{"slug":"follistatin-344","seoKey":"follistatin344","displayName":"Follistatin-344","codes":["AAV1-FS344","rAAV1.CMV.huFollistatin344"],"synonyms":["FST-344","FST344","FS-344","FS344","follistatin isoform 344","follistatin isoform FST344 precursor","follistatin","FS","activin-binding protein"],"legalClass":"research_chemical","identifiers":{"wikidataQid":"Q408122","molecularWeight":38007},"approvals":[{"market":"US","status":"not_approved","note":"Not approved and never has been, neither as a protein nor as gene therapy. Queries on 2026-09-15 returned no entry in the drug approval records, no product listing, no labelling and no enforcement record, while control queries for an approved medicine on the same endpoints returned results. The substance appears on none of the compounding lists, not even among those nominated and rejected, which fits a 35-kilodalton glycoprotein no pharmacy could prepare. A product marketed for human use is therefore an unapproved new drug; a research-use-only label does not change that.","date":"2026-09-15","source":"https://api.fda.gov/drug/drugsfda.json?search=follistatin"},{"market":"EU","status":"not_approved","note":"No authorised medicine, no assessment report and no code in the anatomical therapeutic classification. This finding is DERIVED rather than measured: the regulator's full-text search answered with HTTP 401 on 2026-09-15 and both known bulk data files with HTTP 404, so no control query was possible. It rests on the absence of any authorisation in every other register checked with a working control and on the fact that the whole published and register record treats the substance as preclinical or as a gene therapy transgene.","date":"2026-09-15","source":"https://www.ema.europa.eu/en/medicines"},{"market":"DE","status":"not_approved","note":"Not an authorised medicine and not listed in annex 1 of the prescription-only ordinance, the full text having been searched on 2026-09-15 with a working control term. It IS named in the annex to the anti-doping act, section III item 3 on substances altering myostatin function, in the line 'follistatin and its derivatives', directly above stamulumab; the annex expressly covers salts, esters, isomers, complexes and derivatives, so the isoform variants are caught without room for interpretation. The 2023 doping-agent quantity ordinance sets a 'not small quantity' of 450 mg for that line, above which acquisition and possession are criminal offences. This is the hardest regulatory finding in the file.","date":"2026-09-15","source":"https://www.gesetze-im-internet.de/antidopg/anlage.html"},{"market":"UK","status":"not_approved","note":"No authorised medicine known. A direct query of the products register was not evaluable on 2026-09-15, because results load by script and the embedded data block was empty while the interface path answered with HTTP 404; a control query was therefore impossible. The negative finding is inferred from the absence of any authorisation worldwide. Without an authorisation, supply would only be conceivable as an unlicensed special on a named prescriber's responsibility, never to consumers.","date":"2026-09-15","source":"https://products.mhra.gov.uk/search/?search=follistatin"},{"market":"AU","status":"scheduled","note":"Named in the June 2026 Poisons Standard, and the strictest of the seven markets. The 674-page instrument carries the schedule 4 line '# FOLLISTATIN.' among the prescription-only substances, and the hash mark refers it to appendix D, where it stands as item 16 in clause 5, the table of poisons that may not be possessed without authority under state or territory law. No product has ever been licensed there, so a prescription could not realistically be written; a full-text query of the register of therapeutic goods was not possible on 2026-09-15, the endpoints answering with an empty body or HTTP 500. Advertising schedule 4 substances to the public is prohibited.","date":"2026-05-28","source":"https://www.legislation.gov.au/F2026L00633/asmade"},{"market":"CA","status":"not_approved","note":"No authorised medicine. The drug product database returned an empty list for the active ingredient on 2026-09-15, while the same query for an approved peptide hormone returned several records, so the endpoint was working.","date":"2026-09-15","source":"https://health-products.canada.ca/api/drug/activeingredient/?ingredientname=follistatin"},{"market":"CH","status":"not_approved","note":"No authorisation. The official extended list of authorised human medicines was downloaded on 2026-09-15 and searched in full for the substance name, its latinised form and the blocked signal with no match, while four control terms in the same file returned between 15 and 61 entries. Switzerland is no softer harbour: advertising prescription-only medicines to the public is prohibited, and for unauthorised medicines advertising is barred in any case.","date":"2026-09-15","source":"https://www.swissmedic.ch/"}],"devStage":"phase1","strongestEvidence":"observational","wada":{"status":"prohibited","section":"S4.3","listYear":2026,"source":"https://www.wada-ama.org/en/prohibited-list"},"trials":[{"nct":"NCT01519349","name":"Gene therapy, not the protein: intramuscular transfer of rAAV1.CMV.huFollistatin344 in Becker muscular dystrophy and sporadic inclusion body myositis","phase":"Phase 1","n":15,"status":"COMPLETED"},{"nct":"NCT02354781","name":"Gene therapy, not the protein: intramuscular transfer of rAAV1.CMV.huFollistatin344 in Duchenne muscular dystrophy","phase":"Phase 1/2","n":3,"status":"COMPLETED"},{"nct":"NCT06411366","name":"Gene therapy, not the protein: injectable follistatin plasmid in healthy adults","phase":"Phase 1","n":43,"status":"COMPLETED"},{"nct":"NCT07285629","name":"Gene therapy, not the protein: combined klotho and follistatin plasmid in healthy adults","phase":"Early Phase 1","n":14,"status":"COMPLETED"},{"nct":"NCT07443826","name":"Gene therapy, not the protein: AAV-follistatin with an angiogenesis-inducing VEGF plasmid in age-related muscle decline","phase":"Phase 1/2","n":12,"status":"RECRUITING"}],"sameAs":["https://www.uniprot.org/uniprotkb/P19883/entry","https://www.wikidata.org/wiki/Q408122"],"lastVerified":"2026-09-15","version":"1.0","published":true,"locale":"en","title":"Follistatin-344: what the trials show, status and safety","summary":"Follistatin is a protein the human body makes itself, isolated in 1987 at the Salk Institute. It catches activin A, myostatin and related signals before they reach their receptor, and in mice that makes muscles grow. No country has approved it, for any purpose. Every human study delivered it as gene therapy rather than as an injected protein, and of the three published trials one failed outright. Of 17 products sold under the name, only nine contained follistatin.","updated":"2026-09-15","url":"https://mypep.app/peptides/follistatin-344"}