Follistatin-344 research: studies, doses and safety
Human gene-therapy findings do not establish a dose for follistatin-344 protein vials.
Also called: FS344, FST344, FS-344, Follistatin 344.
Myostatin pathway · Myostatin- and activin-binding protein precursor.
Gene-vector administration is separate from direct protein exposure. Registrations do not establish results. A protein-injection evidence level is not established here.
Key studies
- Becker gene transfer, six adults: Four of six improved walking distance after gene transfer; no randomized control. (source)
- Myositis gene transfer, six adults: Walking gains were reported, but exercise, steroids and unequal follow-up limit attribution. (source)
- Registry and early myositis cohort: Registry includes three early low-dose myositis patients beyond the two six-person publications. (source)
- Duchenne gene transfer, phase 1/2: No dose-limiting toxicity was reported; the registry does not show improved walking at two years. (source)
- Plasmid gene delivery, unreviewed report: An uncontrolled manuscript reports small body-composition changes and increased LDL cholesterol. (source)
- Klotho plus follistatin plasmids: Completed registration has no posted results or verified clinical benefit. (source)
Related to Follistatin-344
- ACE-031: An experimental muscle-growth protein whose Duchenne program stopped over bleeding concerns.
- Ipamorelin: An experimental peptide that triggers growth hormone release.
- IGF-1 LR3: An unapproved growth signal with no human trials found.
- PEG-MGF: A modified MGF peptide with no human dosing studies and uncertain identity in unregulated vials.
Sources
- 503B Bulk Drug Substances List, FDA · FDA · 2026
- Bulk Drug Substances Nominated for Use in Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act, FDA · FDA · 2026
- Bulk Drug Substances Used in Compounding Under Section 503A of the FD&C Act, FDA · FDA · 2026
- Cellulitis, NHS · NHS · 2026
- Find product information about medicines, Medicines and Healthcare products Regulatory Agency · MHRA · 2026
- Medicines, European Medicines Agency · European Medicines Agency · 2026
- Pyrogen and Endotoxins Testing: Questions and Answers, FDA · 2026
- The 2026 Prohibited List, World Anti-Doping Agency · WADA · 2026
- Therapeutic Goods (Poisons Standard—October 2026) Instrument 2026, Australian Government · Australian Government · 2026
- Anaphylaxis, NHS · NHS · 2023
- Definition of the Term “Biological Product” Final Regulatory Impact Analysis, FDA · 2020
- Tailor Made Compounding LLC - 594743 - 04/01/2020, FDA · FDA · 2020
- Australian Register of Therapeutic Goods (ARTG), Therapeutic Goods Administration · TGA
- Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application Guidance for Industry, FDA
- Search criteria - Drug Product Database online query, Health Canada · Health Canada
Sources checked: 2026-10-18.
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