS, designed to do one specific trick: activate the EPOR-CD131 innate repair receptor while leaving the hematopoietic EPOR dimer alone.

The design worked well enough to test in people. In sarcoidosis-associated small-fiber neuropathy, small blinded and randomized studies reported improved neuropathic symptoms and changes in corneal nerve-fiber measures, with the 4 mg daily arm of the phase 2b producing the clearest structural signal over 28 days. A small phase 2 in early type 2 diabetes reported HbA1c, lipid, PainDetect, and corneal-nerve signals after the same 4 mg, 28-day course.

Then the trail thins. A healthy-volunteer study found some emotional-processing changes but no antidepressant-like profile. An open-label diabetic macular edema pilot ran 12 weeks with nine recruited patients and produced reassuring safety plus exploratory signals. FDA granted orphan designations, including one for sarcoidosis neuropathic pain, but no phase 3 program and no approval followed, and cibinetide now sits in 503A Category 3, meaning the compounding nomination lacked adequate support to evaluate.

The market did not wait. Clinics sell staged 12-week nerve-regeneration programs, vendors sell 10 mg vials with reconstitution guides, and forum users copy the 4 mg trial schedule with mixed results. All of that activity borrows the credibility of small, short, disease-specific trials and spends it elsewhere.

How people talk about it online

Forum and Reddit-style ARA-290 talk is unusually concrete for a peptide, because users copy the actual trial schedule: 4 mg daily, 28 days. The firsthand record is mixed. One user escalating from 0.5 to 4 mg stopped after five days with a painful tingling flare; another ran 4 mg daily for about 60 days with no benefit; a neuropathy thread mixes no-effect reports with stacked-use improvement stories that cannot isolate the peptide.

Clinic marketing goes further than any study: a staged 12-week home-injection program for neuropathic pain, inflammation, sleep, and regeneration, with no published amount. That is triple the longest controlled treatment exposure in the literature, sold as a service.

Vendor pages borrow the trial vocabulary while selling 10 mg research vials with purity and reconstitution documentation. Given the 503A Category 3 status, the paperwork describes a product the FDA review process has explicitly not vetted.

Use context

Routes, doses, and cycle patterns

Most route and amount details come from human studies, not from an approved label. Early sarcoidosis work included an intravenous schedule, while later neuropathy and diabetic-complication studies mostly used subcutaneous ARA-290 over 28 days to 12 weeks. Online and clinic discussion usually talks as if injectable use is assumed, but exact amounts and cycle lengths are often copied from studies or left unclear.

Human studies and product labels

Early sarcoidosis small-fiber-neuropathy pilot

Purpose
Neuropathic symptoms in sarcoidosis
Context
Double-blind exploratory trial
Route
Intravenous
Amount
2 mg
Frequency
Three times weekly
Duration
4 weeks

This older pilot matters because it shows that not every ARA-290 human schedule was subcutaneous. It studied sarcoidosis patients with small-fiber-neuropathy symptoms, not broad pain or recovery use.

Sarcoidosis small nerve fiber loss study

Purpose
Neuropathic symptoms and corneal nerve fiber density
Context
Blinded placebo-controlled study
Route
Subcutaneous
Amount
The cited study summary does not give a usable dose amount
Frequency
Daily
Duration
28 days

This study reported symptom improvement and corneal small-fiber changes after a short daily subcutaneous course in sarcoidosis-associated small nerve fiber loss.

Sarcoidosis phase 2b dose-ranging study

Purpose
Corneal nerve fiber and neuropathic-pain endpoints
Context
Randomized placebo-controlled phase 2b trial
Route
Subcutaneous
Amount
1 mg, 4 mg, or 8 mg
Frequency
Once daily
Duration
28 days

The 4 mg arm produced the clearest structural signal in the public phase 2b reporting. Pain and symptom results were less uniformly decisive, so this remains an investigational finding.

Type 2 diabetes neuropathic-symptom study

Purpose
Metabolic control and neuropathic symptoms
Context
Phase 2 clinical study and registry record
Route
Subcutaneous
Amount
4 mg
Frequency
Once daily
Duration
28 days, followed by 28 days without treatment

This is the main diabetes-neuropathy signal. It reported metabolic and neuropathic-symptom signals, but the study was small and short.

