ARA-290 (Cibinetide) (ARA 290)
11-amino-acid peptide designed from the helix B surface of erythropoietin; innate repair receptor agonist without erythropoietic activity; phase 2 studies in sarcoidosis-associated small fibre neuropathy and type 2 diabetes; not approved.
60-Second Scientific Briefing
ARA-290 (cibinetide) is an investigational peptide engineered from part of erythropoietin (EPO). It activates the "innate repair receptor", which is linked to tissue protection, without stimulating red blood cell production. It is not approved anywhere. Small randomised phase 2 trials in sarcoidosis-related small nerve fibre damage and in type 2 diabetes with painful neuropathy reported improvements in neuropathic symptoms and nerve fibre measures, with no safety concerns identified.
What is ARA-290 (Cibinetide)?
Pharmacological Classification & Molecular IdentityARA-290 (cibinetide) is a small peptide designed from the structure of erythropoietin to activate the innate repair receptor, which mediates tissue protection, anti-inflammatory effects and healing, without stimulating red blood cell production. [1] Mol Med, 2012 ↗
Verified Chemical & Regulatory Registry Identifiers
Mechanism of Action & Receptor Targets
Biological Pathway and Target BindingReceptor Selectivity: Interacts selectively with the innate repair receptor, which mediates tissue protection, rather than the classic erythropoietin receptor complex that drives red blood cell production. In preclinical neuropathy models it reduced allodynia. [1] Mol Med, 2015 ↗ [2] Mol Med, 2012 ↗
Regulatory & FDA Approval Status
Legal and Regulatory ClassificationsInvestigational and not approved by the US FDA or any other regulator. Published human research consists of small phase 2 trials. [1] Mol Med, 2015 ↗
ARA-290 (Cibinetide) is not approved for commercial sale, prescription therapy, or compounded medication distribution. It exists strictly within authorized scientific and clinical research frameworks.
Human Evidence & Clinical Trials
Clinical Study Readouts and Evidence SynthesesSarcoidosis with small fibre neuropathy: a double-blind pilot (22 patients, 4 weeks of intravenous dosing, 2012) improved the small fibre neuropathy screening score vs placebo; a blinded placebo-controlled trial of 28 days of subcutaneous dosing (2013) improved neuropathic symptoms and increased corneal nerve fibre density; a phase 2b trial (64 subjects, 28 days, 2017) increased corneal nerve fibre area significantly in the middle dose group. Type 2 diabetes with painful neuropathy (phase 2, 2015): 28 days of daily subcutaneous dosing improved HbA1c, lipid profile and neuropathic symptoms vs placebo. [1] Invest Ophthalmol Vis Sci, 2017 ↗ [2] Mol Med, 2015 ↗ [3] Mol Med, 2013 ↗ [4] Mol Med, 2012 ↗
Clinical Evidence
Sarcoidosis with small fibre neuropathy: a double-blind pilot (22 patients, 4 weeks of intravenous dosing, 2012) improved the small fibre neuropathy screening score vs placebo; a blinded placebo-controlled trial of 28 days of subcutaneous dosing (2013) improved neuropathic symptoms and increased corneal nerve fibre density; a phase 2b trial (64 subjects, 28 days, 2017) increased corneal nerve fibre area significantly in the middle dose group. Type 2 diabetes with painful neuropathy (phase 2, 2015): 28 days of daily subcutaneous dosing improved HbA1c, lipid profile and neuropathic symptoms vs placebo.
Safety Profile & Clinical Limitations
Documented Adverse Events and Known UncertaintiesNo safety concerns were raised by clinical or laboratory assessments in the 2012 sarcoidosis pilot, and no potential safety issues were identified in the 2015 diabetes trial. These trials were small and short. [1] Mol Med, 2015 ↗ [2] Mol Med, 2012 ↗
No phase 3 trial has been published; the trials were small (22 to 64 patients) and lasted about a month. Long-term safety and durable benefit are unknown. [1] Invest Ophthalmol Vis Sci, 2017 ↗
Dose Approval Status
Commercial Dosing Status and Policy DirectivesNo dose is approved or established. The amounts used in the published studies are part of each study's design and are described in the linked papers; they are not a recommendation. [1] Mol Med, 2015 ↗
Under Egypt Peptides medical governance policies, no personal dosages, titration intervals, cycles, stacking recommendations, or self-injection instructions may be provided for unapproved investigational compounds. Clinical study protocols represent controlled experimental research parameters exclusively.
What is Known vs. What is Unknown
Evidence Comparison and Clinical Evidence Boundaries✓ Confirmed Scientific Evidence
- ARA-290 (cibinetide) is a small peptide designed from the structure of erythropoietin to activate the innate repair receptor, which mediates tissue protection, anti-inflammatory effects and healing, without stimulating red blood cell production.
- Targets & Selectivity: Interacts selectively with the innate repair receptor, which mediates tissue protection, rather than the classic erythropoietin receptor complex that drives red blood cell production. In preclinical neuropathy models it reduced allodynia.
- Sarcoidosis with small fibre neuropathy: a double-blind pilot (22 patients, 4 weeks of intravenous dosing, 2012) improved the small fibre neuropathy screening score vs placebo; a blinded placebo-controlled trial of 28 days of subcutaneous dosing (2013) improved neuropathic symptoms and increased corneal nerve fibre density; a phase 2b trial (64 subjects, 28 days, 2017) increased corneal nerve fibre area significantly in the middle dose group. Type 2 diabetes with painful neuropathy (phase 2, 2015): 28 days of daily subcutaneous dosing improved HbA1c, lipid profile and neuropathic symptoms vs placebo.
- Safety considerations: No safety concerns were raised by clinical or laboratory assessments in the 2012 sarcoidosis pilot, and no potential safety issues were identified in the 2015 diabetes trial. These trials were small and short.
