Important limitations
- Individual claims and source links have not yet completed editorial verification.
- Evidence level, applicable study model, formulation, route and population remain unassigned.
ARA-290
ARA-290, given the international name cibinetide, is an 11-amino-acid peptide that reproduces one face of the erythropoietin molecule.
Dosing & scaling, explained
The moderated mass amounts below are retained for comparison. Near-duplicates, mix-dependent volumes and device markings are excluded. This is educational source context, not a protocol or recommendation.
Mass amounts available for comparison
- Lower range4 mgDose
Recorded example with no verified study backing; shown for amount literacy only.
- Mid range8 mgDose
Recorded example with no verified study backing; shown for amount literacy only.
Only mcg or mg amounts are retained. The calculator derives mL, syringe units or pen clicks from the current vial strength, water volume and device.
No independently verified schedule
Evidence context
No clinical amount or schedule is inferred from this material. Source verification is pending, and every displayed amount remains educational context rather than guidance.
Storage, handling and interpretation
Product identity
Verify the exact compound, formulation and amount against the product label or certificate before calculation.
Storage & handling
Follow the product label, certificate and validated laboratory SOP; no universal storage assumption is applied here.
Prepared solutions
Label concentration and preparation date, use sterile technique where applicable, and follow a validated stability protocol.
Reported protocols for ARA-290
What published studies and recent community write-ups report about amounts, timing and course length. 6 clinical, 1 preclinical and 4 community-reported rows, each linked to its source. These are descriptions of what others report, not instructions, and nothing here is medical advice.
| Context | Dose | Frequency | Route | Course | Source |
|---|---|---|---|---|---|
| Clinical6 rows | |||||
| Randomized intravenous pilot in sarcoidosis22 patients with sarcoidosis and small fiber neuropathy symptoms with a spontaneous pain score of 5 or more | 2 mg | Three times weekly | Intravenous | 4 weeksNone described | Molecular Medicine (PubMed)2012 |
| The small fiber neuropathy screening list score improved significantly against placebo at week 4, and the pain and physical functioning dimensions of the SF-36 improved from baseline. Pain inventory and fatigue scores improved in both arms equally, and no safety concerns were raised by clinical or laboratory assessment. | |||||
| Randomized subcutaneous trial in sarcoidosisPatients with documented sarcoidosis-associated small nerve fiber loss | 4 mg | Once daily | Subcutaneous | 28 daysNone described | Molecular Medicine (PubMed)2013 |
| The authors moved from intravenous to subcutaneous dosing because three-times-weekly infusions are impractical outside hospital, and ran a crossover pharmacokinetic study in 10 volunteers first to pick the subcutaneous dose. Symptoms, corneal small nerve fiber density, cutaneous temperature sensitivity and 6-minute walk distance all improved, and the symptom change at 4 mg subcutaneously closely matched what 2 mg intravenously had produced. | |||||
| Phase 2b dose-ranging trial in sarcoidosis64 adults with sarcoidosis-associated small nerve fiber loss and neuropathic pain, roughly 16 per group, at Leiden University Medical Center and the Cleveland Clinic | 1, 4 or 8 mg | Once daily | Subcutaneous, self-injected at home before breakfast after the first supervised dose | 28 consecutive days, with follow-up to 16 weeksNo further dosing after day 28 | Investigative Ophthalmology and Visual Science (PubMed)2017 |
| Corneal nerve fiber area rose by a placebo-corrected 697 square micrometres at 4 mg, which was significant, while 1 mg and 8 mg were not, an inverted dose response the trial did not explain. Regenerating intraepidermal nerve fibers increased only in the 4 mg group, and the reduction in pain intensity in that group did not reach significance. | |||||
| Trial registration for the dose-ranging studyAdults with sarcoidosis and symptoms of small fiber neuropathy | 1, 4 or 8 mg per day | Once daily | Subcutaneous, using individual vials and disposable insulin syringes | 28 days of dosing within a total 16-week participation12-week follow-up after dosing ended | ClinicalTrials.gov2014 |
| The registry record describes the practical handling: participants stayed at the site for an hour after the first injection for safety observation, then were trained to inject themselves at home each morning before breakfast. Corneal imaging was repeated at the end of dosing and again at the 12-week follow-up. | |||||
| Phase 2 trial in type 2 diabetes with painful neuropathyAdults aged 18 to 70 with type 2 diabetes, painful small fiber neuropathy and a BMI under 40 | 4 mg | Once daily, self-administered | Subcutaneous | 28 days, then 28 further days of observation with no treatmentThe month after dosing was used as a washout and follow-up | Molecular Medicine (PubMed Central)2015 |
