ARA-290 (10 mg Vial) Dosage Protocol

This worked quantity plan mirrors the 28-day, 4 mg once-daily subcutaneous schedule used in the cited phase 2 study. It is an arithmetic example, not a purchasing or treatment recommendation.^[3]

• Peptide Vials (ARA-290, 10 mg each):
  • 28 days at 4 mg/day = 112 mg total
  • 112 mg ÷ 10 mg/vial = 11.2, so the calculation requires 12 vials when rounded up to whole vials
• Insulin Syringes (U-100):
  • One new syringe per administration
  • 28 days: 28 syringes
• Bacteriostatic Water (10 mL bottles): Use 2.0 mL per vial for this calculation.
  • 12 vials × 2.0 mL = 24 mL total
  • Round up to 3 × 10 mL bottles
• Alcohol Swabs: One for the vial stopper and one for the administration site each day.
  • 28 days × 2 = 56 swabs
  • Round up to 1 × 100-count box

ARA-290 10 mg

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U-100 syringes

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Bacteriostatic water

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Alcohol swabs

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Practice preparing this vial with the verified strength and final volume from this protocol.

• Reconstitute: Add 2.0 mL bacteriostatic water for a 5 mg/mL concentration.
• Human study context: 4 mg once daily by subcutaneous administration for 28 days was evaluated in a phase 2 trial.^[3]
• U-100 conversion: At 5 mg/mL, 1 unit = 0.01 mL = 50 mcg; 4 mg equals 80 units (0.80 mL).
• Storage: Follow the exact product label and laboratory stability instructions. Do not infer a universal use-by period from vial strength alone.

ARA-290, also called cibinetide, is an investigational 11-amino-acid peptide derived from erythropoietin.^[1][2] Researchers have examined innate repair receptor signaling and small-fiber neuropathy outcomes in diabetes and sarcoidosis, but the evidence remains preliminary and condition-specific.^[3][4][10]

This 10 mg vial page keeps the clinical-study amount separate from the concentration and syringe-volume calculation.

• Compound: ARA-290, also called cibinetide, is an investigational erythropoietin-derived peptide.^[1][2]
• Study schedule: A phase 2 trial evaluated 4 mg subcutaneously once daily for 28 days in participants with type 2 diabetes and painful neuropathy.^[3]
• 10 mg calculation: Adding 2.0 mL produces 5 mg/mL; 4 mg equals 0.80 mL or 80 U-100 units.
• Route distinction: Other ARA-290 studies used different routes, populations, and amounts and should not be merged into one generalized schedule.^[5][6]
• Status: ARA-290 is not FDA-approved, and the available human evidence remains condition-specific.^[10]

Published human studies used distinct research designs rather than one universal ARA-290 regimen.

• Type 2 diabetes with painful neuropathy: 4 mg subcutaneously once daily for 28 days.^[3]
• Sarcoidosis pilot: 2 mg intravenously three times weekly for four weeks.^[5]
• Sarcoidosis dose-ranging study: 1, 4, and 8 mg subcutaneous arms administered for 28 consecutive days.^[6]
• Calculation scope: The primary table converts only the cited 4 mg subcutaneous study amount for this 10 mg vial.

The diabetes study record and published report document the 4 mg, 28-day schedule, while the sarcoidosis review, published outcomes, and European trial record describe separate condition-specific designs and endpoints.^{[7][11][18][19][20]}

Storage conditions and use-by periods depend on formulation, container, sterility controls, and validated product data.

• Follow the exact product label and supplier documentation for the unopened lyophilized vial.
• After reconstitution, refrigerate only when supported by the product’s validated instructions.
• Protect the vial from light and avoid repeated temperature cycling.
• Do not use a vial that is cloudy, discolored, damaged, or contains unexpected particles.

General references on lyophilized formulations and compounding explain why stability and beyond-use dating must be formulation-specific; neither source establishes a product-specific shelf life.^[21][22]

These checks keep the mass, concentration, route, and evidence source from being confused.

