ARA-290: research
Experimental peptide studied for small-fiber nerve damage, with uncertain pain relief and safety.
Also called: Cibinetide, ARA 290, ARA290, pHBSP, pHSBP, Pyroglutamate helix B surface peptide.
Healing and repair peptides · EPO-derived peptide designed to activate the innate repair receptor.
Nine separate studies reported results, including a blood-level study and three dental cases. No confirmatory phase 3 trial was found.
Studies
- First neuropathy pilot. open-label, n=20, 20 adults with sarcoidosis or diabetes and neuropathic symptoms. Whole-group pain scores fell about 40% in sarcoidosis and 30% in diabetes; there was no placebo group. (source)
- Healthy volunteers: IV versus under the skin. pk-study, n=10, 10 healthy volunteers in a crossover PK study. Exposure data supported selecting 4 mg under the skin for later trials. (source)
- Sarcoidosis: 2 mg IV. rct, n=22, Adults with sarcoidosis and painful small-fiber neuropathy symptoms. Neuropathy symptom scores improved; pain intensity improved similarly with placebo. (source)
- Sarcoidosis: 4 mg daily. rct, n=38, 38 adults with sarcoidosis and documented small-fiber loss. Several nerve and symptom measures improved; pain intensity did not beat placebo. (source)
- Diabetic neuropathy: 4 mg daily. rct, n=49, Adults with type 2 diabetes and painful distal limbs. PainDetect and HbA1c improved modestly; other symptom tests did not consistently improve. (source)
- Healthy volunteers: emotional processing. rct, n=36, 36 healthy adults, not patients with depression. No mood benefit was found; emotional-processing findings were mixed. (source)
- Sarcoidosis: 1, 4 or 8 mg daily. rct, n=64, 64 adults with sarcoidosis-associated small-fiber loss and neuropathic pain. Only 4 mg beat placebo on the nerve-area endpoint; pain benefit was not significant. (source)
- Same trial: posted raw results and harms. rct, n=64, Same 64 randomized participants; 62 in the posted safety population. Posted results show frequent reported events and three people with serious events. (source)
- Diabetic eye swelling: 12 weeks. single-arm, n=9, Nine adults with untreated diabetic macular edema; eight completed. Vision and retinal thickness did not improve on average. (source)
- Dental nerve injury: three cases. case-series, n=3, Three adults with lower-lip or chin sensory loss after dental procedures. Sensation improved during a multi-drug course; no component’s effect can be isolated. (source)
- Corneal imaging: reanalysis. cohort, Existing diabetes and sarcoidosis imaging datasets, including treated participants. Nerve area and width may help measure neuropathy; this is not a new treatment trial. (source)
- Prediabetes: results unavailable. rct, Planned 24 adults with prediabetes or drug-naive type 2 diabetes. Public outcome and adverse-event results were not located. (source)
- Regional pain syndrome: registry only. rct, Planned 40 adults with complex regional pain syndrome. Public outcome and adverse-event results were not located. (source)
- Rheumatoid arthritis: registry only. open-label, Planned 12 adults with active rheumatoid arthritis. Public outcome and adverse-event results were not located. (source)
- Critical limb ischemia: registry only. rct, Planned eight adults with no-option critical limb ischemia. Public outcome and adverse-event results were not located. (source)
- Small-fiber neuropathy: evidence review. systematic-review, 42 publications on small-fiber neuropathy therapies. The review found varied treatment approaches and a need for stronger trials. (source)
- Original tissue-protection experiments. animal, Cell and rodent injury models. Short EPO-derived peptides showed tissue-protective effects without increasing red-cell production. (source)
- Blood-vessel repair: cells and mice. animal, Endothelial colony-forming cells and mice with limb ischemia. ARA290 increased cell migration and vessel repair with transplanted cells. (source)
- Diabetic wounds: mice. animal, Mice with genetic diabetes and surgical skin wounds. Daily cibinetide improved wound markers and repair in diabetic mice. (source)
- Receptor structure: conflicting result. in-vitro, Biophysical receptor experiments and mouse anemia models. Direct binding between the proposed receptor components was not demonstrated. (source)
- Kidney experiment: retracted in 2026. animal, Retraction notice concerning a 2012 animal kidney-injury paper. The 2012 delayed-dose kidney paper was retracted in February 2026. (source)