Healthy-volunteer neuropsychology study

Purpose
Emotional and cognitive processing
Context
Randomized healthy-volunteer study
Route
Study abstract does not report a usable route
Amount
2 mg
Frequency
Single dose
Duration
Outcomes assessed one week later

This study is useful mainly as a reminder that depression-related ARA-290 claims are exploratory. The authors did not report a clear antidepressant-like profile.

Diabetic macular edema pilot

Purpose
Diabetic macular edema exploratory outcomes
Context
Open-label phase 2 pilot
Route
Subcutaneous
Amount
4 mg/day
Frequency
Daily
Duration
12 weeks

Eight of nine recruited participants completed the pilot. The study reported no serious adverse events or anti-cibinetide antibodies, plus exploratory signals in some measures, but it was uncontrolled.

Real-world discussion

Trial-mirroring community protocols

Purpose
Neuropathy and nerve-pain discussion
Context
Forums, clinics, and vendor listings
Route
Subcutaneous injection
Amount
Community protocols commonly mirror the 4 mg per day schedule used in the sarcoid neuropathy trials
Frequency
Once daily in trial-mirroring descriptions
Duration
Commonly described as 28-day runs, matching the cited trial duration

ARA-290 has small human trials behind the schedule community sources imitate, which makes it more anchored than most compounds on this site, but the trial population was sarcoidosis-related neuropathy, not general pain or wellness use. Reported as context, not a recommendation.

What varies

  • Goal: sarcoidosis neuropathic symptoms, diabetic neuropathic symptoms, diabetic macular edema, mood research, and broad repair claims use different endpoints and populations.
  • Route: early sarcoidosis research included intravenous dosing, while later human studies mostly used subcutaneous dosing.
  • Amount: concrete numbers come from study facts such as 2 mg IV three times weekly, 1 mg to 8 mg daily subcutaneous arms, 4 mg daily subcutaneous diabetes and eye-study schedules, and a single 2 mg neuropsychology dose.
  • Duration: most therapeutic studies were short: four weeks, 28 days, or 12 weeks.
  • Product: trial material and research-use vials need separate identity, sterility, endotoxin, potency, and storage review.

Human data

Human evidence

Small but real, and tightly bounded. The sarcoidosis small-fiber-neuropathy program produced the clearest signals: symptom improvement and corneal nerve-fiber changes in blinded early work, and a dose-ranging phase 2b where 4 mg daily for 28 days gave the strongest structural result, though pain endpoints were less decisive and sponsor involvement is a caveat. The type 2 diabetes phase 2 reported metabolic and neuropathic-symptom signals over the same 28-day course. The macular edema pilot and the healthy-volunteer mood study are exploratory footnotes. Everything is short, small, and disease-specific; there is no phase 3, and nothing addresses the wellness uses.

Evidence maturity

ARA-290 is unusually evidence-anchored for a gray-market peptide, with real randomized phase 2 data in narrow neuropathy settings, but development stalled before phase 3 and marketing runs past the studies.

Rational design

ARA-290 was engineered from erythropoietin to trigger tissue-protective EPOR/CD131 signaling without red-cell stimulation.

Early human pilots

Small IV and subcutaneous sarcoidosis small-fiber-neuropathy studies reported symptom and nerve-fiber signals.

Phase 2 expansion

A dose-ranging sarcoidosis phase 2b, a type 2 diabetes neuropathy study, and a small diabetic macular edema pilot kept the signals short and exploratory.

Late-stage gap

Orphan designations exist, but no phase 3 program or approval followed, and FDA lists cibinetide in 503A Category 3 for compounding.

Market reality

Research-use vials and clinic nerve-repair programs sell uses the small trials never tested.

