What is Cerebrolysin?

The short answer

Cerebrolysin is a protein.

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What it is

Also known as
cerebrolysine, fpf-1070

Regulatory status

Approved outside the US How we label status

As of October 4, 2026, Cerebrolysin is not FDA-approved for any use and is not on FDA's 503A bulks list.

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Federal (FDA)
Not FDA-approved (no drugsfda/DailyMed record)
503A compounding
No category; not on 216.23 as of 2026-10-07 (as of October 7, 2026)
WADA 2026
Not named; approved in Austria and Russia, so S0 does not apply

Timeline

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Timeline table
DateWhat happenedSource
FDA warning letter to a compounding pharmacy states that cerebrolysin was not nominated for inclusion on the 503A bulks list.FDA, event of November 10, 2021, on fda.gov

References

Sources as of October 4, 2026

  1. FDA warning letter, April 1, 2020
  2. FDA warning letter, November 10, 2021
  3. FDA: www.fda.gov/media/94155/download
  4. WADA: www.wada-ama.org/sites/default/files/2025-09/2026list_en_final_clean_september_2025.pdf
  5. eCFR: www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-216/subpart-B/section-216.23