Ara-290 (16 mg Vial) Dosage Protocol

Plan based on an 8–16 week daily protocol with gradual titration (2 mg week 1, then 4 mg daily).

• Peptide Vials (Ara-290, 16 mg each):
  • 8 weeks: approximately 14 vials required
  • 12 weeks: approximately 21 vials required
  • 16 weeks: approximately 28 vials required
• Insulin Syringes (U-100):
  • Per week: 7 syringes (1/day)
  • 8 weeks: 56 syringes
  • 12 weeks: 84 syringes
  • 16 weeks: 112 syringes
• Bacteriostatic Water (10 mL bottles): Use 2.0 mL per vial for reconstitution.
  • 8 weeks (14 vials): 28 mL - 3 bottles required (10 mL each)
  • 12 weeks (21 vials): 42 mL - 5 bottles required (10 mL each)
  • 16 weeks (28 vials): 56 mL - 6 bottles required (10 mL each)
• Alcohol Swabs: One for the vial stopper + one for the injection site each day.
  • Per week: 14 swabs (2/day)
  • 8 weeks: 112 swabs - 2 boxes required (100 swabs each)
  • 12 weeks: 168 swabs - 2 boxes required (100 swabs each)
  • 16 weeks: 224 swabs - 3 boxes required (100 swabs each)

Ara-290 16 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 → 8 mg/mL concentration.
• Target dose: 4 mg once daily subcutaneously (after initial 2 mg titration).
• Easy measuring: At 8 mg/mL, 1 unit = 0.01 mL = 80 mcg on a U-100 insulin syringe.
• Storage: Lyophilized: refrigerate at 2–8 °C (35.6–46.4 °F) or freeze at −20 °C (−4 °F); reconstituted: refrigerate and follow a validated product-specific use-by period.

ARA-290, also called cibinetide, is an investigational 11-amino-acid peptide derived from erythropoietin. It was engineered to activate the innate repair receptor without the red-blood-cell-stimulating activity associated with erythropoietin.^[1][2] Human research has examined small-fiber neuropathy in type 2 diabetes and sarcoidosis, but ARA-290 is not FDA-approved and the evidence does not establish a general treatment recommendation.^[3][4][10]

This 16 mg protocol translates published ARA-290 research amounts into vial concentration, U-100 syringe volume, and supply calculations while keeping the evidence limits visible.

• Compound: ARA-290, also known as cibinetide, is an investigational erythropoietin-derived peptide.^[1]
• Evidence anchor: A phase 2 study evaluated 4 mg subcutaneously once daily for 28 days in participants with type 2 diabetes and painful neuropathy.^[3]
• 16 mg calculation: 2.0 mL yields 8 mg/mL; 4 mg equals 50 U-100 units, or 0.50 mL.
• Scope: The calculation does not validate the identity, purity, sterility, or equivalence of a commercial research vial.
• Status: ARA-290 is not FDA-approved. Human findings remain investigational and condition-specific.^[10]

Published studies used different routes, populations, and schedules. They should not be blended into one generalized 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 mg, 4 mg, or 8 mg subcutaneously for 28 consecutive days.^[6]
• Study design: The cited 4 mg daily phase 2 study used the same amount throughout its 28-day treatment period.^[3]

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]

The vial strength changes concentration, syringe markings, and whole-vial supply totals. It does not change what a clinical study administered. With 2.0 mL added to a 16 mg vial, the concentration is 8 mg/mL.

• 1 U-100 unit: 0.01 mL × 8 mg/mL = 0.08 mg, or 80 mcg.
• 2 mg calculation: 2 mg ÷ 8 mg/mL = 0.25 mL, or 25 units.
• 4 mg calculation: 4 mg ÷ 8 mg/mL = 0.50 mL, or 50 units.
• Whole-vial yield: A 16 mg vial contains four complete 4 mg amounts. That arithmetic does not establish a stability period or authorize any use beyond verified product instructions.

U-100 syringe units are volume markings. They are not peptide international units and should never be substituted for mass in milligrams or micrograms.

• Do not confuse a 16 mg vial strength with a 16 mg amount per administration.
• Recalculate units whenever vial mass or final liquid volume changes.
• Round supply quantities up to whole vials and whole packages. Never round the required mass down.
• Keep intravenous and subcutaneous research schedules separate. Route changes alter interpretation and cannot be made by unit conversion alone.
• Use a new sterile syringe for every administration and place used sharps in an approved sharps container.