| HbA1c and lipid profiles improved across the full 56-day observation window and PainDetect scores improved significantly, with corneal nerve fiber density rising in the participants who started most impaired. The paper reports that after a 4 mg subcutaneous dose the plasma peak is about 3 ng/mL with a terminal half-life near 20 minutes, which is why the authors describe the effect as outlasting exposure. | |||||
| Open-label phase 2 trial in diabetic macular edema9 patients with untreated diabetic macular edema and central retinal thickness above 400 micrometres, 8 of whom completed | 4 mg | Once daily, self-administered | Subcutaneous | 12 weeksNone | Journal of Clinical Medicine (MDPI)2020 |
| This is the longest published course, at 12 weeks rather than 28 days, and it was safe with no anti-cibinetide antibodies detected. Visual acuity, retinal thickness, retinal sensitivity and tear production did not improve on average, although the vision questionnaire score did and a few individuals improved on several measures. | |||||
| Preclinical1 row | |||||
| Rat nerve injury dose-response studyRats after a spared nerve injury | 3, 10, 30 or 60 mcg/kg | On days 1, 3, 6, 8 and 10 only | Systemic injection | 5 doses over 10 days, with animals followed to 20 weeksNo dosing after day 10 | Molecular Pain (PubMed)2014 |
| Five doses over ten days reduced mechanical and cold allodynia for up to 20 weeks, and 30 mcg/kg prevented the spinal microglia response at both 2 and 20 weeks while astrocyte reactivity did not change. This long tail after brief exposure is the preclinical basis for describing the peptide as a switch rather than something that needs continuous presence. | |||||
| Community-reported4 rows | |||||
| Evidence page listing doses as studied | 2 mg intravenously; 1, 4 or 8 mg subcutaneously | Three times weekly for the intravenous dose, once daily for the subcutaneous doses | Intravenous in the first trial, subcutaneous in all the later ones | 4 weeks in every published trialNone studied; no trial has tested a repeat course | Community resource2026 |
| This 2026 reference page lists only the doses that appear in published trials and flags what the record does not cover: total published human exposure is on the order of a hundred patients for 28 days each, with no long-term data, no data on repeated courses and no study of dosing duration. It also notes that the short half-life means pharmacokinetics say little about how to dose it. | |||||
| Community protocol mirroring the trial doses | 1-4 mg per day, with 8 mg described as the trial ceiling | Once daily | Subcutaneous into the lower abdomen or thigh with an insulin syringe, rotating sites | About 4 weeks, matching the trial blocksNot specified; the page notes long-term safety at these doses is not established | Community resource2026 |
| This 2026 protocol page gives the reconstitution arithmetic for a 16 mg vial in 2 mL of bacteriostatic water, which yields 8 mg/mL so that a 4 mg dose is 50 units on a U-100 syringe, and counts vials for 2 to 8 week courses. It states plainly that the community figures simply mirror the trial doses rather than resting on separate evidence. | |||||
| Community cycle with a break pattern | 2-4 mg for the first 3 to 5 days, then 4 mg; 8 mg described for severe neuropathic pain | Once daily in the morning | Subcutaneous into the abdomen, thigh or upper arm, rotating sites | 14-28 days2-4 weeks between cycles, with no more than 4 cycles a year described as typical | Community resource2026 |
| This 2026 guide adds a short run-in at a lower dose and a repeat-cycle structure that no trial tested, since every published study was a single 28-day block. It presents 4 mg as the figure where the trials and community practice coincide. | |||||
| Four protocols compared side by side | 4 mg daily (trial standard); 4 mg three times weekly; 8 mg daily for refractory cases; 1-4 mg as the lower gray-market range | Once daily or Monday, Wednesday and Friday | Subcutaneous, abdomen or thigh, 29 to 31 gauge insulin syringes | 28 days for the daily protocols; 4-8 weeks for the three-times-weekly one4-8 weeks off before any repeat course | Community resource2026 |
| This page separates the trial regimen from the lighter protocols circulating online and states that no maintenance regimen exists in the trial data. It describes clinical exposure as discrete 28-day courses and notes that sourcing is difficult because clinical-grade material was largely restricted to trials. | |||||
How a course is commonly described
- Days 1-5Community-reported
Community guides describe a short run-in at 2 to 4 mg before settling at the working dose, injected once each morning with sites rotated. The trials had no run-in: participants took the full assigned dose from day one, with the first injection given at the study site followed by an hour of observation.