- First-in-human single-dose IV program. pk-study, Healthy volunteers; participant number not verified. Mentioned in a later trial protocol; public primary outcomes and dosing tables were not located. (source)
- Healthy volunteers: repeat-dose IV program. pk-study, Healthy volunteers; participant number not verified. Mentioned in a later trial protocol; public primary outcomes and dosing tables were not located. (source)
- Kidney impairment: drug-level program. pk-study, Adults with kidney impairment; participant number not verified. Mentioned in a later trial protocol; public primary outcomes and dosing tables were not located. (source)
- Hemodialysis: repeat-dose IV program. open-label, Adults receiving hemodialysis; participant number not verified. Mentioned in a later trial protocol; public primary outcomes and dosing tables were not located. (source)
ARA-290 dosage
Typical reported dose: 4 mg once a day for 4 weeks
- First pilot: three IV doses: 2 mg every two days for three doses every two days for three doses, into a vein. Studied in a trial. Studied in: 20 adults with sarcoidosis or diabetes and neuropathic symptoms. (source)
- Drug levels: 2 mg IV: 2 mg as a single dose as a single dose, into a vein. Studied in a trial. Studied in: 10 healthy volunteers in a crossover PK study. (source)
- Drug levels: 2 mg under the skin: 2 mg as a single dose as a single dose, under the skin. Studied in a trial. Studied in: 10 healthy volunteers in a crossover PK study. (source)
- Drug levels: 4 mg under the skin: 4 mg as a single dose as a single dose, under the skin. Studied in a trial. Studied in: 10 healthy volunteers in a crossover PK study. (source)
- Drug levels: 6 mg under the skin: 6 mg as a single dose as a single dose, under the skin. Studied in a trial. Studied in: 10 healthy volunteers in a crossover PK study. (source)
- Sarcoidosis: 2 mg IV three days a week: 2 mg on Monday, Wednesday and Friday on Monday, Wednesday and Friday, into a vein. Studied in a trial. Studied in: Adults with sarcoidosis and painful small-fiber neuropathy symptoms. (source)
Highest studied: 8 mg subcutaneous once daily for 28 days; not a safe personal maximum..
These are doses reported in labels, trials or user reports, not a personal plan. Check the source behind each one.
ARA-290 side effects and risks
Reported side effects
- Headache: Dose study, 1/4/8 mg: 3/16, 3/16, 2/14; placebo 0/16. Twelve week eye pilot: 4/9., mild. New severe headache, fainting or chest symptoms need urgent assessment. (source)
- Nausea: Dose study, 1/4/8 mg: 2/16, 2/16, 1/14; placebo 0/16. Twelve week eye pilot: 2/9., mild. Review persistent symptoms and hydration with a clinician. (source)
- Diarrhea: 1/4/8 mg: 2/16, 1/16, 2/14; placebo 2/16. Rates crossed the 10% band between arms., mild. Seek care for dehydration, blood in stool or severe pain. (source)
- Injection-site pain: 1/4/8 mg: 1/16, 1/16, 1/14; placebo 4/16., mild. Spreading redness, warmth, fever or pus needs assessment. (source)
- Fatigue: 1/4/8 mg: 3/16, 2/16, 0/14; placebo 2/16., mild. Persistent or worsening fatigue warrants review. (source)
- Suicidal thoughts: 1/14 at 8 mg; 0/16 in each other arm. This small trial cannot establish the true frequency., serious. Stop exposure and get emergency help for thoughts of self-harm. (source)
- Fainting, chest tightness or breathlessness: Each listed in 1/16 at 1 mg; the group had two people with serious events overall., serious. Stop exposure and seek urgent care. (source)
- Worsening kidney function: One diabetes trial participant stopped after creatinine rose from 119 to 159 µmol/L., serious. Prompt kidney-function review is needed; a concurrent furosemide increase confounded the event. (source)
- Head cold: 4/9 in the uncontrolled 12 week eye pilot; 3/16 at 4 mg versus 2/16 placebo in the dose study., mild. Reported as an adverse event; a cold does not establish a drug effect. Review persistent or severe symptoms. (source)
- Raised glucose or triglycerides: Eye pilot: raised glucose 3/9; raised triglycerides 5/9. Fasting was not confirmed, so meals may explain the changes., mild. Review glucose readings and repeat abnormal tests under appropriate conditions. (source)
Stop and get help if
- Thoughts of suicide or self-harm: Stop exposure and get emergency mental-health help now.
