Is ARA-290 (cibinetide) approved as a drug?

No. ARA-290 has completed Phase 2 clinical trials but no Phase 3 programme has been published, and it is not approved by the FDA, EMA, or other major regulators. It is used only in research and investigational contexts.

How does ARA-290 differ from EPO?

Standard EPO stimulates red blood cell production through the homodimeric EPO receptor. ARA-290 was engineered to bind only the innate repair receptor (IRR) — a different complex — which mediates tissue-protective and anti-inflammatory effects without triggering erythropoiesis or haematological changes.

What does the human clinical evidence show?

Phase 2 trials in sarcoidosis-related small fiber neuropathy (three studies, up to 38 patients) consistently showed improvements in neuropathic pain scores, corneal nerve fiber density, functional capacity, and quality of life. A Phase 2 trial in type 2 diabetic neuropathy showed similar neuropathic symptom improvements plus HbA1c and lipid benefits. No Phase 3 data exist yet.

What dosing was used in clinical trials?

Clinical trials used either 2 mg intravenous three times weekly for 4 weeks, or 4 mg subcutaneous once daily for 28 days. No approved dosing exists. Community anecdotal protocols mirror the 4 mg/day subcutaneous trial design. These are research reference figures, not prescriptions.

Is ARA-290 prohibited in sport?

WADA prohibits erythropoietin, EPO receptor agonists, and related compounds. While ARA-290 may not be individually named on the prohibited list, it is an EPO-derived peptide acting on the EPO receptor complex; athletes should treat it as prohibited under the relevant class and confirm with their national anti-doping authority before use.

Published Phase 2 trials report a good short-term tolerability profile with no serious drug-related adverse events across approximately 100 trial participants. Long-term safety has not been formally studied. As an unregulated research compound, product quality from commercial sources is not guaranteed.

Recovery

ARA-290

Also known as: Cibinetide, ARA290, Araim-290

An 11-amino-acid synthetic peptide derived from erythropoietin (EPO), engineered to activate the innate repair receptor without stimulating red blood cell production; studied...

Last updated July 11, 2026

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Overview

ARA-290 (also known as cibinetide) is a synthetic 11-amino-acid peptide designed by Araim Pharmaceuticals. It is derived from the three-dimensional structure of erythropoietin (EPO) and engineered to selectively bind and activate the innate repair receptor (IRR) — a heterodimer of the EPO receptor and the beta-common receptor (CD131) — without triggering the classical homodimeric EPO receptor responsible for erythropoiesis (red blood cell production). This separation of tissue-protective from erythropoietic activity is the central pharmacological rationale for ARA-290. The IRR was characterised by Brines and colleagues in a foundational 2004 paper as the mediator of EPO's cytoprotective, anti-inflammatory, and tissue-regenerative effects. ARA-290 was subsequently developed to harness these tissue-repair properties without the thromboembolic and haematological risks of exogenous EPO. Human clinical evidence for ARA-290 is more advanced than for most research peptides: it has been evaluated in multiple Phase 2 randomised controlled trials, primarily for sarcoidosis-associated small fiber neuropathy (SFN) and for neuropathic symptoms in type 2 diabetes. Results have been encouraging — improved neuropathic pain scores, increased corneal nerve fiber density, and metabolic benefits — but no Phase 3 programme has been completed and the compound is not approved by any regulatory authority as of 2026. All use outside clinical trials is for research purposes only.

How it works

ARA-290 selectively binds the innate repair receptor (IRR), a heterodimer of the EPO receptor (EPOR) and the beta-common receptor (CD131), initiating intracellular signalling cascades that suppress pro-inflammatory cytokine production, inhibit apoptotic death signals in stressed or injured cells, and promote tissue repair. IRR activation downstream engages PI3K-Akt and JAK2-STAT5 pathways associated with cell survival and anti-inflammatory responses, but does not engage the erythropoietic JAK2-STAT5 signalling that occurs through the homodimeric EPOR. In preclinical and human studies, ARA-290 has been associated with regeneration of small nerve fibers as measured by corneal nerve fiber density and intraepidermal nerve fiber density. Its very short plasma half-life (~20 min subcutaneously, ~2 min intravenously) means systemic exposure is transient, yet the tissue-protective signalling cascades appear to persist for hours to days, consistent with a downstream receptor-mediated effect rather than continuous receptor occupancy. These mechanisms are supported by both preclinical and Phase 2 human data, though the full translational picture awaits confirmatory Phase 3 trials.

Researched effects

Clinical Reduces neuropathic pain scores in sarcoidosis-associated small fiber neuropathy
Clinical Increases corneal nerve fiber density in sarcoidosis-associated SFN after 28 days of dosing
Clinical Improves HbA1c and neuropathic symptoms in type 2 diabetes patients
Clinical Improves 6-minute walk test distance and quality of life in sarcoidosis patients
Preclinical Promotes small nerve fiber regeneration in preclinical neuropathy models
Preclinical Anti-apoptotic and cytoprotective effects in ischaemia and inflammatory injury models
Anecdotal Reduces systemic inflammation markers in autoimmune and metabolic contexts

Evidence levels: Clinical (human trials) · Preclinical (animal/lab) · Anecdotal (community-reported).

Dosing reference

For research reference only — not a recommendation.