Study / evidence areaPopulationDesignProduct contextMain outcomeLimitationsWeight
Early sarcoidosis small-fiber-neuropathy pilotPatients with sarcoidosis and symptoms of small-fiber neuropathyDouble-blind placebo-controlled exploratory trialInvestigational study drugThe study evaluated symptom reduction over four weeks using 2 mg ARA-290 intravenously three times weekly. Small early study, short duration, and not the same route used in several later ARA-290 studies. Early limited human evidence
Sarcoidosis small nerve fiber loss and corneal density studyPatients with sarcoidosis-associated small nerve fiber lossBlinded placebo-controlled studyInvestigational study drugReported improvement in neuropathic symptoms, corneal small-fiber density, temperature sensitivity, and six-minute walk performance after daily subcutaneous treatment. Short 28-day exposure and disease-specific population; too narrow for broad nerve-repair claims. Limited human evidence
Sarcoidosis phase 2b corneal nerve fiber studyAdults with sarcoidosis-associated small nerve fiber loss and neuropathic painRandomized placebo-controlled dose-ranging phase 2b studyInvestigational study drugPublic reporting described improved corneal nerve fiber abundance, with the 4 mg/day group producing the clearest structural signal. Short duration, surrogate-heavy endpoints, sponsor involvement, and symptom changes that were not uniformly decisive. Moderate but still investigational human evidence
Type 2 diabetes neuropathic-symptom phase 2 studyAdults with early type 2 diabetes or prediabetes and neuropathic symptomsPhase 2 study with registry record and peer-reviewed publicationInvestigational study drugReported metabolic-control, lipid-profile, PainDetect, and corneal nerve fiber density signals after 4 mg subcutaneously once daily for 28 days. Small sample, short treatment window, and no approval label or practice-standard adoption. Limited human evidence
Healthy-volunteer emotional-processing studyHealthy participantsRandomized double-blind parallel-group experimental studyInvestigational single-dose studyA single 2 mg dose changed some emotional-processing measures, but the pattern did not amount to an antidepressant-like result. Not a patient-efficacy trial and not a basis for mood-treatment claims. Exploratory human evidence
Diabetic macular edema pilotPatients with diabetic macular edemaOpen-label phase 2 pilotInvestigational study drugParticipants used 4 mg/day subcutaneously for 12 weeks. The pilot reported no serious adverse events or anti-cibinetide antibodies and exploratory improvements in some measures. Very small and uncontrolled; it cannot show whether ARA-290 changes diabetic macular edema outcomes beyond short-course exploratory signals. Exploratory human evidence

Use context

Reported use context

ARA-290 has no FDA-approved use schedule. The concrete patterns come from study schedules, while clinic, forum, and vendor materials usually repeat or adapt those schedules without the same product controls.

Study and label context

01
Early sarcoidosis exploratory trialIntravenous

2 mg three times weekly for four weeks in sarcoidosis patients with small-fiber-neuropathy symptoms.

02
Sarcoidosis daily subcutaneous studySubcutaneous

Daily subcutaneous dosing for 28 days in sarcoidosis-associated small nerve fiber loss; exact dose is not repeated in the public summary.

03
Sarcoidosis phase 2b dose-ranging studySubcutaneous

1 mg, 4 mg, or 8 mg once daily for 28 days.

04
Type 2 diabetes phase 2 studySubcutaneous

4 mg once daily for 28 days, followed by 28 days without treatment.

05
Diabetic macular edema pilotSubcutaneous

4 mg/day for 12 weeks in a small open-label study.

Real-world discussion

01
Clinic and wellness marketingUsually injectable

One clinic page markets a provider-directed 12-week home-injection program for neuropathic pain, inflammation, sleep, and nerve-regeneration goals without publishing a usable amount.

02
Forum and Reddit-style reportsOften injection-centered when discussed

Direct reports include a 0.5-to-4 mg daily escalation stopped after five days, 4 mg/day for about 60 days with no benefit, and 3 mg/day with perceived improvement during stacked use. None verifies product identity or isolates ARA-290.

03
Vendor and gray-market listingsInjectable-vial sales

One seller markets a 10 mg vial, greater-than-99% HPLC/MS purity, and a detailed reconstitution page. Those claims do not show clinical-study equivalence, sterility, endotoxin control, fill accuracy, or storage history.

Cautions

Safety and unknowns

  • Most human therapeutic exposure windows were short: four weeks, 28 days, or 12 weeks. Long-term repeated-course safety is not well characterized.
  • Short studies are somewhat reassuring, but they do not settle immunogenicity, pregnancy and lactation, pediatric use, renal or hepatic impairment, malignancy history, or drug-interaction questions.
  • The sarcoidosis phase 2b record included serious adverse events in active arms even when specific event listings were not judged causally related. That still matters for safety interpretation because the exposed population was small.
  • The peptide was designed to avoid erythropoiesis, but "nonerythropoietic" does not mean "risk-free."
  • Non-study products add risks outside the trial record: identity, potency, sterility, endotoxin, impurities, reconstitution, repeated vial access, and shipping or storage conditions.

Product quality

A vial label is only a starting point

Clinical-study ARA-290 and gray-market ARA-290 are not interchangeable. The studies can describe what happened under controlled conditions; they do not verify every vial sold with the ARA-290 name.

