ARA-290: where it stands with the FDA, and what it costs
No FDA-approved drug contains it, and the FDA lists it among substances nominated without enough information to evaluate.
Go to clinicLowest per monthARA-290 injection
Pepti · $219/mo (≈ $235 per 30 days with its fees)
Where ARA-290 stands today
No FDA-approved drug contains ARA-290 (cibinetide). FDA lists cibinetide (ARA-290) in 503A Category 3, substances nominated without enough supporting information for FDA to evaluate them; FDA says they are not eligible for the policy it applies to Category 1 and that it would consider taking action against a compounder using them. It is not on the 503A bulks list, has had no advisory committee review, is not in HHS's October 2026 interim policy, and is not on the 503B bulks list or in any 503B category.
For pharmacies compounding one patient's prescription (section 503A)
Category 3 (Bulk Drug Substances Nominated Without Adequate Support): nominated with too little information for FDA to evaluate it, and not eligible for FDA's Category 1 policy. Not on the 503A bulks list; no FDA-approved drug contains it; not in HHS's Oct 2026 interim policy.
“503A Category 3: Bulk Drug Substances Nominated Without Adequate Support ... Cibinetide (ARA-290)”
What Category 3 means (FDA 503A page)
“Category 3 – These substances may be eligible for inclusion on the 503A bulks list but were nominated with insufficient supporting information for FDA to evaluate them. ... These substances are not eligible for the policy that applies to substances in category 1. FDA would consider taking action against a compounder for compounding drug products with this bulk drug substance under its general enforcement policies.”
HHS's list of six does not include cibinetide (ARA-290)
“Appendix A. List of Peptide Bulk Drug Substances Addressed by HHS Interim Enforcement Policy Regarding 503A Compounding 1. BPC-157 2. Epitalon 3. KPV 4. MOTS-c 5. Semax 6. TB-500”
21 CFR 216.23(a), the 503A bulks list itself: six substances (Brilliant Blue G, cantharidin, diphenylcyclopropenone, N-acetyl-D-glucosamine, squaric acid dibutyl ester, thymol iodide); none of the compounds in this file
“The following bulk drug substances can be used in compounding under section 503A(b)(1)(A)(i)(III) of the Federal Food, Drug, and Cosmetic Act.”
For outsourcing facilities (section 503B)
Not on the 503B bulks list and not in any 503B category (FDA's 503B nominations list, updated March 21, 2025, does not name it)
“Outsourcing facilities, which operate under section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act), may not compound a drug product that includes a bulk drug substance unless: The bulk drug substance appears on a list identifying bulk drug substances for which there is a clinical need (the 503B bulks list), or”
The 503B bulks list holds five substances (diphenylcyclopropenone, glycolic acid, quinacrine HCl oral, squaric acid dibutyl ester, trichloroacetic acid); none of the compounds in this file
“FDA has evaluated the following bulk drug substances and determined that there is a clinical need for outsourcing facilities to compound drug products using these bulk drug substances under section 503B of the FD&C Act:”
Our reading
There is no current route to lawful 503A or 503B compounding of ARA-290: Category 3 gives no enforcement discretion, and nothing else (a monograph, an approved drug, the bulks list) covers it. That changes only if it is nominated again with enough support and FDA lists it.
Every source above was checked again on 14 November 2026.
What 4 clinics charge
- PeptiARA-290 injection$219/mo≈ $235 per 30 days with its fees
- Better Med SpaARA-290 injection$420/mo
- TransformYouARA-290 (100mg)≈ $639/mo$895 for 42 days
What ARA-290 is
- What it is
- Synthetic peptide (11 amino acids, from erythropoietin)
- How it works
- An 11-amino-acid peptide modelled on a part of erythropoietin (EPO) that acts on its tissue-protective receptor without raising red blood cell counts; studied mainly for nerve damage and pain.
- How it is given
- Subcutaneous injection
- Also called
- cibinetide, ARA 290
About ARA-290
Is ARA-290 FDA-approved?
No. No FDA-approved drug contains ARA-290. What clinics sell is compounded by a pharmacy for a prescription, and the FDA does not review compounded products before they are sold.
Is ARA-290 legal in the US?
Whether a pharmacy may compound it for your prescription is what decides it. No FDA-approved drug contains ARA-290 (cibinetide). FDA lists cibinetide (ARA-290) in 503A Category 3, substances nominated without enough supporting information for FDA to evaluate them; FDA says they are not eligible for the policy it applies to Category 1 and that it would consider taking action against a compounder using them. It is not on the 503A bulks list, has had no advisory committee review, is not in HHS's October 2026 interim policy, and is not on the 503B bulks list or in any 503B category.
How much does ARA-290 cost?
4 clinics publish a price. The lowest that compares per month is $219/mo at Pepti, and the middle of 3 clinics' lowest monthly prices is about $420. What a month buys differs by clinic, so each price lists what it includes. every ARA-290 price
What forms does ARA-290 come in?
Clinics sell it as injection (3 prices), other (1 price).