4 weeks
Sarcoidosis pilot treatment period.
Protocol / Research Dosing Guide
ARA-290 (Cibinetide) Dosage Guide: Trials, Reconstitution and Safety
An evidence-organized ARA-290 reference separating published Phase 2 trial designs from unvalidated community protocols and vial calculations.
Last reviewed September 15, 202620 minute readResearch information only
Level 4 — Early human trialsPhase 2 researchNot FDA approved
ARA-290 Quick Start
ARA-290, also called cibinetide, is an erythropoietin-derived peptide designed to activate the innate repair receptor without stimulating red-blood-cell production. Small Phase 2 studies examined neuropathy and retinal conditions.
Why researchers care
Innate repair receptor and small-fiber neuropathy research
Class
Synthetic erythropoietin-derived 11-amino-acid peptide
Route reported
Subcutaneous and intravenous in human trials
Cycle length
4 days to 12 weeks in distinct trials; repeat cycles not established
Regulatory status
Not FDA approved
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ARA-290 Dosing Protocol and Schedule
Published studies used defined trial regimens, including 2 mg IV three times weekly for four weeks and 1, 4, or 8 mg SC daily for 28 days. These parameters describe studies, not general protocols.
| Phase or study | Amount | Frequency / evidence |
|---|---|---|
| Pilot study | 2 mg intravenous | Three times weekly for 4 weeks |
| Phase 2b | 1 mg subcutaneous | Daily for 28 days |
| Phase 2b | 4 mg subcutaneous | Daily for 28 days |
| Phase 2b | 8 mg subcutaneous | Daily for 28 days |
| Macular edema pilot | 4 mg subcutaneous | Daily for 12 weeks |
Patient population, route, endpoints, and study supervision are integral to each record. The figures are not interchangeable or recommendations.
ARA-290 Supplies Needed
Neutral research-material planning only. This does not establish an appropriate amount or route.
Research planning item
Exact labeled research vial
Research planning item
Measured diluent volume
Research planning item
U-100 measurement reference
Research planning item
Alcohol swabs
Research planning item
Appropriate sharps container
Research planning item
Written concentration label
ARA-290 Reconstitution Calculator
Vial-format concentration math
Concentration
5 mg/mL
Draw volume
0.8 mL
U-100 units
80
Mathematical draws
2
Arithmetic only. The entered amount is not a recommendation and does not establish suitability.
Best Time to Take ARA-290: Morning or Night?
Morning or evening?
No trial established a superior time of day.
Daily frequency
Daily SC administration appeared in specific Phase 2 protocols; it is not universal guidance.
With food?
Not applicable to the studied SC and IV routes.
Missed amount?
No general missed-amount procedure is established outside a study protocol.
ARA-290 Route Comparison
| Route | Published context | Evidence limit |
|---|---|---|
| Intravenous | 2 mg three times weekly in a small sarcoidosis pilot | Population-specific study design |
| Subcutaneous | 1, 4, or 8 mg daily in a 28-day Phase 2b trial | Not an approved regimen |
| Subcutaneous | 4 mg daily for 12 weeks in a nine-person macular edema study | Very small exploratory study |
| Oral or nasal | Not established | No verified human exposure study |
Routes and amounts are not interchangeable unless a verified study explicitly establishes a conversion.
ARA-290 Half-Life and Dosing Frequency
| Measure | Finding | Evidence limit |
|---|---|---|
| Human plasma half-life | Not established in the primary sources reviewed | Do not infer frequency |
| Daily SC frequency | Used in defined Phase 2 studies | Trial design, not general dosing |
| IV frequency | Three times weekly in one pilot | Population-specific |
| Repeat-cycle interval | Not established | No validated restart criteria |
ARA-290 Dosage Chart
| Route | Amount | Frequency | Source | Human validation |
|---|---|---|---|---|
| Intravenous | 2 mg | Three times weekly for 4 weeks | Human pilot | Study design |
| Subcutaneous | 1 mg | Daily for 28 days | Human Phase 2b | Study design |
| Subcutaneous | 4 mg | Daily for 28 days | Human Phase 2b | Study design |
| Subcutaneous | 8 mg | Daily for 28 days | Human Phase 2b | Study design |
| Subcutaneous | 4 mg | Daily for 12 weeks | Human pilot | Study design |
Published study values describe those studies. Community-reported values are not validated dosing recommendations.
ARA-290 Reconstitution Guide
Concentration: 5 mg/mL
| Entered amount | Volume | U-100 units |
|---|---|---|
| 4 mg | 0.8 mL | 80 units |
| 8 mg | 1.6 mL | 160 units |
| 10 mg | 2 mL | 200 units |
- 1.Confirm the exact vial quantity.
- 2.Choose and record the measured diluent volume.
- 3.Clean the vial stopper.
- 4.Add liquid slowly along the wall.
- 5.Swirl gently; do not shake.
- 6.Inspect the prepared solution.
- 7.Label the concentration and date.
- 8.Keep arithmetic separate from trial eligibility or appropriateness.
Reconstitution does not establish identity, purity, sterility, stability, or an appropriate amount.
How ARA-290 Works
Erythropoietin-derived sequence
ARA-290 reproduces the helix-B surface involved in tissue-protective signaling.
ARA-290 Human Trials and FDA Status
Current status · verified September 15, 2026
Not FDA approved
- A 22-person sarcoidosis pilot used 2 mg IV three times weekly for four weeks.
