Also known as: Cibinetide, ARA290, EPO Helix B Peptide
Half-life: ~2 minutes (plasma); longer functional duration via receptor binding
Last reviewed: · Published:
ARA-290 (Cibinetide) is an 11-amino-acid peptide derived from the helix-B region of erythropoietin (EPO). EPO has long been known to have tissue-protective and anti-inflammatory effects in addition to its classical erythropoietic function (stimulating red blood cell production), but using full-length EPO clinically for tissue-protection purposes is impossible because of the hematological effects — raising hemoglobin in non-anemic patients increases stroke, thrombosis, and cardiovascular risk. ARA-290 was designed to separate the two: it activates the "tissue-protective" innate repair receptor (IRR, a heterodimer of the EPO receptor and the β-common receptor) without binding the homodimeric EPO receptor responsible for erythropoiesis.
In preclinical models and early clinical work, ARA-290 has shown anti-inflammatory and tissue-protective effects across diverse conditions — sarcoidosis-associated neuropathy, diabetic small-fiber neuropathy, traumatic brain injury models, kidney ischemia-reperfusion injury, and others. The Phase 2b trial in sarcoidosis small-fiber neuropathy by Anna Heij and colleagues at Leiden University Medical Center showed improvements in quality of life and small-fiber-related symptoms. The compound has been advanced through clinical development by Araim Pharmaceuticals.
ARA-290 is sold by some research-peptide vendors. It is generally well-tolerated based on clinical-trial evidence to date, with the safety advantage of not raising hemoglobin or causing the cardiovascular events that limited EPO's expansion into tissue-protection indications.
The recognition that EPO has tissue-protective activity independent of erythropoiesis emerged from the work of Anthony Cerami's group (the same Cerami who, as a young researcher, had codiscovered erythropoietin's clinical applications) and Michael Brines starting in the early 2000s. The helix-B sequence of EPO was identified as containing the tissue-protective signal. The 11-amino-acid ARA-290 peptide was specifically engineered to retain this activity while abolishing erythropoietic effects. Araim Pharmaceuticals (founded by Brines and Cerami) has carried the compound through clinical trials including the sarcoidosis neuropathy Phase 2b study.
Clinical trial tolerability of ARA-290 across multiple Phase 1 and 2 studies has been excellent, with no significant safety signals and notably no rise in hemoglobin or platelet count — confirming the design intent to separate tissue-protective from hematological effects. The most common adverse events have been mild injection-site reactions and occasional headache. The peptide is positioned as one of the safer tissue-protective research peptides currently available.
Dose Range
2-8 mg
Frequency
Once daily (SubQ)
Duration
4-12 weeks per cycle
Dose Range
1-4 mg
Frequency
Daily or alternate-day
Duration
Per research protocol
Dosing information is for educational purposes only. Consult a healthcare professional before using any peptide.
Typical Vial Size
8 mg
Water Type
Bacteriostatic water (BAC water)
Mixing Volume
2 mL
Half-Life
~2 minutes (plasma); longer functional duration via receptor binding
Molecular Weight
1,257 Da
Store reconstituted vial refrigerated at 2-8°C. Use within 21-30 days. Subcutaneous administration is the most studied route in clinical trials.
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FDA Status
Not FDA approved. In clinical development by Araim Pharmaceuticals. Granted orphan drug designation for sarcoidosis-related conditions.
Legal Status
Unregulated research chemical outside clinical trials.
USA
Not approvedClinical development ongoing; FDA orphan drug designation
EU
Not approvedNot yet authorized as medicinal product
UK
Not approvedResearch / clinical trial only
Australia
Not approvedTGA has not authorized
Canada
Not approvedNot authorized for human use
Heij L, Niesters M, Swartjes M, Hoitsma E, Drent M, Dunne A, Grutters JC, Vogels O, Brines M, Cerami A, Dahan A
Molecular Medicine (2012)
Clinical trial demonstrating ARA-290 improved symptoms and corneal nerve fiber density in patients with sarcoidosis-associated small-fiber neuropathy, supporting its tissue-protective mechanism in humans.
View Study →Brines M, Cerami A
Hematology (2008)
Foundational review by the discoverers of EPO's tissue-protective effects, providing the mechanistic context for engineering ARA-290 as a non-erythropoietic tissue-protective derivative.
View Study →Brines M, Dunne AN, van Velzen M, Proto PL, Ostenson CG, Kirk RI, Petropoulos IN, Javed S, Malik RA, Cerami A, Dahan A
Molecular Medicine (2015)
Phase 2 study in diabetic small-fiber neuropathy patients showing ARA-290 reduced pain and improved quality of life, extending the small-fiber neuropathy evidence base beyond sarcoidosis to a much larger patient population.
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