FDA's current 503A materials place Cibinetide (ARA-290) in Category 3, meaning the nomination lacked adequate support for FDA to evaluate it. That weakens any compounded or retail-product claim.

Identity

The vial has to contain the intended 11-amino-acid cibinetide material, not merely use the ARA-290 name.

Assay and fill amount

A purity percentage does not by itself show how much active peptide is present in the vial or whether the amount matches the label.

Sterility and endotoxin

Injectable material can have a plausible identity result while still leaving contamination risk open.

Impurities and degradation

Peptide fragments, synthesis impurities, and storage degradation matter for a short injectable peptide.

Chain of custody

A COA is weaker if it cannot be tied to the exact lot, storage history, shipping conditions, and vial in hand.

Mechanism

How it is proposed to work

ARA-290 is built from erythropoietin biology, but its intended target is repair signaling rather than red-blood-cell production. The simplified idea is: trigger tissue-protective and anti-inflammatory signaling without turning on the classic EPO pathway.

01

The relevant receptor model centers on EPOR plus the beta-common receptor, often discussed as an innate repair or tissue-protective receptor complex.

02

That mechanism helps explain why sarcoidosis small-fiber neuropathy, diabetes-related neuropathic symptoms, and diabetic eye complications were studied.

03

The same mechanism also explains the overreach problem: a plausible repair pathway can be stretched into claims for many conditions that were never tested in human ARA-290 trials.

04

The absence of intended erythropoietic activity is important, but it does not replace long-term safety data.

05

ARA-290 is an 11-amino-acid peptide derived from erythropoietin's helix-B surface. It activates the innate repair receptor (an EPOR-CD131 heteromer) without engaging the hematopoietic EPOR dimer: designed to get EPO's tissue-protective signaling without raising red-cell production.

FAQ

Common questions

Is cibinetide FDA-approved for sarcoidosis neuropathy?

FDA identity records and an FDA orphan-drug designation entry exist, but not a current FDA approval label. Cibinetide remains investigational rather than an approved sarcoidosis-neuropathy drug.

Do the sources back generic repair or anti-aging claims?

No. The human evidence is tied to sarcoidosis-associated small-fiber neuropathy and an early type 2 diabetes neuropathy setting. Those trials do not justify broad repair, anti-aging, or pain-cure language.

Does cibinetide evidence give practical directions?

No. The evidence is disease-specific and regulatory. It does not establish preparation, access, timing, stacking, or administration routines.

Details

Technical details

ARA-290 technical details
Canonical name
Cibinetide
Common names
ARA-290, ARA 290, PHBSP
Class
Investigational erythropoietin-derived nonerythropoietic peptide
Sequence
pEQLERALNSS
Length
11 amino acids
Main receptor concept
EPOR/CD131 tissue-protective signaling
Best-studied human setting
Sarcoidosis-associated small-fiber neuropathy
Other human settings found
Type 2 diabetes neuropathic symptoms, healthy-volunteer neuropsychology, diabetic macular edema
Study routes found
Intravenous in an early pilot; subcutaneous in later human studies
Study amounts found
2 mg IV three times weekly; 1 mg to 8 mg daily subcutaneous arms; 4 mg daily subcutaneous schedules; single 2 mg neuropsychology dose
Regulatory status
Investigational; FDA orphan designation does not equal approval
503A compounding status
FDA Category 3 nomination status in current 503A materials
Main product concern
Research-use and gray-market products need separate identity, sterility, potency, endotoxin, and storage documentation
Half-life
Short (minutes-scale). Trials used daily subcutaneous dosing over weeks despite the short plasma persistence.

Sources

References

  1. 1.

    FDA. FDA GSRS substance record for cibinetide (UNII 9W5677JKDA) 2026.

    Accessed 2026-06-09.

    FDA GSRS identity record listing CIBINETIDE as the display name with ARA 290 / ARA-290 aliases and an 11-amino-acid sequence.

  2. 2.

    FDA. FDA GSRS orphan-designation code for cibinetide in sarcoidosis neuropathic pain 2026.

    Accessed 2026-06-09.

    FDA GSRS code comment maps orphan-drug designation 349111 to treatment of neuropathic pain in patients with sarcoidosis; designation is not the same as an approval label.

  3. 3.

    ClinicalTrials.gov. ClinicalTrials.gov record NCT02039687 2026.

    NCT02039687 Accessed 2026-06-09.

    Completed phase 2 dose-ranging sarcoidosis neuropathy study with posted results on corneal nerve fiber area and related endpoints.

