Cibinetide (ARA-290) Research and Status

Last evidence review: August 27, 2026

Cibinetide is the preferred substance name in FDA’s identity record; ARA-290, ARA 290, pHBSP, and related spellings are listed synonyms.[1] It is an engineered 11-residue peptide designed from the three-dimensional surface of erythropoietin’s helix B.

That wording is important. The original design paper says the assembled peptide was intended to mimic residues that sit next to one another on the outward-facing surface of the folded protein, even though the resulting sequence is not a contiguous primary-sequence fragment of erythropoietin.[5]

Cibinetide has been studied in cell and animal models and in several small, short human studies. Those studies do not establish FDA approval, broad clinical effectiveness, or equivalence between the studied product and a research catalog material.

Evidence state at a glance

Field	Current record
FDA preferred substance name	Cibinetide
Common development name	ARA-290
Other identity term	Pyroglutamate helix-B surface peptide, or pHBSP
Sequence	`pGlu-EQLERALNSS`
FDA UNII	`9W5677JKDA`
Forms that must be distinguished	Cibinetide free base and cibinetide acetate
Human evidence	Small phase 2 and exploratory studies; mixed results and surrogate endpoints
FDA compounding-category state	503A Category 3 as of FDA’s May 14, 2026 document
Evidence reviewed	August 27, 2026

FDA’s UNII page explicitly states that availability of a UNII does not imply regulatory review or approval.[1]

Is emideltide another name for cibinetide?

No. FDA’s cibinetide identity record lists ARA-290 and pHBSP among its synonyms, under UNII 9W5677JKDA. The separate emideltide identity record lists delta sleep-inducing peptide and DSIP, under UNII YN28Z5YZ73. These are different peptide identities, not alternative names for one study material.

This distinction also determines which regulatory documents belong in an evidence review. FDA’s July 2026 emideltide evaluation concerns DSIP-related substances; it should not be used as a regulatory assessment of cibinetide or ARA-290. When tracing a paper, trial, or agency document, match the substance identifier and sequence before grouping names or transferring a conclusion. A matching broad peptide category is insufficient, and an identity record itself does not establish approval.

Free base and acetate are different records

PubChem’s free-base record gives formula C51H84N16O21 and molecular weight 1,257.31 g/mol. Its acetate record includes acetic acid and gives formula C53H88N16O23 and molecular weight 1,317.4 g/mol.[2]

The forms share the same peptide active moiety, but a catalog label should still state which form is supplied and whether its displayed mass represents the active-moiety equivalent or total salt/material mass. “ARA-290” alone does not answer those questions.

What was the peptide designed to model?

The 2008 primary paper created a helix-B surface peptide intended to reproduce a selected three-dimensional feature of erythropoietin without reproducing the full protein or its primary sequence.[5] The paper reported activity in cell and animal injury models and no erythropoietic activity under the conditions tested.

Later development papers describe cibinetide as engaging a proposed receptor complex involving the erythropoietin receptor and CD131, often called the innate repair receptor. That is the investigators’ mechanistic model. It should not be converted into a general promise of “tissue repair,” “nerve repair,” or “anti-inflammatory” effects in people.

Human studies

Exploratory sarcoidosis pilot

A randomized, double-blind, placebo-controlled pilot enrolled 22 people with sarcoidosis and symptoms of small-fiber neuropathy.[6] One symptom-scale comparison favored ARA-290, while pain and fatigue measurements improved in both groups. The study was small, short, and exploratory.

Phase 2b sarcoidosis study

NCT02039687 enrolled 64 participants and has posted registry results. The primary endpoint was a corneal-nerve imaging measure used as a surrogate.[8] One studied group showed a statistically significant placebo-corrected change; the confidence intervals for the other studied groups crossed zero. Pain improved in all groups, and the cited placebo-corrected pain comparison did not reach statistical significance.

This pattern does not support a broad claim that cibinetide has been proven to treat pain or neuropathy.

Type 2 diabetes study

A small phase 2 study examined metabolic, symptom, and corneal-nerve measurements in people with type 2 diabetes and neuropathy.[7] The findings were exploratory, the study was short, and several authors were affiliated with the developer. It supports continued research, not a settled clinical claim.

Diabetic macular edema study

A phase 2 study enrolled nine participants and eight completed it.[9] It had no control group and used descriptive analysis. The paper reported no mean improvement in several central visual or anatomic outcomes, while noting changes in some exploratory or participant-reported measures. The corresponding migrated ClinicalTrials.gov record is listed as terminated and has no posted results module.[9]

Current FDA compounding-category status

FDA’s 503A categories document updated May 14, 2026 lists Cibinetide (ARA-290) in Category 3.[4] FDA explains that Category 3 contains substances nominated with insufficient supporting information for FDA to evaluate and that these substances are not eligible for the interim policy applied to Category 1.[3]

Category placement is not a finding that a catalog sample matches cibinetide, and it is not marketing approval. Likewise, a UNII, USAN/INN name, trial record, or orphan designation does not make a substance or product FDA approved.

Major evidence limitations

The human studies are small and generally short.
Several outcomes are surrogate, exploratory, or participant-reported rather than definitive clinical outcomes.
A statistically significant result in one group or endpoint does not establish a consistent dose-response pattern or broad effectiveness.
Developer involvement and study sponsorship should be considered when interpreting the literature.
The proposed receptor mechanism remains a model and is not a certificate of clinical effect.
Free base and acetate require separate identity and mass-basis disclosure.
Study publications do not establish the identity, content, purity, stability, sterility, or clinical equivalence of a catalog material.

Frequently asked questions

Are ARA-290 and cibinetide the same compound name?

FDA’s substance record lists ARA-290 and related spellings as synonyms for cibinetide.[1]

Is cibinetide a fragment cut directly from erythropoietin?

Not in the simple contiguous-sequence sense. The original design paper says the peptide was assembled to mimic residues adjacent on the three-dimensional surface of erythropoietin helix B and was unrelated to EPO in primary sequence.[5]

What is pHBSP?

It means pyroglutamate helix-B surface peptide, an identity term associated with cibinetide in official substance records.

Have human studies been conducted?

Yes. Small exploratory and phase 2 studies have been conducted in several populations. Their size, duration, endpoints, mixed findings, and development-stage context do not establish broad clinical effectiveness.

Is cibinetide FDA approved?

The official sources reviewed for this page do not identify an FDA-approved cibinetide product. FDA’s current compounding document lists it in 503A Category 3, and FDA’s UNII page states that an identity record does not imply approval.[1][4]

Does this page validate the catalog’s ARA-290 item?

No. The supplied form, sequence, terminal chemistry, amount basis, and matching lot evidence must be documented before a product link is added.

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Cibinetide (ARA-290): Identity, Human Studies, and FDA Status