ARA-290

ARA-290 (Cibinetide) is a synthetic 11-amino-acid peptide derived from the helix B region of erythropoietin (EPO), researched for neuroprotection, tissue repair, and anti-inflammatory effects without the erythropoiesis (red blood cell production) effect of full-length EPO. It is in development by Araim Pharmaceuticals for sarcoidosis-associated small fiber neuropathy and other neuropathic pain indications. ARA-290 is not currently FDA-approved and is sold as a research-use-only compound by third-party laboratories.

What is ARA-290 and how does the EPO-derived mechanism work?

ARA-290 is a synthetic 11-amino-acid peptide derived from the helix B surface of erythropoietin, designed to retain EPO's tissue-protective effects (anti-inflammatory, neuroprotective, anti-apoptotic) while losing EPO's effect on red blood cell production. It binds an alternative EPO receptor heterodimer (containing the beta common receptor) that mediates tissue-protective effects separately from the classical erythropoietic EPO receptor.

Evidence level: phase 2 human trials (sarcoidosis small fiber neuropathy, diabetic neuropathy); preclinical extensive

What does the research show for ARA-290?

In Phase 2 trials for sarcoidosis-associated small fiber neuropathy, cibinetide (ARA-290) at 4 mg daily significantly increased corneal small-nerve-fiber abundance over 28 days in a Phase 2b, double-blind, randomized, placebo-controlled dose-ranging trial of 64 patients — an objective marker of nerve-fiber regeneration — while the accompanying improvement in neuropathic pain was directional but did not reach statistical significance in that trial. Phase 2 trials in diabetic neuropathy have shown similar tissue-protective and anti-inflammatory signals. The compound's distinguishing feature is achieving EPO-pathway tissue protection without raising hematocrit, sidestepping the cardiovascular risks of EPO administration.

Source: Cibinetide Improves Corneal Nerve Fiber Abundance in Patients With Sarcoidosis-Associated Small Nerve Fiber Loss and Neuropathic Pain, Culver D.A., Dahan A., Bajorunas D., Jeziorska M., van Velzen M., Aarts L.P.H.J., Tavee J., Tannemaat M.R., Dunne A.N., Kirk R.I., Petropoulos I.N., Cerami A., Malik R.A., Brines M., Investigative Ophthalmology & Visual Science, 2017 · Evidence level: phase 2 (multiple neuropathic indications); preclinical extensive

How does ARA-290 compare to EPO and other tissue-protective peptides?

ARA-290 occupies a unique mechanism niche — derived from EPO but selective for tissue protection without erythropoiesis — distinguishing it from EPO (full-length, both effects) and other tissue-repair peptides.

What are the documented side effects of ARA-290?

ARA-290's safety profile in Phase 2 trials has been favorable — common side effects are mild injection-site reactions and occasional transient headache. The selective tissue-protective receptor mechanism appears to avoid the cardiovascular and thrombotic risks associated with full-length EPO administration. Hematocrit is not affected at researched doses.

Evidence level: phase 2 human safety; long-term unestablished

What is the regulatory status of ARA-290?

ARA-290 (cibinetide) is not FDA-approved for any use and remains investigational as of August 2026. The FDA granted it orphan drug designation for sarcoidosis in July 2016, plus orphan and Fast Track designations for neuropathic pain in sarcoidosis-associated small fiber neuropathy — but designation is a development-stage incentive, not marketing approval. Its most advanced published human evidence is a completed Phase 2b dose-ranging trial in sarcoidosis-associated small fiber neuropathy; it has not completed a confirmatory Phase 3 program. Current status in FDA peptide regulation 2025–2026 timeline.

Sources: FDA orphan drug designation for ARA-290 (cibinetide) — sarcoidosis; orphan + Fast Track for neuropathic pain in sarcoidosis-associated small fiber neuropathy, FDA (reported by Pharmaceutical Business Review; Araim Pharmaceuticals), via pharmaceutical-business-review.com (secondary); Cibinetide Improves Corneal Nerve Fiber Abundance in Patients With Sarcoidosis-Associated Small Nerve Fiber Loss and Neuropathic Pain, Culver D.A., Dahan A., Bajorunas D., Jeziorska M., van Velzen M., Aarts L.P.H.J., Tavee J., Tannemaat M.R., Dunne A.N., Kirk R.I., Petropoulos I.N., Cerami A., Malik R.A., Brines M., Investigative Ophthalmology & Visual Science, 2017

Why does ARA-290 vendor verification matter?

ARA-290 has a relatively narrow research-grade market with limited vendor distribution, but quality variance still matters — and the structural distinction (specific 11-amino-acid fragment of EPO) requires mass spectrometry confirmation to verify the correct sequence. Independent HPLC purity testing is the standard quality signal. Guidance in how-to-test-peptides hub.

How does Peptigrity verify ARA-290 vendors?

Peptigrity collects independent third-party Certificates of Analysis for ARA-290 from shops' official channels and verifies each for authenticity before publishing. Because shops choose which COAs to publish, results reflect the batches shops have made public rather than every production batch — a selection bias we state openly. A community-funded Testing Grant to purchase and test vials anonymously is in development. Tests in the database come from independent labs such as Janoshik Analytical, Freedom Diagnostics, and Chromate. Methodology in how we calculate trust scores.

Frequently asked questions

What does ARA-290 do?

ARA-290 binds an alternative EPO receptor complex to produce tissue-protective, anti-inflammatory, and neuroprotective effects without raising red blood cell production. Phase 2 trials in sarcoidosis-associated small fiber neuropathy have shown regeneration of small nerve fibers, with improvements in neuropathic symptoms that have been inconsistent across endpoints.

Is ARA-290 the same as EPO?

No. ARA-290 is an 11-amino-acid synthetic peptide derived from a specific region (helix B) of the much larger EPO glycoprotein, engineered to retain tissue-protective effects while losing the erythropoiesis effect. They are not interchangeable; EPO is FDA-approved for anemia, while ARA-290 is in Phase 2 for neuropathy.

Is ARA-290 legal to purchase?

ARA-290 is legal to purchase as a research chemical for laboratory use in most jurisdictions, but it is not approved for human consumption. Country breakdown in peptide legal status guide.

Does ARA-290 show up on a drug test?

ARA-290 itself is not explicitly listed on the WADA Prohibited List but EPO-related compounds receive scrutiny in competitive sport. Anti-doping testing methods for EPO-derived peptides are evolving. For drug-testing context, see do peptides show up on drug tests.

How can I verify an ARA-290 vendor is selling real product?

Independent third-party HPLC certificate of analysis from a lab the vendor does not own or pay, with mass spectrometry identity confirmation. COA interpretation in red flags in peptide certificates of analysis.

Does Peptigrity recommend an ARA-290 dose?

No. ARA-290 is not approved for human consumption and Peptigrity is an independent review platform, not a medical authority. Clinical trial dosing has varied by indication. Anyone considering use should consult a licensed physician.

This section is for educational and informational purposes only and does not constitute medical advice. ARA-290 (Cibinetide) is not currently FDA-approved but is in Phase 2 clinical development. Always consult a qualified healthcare provider before using any peptide or research compound. Peptigrity is an independent review platform and does not sell, endorse, or recommend specific products or vendors.