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Follistatin-344 regulatory status

Current status of Follistatin-344 in the United States: Unscheduled. 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 Follistatin-344?

Regulatory: UnscheduledWADA: WADA prohibitedVerified: Verified Sep 22, 2026
FDA and compounding
Follistatin-344 has never been submitted to or reviewed by FDA as a drug and does not appear on the 503A bulk drug substance Category 1, 2, or 3 lists or the 503B bulks list as of the last verification date. It is a biologic sized protein rather than a small peptide, so even a nomination would face the biologics compounding limits. There is no approved product and no lawful compounding pathway; products sold online are labeled for research use only.
WADA
WADA prohibited
Access path
  1. Not legally available for human use in the United States.
  2. Gene therapy form (AAV1-FS344) was available only inside registered clinical trials.
  3. Products labeled research use only are not lawful for human use and are not verified.

Full Follistatin-344 page: evidence, dosing in the literature, and sources

How has the status of Follistatin-344 changed over time?

No dated regulatory event has been recorded for Follistatin-344. 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 Follistatin-344 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, section S4 hormone and metabolic modulators (names follistatin as a myostatin binding protein)WADA, 2026