ARA-290 (Cibinetide)

Typical use cases

Dosing guidelines

Titration

Trials used fixed daily doses rather than titration; community reports describe starting lower (e.g., 1-2 mg) and moving toward ~4 mg. Educational information only, not dosing guidance.

Reconstitution

Supplied as a lyophilized powder; commonly reconstituted with bacteriostatic or sterile water to a working concentration (e.g., ~4 mg/mL), swirled gently rather than shaken, and used within the storage window.

Injection sites

Subcutaneous injection (anterior thigh used in trials; abdomen also commonly reported); intravenous infusion was used in the earliest sarcoidosis pilot study.

Storage & handling

Lyophilized powder is typically stored refrigerated at 2-8 C or frozen at -20 C for longer term; once reconstituted, generally kept refrigerated and used within roughly 2-4 weeks. Protect from light and avoid repeated freeze-thaw.

Side effects

• Injection-site reaction (redness, soreness, irritation) Mild · Common
• Headache Mild · Uncommon
• Fatigue or transient dizziness Mild · Uncommon
• Nausea or mild gastrointestinal upset Mild · Uncommon
• Worsening of pre-existing renal insufficiency (single trial case, confounded) Severe · Rare

Research summary

ARA-290 was engineered at Araim Pharmaceuticals from the helix-B surface domain of erythropoietin (EPO) to retain EPO's tissue-protective signaling while eliminating its hematopoietic activity; it agonizes the heterodimeric innate repair receptor (IRR), formed of the EPO receptor and the beta-common receptor/CD131, rather than the classical EPOR homodimer that drives red-blood-cell production. The strongest human evidence comes from small randomized, placebo-controlled trials in sarcoidosis-associated small fiber neuropathy: a 2012 pilot study (22 patients, 2 mg IV three times weekly for 4 weeks) improved neuropathic and autonomic symptom scores and was reported as well tolerated, and a subsequent dose-ranging trial of daily subcutaneous 1, 4, or 8 mg for 28 days found that the 4 mg dose produced the largest placebo-corrected increase in corneal nerve fiber area (~23% from baseline) plus increased regenerating skin nerve fibers (NCT02039687). A separate randomized trial in type 2 diabetes reported improved metabolic control (including HbA1c) and neuropathic-symptom measures at 4 mg subcutaneously daily, with a favorable safety profile and no anti-drug antibodies. Mechanistically the peptide is described as anti-apoptotic and anti-inflammatory, and notably does not raise hematocrit, which is thought to avoid EPO's cardiovascular/thrombotic risks. Important limitations remain: trials are small, mostly short (about 4 weeks) and concentrated in orphan indications, no large Phase 3 confirmation or regulatory approval exists, and despite an extremely short plasma half-life (minutes) the durable downstream signaling and long-term safety are not fully characterized. Most non-trial use occurs in unregulated research/community settings, so purity, dosing, and outcome data outside the published studies are anecdotal.

Key references

• https://pmc.ncbi.nlm.nih.gov/articles/PMC3563705/
• https://pmc.ncbi.nlm.nih.gov/articles/PMC4365069/
• https://clinicaltrials.gov/study/NCT02039687
• https://www.tandfonline.com/doi/full/10.1517/21678707.2013.719289
• https://www.prnewswire.com/news-releases/araim-pharmaceuticals-cibinetide-ara-290-regenerates-small-nerve-fibers-and-improves-neuropathic-clinical-symptoms-in-the-orphan-disease-of-sarcoidosis-300452818.html

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