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Not FDA approved
This peptide is not FDA approved for human use, and because peptides are often incompletely studied you should not use or self-experiment with it outside qualified medical supervision.
Overview
Cibinetide, also called ARA-290, is a synthetic peptide engineered from the helix-B surface of erythropoietin and designed to be nonerythropoietic. The reviewed source set supports real human clinical studies in sarcoidosis-associated small fiber loss, type 2 diabetes with neuropathic symptoms, and diabetic macular edema, plus broader preclinical tissue-protection literature.
It does not support an FDA-approved product or a validated consumer-use protocol.
Reported benefits
- Human clinical literature exists for neuropathy-related indications.
- The intended mechanism is tissue-protective rather than red-blood-cell stimulation.
- Preclinical literature extends into wound, retinal, renal, and inflammatory models.
- No FDA-approved therapeutic product was identified.
Mechanism of action
Reviewed papers describe cibinetide as a nonerythropoietic erythropoietin-derived peptide that targets the so-called innate repair receptor rather than the classical erythropoietic EPO receptor pathway. The practical point is that the compound is being studied for tissue-protective and anti-inflammatory signaling without the red-blood-cell effects expected from full erythropoietin.
Exact downstream pathway descriptions should still be treated as mechanistic research framing, not a guarantee of clinical benefit.
Reported Use
No FDA dosing guidance
This peptide is not covered by FDA-labeled dosing guidance on this page. Peptides are often investigational or incompletely studied. Do not self-experiment; use only with a doctor or qualified clinician.
Typical dose
No validated consumer-use dose was identified; published human studies commonly used 4 mg subcutaneously once daily, usually for 28 days, with one diabetic macular edema pilot using 12 weeks
Frequency
Once daily in the better-known human studies
Injection sites
Human studies used subcutaneous administration; some preclinical papers used other routes that should not be reframed as self-use guidance
Best timing
Not established
Effects timeline
Human studies assessed symptom and corneal-nerve outcomes over weeks, not days
Storage
Do not treat generic peptide-vial storage instructions as validated Cibinetide protocol
Cycle length
Human studies commonly used fixed study periods such as 28 days or 12 weeks; this is not the same as a validated casual-use cycle
Break between
Not established
Sequence
UEQLERALNSS
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Quick Signals
At A Glance
A faster read on evidence, focus, structure, and status.
Evidence
Mostly preclinical
Mixed human clinical and preclinical evidence.
52 indexed studiesCurrent level
Preclinical
Scale: low evidence to established use
Status
Regulatory and sport context
Safety
Side Effects And Safety
Switch between common side-effect notes and stop criteria to keep safety context visible.
Key cautions
- No FDA-labeled safety profile exists for Cibinetide.
- Short human studies did not identify the erythropoietic effects expected from full erythropoietin, but that is not the same as proving broad long-term safety.
- Human-study safety data remain limited by small sample sizes and narrow trial populations.
- Injection-site reactions and general tolerability issues remain practical concerns with subcutaneous use.
- Do not turn trial eligibility rules or washout criteria into blanket contraindications unless a real product label supports them.
Molecule
Molecular Information
Core structure fields that help explain what kind of peptide this is and how much sequence detail is available.
Molecular weight
1257.3 Da
Chain length
11 amino acids
Sequence type
Linear synthetic peptide with N-terminal pyroglutamate
Derived from
Helix-B surface region of erythropoietin
Amino acid sequence source string
UEQLERALNSS
N-terminal pyroglutamate (pGlu) residue
Context
Important Context
The main context that changes how confidently this peptide should be interpreted.
Research status
Mixed human clinical and preclinical evidence. Published human trials exist for a few neuropathy- and retina-related indications, but no approved product or labeled treatment program was identified.
Regulatory and sport status
FDA review shows it is not FDA approved. Source: openFDA drugsfda API. Sport review: likely S0 prohibited; athlete-specific review advised.
Compare
How Well Documented Is It?
A quick five-point snapshot of how visible and well-documented this peptide is. Higher values mean more coverage or clearer status in that area, not better medical performance.
Research
How much published research coverage this peptide has in the linked sources, with an approval-context floor for clearly established drug products.
