ARA-290 Dosage: Trial Doses, Common Protocol and Calculator
ARA-290/cibinetide has no FDA-approved product or established dose. Here is exactly what its four published human trials used - dose, route, frequency, duration.
The short version
ARA-290 (cibinetide) has no FDA-approved product and no dose set by any regulator. A compounding pharmacy protocol titrates 2 mg toward 4 mg twice weekly, while the published phase 2b trial dosed 1, 4 or 8 mg once daily. Together that spans 1-8 mg, twice weekly to once daily, over 4-6 weeks: common practice, not a trial-established protocol. Unusually for a research peptide, ARA-290 has four published human trials, all run by its developer, Araim Pharmaceuticals. This page states what each trial used. None of it is an approved protocol.
- Common practice is 1-8 mg subcutaneous, twice weekly to once daily, over 4-6 weeks. No trial set it as one protocol, and sources disagree on frequency.
- Four published human trials exist, and all four came from the same sponsor.
- Trial doses ran from 1 to 8 mg per day, by intravenous or subcutaneous injection, for 4 weeks per trial.
- None of the trials led to FDA approval in any tested condition, so no dose from them is an approved one.
No FDA-approved ARA-290 (cibinetide) product exists, and no regulator has approved a dose. Unusually for a research peptide, it does have four published human trials, all sponsored by its developer, Araim Pharmaceuticals. This page gives the protocol vendor guides commonly describe, then exactly what each trial used. For the full regulatory record and the evidence, see the main ARA-290 guide.
US legal status - Research use only
ARA-290/cibinetide is not FDA-approved for any indication. Four FDA orphan drug designations exist and none has converted to approval. No FDA-reviewed dose, label or contraindication list exists.
ARA-290 dosage: the common protocol
A licensed compounding pharmacy protocol titrates 2 mg toward 4 mg subcutaneous, twice weekly. The published phase 2b trial instead dosed 1, 4 or 8 mg once daily. Together that spans 1-8 mg, twice weekly to once daily, over a 4-6 week course. This is common practice, not a dose any trial or regulator has established, and the sources disagree on frequency.
Common protocol
What is commonly used, not a dose established in trials. No regulator has set a dose for ARA-290 (Cibinetide). Sources differ, so the ranges below span them.
- Dose per administration
- 1-8 mg
- How often
- twice weekly to once daily, subcutaneous - a compounding pharmacy protocol titrates 2 mg toward 4 mg twice weekly, while the published phase 2b trial dosed 1, 4 or 8 mg once daily
- Route
- Subcutaneous injection
- Cycle length
- 4-6 weeks
- Common vial size
- 10 mg
- Timing
- Subcutaneous injection; sites rotated between abdomen, thigh and upper arm using insulin syringes, per the compounding pharmacy's protocol.
Upgraded 2026-09-27: replaced two vendor/aggregator dosing pages with a published, peer-reviewed phase 2b trial and a licensed 503A compounding pharmacy's protocol page. The trial (Culver et al., IOVS) randomized sarcoid small-nerve-fiber-loss patients to 1, 4 or 8 mg cibinetide SC once daily for 28 days, with 4 mg showing the most significant corneal nerve fiber gain; the compounding pharmacy instead uses 2 mg SC twice weekly, escalating to 4 mg twice weekly, over 4-6 weeks before reassessment. Dose and frequency ranges span both. Neither source states a break/washout period or a peptide pairing, so those are left blank rather than carried over from the dropped sources.
Plan a cycle in the protocol builder or work out injection volume in the dosage calculator.
The common ARA-290 (Cibinetide) dose is 1-8 mg, twice weekly to once daily, subcutaneous - a compounding pharmacy protocol titrates 2 mg toward 4 mg twice weekly, while the published phase 2b trial dosed 1, 4 or 8 mg once daily. From a 10 mg vial mixed with 1 mL of bacteriostatic water, 4.5 mg is 45 units (0.45 mL) on a U-100 insulin syringe.
