ARA-290

Definition

ARA-290, also called cibinetide, is an eleven-amino-acid peptide engineered from a surface region of erythropoietin. It was designed to keep the tissue-protective signaling attributed to erythropoietin while dropping the effect on red cell production, and it acts at a receptor complex distinct from the erythropoietin receptor itself.

It is the one substance in this index's Category 3 cohort with a genuine clinical development record. It is also sold as research-use-only material, and this page exists because those two facts are usually reported as though the first cancels the second.

Evidence

Across five name variants PubMed returns 99 indexed records, of which 40 carry the Humans subject heading, 5 the clinical-trial publication type, and 4 the randomized-controlled-trial type ^[1]. The publication-type filter was proved live in the same run against a control term returning 8,906 records under the clinical-trial type and 6,115 under the randomized type; the invalid tag returned zero for that control term; and a deliberately invalid record identifier errored in the same run ^[1].

All five trial-type records were opened and every one administers the peptide to people. Three concern sarcoidosis-associated small fiber neuropathy: a randomized, double-blind pilot study of safety and efficacy ^[2], a study reporting symptom improvement and an increase in corneal nerve fiber density ^[3], and a later study of corneal nerve fiber abundance in patients with the same condition and neuropathic pain ^[4]. One concerns metabolic control and neuropathic symptoms in patients with type 2 diabetes ^[5]. One tests antidepressant properties in a human neuropsychological model of drug action ^[6].

That is a coherent early-phase program in one indication, with a mechanistic rationale and an objective imaging endpoint attached to it. It is also small, concentrated in a small number of centers, and it stops. No indexed record reports a registrational trial, and the compound holds no approval anywhere this index has checked.

The gap between the program and the marketplace is the usual one, and larger here than usual. The published work concerns nerve fiber density in a rare inflammatory disease and neuropathic symptoms in diabetes. The material sold under the name is marketed for general recovery and inflammation, which is neither of those, and the trials say nothing about it.

Lawful access

There is no lawful United States supply route. Drugs@FDA holds no approved product with cibinetide as an active ingredient; the same query form in the same session returned one application for bremelanotide and fourteen for liraglutide, and returned nothing for a deliberately invented ingredient name ^[7].

The section 503A bulks list FDA published May 14, 2026 lists Cibinetide (ARA-290) in Category 3 — the file for substances nominated without adequate support to evaluate — and in neither of the other two categories ^[8]. The category is not a judgment on the papers above. It is a judgment on what the nomination submitted to the agency contained, and the two are separate documents assembled by separate parties for separate purposes. A substance with a published phase 2 record and a thin nomination lands exactly here.

The compound was not among the seven peptides the advisory committee reviewed in July 2026, so it has no vote, no recommendation, and no pending rulemaking attached to it ^[8]. Nothing in the 2026 record moved it. What is sold is research-use-only material, and the quality obligations that attach to a drug do not attach to it.

Related molecules

ARA-290 sits with the repair peptides, where it is the only member with a completed randomized trial: BPC-157 and TB-500 have none of the marketed compound, and KPV has none at all. The human trial record prints those four rows together, and the nomination tracker shows that the one with trials and the ones without hold the same absence of a lawful route.

Elsewhere in this index