What is Cibinetide (ARA-290)?

The short answer

Cibinetide, or ARA-290, is a lab-made peptide based on part of the body's red blood cell hormone.

Get updates on Cibinetide (ARA-290)

What it is

Type
EPO-derived peptide

Regulatory status

Not FDA-approved How we label status

As of October 4, 2026, Cibinetide (ARA-290) is not FDA-approved for any use and is not on FDA's 503A bulks list.

See Cibinetide (ARA-290) in the Index →

Federal (FDA)
Not FDA-approved
503A compounding
Category 3 (since 2023-09-29); not on 216.23 as of 2026-10-07 (as of October 7, 2026)

Timeline

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Timeline table
DateWhat happenedSource
FDA list of bulk drug substances nominated under section 503A, updated May 14, 2026, places cibinetide (ARA-290) in category 3, nominated without adequate support.FDA, event of May 14, 2026, on fda.gov

References

Sources as of October 4, 2026

  1. FDA: www.fda.gov/media/94155/download
  2. WADA: www.wada-ama.org/sites/default/files/2025-09/2026list_en_final_clean_september_2025.pdf
  3. eCFR: www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-216/subpart-B/section-216.23