Summary
ARA-290 (cibinetide) is an investigational peptide copied from a surface region of erythropoietin that activates a tissue protective receptor without raising hemoglobin. In small randomized placebo controlled trials in sarcoidosis associated small fiber neuropathy (n = 22 and n = 64) and in type 2 diabetes with neuropathy, 28 days of daily injections improved neuropathic symptoms and increased corneal nerve fiber density. It is not approved by FDA or any other regulator, so it cannot be compounded and is prohibited in sport under WADA section S0.
What is ARA-290 (cibinetide)?
ARA-290 (cibinetide) is an investigational 11 amino acid peptide derived from the helix B surface of erythropoietin, engineered to activate the innate repair receptor without stimulating red blood cell production. It is also known as Cibinetide, ARA 290, ARA290, pyroglutamate helix B surface peptide, pHBSP, innate repair receptor agonist.
How does it work?
Erythropoietin has two receptor systems: the classic homodimeric receptor that drives red cell production, and a heteromeric innate repair receptor (erythropoietin receptor plus the beta common receptor) expressed on injured tissue that mediates anti-inflammatory and tissue protective effects. ARA-290 copies helix B of erythropoietin and binds only the repair receptor, so it protects and repairs tissue in animal models without the thrombosis and hypertension risks of erythropoietin. It has a plasma half life of only minutes but a sustained biological effect.
| Cluster | Tissue repair and healing |
|---|---|
| Routes | Subcutaneous injection once daily (phase 2 trials); Intravenous infusion (early pilot trial) |
| Conditions studied | Inflammation and inflammatory bowel disease; Peripheral and small fiber neuropathy; Autoimmune disease; Chronic pain |
| Record | v2, draft, verified Sep 22, 2026 |
What does the evidence say about ARA-290 (cibinetide)?
Several small phase 2 randomized controlled trials from a single development program. In 22 sarcoidosis patients with small fiber neuropathy, 4 weeks of intravenous ARA-290 improved the small fiber neuropathy screening list score more than placebo (minus 11.5 versus minus 2.9 points). A second placebo controlled trial of 28 days of subcutaneous dosing improved symptoms and increased corneal nerve fiber density. A phase 2b trial of 64 patients found a significant increase in corneal nerve fiber area at 4 mg per day. In type 2 diabetes with neuropathy, 28 days of 4 mg daily improved HbA1c, lipids, and PainDetect scores. All trials were short, small, and sponsored by the developer; no phase 3 trial has reported.
| Evidence type | Indexed studies | Participants (human) |
|---|---|---|
| Human randomized trials | 4 | 86 |
| Human observational studies | 0 | n/a |
| Animal studies | 0 | n/a |
| All indexed studies | 4 | 86 |
Human evidence
Heij 2012: 22 sarcoidosis patients with small fiber neuropathy symptoms, double blind, ARA-290 2 mg intravenously three times weekly (n = 12) or placebo (n = 10) for 4 weeks; screening list score improved minus 11.5 versus minus 2.9, with improvements in SF-36 pain and physical functioning, and no safety concerns. Dahan 2013: blinded placebo controlled trial of 28 days of daily subcutaneous ARA-290 in sarcoidosis small fiber neuropathy; improved neuropathic symptoms, increased corneal nerve fiber density, improved temperature sensitivity and 6 minute walk. Culver 2017: 64 patients, phase 2b, cibinetide 1, 4, or 8 mg daily versus placebo for 28 days; placebo corrected corneal nerve fiber area increased 697 square micrometers at 4 mg (P = 0.012) with more regenerating skin fibers. Brines 2015: type 2 diabetes with painful neuropathy, 4 mg daily subcutaneously versus placebo for 28 days; improved HbA1c, lipids, and PainDetect score, and increased corneal nerve fiber density in those with low baseline density.
Animal evidence
ARA-290 reduced allodynia in preclinical neuropathy models and showed tissue protection in rodent models of ischemia, inflammation, and metabolic injury, without increasing hematocrit. These findings underpinned the human program.