- Days 1-28Clinical
Twenty-eight days of daily subcutaneous dosing is the shape of almost the entire human record. In the dose-ranging trial, corneal nerve fiber area and regenerating skin fibers had both increased by day 28 at the 4 mg dose, and changes in corneal fibers tracked with changes in 6-minute walk distance.
- Days 29-56: after dosing stopsClinical
In the type 2 diabetes trial, dosing stopped at day 28 and the improvements in HbA1c and lipids held through a further four weeks with no treatment. The dose-ranging sarcoidosis trial also repeated its corneal imaging at a 12-week follow-up.
- Break, 2-8 weeksCommunity-reported
Community sources put a 2 to 8 week gap between courses and cap repeats at about four a year, reasoning from the 28-day trial blocks rather than from any tested rule. One page states outright that the trial data contain no maintenance regimen.
- Longer coursesClinical
Only one published study ran past a month: an open-label macular edema trial gave 4 mg daily for 12 weeks to nine patients, found it safe and detected no antibodies against the peptide. Nothing longer, and no repeat course, has been published.
- Every published human course is short: 28 days of daily subcutaneous dosing in the neuropathy trials and 12 weeks in one small macular edema study. No trial has tested repeated courses, so community break patterns are conventions rather than findings.
- The dose response is not orderly. In the only dose-ranging trial, 4 mg a day significantly increased corneal nerve fiber abundance while both 1 mg and 8 mg did not, and the authors offered no explanation. Higher is not better here on the available evidence.
- Plasma half-life after a 4 mg subcutaneous dose is roughly 20 minutes, yet effects were measured over weeks, which is why the developers describe the mechanism as flipping a switch. That also means pharmacokinetics give little guidance on frequency.
- ARA-290 is not approved anywhere. Total published human exposure is on the order of a hundred patients, mostly from one research group, and no phase 3 trial has appeared in more than a decade since the first positive result.
Sources for this section (12)
- Safety and efficacy of ARA 290 in sarcoidosis patients with symptoms of small fiber neuropathy: a randomized, double-blind pilot study
- ARA 290 improves symptoms in patients with sarcoidosis-associated small nerve fiber loss and increases corneal nerve fiber density
- Cibinetide Improves Corneal Nerve Fiber Abundance in Patients With Sarcoidosis-Associated Small Nerve Fiber Loss and Neuropathic Pain
- Study of Efficacy of ARA 290 on Corneal Nerve Fiber Density and Neuropathic Symptoms of Subjects With Sarcoidosis (NCT02039687)
- ARA 290, a nonerythropoietic peptide engineered from erythropoietin, improves metabolic control and neuropathic symptoms in patients with type 2 diabetes
- A Phase 2 Clinical Trial on the Use of Cibinetide for the Treatment of Diabetic Macular Edema
- ARA 290, a peptide derived from the tertiary structure of erythropoietin, produces long-term relief of neuropathic pain coupled with suppression of the spinal microglia response
- ARA 290 for treatment of small fiber neuropathy in sarcoidosis
Plus 4 community resources (dosing guides, forum threads and vendor write-ups), reported above but not linked.
