{"slug":"ara-290","seoKey":"ara290","inn":"Cibinetide","displayName":"Ara-290","codes":["ARA 290","ARA-290","ARA290","pHBSP","PH-BSP","BC-123"],"synonyms":["Cibinetide","pyroglutamate helix B surface peptide (pHBSP)","Pglu-Glu-Gln-Leu-Glu-Arg-Ala-Leu-Asn-Ser-Ser","L-Pyr-L-Glu-L-Gln-L-Leu-L-Glu-L-Arg-L-Ala-L-Leu-L-Asn-L-Ser-L-Ser","Cibinetide Acetate","Cibinetida","cibinetidum"],"legalClass":"investigational","identifiers":{"cas":"1208243-50-8","pubchemCid":91810664,"unii":"9W5677JKDA","inchikey":"WZTIQQBMSJTRBR-WYKNNRPVSA-N","drugbankId":"DB13006","chemblId":"CHEMBL3545305","wikidataQid":"Q27273306","formula":"C51H84N16O21","molecularWeight":1257.3,"sequence":"Pyr-Glu-Gln-Leu-Glu-Arg-Ala-Leu-Asn-Ser-Ser"},"approvals":[{"market":"US","status":"investigational","date":"2022-04-21","note":"Not approved. Queries on 2026-09-15 returned no entry in the drug approval records and no product labelling: the openFDA label endpoint answered NOT_FOUND for both the international non-proprietary name and the development code, and the approval endpoint answered NOT_FOUND as well, while a control query for an approved medicine on the same endpoint returned 18 results. Four orphan drug designations were granted between 2009 and 2016 for the prevention of delayed graft function after renal transplant, for neuropathic pain in sarcoidosis, for sarcoidosis and for the prevention of graft loss in islet transplantation; all four records carry the status line Not FDA Approved for Orphan Indication, and a designation is a development incentive, not an approval. The substance was never nominated as a bulk substance for compounding, so it appears neither in the safety-risk category nor among the withdrawn nominations. A compounding pharmacy nevertheless manufactured and distributed it nationwide as a prescription-labelled sterile injection; that product was recalled as a class II recall, recall number D-0775-2022, for lack of assurance of sterility, the date given here being the classification date. A claimed fast track designation could not be verified, because that programme is not published in any official database.","source":"https://api.fda.gov/drug/enforcement.json?search=cibinetide"},{"market":"EU","status":"investigational","date":"2016-08-29","note":"No authorised medicine. There is no centralised marketing authorisation and no ATC code, a WHO index query on 2026-09-15 returning no match. Two orphan designations are positive and show no sign of revocation: one for sarcoidosis granted on 2013-07-10 and one for the prevention of graft loss in pancreatic islet transplantation granted on the date given here, both held by the sponsor's Irish subsidiary since April 2019. The designation page for the first states that at the time of submission the medicine was not authorised anywhere in the European Union for that condition. Six trials with the substance as investigational medicinal product are on the European register; three of them still read as ongoing, which is plainly out of date, two of those three have no traceable results publication at all. The medicines database could not be queried directly on 2026-09-15, the search returning HTTP 401; the negative finding therefore rests on the designation pages, the missing ATC code and the absence of any authorised product in all other registers checked, not on an authorisation document.","source":"https://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-16-1721"},{"market":"DE","status":"investigational","note":"Not approved; a substance with a medicinal purpose may not be placed on the market without an authorisation, and there is neither a centralised European authorisation nor a national finished medicine. Human use took place in approved clinical trials only. Separately from medicines law: the substance is not named in the annex to the anti-doping act, the full text having been searched on 2026-09-15 for all its names with no match, while the section on erythropoiesis-stimulating substances in the same annex was found and read. That annex has no category at all for non-erythropoietic receptor agonists, so the criminal provisions attached to it do not reach this substance by their wording. The anti-doping rules of sport apply regardless and independently.","source":"https://www.gesetze-im-internet.de/amg_1976/__21.html"},{"market":"UK","status":"investigational","note":"No