Key studies
| Study | Design and population | Outcome | Grade |
|---|---|---|---|
| Safety and efficacy of ARA 290 in sarcoidosis patients with symptoms of small fiber neuropathy: a randomized, double-blind pilot study2012 PMID 23168581 | Randomized, double blind, placebo controlled pilot trial, 4 weeksn = 22 Sarcoidosis patients with small fiber neuropathy symptoms and pain score 5 or more | Small fiber neuropathy screening list score improved minus 11.5 versus minus 2.9 with placebo; SF-36 pain and physical functioning improved; no safety concerns | Evidence: Human RCT evidence |
| ARA 290 improves symptoms in patients with sarcoidosis-associated small nerve fiber loss and increases corneal nerve fiber density2013 PMID 24136731 | Blinded, placebo controlled trial of 28 days of daily subcutaneous dosingSarcoidosis patients with documented small nerve fiber loss | Improved neuropathic symptoms, increased corneal small nerve fiber density, improved temperature sensitivity and 6 minute walk distance | Evidence: Human RCT evidence |
| Cibinetide improves corneal nerve fiber abundance in patients with sarcoidosis-associated small nerve fiber loss and neuropathic pain2017 PMID 28475703 | Randomized, placebo controlled phase 2b trial, 28 daysn = 64 Sarcoidosis patients with small nerve fiber loss and neuropathic pain | Placebo corrected corneal nerve fiber area increased 697 square micrometers at 4 mg per day (P = 0.012); regenerating intraepidermal fibers increased | Evidence: Human RCT evidence |
| ARA 290, a nonerythropoietic peptide engineered from erythropoietin, improves metabolic control and neuropathic symptoms in patients with type 2 diabetes2015 PMID 25387363 | Randomized, placebo controlled phase 2 trial, 28 days of dosing with 56 days of follow upAdults with type 2 diabetes and painful neuropathy | Improved HbA1c and lipids, improved PainDetect neuropathy score, increased corneal nerve fiber density in those with low baseline density; no safety issues | Evidence: Human RCT evidence |
Conditions studied
| Condition | Grade | Note |
|---|---|---|
| Inflammation and inflammatory bowel disease | Not graded | KPV, thymosin alpha-1, LL-37, VIP, and BPC-157 are marketed as anti-inflammatory peptides. Thymosin alpha-1 has human trials in hepatitis and sepsis outside the United States. KPV has rodent colitis data only. VIP analogs have been studied in small human trials for sarcoidosis and pulmonary hypertension. |
| Peripheral and small fiber neuropathy | Evidence: Human RCT evidence | In 64 patients with sarcoidosis associated small fiber loss, 4 mg daily increased corneal nerve fiber area versus placebo; a smaller type 2 diabetes trial improved neuropathy pain scores; not approved. |
| Autoimmune disease | Evidence: Human RCT evidence | Improved small fiber neuropathy symptoms in sarcoidosis, an immune mediated disease, without treating the underlying disease; not approved. |
| Chronic pain | Evidence: Human RCT evidence | Improved neuropathic pain scores in small trials in sarcoidosis and type 2 diabetes; not approved. |
Is ARA-290 (cibinetide) legal in the United States?
FDA and compounding status
Investigational drug that has completed phase 2 trials but is not approved by FDA or any other regulator as of the last verification date. Because cibinetide is not a component of an approved drug, has no USP monograph, and is not on the 503A bulks list, it cannot lawfully be compounded by 503A pharmacies or 503B outsourcing facilities. Products sold online as ARA-290 are unapproved drugs not lawful for human use.
WADA status
WADA prohibited. Athletes subject to anti-doping testing should treat this as prohibited at all times unless the current prohibited list says otherwise.
Regulatory timeline
No regulatory events recorded.
Full tracker for ARA-290 (cibinetide) or the category-wide tracker.
What published studies of ARA-290 (cibinetide) used
Ranges below are reported from published studies and labeling only. PeptideAgent does not recommend doses or protocols.
Trial regimens only: 2 mg intravenously three times weekly for 4 weeks (Heij 2012); 4 mg subcutaneously once daily for 28 days (Brines 2015); 1, 4, or 8 mg subcutaneously once daily for 28 days (Culver 2017), with 4 mg the most effective dose. No approved label exists.
