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Follistatin-344

Myostatin inhibitor (glycoprotein isoform)

Also known as: FS-344, FS344, AAV1-FS344 (gene-therapy construct)

Tier 3, Preclinical only

Evidence is limited to animal or in-vitro work. No human pharmacokinetics. Any human dose in circulation is extrapolated, and extrapolation across species routinely fails.

Half-life
Not established

Follistatin-344 is a 344-amino-acid follistatin isoform, not a short injectable peptide; it has been studied as an AAV gene-therapy transgene (e.g., AAV1-FS344), not as a dosed peptide, so conventional peptide pharmacokinetics/half-life do not apply and none are published. Molecular weight left null (protein isoform; no clean value at an allowed primary source).

Dosing
No established dose

No peptide dosing exists. Human experience is intramuscular AAV vector dosing (viral genomes), not a microgram peptide dose.

Regulatory status
Not approved. Investigational gene therapy; a Phase 1/2a AAV-FS344 trial was conducted in Becker muscular dystrophy.
Evidence base
mixed · confidence: low

Strong preclinical (mouse, non-human primate) muscle-hypertrophy data and an early-phase human gene-therapy trial; no data supporting an injectable 'follistatin-344 peptide' product.

Safety

No boxed warning (unapproved). Gene-therapy-specific risks (vector immunogenicity) apply to the AAV construct. Peptide products marketed as 'Follistatin-344' are not the studied gene therapy and have no clinical safety or PK data.