Cibinetide (ARA-290) High Purity Peptide API, Erythropoietin/CD131 Heteroreceptor Agonist CAS 1208243-50-8

Cibinetide More Info

Cibinetide , also known by its developmental code ARA 290, is an eleven-amino-acid peptide (11-mer) derived from the endogenous erythropoietin (EPO) molecule. Structurally, it corresponds to the C-terminal region of erythropoietin, specifically helix B, and consists of the sequence pyroGlu-Gln-Leu-Glu-Arg-Ala-Leu-Asn-Ser-Ser-NH₂, with a molecular formula of C₄₉H₈₀N₁₈O₁₉ and a molecular weight of approximately 1177.27 g/mol. Unlike full-length erythropoietin, cibinetide lacks the tertiary structure necessary for erythropoiesis-stimulating activity at the EPO receptor homodimer. This distinction is critical, as it allows cibinetide to activate a different receptor complex—the heterodimer comprising the erythropoietin receptor (EpoR) and the β-common receptor (CD131)—thereby separating its tissue-protective and anti-inflammatory properties from the erythropoietic effects associated with traditional EPO-based therapies.

The primary mechanism of action of cibinetide involves the activation of the innate repair receptor (IRR), a tissue-protective receptor complex composed of the erythropoietin receptor and the β-common receptor subunit. Activation of this receptor triggers intracellular signaling pathways that inhibit apoptosis, reduce oxidative stress, suppress pro-inflammatory cytokine production, and promote neurotrophic support. Preclinical studies have demonstrated that cibinetide exerts potent protective effects in models of ischemic injury, inflammatory neuropathy, diabetes-related complications, and traumatic nerve damage. Notably, the peptide demonstrates high selectivity for the tissue-protective receptor without significant binding to the erythropoietic receptor homodimer, a property that eliminates the risk of polycythemia, hypertension, or thrombotic complications associated with erythropoietin therapy.

Clinically, cibinetide has been investigated for multiple indications involving tissue protection and repair. In sarcoidosis patients with small-fiber neuropathy, a condition characterized by debilitating neuropathic pain and autonomic dysfunction, clinical trials have demonstrated that cibinetide administration produces significant and sustained reductions in pain scores, improvements in small nerve fiber density and function, and enhanced quality of life measures. Additional clinical investigations have explored cibinetide for the treatment of diabetic neuropathy, where it has shown improvements in neuropathic symptoms and nerve function parameters. The compound has also been evaluated for its potential neuroprotective effects in conditions involving retinal ganglion cell degeneration, including non-arteritic anterior ischemic optic neuropathy, as well as for cardioprotection following ischemic events. Phase 2 clinical trials have yielded promising results, leading to continued development for peripheral neuropathic conditions.

The pharmacokinetic properties of cibinetide reflect its peptide nature, with limited oral bioavailability and a relatively short elimination half-life in systemic circulation. Following administration, the compound undergoes rapid distribution and is cleared primarily through renal pathways and proteolytic degradation. For research and clinical development purposes, cibinetide has been formulated to maintain stability and bioactivity, with the ability to cross biological barriers including the blood-brain barrier and the blood-nerve barrier, albeit with limited efficiency. The peptide is typically stored at low temperatures (-20°C or below) to preserve structural integrity and biological activity during laboratory handling. These physicochemical characteristics have guided the development of sustained-release and targeted delivery approaches to optimize therapeutic exposure while minimizing administration frequency.

The safety profile of cibinetide is well-characterized from extensive preclinical and clinical research, with the compound demonstrating a favorable tolerability profile across multiple studies. Unlike erythropoietin, cibinetide does not increase hematocrit, hemoglobin, or red blood cell counts, even at high doses or with repeated administration, confirming the functional separation of its tissue-protective and erythropoietic activities. Reported adverse effects have been generally mild and include transient local reactions at the site of administration, such as discomfort or erythema, without serious systemic toxicities. The compound has not been associated with increased risks of thrombosis, hypertension, immunogenicity, or malignancy in clinical studies to date. Cibinetide is strictly designated for research and investigational clinical use, and its continued development represents a promising approach to the tissue-protective pathways of erythropoietin without the hematologic liabilities that have limited the therapeutic application of the parent molecule.

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