authorised medicine. Human use took place in approved clinical trials only, one of them run by a Belfast trust, and the holder of the two European orphan designations was a British company until 2019. A direct query of the products register was not evaluable on 2026-09-15, because both that register and the electronic medicines compendium load results by script and the presumed interface path answered with HTTP 404. The negative finding therefore rests on the register and publication record and on the fact that no finished medicine with this active substance exists anywhere, not on a primary regulator document.","source":"https://products.mhra.gov.uk/search/?search=cibinetide"},{"market":"AU","status":"not_approved","note":"Not named in the Poisons Standard; the full text was searched on 2026-09-15 for all names of the substance and for the helix it copies with no match, while control terms in the same document were found, among them schedule 4 with 2493 occurrences and erythropoietin with six. The absence of a listing does not make the substance freely available: an unlisted substance with a therapeutic purpose falls under the rules for unregistered therapeutic goods, and the regulator treats unapproved peptides as prescription substances in practice. A full-text query of the register of therapeutic goods could not be completed on that date, the request timing out after 60 seconds and a second attempt breaking off.","source":"https://www.legislation.gov.au/F2026L00633/asmade"},{"market":"CA","status":"not_approved","note":"No authorised medicine. The drug product database returned an empty result for the active ingredient on 2026-09-15, under both the international non-proprietary name and the development code, while a control query on the same endpoint returned 49 entries, so the negative finding is verified.","source":"https://health-products.canada.ca/api/drug/activeingredient/?ingredientname=cibinetide"},{"market":"CH","status":"not_approved","note":"No authorisation. Two official regulator lists were downloaded and searched in full text on 2026-09-15. The extended medicines list, which carries an active substance column across 29 625 text elements, returned no match for any name of the substance, while control terms in the same file returned 61, 18, 17 and 12 entries. The list of authorised human medicines with indications returned no match either, with three control product names found there. Switzerland is no softer harbour: advertising to the public is prohibited for prescription medicines and, all the more, for unauthorised ones.","source":"https://www.swissmedic.ch/"}],"devStage":"phase2","strongestEvidence":"rct_phase2","wada":{"status":"prohibited","section":"S2.1.5","listYear":2026,"source":"https://www.wada-ama.org/en/prohibited-list"},"trials":[{"nct":"NCT02039687","name":"Phase 2 dose ranging study of ARA 290 on corneal nerve fibre density and neuropathic symptoms in sarcoidosis","phase":"Phase 2 (in der Publikation als Phase 2b bezeichnet)","n":64,"status":"COMPLETED"},{"nct":"NCT06626971","name":"Phase 2 trial of ARA 290 for the treatment of diabetic macular oedema","phase":"Phase 2","n":9,"status":"TERMINATED"},{"nct":"NCT02070783","name":"Effects of ARA290 on the cognitive and neural processing of emotions in healthy volunteers","phase":"Phase 1/Phase 2","n":36,"status":"COMPLETED"},{"nct":"NCT01933529","name":"ARA 290 and glucose tolerance, insulin secretion and long-term glucose control in prediabetes and drug-naive type 2 diabetes","phase":"Phase 2","n":24,"status":"UNKNOWN"}],"sameAs":["https://pubchem.ncbi.nlm.nih.gov/compound/91810664","https://www.wikidata.org/wiki/Q27273306","https://go.drugbank.com/drugs/DB13006","https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL3545305/"],"lastVerified":"2026-09-15","version":"1.0","published":true,"locale":"en","title":"Ara-290: what the studies show, status and safety","summary":"Ara-290, also called cibinetide, is a designed eleven-unit peptide copying one surface of erythropoietin, a surface with no role in making red blood cells. In small studies in sarcoidosis it increased the nerve fibre measured in the cornea. The largest of those studies missed its pain endpoint, no country has approved it, and the receptor it was built for is unconfirmed.","updated":"2026-09-15","url":"https://mypep.app/peptides/ara-290"}