Bone & muscle Protein

Follistatin-344

Also known as: FS-344

Not FDA-approved

Last verified: October 30, 2026

At a glance

FDA approval Not FDA-approved No record in Drugs@FDA

Randomized controlled trials 0 of 10 publications on PubMed

Registered clinical trials 1 0 active

Adverse event reports 0 0 classified as serious

Follistatin-344 is not an FDA-approved drug: Drugs@FDA has no record of it.
PubMed lists 10 publications mentioning it, including 0 randomized controlled trials and 3 animal-only studies.
ClinicalTrials.gov lists 1 registered study testing it (0 active).
FDA’s adverse event system (FAERS) has no reports mentioning it.

Research topics

Glycoproteins 4
RNA, Messenger 4
Organ Specificity 3
Androstanols 2
Base Sequence 2
Gene Expression 2
Inhibins 2
RNA 2
RNA Probes 2
Activins 1

Most frequent MeSH subject headings in the latest PubMed records (English, as indexed).

Regulatory status

Drugs@FDA applications

No application found in Drugs@FDA, FDA's database of approved drugs.

Source: Drugs@FDA (openFDA) · verified October 30, 2026 · API query

FDA compounding safety list

Not on FDA's list of bulk drug substances that may present significant safety risks in compounding.

Source: FDA.gov — Category 2 bulk drug substances · verified October 30, 2026

Removal of a substance from a regulatory list does not mean it has been approved. A "research use only" label does not make a product safe or legal for human use.

Scientific publications

All publications 10
Human (MeSH) 5
Animal only 3
Clinical trials 0
Randomized controlled trials 0
Systematic reviews & meta-analyses 0
Case reports 0
Retracted 0

Counts are PubMed records that mention the peptide in the title or abstract. Categories overlap, and a mention is not the same as testing the peptide as a treatment. Each number opens the exact PubMed search. Effects seen in laboratory or animal studies may not occur in humans. A registered clinical trial does not show that a substance is effective or safe.

Latest publications

Safety and Efficacy of Approved and Unapproved Peptide Therapies for Musculoskeletal Injuries and Athletic Performance. Review 2026 Sports medicine (Auckland, N.Z.)
Detection of black market follistatin 344. Unclassified 2020 Drug testing and analysis
Sub-200 fs, 344 MHz mode-locked Tm-doped fiber laser. Unclassified 2020 Optics letters
Central serous chorioretinopathy associated with high-dose follistatin-344: a retrospective case series. Human study 2020 International ophthalmology
Detection of black market follistatin 344. Human study 2019 Drug testing and analysis
The transgenic expression of human follistatin-344 increases skeletal muscle mass in pigs. Human study 2017 Transgenic research
Production of follistatin in porcine endothelial cells: differential regulation by bacterial compounds and the synthetic glucocorticoid RU 28362. Human study 1996 Endocrinology
Follistatin steady state messenger ribonucleic acid levels in confluent cultures of a rat renal mesangial cell line are regulated by multiple factors. Animal study 1992 Endocrinology
Rat follistatin: ontogeny of steady-state mRNA levels in different tissues predicts organ-specific functions. Animal study 1991 Biochemical and biophysical research communications
Rat follistatin: gonadal and extragonadal expression and evidence for alternative splicing. Animal study 1990 Biochemical and biophysical research communications

Source: PubMed (NCBI) · verified October 30, 2026

Clinical trials

Registered: 1
Active: 0
With posted results: 0

Conditions studied

Frailty 1
Aging 1

Study	Status	Phase	Start
Phase I: Safety and Efficacy of an Injectable Follistatin Plasmid Gene Therapy in Humans NCT06411366 Minicircle	Completed	Phase 1	August 18, 2022

All 1 study on ClinicalTrials.gov ↗

Source: ClinicalTrials.gov · verified October 30, 2026

Adverse event reports

No FAERS reports mention this peptide.

Source: FDA FAERS · verified October 30, 2026 · API query

Change history

No changes since monitoring began on October 30, 2026.