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ARA-290 (cibinetide) protocol

ARA-290 (also called cibinetide) is a lab-made peptide designed to switch on a body receptor linked to repair and calming inflammation. Phase 2 trials in people with sarcoidosis nerve damage have finished. It is not an approved medicine.

Not approved as a medicine by the US FDAPhase 2 and 2b trials completed in sarcoidosis nerve damageFDA compounding list: nominated without adequate support (Category 3, May 2026)
ProtocolMixingResultsSide effectsHow it worksSources

The protocol at a glance

The phase 2b trial gave 1, 4 or 8 mg a day under the skin for 28 days. The 4 mg group showed the clearest gain in nerve fibres.

TrialAmount and schedule
Phase 2b, sarcoidosis nerve loss (64 people)1, 4 or 8 mg under the skin every day for 28 days
Pilot, sarcoidosis (22 people)2 mg by vein, 3 times a week for 4 weeks
Diabetic eye swelling (NCT06626971)4 mg under the skin every day for 12 weeks; ended early with 9 people

Culver 2017 / NCT02039687 (phase 2b), Heij 2012 (pilot), NCT06626971 (Belfast investigator-led, terminated). Only the 4 mg arm clearly beat placebo on the main nerve measure.

Community reports

We note the published phase 2 schedule of 4 mg a day under the skin for 28 days; community reports may differ.

What people say they do, collected from community discussions. Not tested in a trial; shown so you can compare it with the evidence above.

Mixing calculator

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What the trials found

Phase 2b trial, 64 people with sarcoidosis and nerve pain, 28 days. What was measured: gain in nerve fibre area in the cornea, compared with placebo.

+697 µm²4 mg a day (statistically significant)
+431 µm²8 mg a day (not significant)
+109 µm²1 mg a day (not significant)
64people in the trial

Culver DA et al. Invest Ophthalmol Vis Sci 2017 (PMID 28475703), ClinicalTrials.gov NCT02039687. Pain improved in all groups including placebo; the gain over placebo in people with moderate to severe pain was not statistically significant (P = 0.157).

Side effects

  • The 2012 pilot found no safety concerns from clinical or lab checks.
  • Safety beyond a few weeks of use is not known.
  • The diabetic eye trial (NCT06626971) was terminated early; we found no stated reason.

How it works

Innate repair receptor

ARA-290 is designed to activate a receptor that is thought to calm inflammation and start tissue repair. It is described as a non-hematopoietic erythropoietin analogue, meaning it is not meant to raise red blood cells.

Sources

  • Culver DA et al. Invest Ophthalmol Vis Sci 2017 (cibinetide phase 2b), PMID 28475703
  • ClinicalTrials.gov NCT02039687 (Araim Pharmaceuticals, results posted)
  • Heij L et al. Mol Med 2012 (pilot), PMID 23168581
  • Dahan A et al. Mol Med 2013, PMID 24136731
  • ClinicalTrials.gov NCT06626971 (diabetic macular oedema, terminated)
  • FDA 503A bulk drug substances list (Category 3: Cibinetide (ARA-290)), updated May 14 2026