- Chest pain, trouble breathing or fainting: Seek emergency care now.
- Face or throat swelling, widespread hives or trouble breathing: Stop exposure and seek emergency care for possible severe allergy.
- Fever with spreading injection-site redness, heat or pus: Get urgent medical care for possible infection.
- Markedly less urine, new swelling or rapid worsening illness: Stop exposure and obtain urgent medical assessment and kidney tests.
- Sudden or worsening vision loss: Obtain urgent eye care; the eye trial stopped dosing for >10-letter vision loss.
Who should avoid it
- pregnant: Pregnant people were excluded. Fetal safety has not been established.
- breastfeeding: Breastfeeding people were excluded; milk transfer and infant effects are unknown.
- tryingToConceive: Reproductive safety is unknown. Trials required contraception; an evidence-based preconception washout is unknown.
- under18: Trials enrolled adults; safety and dosing under 18 have not been established.
- activeCancer: Cell and animal work promotes blood-vessel growth. Cancer safety is unknown; this is a precaution, not proof of tumor growth.
- cancerHistory: Some trials excluded serious malignancy. Recurrence risk and long-term cancer safety are unknown.
- kidneyDisease: Kidney function worsened in one diabetes-trial participant while furosemide was increased. Dose adjustment is unknown.
- liverDisease: No established dose adjustment or adequate safety dataset for serious liver disease was found.
- heartCondition: Fainting, chest tightness and breathlessness were serious registry events. Causation is uncertain.
- uncontrolledBloodPressure: Abnormal blood pressure was excluded in trials. Safety with uncontrolled pressure remains unknown.
- depressionOrSuicidalThoughts: Suicidal thoughts occurred in one participant at 8 mg daily; later trials added structured mood screening.
- diabetes: A small trial changed HbA1c. Review glucose-lowering drugs and monitor readings; the interaction size is unknown.
- testedAthlete: S0 prohibits unapproved investigational drugs at all times. WADA removed ARA290 from the innate repair receptor section for 2018.
- other: Prior serious allergy to the peptide or formulation should stop further exposure.
Interactions
- Insulin and sulfonylureas: Possible added glucose lowering; a clinically important interaction was not established. Review readings and medicines.
- Furosemide: One participant’s creatinine rose while furosemide was increased. A direct drug interaction has not been proven.
- Erythropoiesis-stimulating drugs: Trials excluded these drugs; combined effects and safety are unknown.
- TNF blockers and other biologic immune drugs: Several trials excluded recent anti-TNF or immunoglobulin use. This is an evidence gap, not a proven interaction.
- Anticoagulants: No specific interaction study was located. Injection-site bleeding was reported; anticoagulation can complicate injections.
- Other self-injected peptides: Controlled combination safety is unknown. Multiple simultaneous products make benefits and adverse reactions hard to attribute.
Product quality risks
- No independent published survey testing online ARA-290 vials for identity, amount, sterility and endotoxin was located.
- TGA warns that unapproved peptide injections may contain the wrong ingredient, too much or too little drug, or contamination. This is a class warning.
- User reports of clumping or gelling do not identify the cause or prove that a vial is sterile.
- A purity percentage, clear liquid or research-use label does not establish injection quality.
How ARA-290 works
ARA-290 copies a small part of erythropoietin. It was designed to reduce cell damage and support repair without increasing red blood cells. The proposed repair receptor contains EPOR and CD131, but its direct structure and binding remain debated.
- Proposed EPOR/CD131 innate repair receptor: Intended to trigger cell-protection and repair signals; direct receptor assembly is disputed.
- Blood-cell EPO receptor: Designed to avoid red-cell stimulation; short trials did not show a meaningful rise in hemoglobin.
Half-life: Reported as about 20 minutes in healthy volunteers after injection under the skin.
