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ARA-290 (cibinetide) regulatory status

Current status of ARA-290 (cibinetide) in the United States: Not eligible for compounding. In sport: WADA prohibited. Details, sources, and the dated timeline follow.

By the PeptideAgent Editorial Team. Draft, pending editorial review.  Last verified

What is the current status of ARA-290 (cibinetide)?

Regulatory: Not eligible for compoundingWADA: WADA prohibitedVerified: Verified Sep 22, 2026
FDA and compounding
Investigational drug that has completed phase 2 trials but is not approved by FDA or any other regulator as of the last verification date. Because cibinetide is not a component of an approved drug, has no USP monograph, and is not on the 503A bulks list, it cannot lawfully be compounded by 503A pharmacies or 503B outsourcing facilities. Products sold online as ARA-290 are unapproved drugs not lawful for human use.
WADA
WADA prohibited
Access path
  1. No lawful United States access path identified on the last verified date outside a registered clinical trial.
  2. Not available as an FDA approved product and not eligible for compounding under section 503A or 503B.
  3. Products labeled research use only are not lawful for human use and are not verified for identity or purity.

Full ARA-290 (cibinetide) page: evidence, dosing in the literature, and sources

How has the status of ARA-290 (cibinetide) changed over time?

No dated regulatory event has been recorded for ARA-290 (cibinetide). That usually means no FDA, PCAC, Federal Register, or WADA action has named it specifically. Category-wide actions are listed on the tracker hub.

Sources

Numbered citations in the answers above point here, followed by the regulatory sources on record for ARA-290 (cibinetide) and the source of each dated event.

  1. [1]FDA: Bulk drug substances used in compounding under section 503A of the FD&C Act (links to the Category 1, 2, and 3 lists and the bulks list)FDA, 2026
  2. [2]WADA Prohibited List, sections S0 non-approved substances and S2 peptide hormonesWADA, 2026