Clinical / studied dosing

Phase 2 trials have used two main protocols: (1) intravenous ARA-290 2 mg in 6 mL saline administered over 2 minutes, three times per week for 4 weeks (sarcoidosis SFN pilot, n=22); and (2) subcutaneous ARA-290 4 mg once daily for 28 days (sarcoidosis open-label study, n=38; diabetic neuropathy Phase 2, n=48). These are the only human dosing regimens with published safety and efficacy data. No approved clinical dosing exists; Phase 3 evidence is lacking.

Community-reported dosing (anecdotal)

Anecdotal and research-reference only; not medical advice. Community and vendor sources (peptide forums, research vendor guides) most commonly describe subcutaneous injection of 2–4 mg once daily, mirroring the Phase 2 study protocol of 4 mg/day. Cycle lengths referenced anecdotally range from 4 to 8 weeks. These figures are extrapolated from published trial data rather than independent community validation. Individual reconstitution protocols vary and are not standardised. This is a research reference, not a treatment recommendation.

Half-life: Approximately 20 minutes after subcutaneous injection (4 mg dose); approximately 2 minutes after intravenous administration (2 mg dose). Despite rapid systemic clearance, the downstream tissue-protective signalling cascades activated through the IRR appear to persist for hours to days, which is consistent with the once-daily or thrice-weekly dosing used in clinical trials. Human pharmacokinetic data come from the published Phase 2 study populations.
Routes: subcutaneous, intravenous

Safety & side effects

In published Phase 2 trials, ARA-290 demonstrated a favourable short-term safety profile with no serious drug-related adverse events reported in the sarcoidosis SFN trials (n=22 and n=38) or the diabetic neuropathy trial (n=48). Laboratory assessments and clinical monitoring in these trials showed no significant haematological changes — consistent with ARA-290's design to avoid erythropoietic stimulation. However, these trials are small and short-duration; long-term safety over months or years has not been formally evaluated. Because it is derived from EPO, a hormone misused in sport for blood doping, EPO derivatives and analogues fall within WADA's prohibited classes even if a specific compound is not individually listed; athletes should assume ARA-290 is prohibited. ARA-290 is not approved by the FDA, EMA, or any major regulator for any indication. It is sold as a research-use-only compound; administration outside of supervised clinical trials or physician oversight carries uncharacterised risks. Product purity from unregulated sources is not guaranteed.

Research summary

ARA-290 has one of the strongest human evidence bases among research peptides, albeit still at the Phase 2 level. Three published randomised or controlled clinical studies in sarcoidosis-associated small fiber neuropathy — a double-blind IV pilot (n=22, 2012), an open-label SC study (n=38, 2014), and a Phase 2b multicentre RCT — consistently report improvements in neuropathic symptoms, corneal nerve fiber density, and functional capacity, with no drug-related serious adverse events. A Phase 2 double-blind trial in type 2 diabetic neuropathy (n=48, 2015) added signals for improved HbA1c and lipid profiles alongside neuropathic symptom relief. These results are notable because sarcoidosis-related SFN is a condition with no approved disease-modifying therapy, giving ARA-290 an unmet-need context that supported orphan-drug interest. However, no Phase 3 trial has been completed or published as of 2026, meaning efficacy in larger, more diverse populations and long-term safety remain unconfirmed. The preclinical base — across models of neuropathy, ischaemia-reperfusion injury, and inflammatory tissue damage — is broad and mechanistically coherent. On balance, ARA-290 is one of the more evidence-supported investigational peptides in the neuroprotection and recovery space, but it remains unproven at the Phase 3 level and unapproved for therapeutic use.

FAQ

Is ARA-290 (cibinetide) approved as a drug?: No. ARA-290 has completed Phase 2 clinical trials but no Phase 3 programme has been published, and it is not approved by the FDA, EMA, or other major regulators. It is used only in research and investigational contexts.
How does ARA-290 differ from EPO?: Standard EPO stimulates red blood cell production through the homodimeric EPO receptor. ARA-290 was engineered to bind only the innate repair receptor (IRR) — a different complex — which mediates tissue-protective and anti-inflammatory effects without triggering erythropoiesis or haematological changes.
What does the human clinical evidence show?: Phase 2 trials in sarcoidosis-related small fiber neuropathy (three studies, up to 38 patients) consistently showed improvements in neuropathic pain scores, corneal nerve fiber density, functional capacity, and quality of life. A Phase 2 trial in type 2 diabetic neuropathy showed similar neuropathic symptom improvements plus HbA1c and lipid benefits. No Phase 3 data exist yet.
What dosing was used in clinical trials?: Clinical trials used either 2 mg intravenous three times weekly for 4 weeks, or 4 mg subcutaneous once daily for 28 days. No approved dosing exists. Community anecdotal protocols mirror the 4 mg/day subcutaneous trial design. These are research reference figures, not prescriptions.
Is ARA-290 prohibited in sport?: WADA prohibits erythropoietin, EPO receptor agonists, and related compounds. While ARA-290 may not be individually named on the prohibited list, it is an EPO-derived peptide acting on the EPO receptor complex; athletes should treat it as prohibited under the relevant class and confirm with their national anti-doping authority before use.
Is ARA-290 safe?: Published Phase 2 trials report a good short-term tolerability profile with no serious drug-related adverse events across approximately 100 trial participants. Long-term safety has not been formally studied. As an unregulated research compound, product quality from commercial sources is not guaranteed.

References

All content is for research and educational use only and is not medical advice. Products are sold for laboratory research only and are not for human consumption.