Routes reported
| # | Route |
|---|---|
| 1 | Subcutaneous injection once daily (phase 2 trials) |
| 2 | Intravenous infusion (early pilot trial) |
What are the side effects and interactions of ARA-290 (cibinetide)?
Side effects
| # | Reported side effect |
|---|---|
| 1 | No safety concerns raised by clinical or laboratory assessments in the 28 day trials |
| 2 | Does not raise hemoglobin or hematocrit, by design |
| 3 | Injection site reactions |
| 4 | Long term safety unknown; no trial exceeded a few weeks of dosing |
| 5 | Products sold online as ARA-290 are unverified and carry the usual risks of unregulated injectables |
Interactions
| # | Interaction |
|---|---|
| 1 | No formal interaction studies published |
| 2 | Theoretical additive effect with erythropoiesis stimulating agents on the shared receptor subunit (not studied) |
Contraindications
| # | Contraindication |
|---|---|
| 1 | Not approved for any use; only available inside registered clinical trials |
| 2 | Pregnancy and breastfeeding (no data) |
| 3 | Competitive athletes subject to WADA testing (prohibited under S0; erythropoietin derived) |
How do people access ARA-290 (cibinetide) legally?
Typical cost: Not available through licensed channels. Products sold as research chemicals are not lawful for human use and are not verified for identity or purity.
Verified access options
Step 1
No lawful United States access path identified on the last verified date outside a registered clinical trial.
Step 2
Not available as an FDA approved product and not eligible for compounding under section 503A or 503B.
Step 3
Products labeled research use only are not lawful for human use and are not verified for identity or purity.
Access paths are verified against public regulatory records and prescriber licensing. We never list unlicensed vendors.
Compare ARA-290 (cibinetide)
What's actually offered, and what that means for you
Licensed compounding pharmacies, clinics, and telehealth prescribers openly offer many unapproved peptides, and prescribers write prescriptions for them. That does not make ARA-290 (cibinetide) lawful. ARA-290 (cibinetide) is not FDA approved and not on the 503A bulks list, so a pharmacy has no lawful basis to compound it. [6]
Enforcement is uneven. FDA mostly acts through warning letters to online sellers and import alerts that let it detain shipments, rather than stopping every seller. State pharmacy boards oversee pharmacies day to day, and their rules differ. [8] [9] [10]
What changes for you
- No FDA review of the product: a product sold outside a trial is an unapproved drug, and FDA has not checked its safety, effectiveness, or quality. [8]
- Identity, purity, sterility, and dose accuracy can vary from batch to batch. [8]
- Insurance rarely covers it, so you usually pay cash.
- For tested athletes, ARA-290 (cibinetide) is prohibited at all times on the WADA list, whatever the source. [7]
What to check
ARA-290 (cibinetide) is not approved in the US, and no check makes a product sold outside a clinical trial lawful. Check for:
- Enrollment in a registered clinical trial (ClinicalTrials.gov lists them). Outside a trial, any product sold as ARA-290 (cibinetide) is an unapproved drug.
- Labels such as "research use only" or "not for human consumption", which FDA does not accept for products sold for people. [8]
- A licensed prescriber's view on whether an approved drug fits your goal.
Frequently asked questions
Is ARA-290 legal or FDA approved?
No. Cibinetide (ARA-290) is an investigational drug that has been through phase 2 trials but has no approval from FDA or any other regulator. It cannot be compounded because it is not a component of an approved product and is not on the 503A bulks list. The only lawful access is a registered clinical trial. Vials sold online are unapproved drugs not lawful for human use. [5] [6]
Does ARA-290 work for small fiber neuropathy?
Small trials say it helps. In 22 sarcoidosis patients, 4 weeks of ARA-290 improved the neuropathy symptom score by 11.5 points versus 2.9 on placebo. A 28 day subcutaneous trial improved symptoms and increased corneal nerve fiber density, and a 64 patient phase 2b trial found a significant increase in corneal nerve fiber area at 4 mg per day, consistent with actual nerve regrowth. The trials are short, small, and from a single sponsor, and no phase 3 has reported, so the evidence is promising rather than conclusive. [1] [2] [3]
What are the side effects of ARA-290?