• A 10 mg vial contains 10 mg total; it does not define the amount used per administration.
• At 5 mg/mL, one U-100 unit represents 50 mcg. Recalculate whenever vial mass or final liquid volume changes.
• U-100 units are volume markings, not peptide international units.
• Intravenous and subcutaneous research schedules are not interchangeable through simple unit conversion.
• Short trials cannot establish long-term safety or general effectiveness.^[3][5]

ARA-290 is an 11-amino-acid peptide designed to study tissue-protective signaling without erythropoietin’s classical red-blood-cell response.^[1][2] Researchers propose activity at the innate repair receptor, a complex involving the erythropoietin receptor and the beta-common receptor CD131.^[8][16]

Preclinical research has examined inflammatory signaling, neuropathic pain, and TRPV1-related mechanisms, while early human studies have focused on small-fiber neuropathy in diabetes and sarcoidosis.^[3][4][9] These findings do not establish a general treatment recommendation.

Additional tissue-protection and neuropathy reviews discuss the injury-response context and innate repair receptor rationale, while a preclinical study examined TRPV1-related pain signaling.^{[9][16][17][24]}

Human findings are preliminary, short-term, and limited to specific research populations.

• Diabetic neuropathy research: A phase 2 study examined metabolic measures, neuropathic symptoms, and corneal nerve fiber density after 28 days.^[3]
• Sarcoidosis-associated neuropathy: Small studies reported changes in symptoms and corneal or cutaneous nerve-fiber measures.^[4][5][6]
• Non-erythropoietic design: ARA-290 was engineered to separate tissue-protective signaling from erythropoietin’s red-blood-cell-stimulating activity.^[1][2]
• Tolerability limits: The cited studies were too small and short to establish long-term safety.
• Guideline uncertainty: The European Respiratory Society found insufficient evidence to recommend ARA-290 for sarcoidosis-related small-fiber neuropathy.^[10]

Corneal nerve-fiber outcomes were also reported in ophthalmic research involving sarcoidosis-associated small-fiber neuropathy.^[25]

Results should be interpreted within the population, route, duration, formulation, and outcome measures used in each study.

• Diabetic and sarcoidosis-associated neuropathy studies addressed different participant groups.
• Subcutaneous and intravenous schedules cannot be treated as equivalent.
• Clinical-trial material was manufactured and administered under controlled research conditions.
• A third-party research vial cannot be assumed to match a clinical formulation in identity, purity, sterility, excipients, bioavailability, or stability.

The primary calculation represents subcutaneous administration under the conditions of the cited phase 2 study. General injection literature describes technique and absorption considerations but does not validate a specific research product.^{[12][13][14][15]}

• Use a new sterile syringe and needle for every administration.
• Clean the vial stopper and selected site with alcohol and allow both to dry.
• Use an appropriate subcutaneous site and rotate sites systematically.
• Keep syringe-volume calculations separate from decisions about route, amount, and schedule.
• Place used needles immediately in an approved sharps container.

General subcutaneous-delivery reviews and patient guidance from Cleveland Clinic and Johns Hopkins, together with CDC route guidance, describe technique considerations; these sources do not validate ARA-290 or a specific research product.^{[14][15][23][26][27]}

ARA-290 is investigational and is not FDA-approved. This page is for research education and transparent calculation only. It does not provide medical advice, diagnosis, treatment, or a direction for human use.