ARA-290 (Cibinetide) 10 mg vial: units per dose
Full 10 mg vial page: mixing, doses per vial, how long it lasts →
| Water added | Concentration | 1 unit = | 1 mg | 4.5 mg | 8 mg |
|---|---|---|---|---|---|
| 1 mL | 10 mg/mL | 100 mcg | 10 units | 45 units | 80 units |
| 2 mL | 5 mg/mL | 50 mcg | 20 units | 90 units | over 100 units |
| 3 mL | 3.33 mg/mL | 33.33 mcg | 30 units | over 100 units | over 100 units |
ARA-290 (Cibinetide) 16 mg vial: units per dose
Full 16 mg vial page: mixing, doses per vial, how long it lasts →
| Water added | Concentration | 1 unit = | 1 mg | 4.5 mg | 8 mg |
|---|---|---|---|---|---|
| 1 mL | 16 mg/mL | 160 mcg | 6.5 units | 28 units | 50 units |
| 2 mL | 8 mg/mL | 80 mcg | 12.5 units | 56.5 units | 100 units |
| 3 mL | 5.33 mg/mL | 53.33 mcg | 19 units | 84.5 units | over 100 units |
All ARA-290 (Cibinetide) vial sizes: 10 mg · 16 mg
Units are on a standard U-100 insulin syringe (100 units = 1 mL), rounded to the nearest half unit - half-unit marks are on 0.3 mL syringes. Water volumes are examples: more water means more units per dose, not more doses per vial. For any other vial or dose, use the calculator below.
How many 10 mg vials a cycle takes
| Scenario | Dose | Doses a week | Weeks | Total | 10 mg vials |
|---|---|---|---|---|---|
| Low end of the common protocol | 1 mg | 2 | 4 | 8 mg | 1 |
| High end of the common protocol | 8 mg | 7 | 6 | 336 mg | 34 |
Whole vials, rounded up. Plan a cycle with your own numbers in the protocol builder. Keep mixed vials cold and use them within the window in how long reconstituted peptides last; where to inject: subcutaneous injection sites.
ARA-290 doses used in human studies
All four trials trace to the same sponsor and the same small-nerve-fiber-loss research programme. None led to an FDA-approved product in any tested condition. The table shows what was studied, not a protocol to copy.
What is not established
- No FDA-approved dose exists. Every dose above comes from a sponsor-run trial in a specific studied condition, and none reached approval.
- No trial tested dosing beyond 28 days of active treatment. Long-term or indefinite dosing has no published human data.
- No human half-life is established in a source this page could verify, so no dosing interval can be derived from pharmacokinetics.
- The common protocol above is current vendor practice, not a trial finding. Each source is recorded, but no trial or regulator has established that dose.
How to reconstitute ARA-290
The injection volume for a target milligram amount depends on a specific vial’s concentration and diluent, which this page cannot know. That arithmetic does not make an unapproved dose an approved one. The dosage calculator handles concentration and draw-volume math. It does not supply or endorse a dose.
Who should not use it
No FDA-reviewed contraindication list exists, because ARA-290/cibinetide has never been approved. The published trials excluded people by their own study criteria. This page has no verified, generalizable list of who should avoid it, including pregnancy, breastfeeding, children or specific drug interactions. A compound with no approved label is not something to self-direct dosing around, however many trials exist.
ARA-290 side effects and risks
The published trials reported no major safety findings in their own assessments, but none is an independent FDA safety review. ARA-290/cibinetide has also never been nominated to FDA’s bulk drug substances compounding safety-risk list, so no regulator-published safety evaluation exists in either direction. Material sold as a research chemical outside these trials carries no independently verified purity, identity or concentration.
Related
ARA-290 (Cibinetide) dosage calculator
Preset to a 10 mg vial and 1,000 mcg, the low end of the common protocol. Enter your own vial size, water and dose to get the syringe units to draw.
Your vial
Printed on the vial. There is no standard size - enter what yours says.
This changes how much you draw - never how many doses the vial holds.
100 units per mL. 1 unit = 0.01 mL. This is what almost every insulin syringe sold is, in every barrel size.
Capacity only. A 1 mL U-100 syringe holds 100 units - the scale decides that, not the barrel.
Draw this much
= 0.2 mL on a 1 mL U-100 syringe
- Concentration
- 5,000 mcg/mL
- Exact volume
- 0.2 mL
- Dose you actually get
- 1,000 mcg
- Doses per vial(unaffected by water volume)
- 10
Where to buy ARA-290 (Cibinetide) for research
Each vendor is checked against my vendor checklist.
