Pain & nerve
ARA-290
Also called cibinetide, ARA 290, helix B surface peptide (related)
ARA-290 (cibinetide) is a small lab-made peptide based on part of the hormone erythropoietin (EPO). It was designed to keep EPO's tissue-protecting effects without raising red blood cell counts. Small human trials tested it for nerve pain from sarcoidosis and type 2 diabetes, with some encouraging but early results.
Overview
ARA-290 (cibinetide) is a small lab-made peptide based on part of the hormone erythropoietin (EPO). It was designed to keep EPO's tissue-protecting effects without raising red blood cell counts. Small human trials tested it for nerve pain from sarcoidosis and type 2 diabetes, with some encouraging but early results.
How it works
Proposed: ARA-290 activates the 'innate repair receptor', a complex of the EPO receptor and the beta common receptor (CD131), which is thought to reduce inflammation and protect tissue. Unlike EPO, it does not bind the receptor form that drives red blood cell production. In trials, researchers measured regrowth of small nerve fibers in the cornea as a marker of effect.
What research shows
- Sarcoidosis small-fiber neuropathy (Heij et al. 2012, randomized double-blind pilot, n=22 analysed): intravenous ARA-290 three times weekly for 4 weeks improved small-fiber neuropathy symptom scores versus placebo; no safety concerns were raised.
- Sarcoidosis-associated small nerve fiber loss (Dahan et al. 2013, randomized placebo-controlled, n=38 analysed): 28 days of daily subcutaneous ARA-290 increased corneal nerve fiber area (median +14.5% versus a non-significant fall on placebo), improved symptom scores and lengthened 6-minute walk distance.
- Sarcoidosis small-fiber neuropathy (Culver et al. 2017, phase 2b RCT, n=64): 28 days of daily subcutaneous cibinetide; the 4 mg group showed a significant placebo-corrected increase in corneal nerve fiber area, while the 1 mg and 8 mg groups did not.
- Type 2 diabetes with painful neuropathy (Brines et al. 2015, randomized placebo-controlled phase 2): 4 mg daily subcutaneous for 28 days improved HbA1c, lipid profile and neuropathic symptom scores; corneal nerve fiber density rose in a subgroup with low baseline values.
- All published trials were small and short; no phase 3 trial has been published.
Doses studied in people
| Study or label | Dose used | Source |
|---|---|---|
| Randomized double-blind pilot trial, sarcoidosis small-fiber neuropathy (Heij 2012, n=22 analysed) | 2 mg intravenous three times weekly for 4 weeks | 1 |
| Randomized placebo-controlled trial, sarcoidosis-associated small nerve fiber loss (Dahan 2013, n=38 analysed) | 4 mg subcutaneous once daily for 28 days | 2 |
| Phase 2b RCT, sarcoidosis small-fiber neuropathy (Culver 2017, n=64) | 1, 4 or 8 mg subcutaneous once daily for 28 days | 3 |
| Phase 2 RCT, type 2 diabetes with painful neuropathy (Brines 2015) | 4 mg subcutaneous once daily for 28 days | 4 |
All doses are from small, short phase 2 trials; no dose is approved.
Read this first: these are the amounts given to participants in published studies or written on official prescribing labels, reported for reference. They are not recommendations. Trial doses were chosen for specific patients under medical supervision, and a dose that is safe in one person can be harmful in another.
Weekly protocol
How the schedule looks week by week. Each chart says where it comes from: a prescribing label, a clinical trial, or a protocol commonly reported online.
Sarcoidosis small-fiber neuropathy trial (Dahan 2013)
Clinical trialOne week
Once daily · Subcutaneous injection
Syringe units (U-100)
Dose by week
Supplies for one course (estimate)
Counts only. This site does not sell or link to supplies.
Commonly reported protocol
Commonly reported, not studiedOne week
Once daily · Subcutaneous injection
Syringe units (U-100)
Dose by week
Supplies for one course (estimate)
Counts only. This site does not sell or link to supplies.