• 1
  1

  IUPHAR/BPS Guide to Pharmacology: Cibinetide (ARA-290) ligand profile, structure, and pharmacology

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• 2
  2

  Hand and Brines, Journal of Investigative Medicine (2011): Promises and pitfalls in erythropoietin-mediated tissue protection

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• 3
  3

  Brines et al., Molecular Medicine (2015): Phase 2 study of 4 mg subcutaneous ARA-290 daily for 28 days in type 2 diabetes with painful neuropathy

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• 4
  4

  Dahan et al., Molecular Medicine (2013): Symptoms and corneal nerve fiber density in sarcoidosis-associated small nerve fiber loss

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• 5
  5

  Heij et al., Molecular Medicine (2012): Randomized pilot using 2 mg intravenous ARA-290 three times weekly for four weeks in sarcoidosis

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• 6
  6

  ClinicalTrials.gov NCT02039687: Sarcoidosis dose-ranging study with 1 mg, 4 mg, and 8 mg subcutaneous arms for 28 days

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• 7
  7

  van Velzen et al., Expert Opinion on Investigational Drugs (2014): Review of ARA-290 research in sarcoidosis-related small-fiber neuropathy

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• 8
  8

  Davis et al., Pain Reports (2017): Review of innate repair receptor targeting for neuropathy

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• 9
  9

  Zhang et al., Peptides (2016): Preclinical study of ARA-290 and TRPV1-related pain signaling

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• 10
  10

  European Respiratory Society Clinical Practice Guideline (2021): Insufficient evidence to support a recommendation for sarcoidosis-related small-fiber neuropathy

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• 11
  11

  ClinicalTrials.gov NCT01933529: Study record for 4 mg ARA-290 daily for 28 days in impaired glucose tolerance or type 2 diabetes

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• 12
  12

  Annersten and Willman, Worldviews on Evidence-Based Nursing (2005): Literature review of the evidence base for subcutaneous injection technique

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• 13
  13

  McLennan et al., Drug Discovery Today: Technologies (2005): Review of subcutaneous drug delivery and lymphatic absorption

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• 14
  14

  Usach et al., Advanced Drug Delivery Reviews (2019): Pharmacologic considerations for subcutaneous drug delivery

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• 15
  15

  Bittner et al., BioDrugs (2018): Review of the challenges and opportunities in subcutaneous administration of biotherapeutics

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• 16
  16

  Collino et al., Pharmacology & Therapeutics (2015): Review of ARA-290 pharmacology and innate repair receptor signaling

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• 17
  17

  Journal of Internal Medicine (2008)
  – Brines & Cerami: Erythropoietin-mediated tissue protection: reducing collateral damage from the primary injury response

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• 18
  18

  Molecular Medicine (2014)
  – Brines M. et al.: ARA 290 improves metabolic control and neuropathic symptoms in patients with type 2 diabetes

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• 19
  19

  Molecular Medicine (2013)
  – Dahan A. et al.: ARA 290 improves symptoms in sarcoidosis-associated small nerve fiber loss and increases corneal nerve fiber density

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• 20
  20

  EU Clinical Trials Register, EudraCT 2013-003016-45 Posted results for 1 mg, 4 mg, and 8 mg ARA-290 subcutaneous arms administered for 28 consecutive days.

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• 21
  21

  NCBI Bookshelf
  – Stability and storage considerations for lyophilized peptide formulations

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• 22
  22

  USP General Chapters
  – Pharmaceutical compounding with bacteriostatic water: stability and beyond-use dating

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• 23
  23

  Cleveland Clinic
  – Subcutaneous injections: where and how to administer at home

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• 24
  24

  Pain Reports (2017)
  – Davis T. et al.: Targeting the innate repair receptor to treat neuropathy (review of ARA-290 mechanisms)

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• 25
  25

  Investigative Ophthalmology & Visual Science (2016)
  – Cibinetide improves corneal nerve fiber abundance in patients with sarcoidosis-associated small fiber neuropathy

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• 26
  26

  Johns Hopkins Arthritis Center
  – How to give a subcutaneous injection: patient guide

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• 27
  27

  CDC
  – Vaccine administration: subcutaneous route (angle, site, and technique guidance)

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Use the research overview for the evidence summary and the strength-variant page for its own concentration and syringe-unit calculations. Vial strengths are not interchangeable without recalculation.