In the 28 day trials no safety concerns emerged from clinical or laboratory monitoring, and by design it does not raise hemoglobin the way erythropoietin does. Injection site reactions are the main reported effect. Long term safety is unknown because no trial lasted more than a few weeks, and unregulated products sold online carry the added risks of unverified contents. [1] [4]
How is ARA-290 taken and what doses were studied?
In trials it was a once daily subcutaneous injection of 1, 4, or 8 mg for 28 days, with 4 mg the most effective dose, or in the earliest pilot 2 mg intravenously three times a week for 4 weeks. No approved dosing exists outside these protocols, and the drug's plasma half life is only minutes despite a longer biological effect. [1] [3] [4]
How much does ARA-290 cost?
It has no licensed price because it is not on the market; trial participants receive it free. Products sold as research chemicals are not lawful for human use and are not verified for identity or purity. [6]
Is ARA-290 banned by WADA?
Yes. Cibinetide has no approval from any government health authority, so it is prohibited at all times under section S0 (non-approved substances) of the WADA Prohibited List. Because it is derived from erythropoietin, athletes should also expect it to be treated under the S2 erythropoietin receptor agonist provisions. [7]
Does ARA-290 help diabetic neuropathy?
One small phase 2 trial suggests it might. In adults with type 2 diabetes and painful neuropathy, 28 days of 4 mg daily ARA-290 improved HbA1c and lipid profiles over 56 days of observation, improved PainDetect neuropathy scores, and increased corneal nerve fiber density in those with low baseline density. It is a single short study, not a basis for treatment. [4]
ARA-290 vs BPC-157 for nerve repair: which has better evidence?
ARA-290, by a wide margin, even though neither is approved. ARA-290 has several placebo controlled human trials showing symptom improvement and measurable nerve fiber regrowth over 28 days. BPC-157 has only rodent data for nerve or tissue repair. The trade off is access: BPC-157 may be compounded in some states after the 2026 FDA advisory vote, while ARA-290 is available only in clinical trials. [3] [5]
Decisions about starting, stopping, or combining any treatment belong with a licensed clinician who knows your history.
Sources
Numbered citations above point to these primary sources. PubMed entries link to the indexed abstract.
- [1]Heij L et al. Safety and efficacy of ARA 290 in sarcoidosis patients with symptoms of small fiber neuropathy: a randomized, double-blind pilot study. Mol Med 2012PubMed 23168581, 2012
- [2]Dahan A et al. ARA 290 improves symptoms in patients with sarcoidosis-associated small nerve fiber loss and increases corneal nerve fiber density. Mol Med 2013PubMed 24136731, 2013
- [3]Culver DA et al. Cibinetide improves corneal nerve fiber abundance in patients with sarcoidosis-associated small nerve fiber loss and neuropathic pain. Invest Ophthalmol Vis Sci 2017PubMed 28475703, 2017
- [4]Brines M et al. ARA 290, a nonerythropoietic peptide engineered from erythropoietin, improves metabolic control and neuropathic symptoms in patients with type 2 diabetes. Mol Med 2015PubMed 25387363, 2015
- [5]Dahan A et al. ARA 290 for treatment of small fiber neuropathy in sarcoidosis. Expert Opin Investig Drugs 2014PubMed 24555851, 2014
- [6]FDA: Bulk drug substances used in compounding under section 503A of the FD&C Act (links to the Category 1, 2, and 3 lists and the bulks list)FDA, 2026
- [7]WADA Prohibited List, sections S0 non-approved substances and S2 peptide hormonesWADA, 2026
- [8]FDA warning letters database: August 24, 2026 letter to an online seller of research-use-only peptides, including retatrutide, tesamorelin, and bremelanotideFDA, 2026
- [9]FDA Import Alert 66-41: Detention without physical examination of unapproved new drugs promoted in the U.S. (includes peptide entries)FDA
- [10]FDA: Compounding and the FDA, questions and answersFDA
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