1.Next Level PharmFeatured
10 mg vial
- No FDA warning letter found
- Names its testing lab
- Batch COAs published
- Takes card payment
2.BioEdge Research Labs
16 mg vial
- No FDA warning letter found
- Names its testing lab
- Batch COAs published
Common questions
What is the usual ARA-290 dose?
A compounding pharmacy protocol titrates 2 mg toward 4 mg subcutaneous, twice weekly. The published phase 2b trial instead dosed 1, 4 or 8 mg once daily. Together that spans 1-8 mg, twice weekly to once daily, over a 4-6 week course. This is common practice reported by those sources, not a dose set by any trial or regulator, and the two disagree on frequency. See the questions below for the four published human trials.
What is the correct dose of ARA-290?
None is established. No FDA-approved ARA-290/cibinetide product exists, so no regulator has reviewed or approved a dose. Four published human trials tested specific doses for specific research questions, all from the same developer, and none led to approval. This page reports what those trials used. It is not a recommended protocol.
What doses of ARA-290 have been tested in humans?
Four published trials, all sponsored by Araim Pharmaceuticals, tested 2 mg intravenously three times weekly and 4 mg subcutaneously once daily. They also ran a dose-ranging comparison of 1, 4 or 8 mg per day. Each ran 4 weeks (28 days). One trial gave daily subcutaneous ARA-290 for 28 days without stating the milligram amount in its published abstract.
How often and for how long was ARA-290 dosed in these trials?
Every trial on record used either three-times-weekly intravenous dosing or once-daily subcutaneous dosing, for 4 weeks (28 days). One trial followed subjects for another 30 days after treatment stopped. No trial tested more than 28 days of active treatment.
Did any ARA-290 trial compare different doses?
Yes. A phase 2b trial randomized 64 subjects with sarcoidosis-associated small nerve fiber loss to 1, 4, or 8 mg per day for 28 days against placebo. The 4 mg arm showed the clearest change in the primary corneal-nerve-fiber measurement. That is a finding from one trial, not a recommended dose.
How do I work out reconstitution and injection volume?
That is arithmetic about a specific vial and diluent. It does not make any consumer dose of ARA-290 FDA-approved or clinically established. The dosage calculator handles concentration and draw-volume math for whatever amount is being discussed. It does not supply or endorse a dose.
Who should not use ARA-290, and what are the risks?
No FDA-reviewed contraindication list or safety label exists for ARA-290/cibinetide, because it has never been approved. The published trials reported no safety concerns in their own assessments. ARA-290 has never been evaluated on FDA's bulk drug substances compounding safety-risk list, so no independent regulatory safety review exists in either direction.
References (4 sources)
Bibliographic detail is fetched from PubMed, not written by me - so a citation here cannot drift from the paper it names. Study design comes from PubMed's own tags rather than my judgement.
- 1.Heij L, Niesters M, Swartjes M et al. Safety and efficacy of ARA 290 in sarcoidosis patients with symptoms of small fiber neuropathy: a randomized, double-blind pilot study. Mol Med. 2012;18(1):1430-6.Randomised trialPMID 23168581full text
- 2.Dahan A, Dunne A, Swartjes M et al. ARA 290 improves symptoms in patients with sarcoidosis-associated small nerve fiber loss and increases corneal nerve fiber density. Mol Med. 2013;19(1):334-45.Randomised trialPMID 24136731full text
- 3.Brines M, Dunne AN, van Velzen M et al. ARA 290, a nonerythropoietic peptide engineered from erythropoietin, improves metabolic control and neuropathic symptoms in patients with type 2 diabetes. Mol Med. 2015;20(1):658-66.Clinical trialPMID 25387363full text
- 4.Culver DA, Dahan A, Bajorunas D et al. Cibinetide Improves Corneal Nerve Fiber Abundance in Patients With Sarcoidosis-Associated Small Nerve Fiber Loss and Neuropathic Pain. Invest Ophthalmol Vis Sci. 2017;58(6):BIO52-BIO60.Randomised trialPMID 28475703