Reference only, not a recommendation. Charts marked "commonly reported" describe what public sources say people use. They have not been tested in trials, and their safety and effect are unknown. Label and trial schedules were set for specific patients under medical supervision. Use the calculator only to understand the arithmetic.
Vial math
Many research vials hold 5 or 10 mg of powder. This table shows how much ends up in each mark on a U-100 insulin syringe for common amounts of added liquid. It is arithmetic only, not a dose.
| Vial | Liquid added | Concentration | Per unit (0.01 mL) | |
|---|---|---|---|---|
| 5 mg | 1 mL | 5 mg/mL | 50 mcg | Open in calculator |
| 5 mg | 2 mL | 2.5 mg/mL | 25 mcg | Open in calculator |
| 5 mg | 3 mL | 1.67 mg/mL | 16.7 mcg | Open in calculator |
| 10 mg | 1 mL | 10 mg/mL | 100 mcg | Open in calculator |
| 10 mg | 2 mL | 5 mg/mL | 50 mcg | Open in calculator |
| 10 mg | 3 mL | 3.33 mg/mL | 33.3 mcg | Open in calculator |
More sizes: all vial sizes · How this works: Syringes and units · Reconstitution guide.
Safety
- Well tolerated in phase 2 trials of up to 28 days; reported adverse events were generally mild and similar to placebo (Dahan 2013, Brines 2015, Culver 2017).
- No rise in red blood cell counts was reported, consistent with its design (trial reports).
- Unknown long-term safety; trials lasted about one month.
Report side effects of any drug or product to the FDA through MedWatch. For a possible poisoning in the US, call Poison Control at 1-800-222-1222.
Legal status
- FDA
- Not FDA-approved; investigational
- Compounding
- 503A: Category 3 ('Cibinetide (ARA-290)', nominated without adequate support; May 14, 2026 list) - not eligible for 503A compounding.
- Sports (WADA)
- Not named on the 2026 Prohibited List; as a substance with no current government approval for human therapeutic use, it would likely fall under S0 (non-approved substances), prohibited at all times. Athletes should confirm with their anti-doping organization. As an EPO-derived tissue-protective peptide it may also be considered under S2 (EPO-receptor agonists and related substances).
Rules change often. See Legal status of peptides for how these categories work.
History
Developed by Michael Brines, Anthony Cerami and colleagues at Araim Pharmaceuticals in the 2000s. Phase 2 trials in sarcoidosis-related small-fiber neuropathy and in type 2 diabetes with neuropathy were published between 2012 and 2017. It was nominated for US compounding but placed in FDA's 503A Category 3 (nominated without adequate support).
Common questions
Is ARA-290 FDA-approved?
No. It is investigational, and FDA placed cibinetide in 503A Category 3 (nominated without adequate support), so it cannot be compounded under 503A 6.
What does the research on ARA-290 show?
What doses were used in trials?
Does ARA-290 raise red blood cell counts like EPO?
Is ARA-290 banned in sport?
It is not named on WADA's 2026 list, but as an unapproved substance it would likely fall under S0, and as an EPO-derived peptide it may also be considered under S2 7.
Related compounds
Sources
- Safety and efficacy of ARA 290 in sarcoidosis patients with symptoms of small fiber neuropathy: a randomized, double blind, pilot study Journal
- ARA 290 improves symptoms in patients with sarcoidosis-associated small nerve fiber loss and increases corneal nerve fiber density Journal
- Cibinetide improves corneal nerve fiber abundance in patients with sarcoidosis-associated small nerve fiber loss and neuropathic pain Journal
- ARA 290, a nonerythropoietic peptide engineered from erythropoietin, improves metabolic control and neuropathic symptoms in patients with type 2 diabetes Journal
- Study of Efficacy of ARA 290 on Corneal Nerve Fiber Density and Neuropathic Symptoms of Subjects With Sarcoidosis (NCT02039687) ClinicalTrials.gov
- Bulk Drug Substances Nominated for Use in Compounding Under Section 503A Regulatory
- WADA Prohibited List Regulatory
Last reviewed 2026-10-25 · How we research · Found an error? See our corrections policy.