Overview
ARA-290, given the international name cibinetide, is an 11-amino-acid peptide that reproduces one face of the erythropoietin molecule. Erythropoietin protects injured tissue in animal models but also raises red cell counts, and the design idea behind ARA-290 is that these two actions run through different receptors: the peptide engages the erythropoietin receptor paired with CD131, often called the innate repair receptor, and not the receptor pair that makes red blood cells. Araim Pharmaceuticals, founded by Anthony Cerami and Michael Brines, took it through small randomized trials in sarcoidosis-associated small fiber neuropathy, type 2 diabetes with painful neuropathy and diabetic macular edema, with positive symptom and corneal nerve findings in a few dozen patients each. No confirmatory phase 3 trial has ever been published, and the peptide is not approved for anything anywhere.
What researchers are exploring
These themes organize the educational information currently available. Individual claims remain under source review and are not treatment claims.
- 1
Research
Scientific studies on ARA-290's effects on blood vessel health and cellular repair
- 2
Reducing Inflammatory Cytokines
ARA-290's effects on inflammatory cytokines and islet cell transplantation
- 3
Tissue Protection
ARA-290's role in tissue protection and immune cell modulation
- 4
Pain Perception
ARA-290's effects on neuropathic pain and small fiber neuropathy
- 5
Orphan Drug
ARA-290's FDA orphan drug status and clinical trial progress
- 6
Summary
Overview of ARA-290's therapeutic potential and research status
What is known and what still needs verification
Available context is organized without assigning unsupported study models or evidence grades.
- Not graded
Research
Scientific studies on ARA-290's effects on blood vessel health and cellular repair
- Not graded
Reducing Inflammatory Cytokines
ARA-290's effects on inflammatory cytokines and islet cell transplantation
Amounts recorded for ARA-290
These amount records are independent from vial strength, reconstitution volume and measuring device. A recorded source is not the same as study backing, and these values are not recommendations.
- 1Dose · lower endpointSign in for schedule, duration and source context.4 mg
- 2Dose · upper endpointSign in for schedule, duration and source context.8 mg
Chemistry identifiers
Sequence, synonyms and registry identifiers as recorded in PubChem, the National Library of Medicine's open chemistry database. Formula, mass and CAS number are summarized at the top of the page.
Sequence
pGlu-Glu-Gln-Leu-Glu-Arg-Ala-Leu-Asn-Ser-Ser
Also listed as
Cibinetide, ARA 290, pHBSP, Pyroglutamate helix B surface peptide, Cibinetide [INN, USAN], UNII 9W5677JKDA, CHEMBL3545305, GTPL9677
InChIKey
WZTIQQBMSJTRBR-WYKNNRPVSA-N
IUPAC name
(4S)-5-[[(2S)-5-amino-1-[[(2S)-1-[[(2S)-1-[[(2S)-1-[[(2S)-1-[[(2S)-1-[[(2S)-4-amino-1-[[(2S)-1-[[(1S)-1-carboxy-2-hydroxyethyl]amino]-3-hydroxy-1-oxopropan-2-yl]amino]-1,4-dioxobutan-2-yl]amino]-4-methyl-1-oxopentan-2-yl]amino]-1-oxopropan-2-yl]amino]-5-(diaminomethylideneamino)-1-oxopentan-2-yl]amino]-4-carboxy-1-oxobutan-2-yl]amino]-4-methyl-1-oxopentan-2-yl]amino]-1,5-dioxopentan-2-yl]amino]-5-oxo-4-[[(2S)-5-oxopyrrolidine-2-carbonyl]amino]pentanoic acid
Limitations and unknowns
Sources
1 link carried over from the earlier page, awaiting verification.