? Unknown / Under Ongoing Investigation
- No phase 3 trial has been published; the trials were small (22 to 64 patients) and lasted about a month. Long-term safety and durable benefit are unknown.
Verified Questions & Answers
10 Verified scientific answers with permanent anchor keysARA-290 (cibinetide) is an investigational peptide engineered from erythropoietin that activates a tissue-protective receptor without increasing red blood cells. It is not approved.
- Safety and efficacy of ARA 290 in sarcoidosis patients with symptoms of small fiber neuropathy: a randomized, double-blind pilot study (Mol Med, 2012-11-15)
- ARA 290 improves symptoms in patients with sarcoidosis-associated small nerve fiber loss and increases corneal nerve fiber density (Mol Med, 2013-11-08)
It acts selectively on the innate repair receptor, linked to tissue protection and anti-inflammatory effects, rather than the classic EPO receptor that drives red blood cell production.
- ARA 290, a nonerythropoietic peptide engineered from erythropoietin, improves metabolic control and neuropathic symptoms in type 2 diabetes (Mol Med, 2015-03-13)
- Safety and efficacy of ARA 290 in sarcoidosis patients with symptoms of small fiber neuropathy: a randomized, double-blind pilot study (Mol Med, 2012-11-15)
No. ARA-290 is investigational and not approved by the FDA or any other regulator.
Small phase 2 trials: in sarcoidosis-related small nerve fibre damage (22 and 64 patients) it improved neuropathic symptoms and corneal nerve fibre measures; in type 2 diabetes with painful neuropathy it improved HbA1c, lipids and symptoms over 28 days.
Mol Med 2012: 22 patients with sarcoidosis and small fibre neuropathy symptoms received intravenous ARA-290 three times weekly (12) or placebo (10) for 4 weeks; the small fibre neuropathy screening score improved more with ARA-290 (−11.5 vs −2.9), and the SF-36 pain and physical-function dimensions improved from baseline; pain and fatigue scores improved equally in both groups. Mol Med 2013: 28 days of daily subcutaneous ARA-290 improved neuropathic symptoms, increased corneal small nerve fibre density and improved the 6-minute walk test vs placebo. Invest Ophthalmol Vis Sci 2017 (phase 2b, 64 subjects, 28 days, three doses vs placebo): corneal nerve fibre area increased significantly only in the middle dose group (P=0.012); pain improved in all groups including placebo. Mol Med 2015 (phase 2, type 2 diabetes with painful neuropathy): 28 days of daily subcutaneous dosing improved HbA1c, lipids and PainDetect scores vs placebo.
- Cibinetide improves corneal nerve fiber abundance in patients with sarcoidosis-associated small nerve fiber loss and neuropathic pain (phase 2b) (Invest Ophthalmol Vis Sci, 2017-05-01)
- ARA 290, a nonerythropoietic peptide engineered from erythropoietin, improves metabolic control and neuropathic symptoms in type 2 diabetes (Mol Med, 2015-03-13)
- ARA 290 improves symptoms in patients with sarcoidosis-associated small nerve fiber loss and increases corneal nerve fiber density (Mol Med, 2013-11-08)
- Safety and efficacy of ARA 290 in sarcoidosis patients with symptoms of small fiber neuropathy: a randomized, double-blind pilot study (Mol Med, 2012-11-15)
No safety concerns were identified in the small, short phase 2 trials (clinical and laboratory checks). These trials cannot establish long-term safety.
- ARA 290, a nonerythropoietic peptide engineered from erythropoietin, improves metabolic control and neuropathic symptoms in type 2 diabetes (Mol Med, 2015-03-13)
- Safety and efficacy of ARA 290 in sarcoidosis patients with symptoms of small fiber neuropathy: a randomized, double-blind pilot study (Mol Med, 2012-11-15)
No phase 3 trial has been published; the trials were small and about a month long. Long-term safety and lasting benefit are unknown.
- Cibinetide improves corneal nerve fiber abundance in patients with sarcoidosis-associated small nerve fiber loss and neuropathic pain (phase 2b) (Invest Ophthalmol Vis Sci, 2017-05-01)
No dose is approved or established. The amounts used in the published studies are part of each study's design and are described in the linked papers; they are not a recommendation.
There is no approved product label, so no official storage instructions exist.
It is not named individually on the 2026 WADA Prohibited List. Under section S0 (non-approved substances), any pharmacological substance without a current approval by a government health authority for human therapeutic use is prohibited at all times. Athletes should confirm with their national anti-doping organisation.
- WADA Prohibited List (World Anti-Doping Agency)
Egypt Peptides publishes reviewed scientific reference monographs for documentation and research. The site does not give individual medical advice, preparation or injection instructions, combination protocols or off-label use instructions. Decisions about any medicine belong to the treating physician.
Authoritative Sources & Literature Registry
Regulatory dossiers, clinical trial registries, and published studiesCibinetide improves corneal nerve fiber abundance in patients with sarcoidosis-associated small nerve fiber loss and neuropathic pain (phase 2b) ↗
https://pubmed.ncbi.nlm.nih.gov/28475703/
ARA 290, a nonerythropoietic peptide engineered from erythropoietin, improves metabolic control and neuropathic symptoms in type 2 diabetes ↗
https://pubmed.ncbi.nlm.nih.gov/25387363/
ARA 290 improves symptoms in patients with sarcoidosis-associated small nerve fiber loss and increases corneal nerve fiber density ↗
https://pubmed.ncbi.nlm.nih.gov/24136731/
Safety and efficacy of ARA 290 in sarcoidosis patients with symptoms of small fiber neuropathy: a randomized, double-blind pilot study ↗
https://pubmed.ncbi.nlm.nih.gov/23168581/