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ARA-290 (cibinetide): dosage in studies

Updated 15 Oct 2026 Author: About 2 min read Drafted with the help of AI; sources and claims checked separately.

Not a recommendation, not treatment guidance. This page shows only what published human studies used, with sources. This site does not say how much anyone should use of any substance. Fimea warns against using injectable peptides bought online: Fimea warning.

ARA-290 (cibinetide) has no marketing authorisation in the EU, and its orphan designations in the EU and the United States are not marketing authorisations [7, 8]regulator.

ARA-290 has been given in six published human studies either into a vein or under the skin, in milligrams not adjusted to body weight, for at most 12 weeks [1, 3, 5]A [2]B [4, 6]B.

Doses used in studies

Doses used in published human studies. Not a recommendation.
StudyParticipantsDoseFrequencyDurationSource and level
Heij 2012 (randomised, placebo) 22 sarcoidosis patients with symptoms of small fibre neuropathy 2 mg into a vein Three times a week 4 weeks [1]A
Dahan 2013 (placebo, double-blind; randomisation not described) 38 sarcoidosis patients (21 received ARA-290, 17 placebo) 4 mg under the skin Once a day 28 days [2]B
Culver 2017 (randomised, placebo, dose comparison) 64 sarcoidosis patients with nerve fibre loss and neuropathic pain 1, 4 or 8 mg under the skin (route from the trial registry, see notes) Once a day 28 days [3]A
Brines 2015 (placebo, randomisation not described) 49 people with type 2 diabetes and painful neuropathy 4 mg under the skin Once a day 28 days, follow-up 28 days [4]B
Cerit 2015 (randomised, placebo) 36 healthy adults 2 mg into a vein (route from the trial registry, see notes) Single dose Measurements one week later [5]A
Lois 2020 (open, no comparison group) 9 patients with diabetic macular oedema 4 mg under the skin Once a day 12 weeks [6]B

Evidence levels: regulator = a regulator's assessment or decision, not research evidence · A = randomised human trial or meta-analysis · B = observational human study or case series · C = animal study · D = cell or laboratory study · E = not peer-reviewed

Notes

4 mg was chosen as the dose under the skin because in ten healthy volunteers its exposure was of the same order as 2 mg into a vein [2]B.

All studies were small, and most were done with researchers from the company developing the substance [3]A [6]B.

The route in Culver 2017 and Cerit 2015 (under the skin and into a vein) is not in the abstracts but comes from the trial registry [9, 10]E, not peer-reviewed.

What points the other way or is uncertain

In the dose comparison, corneal nerve fibre area grew significantly compared with placebo only in the 4 mg group, not in the 1 or 8 mg groups, and pain eased in all groups, including placebo [3]A.

In diabetic macular oedema, 12 weeks of treatment did not improve visual acuity or retinal thickness [6]B.

More on this

Read the research yourself: sources

  1. Heij L, Niesters M, Swartjes M, 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. 2012;18(1):1430-1436. PMID 23168581
  2. Dahan A, Dunne A, Swartjes M, et al. ARA 290 improves symptoms in patients with sarcoidosis-associated small nerve fiber loss and increases corneal nerve fiber density. Mol Med. 2013;19(1):334-345. PMID 24136731
  3. Culver 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;58(6):BIO52-BIO60. PMID 28475703
  4. Brines M, Dunne AN, van Velzen 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. 2015;20(1):658-666. PMID 25387363
  5. Cerit H, Veer IM, Dahan A, et al. Testing the antidepressant properties of the peptide ARA290 in a human neuropsychological model of drug action. Eur Neuropsychopharmacol. 2015;25(12):2289-2299. PMID 26431906
  6. Lois N, Gardner E, McFarland M, et al. A phase 2 clinical trial on the use of cibinetide for the treatment of diabetic macular edema. J Clin Med. 2020;9(7):2225. PMID 32674280
  7. European Medicines Agency. Orphan designation EU/3/13/1191: cibinetide for the treatment of sarcoidosis (granted 7 Oct 2013); EMA medicines data: no centrally authorised medicine containing cibinetide (status 15 Oct 2026). EMA
  8. US Food and Drug Administration, Orphan Drug Designations database: cibinetide for neuropathic pain in patients with sarcoidosis (designated 13 Sep 2011; not FDA approved for the orphan indication). FDA
  9. ClinicalTrials.gov. NCT02039687: phase 2 dose ranging study of ARA 290 in sarcoidosis; arms 1, 4 and 8 mg ARA 290 administered subcutaneously for 28 consecutive days. Registry record, not peer-reviewed. ClinicalTrials.gov not peer-reviewed
  10. ClinicalTrials.gov. NCT02070783: effects of ARA290 on emotional processing in healthy volunteers; intravenous injection with 2 mg ARA290 (single dosage). Registry record, not peer-reviewed. ClinicalTrials.gov not peer-reviewed

Doses are from the abstracts of the sources, read 15 Oct 2026. The Dahan 2013 group sizes are from the full text (PMC). The route in Culver 2017 and Cerit 2015 is from ClinicalTrials.gov (sources 9-10, not peer-reviewed).

Content is general information about research, not medical advice. If you have symptoms, contact a healthcare professional.