Source: PubMed
Regulatory
How clearly the approval or regulatory status is documented for this entry.
Source: openFDA drugsfda API
Sport
How clearly sports or competition status is documented in the linked review sources.
Source: WADA Prohibited List
Breadth
How broadly this peptide appears across discussion topics and use-case groupings in the catalog.
Source: Curated site taxonomy
Sequence
How much structure or residue-sequence detail is available for this entry.
Source: Sequence
Protocols
Research Protocols
Common protocol-style rows shown in a consistent table layout so every peptide page is easy to compare.
| Goal | Dose | Route | Frequency |
|---|---|---|---|
| Sarcoidosis-associated small fiber loss / neuropathic pain | 4 mg | SubQ | 1x daily |
| Type 2 diabetes with neuropathic symptoms | 4 mg | SubQ | 1x daily |
| Diabetic macular edema pilot study | 4 mg | SubQ | 1x daily |
Research
What It Has Been Studied For
Plain-language summaries of the main health areas where this peptide shows up in the linked research.
Stacking
What People Commonly Stack It With
A plain-language view of compounds that are commonly discussed alongside this peptide in the source material.
Practical
Preparation, Quality, And Expectations
Operational checklist blocks designed for quick scanning and repeatable page structure.
How to reconstitute
- •No validated consumer reconstitution protocol was identified for exact Cibinetide.
- •Do not treat generic BAC-water instructions as source-backed medical guidance.
- •Identity, concentration, and handling should be considered unresolved unless independently documented.
Quality indicators
Good signs
- Exact compound identity is documented
- Source trail distinguishes human neuropathy trials from broader preclinical tissue-protection literature
- Regulatory and anti-doping status are checked against official sources
Avoid
- Claims that the peptide is FDA approved or already has a standard clinical-use protocol
- Trial exclusion criteria being presented as universal contraindications
- Community dosing, cycling, or reconstitution guidance presented as if it were label-backed
- Unclear product identity, sterility, or concentration claims
What to expect
Better-known human studies measured outcomes over weeks, not days.
Human studies tracked symptom and corneal-nerve measures rather than immediate subjective effects.
No validated consumer expectation timeline was identified.
References
Research And Source List
Structured reference cards with source metadata and a direct link so users can inspect the original study/source.
PubMed search
Indexed literature overview
Direct PubMed query used to review the indexed cibinetide / ARA-290 literature set.
PubChem compound record
Technical identity
PubChem record supporting molecular identity, formula, molecular weight, and synonym / sequence naming.
Nonerythropoietic, tissue-protective peptides derived from the tertiary structure of erythropoietin
PNAS | 2008
Foundational paper describing the nonerythropoietic EPO-derived peptide concept.
ARA 290 improves symptoms in patients with sarcoidosis-associated small nerve fiber loss and increases corneal nerve fiber density
Molecular Medicine | 2013
Published randomized human study for sarcoidosis-associated small fiber loss.
ARA 290, a nonerythropoietic peptide engineered from erythropoietin, improves metabolic control and neuropathic symptoms in patients with type 2 diabetes
Molecular Medicine | 2015
Published human phase 2 study in type 2 diabetes with neuropathic symptoms.
Cibinetide Improves Corneal Nerve Fiber Abundance in Patients With Sarcoidosis-Associated Small Nerve Fiber Loss and Neuropathic Pain
IOVS | 2017
Multicenter randomized human study extending the sarcoidosis neuropathy evidence.
A Phase 2 Clinical Trial on the Use of Cibinetide for the Treatment of Diabetic Macular Edema
Journal of Clinical Medicine | 2020
Small pilot human study in diabetic macular edema.
Improvement of Islet Allograft Function Using Cibinetide, an Innate Repair Receptor Ligand
Transplantation | 2020
Translational human islet / transplant-context paper, not a broad approved-indication anchor.
openFDA cibinetide query
FDA database
Approval-database query reviewed for cibinetide; no FDA-approved product match was identified.
WADA Prohibited List
WADA
Official anti-doping reference for the current prohibited categories.
WADA S0 page
WADA
Official WADA page for non-approved substances.