ARA-290 is a small, 11-amino-acid peptide modeled on the three-dimensional structure of erythropoietin. It was designed to activate tissue-protective signaling without activating the classical erythropoietin pathway responsible for red blood cell production.^[1][2] The proposed target is the innate repair receptor, described as a receptor complex involving the erythropoietin receptor and the beta-common receptor CD131.^[8]

Preclinical work has examined anti-inflammatory signaling, neuropathic pain, and nerve-injury models. Human clinical trials then evaluated ARA-290 in small-fiber neuropathy associated with type 2 diabetes and sarcoidosis.^[3][4] Mechanistic plausibility and early clinical findings are not the same as proven clinical effectiveness. Longer and larger independent trials are needed.

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]}

The available human evidence is preliminary and population-specific.

• Type 2 diabetes with painful neuropathy: A 28-day phase 2 trial reported changes in neuropathic symptoms, metabolic measures, and corneal nerve fiber density after 4 mg subcutaneous ARA-290 daily.^[3]
• Sarcoidosis-associated small-fiber neuropathy: Small randomized studies reported changes in symptoms and corneal or cutaneous nerve-fiber measures.^[4][5]
• Hematologic design: ARA-290 was engineered to separate tissue-protective signaling from erythropoietin’s red-blood-cell-stimulating activity.^[1][2]
• Short-term tolerability: The cited trials did not identify a clear short-term safety signal at the studied schedules, but their sample sizes and durations cannot establish long-term safety.^[3][5]
• Clinical uncertainty: The ERS guideline found insufficient evidence to support a treatment recommendation for sarcoidosis-related small-fiber neuropathy.^[10]

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

ARA-290 has human research, but the evidence base is still limited. The published trials were small, short, and focused on specific neuropathy populations. The 2014 phase 2 study in type 2 diabetes reported changes in metabolic measures, neuropathic symptoms, and corneal nerve fiber density after 28 days, but the authors called for continued clinical evaluation.^[3]

In sarcoidosis, exploratory studies reported changes in symptoms and corneal nerve measures.^[4][5] Those findings do not prove that ARA-290 is effective for other causes of neuropathy, tissue injury, or pain. European Respiratory Society guidelines later concluded that evidence for treating sarcoidosis-related small-fiber neuropathy was insufficient to support a recommendation.^[10]

Clinical-trial material was manufactured and administered under controlled research conditions. A third-party 16 mg vial cannot be assumed to match those formulations in identity, purity, sterility, excipients, bioavailability, or stability.

The primary calculation on this page follows the subcutaneous route used in the cited phase 2 study. General technique references describe site selection and injection mechanics, but they do not validate ARA-290 or a specific research product.^[12][13]

• Use a new sterile syringe and needle for every administration.
• Clean the vial stopper and selected injection site with alcohol and allow both to dry.
• Use an appropriate subcutaneous site and rotate sites systematically.
• Keep the U-100 volume conversion separate from the clinical decision 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.

How many U-100 units equal 4 mg from this 16 mg vial?

With 2.0 mL added, the concentration is 8 mg/mL. Four milligrams requires 0.50 mL, which is 50 units on a U-100 syringe.

How many U-100 units equal 2 mg?

At 8 mg/mL, 2 mg requires 0.25 mL, or 25 U-100 units. This is a mathematical conversion, not a recommendation to administer 2 mg.

How many 4 mg amounts are in a 16 mg vial?

The vial contains four complete 4 mg amounts. That arithmetic does not establish how long the reconstituted vial remains usable.

Does a 16 mg vial change the amount used in the human studies?

No. Vial strength changes concentration and supply math. It does not change the study protocol. The main phase 2 study cited on this page evaluated 4 mg subcutaneously once daily for 28 days.^[3]

Is ARA-290 FDA-approved?

No. ARA-290, or cibinetide, remains investigational. Human trials do not constitute regulatory approval or a general treatment recommendation.

• 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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• 28
  30

  Pure Lab Peptides
  – Ara-290 (16 mg) product page (quality and batch documentation)

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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.