- A 64-person Phase 2b sarcoidosis study tested 1, 4, and 8 mg SC daily for 28 days and reported a corneal-nerve endpoint.
- A nine-person diabetic macular edema study used 4 mg SC daily for 12 weeks.
- Development has not produced an FDA-approved indication or Phase 3 confirmation.
- Long-term safety beyond the short studies remains unestablished.
Who Should Avoid ARA-290?
This is an evidence-gap and precaution list, not an approved prescribing label.
Pregnancy or breastfeeding
No established safety
Children or adolescents
No established pediatric protocol
Known peptide or excipient sensitivity
Potential allergic risk
Complex hematologic conditions
Requires specialist review despite non-erythropoietic design
Concurrent investigational therapy
Interactions are not established
Long-term use
Safety beyond short trials is unknown
ARA-290 Side Effects, Risks and Safety
Injection-site reactionsHuman trial reported
Important limitation: Generally mild in small studies.
Serious adverse eventsLimited evidence
Important limitation: Small studies cannot exclude uncommon risks.
Hematocrit increaseNot observed as a consistent effect
Important limitation: Designed to avoid erythropoiesis.
Anti-drug antibodiesNot fully verified
Important limitation: Do not claim absence without full source confirmation.
Drug interactionsUnknown
Important limitation: No adequate interaction studies.
Long-term safetyUnknown
Important limitation: Trials were short and enrollment limited.
ARA-290 Timeline and Monitoring
28 days
Phase 2b sarcoidosis treatment period with nerve-fiber assessment.
12 weeks
Small diabetic macular edema study period.
Monitoring
Study endpoints included symptoms, corneal confocal microscopy, ophthalmic measures, adverse events, and hematologic observations; no universal monitoring protocol exists.
ARA-290 Benefits and Results: What the Evidence Shows
| Claim | Evidence level | What research shows | Important limitation |
|---|---|---|---|
| Neuropathic symptoms | Early human research | Small sarcoidosis studies reported signals | Needs larger confirmation |
| Corneal nerve fibers | Phase 2 human research | Phase 2b reported a regeneration endpoint | Population-specific |
| Diabetic macular edema | Exploratory human research | Nine-person study | Too small for established efficacy |
| Anti-aging or bodybuilding | Not established | Not tested as a validated benefit | Unsupported claim |
ARA-290 Storage and Handling
Unreconstituted vial
No independently verified ARA-290 commercial-vial stability duration was identified.
Prepared vial
The supplied source's refrigeration duration is generic handling guidance, not a verified compound-specific stability study.
Trial material
Clinical-trial handling cannot be assumed for every current product.
Appearance
Cloudiness, discoloration, or particles require qualified product review.
ARA-290 Troubleshooting
Solution looks abnormal
Do not assume it is usable; seek qualified product guidance.
Calculated volume is too large
Recheck vial quantity, water volume, target amount, and units.
A trial amount is treated as a recommendation
Return to the original population and study context; it is not general guidance.
Expected effects do not occur
Early trial signals do not guarantee individual outcomes.
A scheduled amount is missed
No universal missed-amount procedure exists outside a trial.
ARA-290 Comparisons
| Compound | Class or mechanism | Evidence | FDA status |
|---|---|---|---|
| ARA-290 | Innate repair receptor peptide | Phase 2 human research | Not approved |
| BPC-157 | Proposed repair peptide | Primarily preclinical evidence | Not approved |
| TB-500 | Thymosin-related research product | Primarily preclinical/indirect evidence | Not approved |
| KPV | Alpha-MSH fragment | Primarily laboratory/preclinical evidence | Not approved |
ARA-290 Frequently Asked Questions
What is ARA-290?
An 11-amino-acid erythropoietin-derived peptide also called cibinetide.
Is it FDA approved?
No.
Does it have human research?
Yes, small Phase 2 and exploratory studies in specific patient populations.
What amounts were studied?
Published designs included 2 mg IV and 1, 4, or 8 mg SC in different studies.
Are these recommended doses?
No. They are study parameters.
What is its half-life?
Not established from the primary sources reviewed.
Is a repeat cycle established?
No.
Does it raise hematocrit?
It was designed to avoid erythropoietic signaling, and trials did not show a consistent rise; evidence remains limited.
Are anti-aging benefits established?
No.
What does the calculator do?
It performs concentration and volume arithmetic only.
Sources and Research
Coverage source
1. ARA-290 protocol coverage source
Information categories and community context; not the primary authority.
Open direct sourceHuman research
2. ARA 290 improves symptoms in patients with sarcoidosis-associated small nerve fiber loss
Small human pilot using IV administration.
Open direct sourceHuman research
3. Cibinetide improves corneal nerve fiber abundance in sarcoidosis-associated small nerve fiber loss
Randomized Phase 2b study with daily SC groups over 28 days.
Open direct sourceHuman research
4. Cibinetide in diabetic macular edema
Small 12-week exploratory human study.
Open direct sourceRegulatory database
5. NCATS drug record for cibinetide
Investigational identity and development context.
Open direct sourceMissing information flagged for review
- Verified human half-life: Not established
- Approved indication: Not established
- Phase 3 confirmation: Not established
- Repeat-cycle and rest-period criteria: Not established
- Compound-specific commercial-vial stability: Not established
- Long-term safety: Not established
- Comprehensive interaction data: Not established