  4. 4.

    PubMed. Cibinetide Improves Corneal Nerve Fiber Abundance in Patients With Sarcoidosis-Associated Small Nerve Fiber Loss and Neuropathic Pain 2017.

    doi:10.1167/iovs.16-21291 PMID:28475703 Accessed 2026-06-09.

    Peer-reviewed phase 2b sarcoidosis-associated small-fiber-loss trial publication.

  5. 5.

    ClinicalTrials.gov. ClinicalTrials.gov record NCT01933529 2026.

    NCT01933529 Accessed 2026-06-09.

    Phase 2 registry record for prediabetes or drug-naive type 2 diabetes glucose-homeostasis study using daily subcutaneous ARA 290 for 28 days; registry shows no posted results.

  6. 6.

    PubMed. ARA 290, a nonerythropoietic peptide engineered from erythropoietin, improves metabolic control and neuropathic symptoms in patients with type 2 diabetes 2015.

    doi:10.2119/molmed.2014.00215 PMID:25387363 Accessed 2026-06-09.

    Published phase 2 type 2 diabetes study reporting metabolic and neuropathic-symptom outcomes after 28 days of treatment with 28 days of follow-up.

  7. 7.

    PubMed. Safety and efficacy of ARA 290 in sarcoidosis patients with symptoms of small fiber neuropathy 2012.

    doi:10.2119/molmed.2012.00315 PMID:23168581 Accessed 2026-06-16.

    Double-blind exploratory sarcoidosis small-fiber-neuropathy trial using 2 mg ARA 290 intravenously three times weekly for four weeks.

  8. 8.

    Other. ARA 290 Improves Symptoms in Patients with Sarcoidosis-Associated Small Nerve Fiber Loss and Increases Corneal Nerve Fiber Density 2013.

    doi:10.2119/molmed.2013.00122 Accessed 2026-06-16.

    Blinded placebo-controlled sarcoidosis-associated small nerve fiber loss study reporting daily subcutaneous ARA 290 for 28 days and corneal nerve fiber density outcomes.

  9. 9.

    PubMed. Testing the antidepressant properties of the peptide ARA290 in a human neuropsychological model of drug action 2015.

    doi:10.1016/j.euroneuro.2015.09.005 PMID:26431906 Accessed 2026-06-16.

    Randomized healthy-volunteer study testing a single 2 mg ARA 290 dose with neural and cognitive outcomes assessed one week later.

  10. 10.

    PubMed. A Phase 2 Clinical Trial on the Use of Cibinetide for the Treatment of Diabetic Macular Edema 2020.

    doi:10.3390/jcm9072225 PMID:32674280 Accessed 2026-06-16.

    Open-label diabetic macular edema pilot in which participants self-administered cibinetide 4 mg/day subcutaneously for 12 weeks.

  11. 11.

    FDA. Bulk Drug Substances Used in Compounding Under Section 503A of the FD&C Act 2026.

    Accessed 2026-06-16.

    FDA's 503A bulks page explains Category 3 as nominated with insufficient supporting information and says Category 3 substances are not eligible for the Category 1 interim policy.

  12. 12.

    FDA. Bulk Drug Substances Nominated for Use in Compounding Under Section 503A of the FD&C Act 2026.

    Accessed 2026-06-16.

    FDA's May 2026 503A bulks download lists Cibinetide (ARA-290) in Category 3, nominated without adequate support.

  13. 13.

    LifeSpann ARA-290 clinic page. Clinic page marketing a staged 12-week ARA-290 home-injection program for neuropathy and inflammation.

    Direct clinic evidence for broader nerve-repair, sleep, and inflammation claims; not efficacy proof.

  14. 14.

    Reddit ARA-290 nerve-regeneration report. First-person PeptideForum report describing a gradual 0.5-to-4 mg increase, pain flare, and early discontinuation.

    Anecdotal amount, duration, adverse-sensation, and trial-copying context.

  15. 15.

    Reddit ARA-290 neuropathy experiences. Neuropathy thread containing mixed personal reports, stacked use, no-benefit reports, and product-legitimacy concerns.

    Anecdotal daily-use, course-length, perceived-effect, failure, and attribution-limit context.

  16. 16.

    WFN Research ARA-290 page. Research-market page promoting a 10 mg vial, purity testing, reconstitution, and broad neuropathy claims.

    Direct vendor evidence for vial, purity, handling, and claim-inflation context.