Claimed effect · ARA-290 (cibinetide)

Does ARA-290 (cibinetide) help with nerve fibre regeneration?

C
Grade C — weak human evidence1 phase 2b RCT (n=64, 28 days) · effect size: small
Short answerWeak human evidence. 1 phase 2b RCT (n=64, 28 days): enough to be interesting, not enough to count on. Where an effect is seen it is a small effect. Corneal nerve fibre area rose significantly on the 4 mg dose but not on 1 mg or 8 mg, and regenerating skin fibres increased at 4 mg — a surrogate signal, in a short trial, with a non-monotonic dose response.

What the studies show

Corneal nerve fibre area rose significantly on the 4 mg dose but not on 1 mg or 8 mg, and regenerating skin fibres increased at 4 mg — a surrogate signal, in a short trial, with a non-monotonic dose response.

“The placebo-corrected mean change from baseline CNFA (μm2) at day 28 was 109 (95% confidence interval [CI], -429, 647), 697 (159, 1236; P = 0.012), and 431 (-130, 992) in the 1, 4, and 8 mg groups, respectively.”

Verbatim, from the abstractCulver DA, Dahan A, Bajorunas D, et al. Cibinetide improves corneal nerve fiber abundance in patients with sarcoidosis-associated small nerve fiber loss and neuropathic pain. Invest Ophthalmol Vis Sci, 2017

A few small or poorly-controlled human studies. Enough to be interesting; not enough to count on. Most of what gets called “clinically proven” online lives here.

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In context

ARA-290 is a short peptide copied from a surface of the erythropoietin molecule that signals tissue protection but not red-cell production. Its developer has run small randomised trials in small-fibre neuropathy, mostly in sarcoidosis: in a 64-person, 28-day phase 2, the 4 mg dose measurably increased nerve fibres in the cornea and skin, while pain improved on placebo as much as on drug. No phase 3 has been completed and it is not approved anywhere. The grey market sells it for pain, healing and inflammation on the strength of that early signal.

ARA-290 (cibinetide) is not approved; investigational. Legal status differs by country — see the regulation section or the jurisdiction pages.

Questions

Is ARA-290 (cibinetide) proven to help with nerve fibre regeneration?
No. The human evidence is weak (1 phase 2b RCT (n=64, 28 days)); LYO grades it C.
What studies are behind the grade?
Corneal nerve fibre area rose significantly on the 4 mg dose but not on 1 mg or 8 mg, and regenerating skin fibres increased at 4 mg — a surrogate signal, in a short trial, with a non-monotonic dose response.
Is ARA-290 (cibinetide) approved for this?
No. ARA-290 (cibinetide) is not approved; investigational; it is not an approved medicine for any indication in the jurisdictions LYO covers.

Other outcomes for ARA-290 (cibinetide)

Written and maintained by LYO Research — how pages are written and checked. Reviewed 10 September 2026. Grades count human evidence only; see how LYO grades. Not medical advice. Correct this page →