Gaps: No approved label, confirmatory phase 3 result or independent clinician dosing guideline was found. Nine independent outcome datasets are counted: open neuropathy pilot, healthy PK, five randomized trials, the eye pilot and dental cases. Registry companion results, imaging reanalysis and the systematic review reuse earlier trials and are not additional independent intervention studies. First-in-human dose-escalation and renal-impairment studies are mentioned in the eye protocol, but public arm-level records and doses were not located. Swedish metabolic, rheumatoid arthritis, complex regional pain and limb-ischemia programs lack located public results. Old registry status may be stale. The Swedish NCT01933529 study is separate from the published NTR3858 diabetic-neuropathy trial. A Dutch diabetes registry amendment describes longer exposure, but no separate long-course outcome report was located. The 2017 nerve-area benefit was significant only at 4 mg. It does not prove meaningful pain relief or a safe maximum dose. The 2015 diabetes paper reports four serious active-arm events but incompletely explains their number and causality. Do not convert event counts to participant rates. Rare harms, repeated courses, pregnancy, breastfeeding, children and safety with major organ disease remain poorly studied. Direct assembly of the proposed EPOR/CD131 receptor is disputed by biophysical work. The 2012 delayed-dose kidney paper was retracted in February 2026 and is excluded from positive efficacy claims. Nasal dosing, split dosing, microdosing and community dose increases have no verified controlled human protocols. Some reports do not state a route. No reliable community population prevalence was measured. Frequency labels describe this search; nMentions counts only explicitly counted reports. No community dose above 8 mg under the skin daily was verified. No above-studied schedule is inferred from vendor pages. No controlled combination trial was found. Three dental cases cannot show which component helped or establish routine combination safety. The dental route is intraoral submucosal and cannot be represented by the schema’s dosing-route enum. The exact mixture remains in the study record. A 503A Category 3 nomination is not authorization. A positive 503B listing, specific PCAC vote or cibinetide warning letter was not verified. EU orphan status is confirmed; UK, Canadian and Australian approval searches did not yield a product, but local legal classifications remain incompletely verified. Australian scheduling may involve broad erythropoietin entries; no named cibinetide entry was found. Import and possession rules vary. No online ARA-290 product-testing study or compound-specific poison-center series was found. General peptide warnings cannot supply its contamination rate. Unregulated vial storage, compatibility and mixed shelf life are unknown. Bacteriostatic water does not sterilize contaminated powder. Four early development programs are listed from a later protocol summary. They lack public arm-level data and are not added to the nine outcome datasets.
Related to ARA-290
- BPC-157: An experimental repair peptide with mostly animal evidence and a few small human reports.
- TB-500: A short piece of thymosin beta-4 with no proven repair benefit in humans.
- GHK-Cu: A copper-binding skin peptide with small topical studies and untested systemic injections.
- AHK-Cu: A copper peptide used in scalp serums, with laboratory findings and weak patent-only human data.
- Thymosin beta-4: A peptide studied for eye conditions and skin wounds; tendon-repair injections lack controlled human evidence.
- Ac-SDKP: An experimental repair peptide with old human studies, but no proven healing dose.
Sources
- Bulk Drug Substances Nominated for Use in Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act, FDA · FDA · 2026
- Bulk Drug Substances Used in Compounding, FDA · 2026
- Bulk Drug Substances Used in Compounding Under Section 503A of the FD&C Act, FDA · FDA · 2026
- Pyrogen and Endotoxins Testing: Questions and Answers, FDA · 2026
- Retraction Note: Delayed administration of pyroglutamate helix B surface peptide (pHBSP), a novel nonerythropoietic analog of erythropoietin, attenuates acute kidney injury., Patel NSA et al. · Molecular medicine (Cambridge, Mass.) · 2026
- Risks of buying peptide products online, Therapeutic Goods Administration · 2026
- The 2026 Prohibited List, World Anti-Doping Agency · WADA · 2026
- Therapeutic Goods (Poisons Standard—October 2026) Instrument 2026, Australian Government · Australian Government · 2026
- Think twice before injecting peptides bought online: unauthorized products can seriously harm you, Health Canada · Health Canada · 2026
- Supply unlicensed medicinal products (specials), MHRA · 2025
- ERS clinical practice guidelines on treatment of sarcoidosis., Baughman RP et al. · The European respiratory journal · 2021
- Health, Medical & Research Committee (HMRC) Meeting Minutes, World Anti-Doping Agency · 2017
- EU/3/13/1191 - orphan designation for treatment of sarcoidosis, European Medicines Agency · 2013
- Q6A Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances, FDA · FDA · 2000
- Case Report: Regenerative peptides for Inferior alveolar nerve injury: a narrative review with hypothesis-generating three clinical cases., Froum S et al. · Frontiers in oral health · 2026
Sources checked: 2026-10-18.
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