Is Follistatin-344 legal in the US?
No. It is not approved and is sold as a research chemical.
Not approved by the FDA for any use and sold as a research chemical. Follistatin has been given to people only as a gene therapy, first in two small academic trials of the follistatin-344 gene and since 2022 in a few small company-run early-phase studies. The injectable protein sold online has never been tested in people.
No. It has never been submitted for approval. The only human use has been as a gene therapy: two academic trials of six patients each and, since 2022, a few small company-run early-phase studies. 456
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Citations
- McPherron 1997, Nature: regulation of skeletal muscle mass in mice by a new TGF-beta superfamily member (myostatin) doi.org
- Mendell 2015, Molecular Therapy: a phase 1/2a follistatin gene therapy trial for Becker muscular dystrophy (DOI record) doi.org
- Al-Zaidy 2015, Journal of Neuromuscular Diseases: follistatin gene therapy improves ambulation in Becker muscular dystrophy doi.org
- Mendell 2015, Molecular Therapy: a phase 1/2a follistatin gene therapy trial for Becker muscular dystrophy pubmed.ncbi.nlm.nih.gov
- Mendell 2017, Molecular Therapy: follistatin gene therapy for sporadic inclusion body myositis improves functional outcomes pubmed.ncbi.nlm.nih.gov
- ClinicalTrials.gov: follistatin intervention studies clinicaltrials.gov
Reference information only, not medical advice. Drawn from the Follistatin-344 article, fact-checked against the cited sources. No dosing anywhere on this site.