Vial Guide

The form of follistatin that circulates in blood, and the one a genuine vial of either “follistatin-315” or “follistatin-344” holds: the 315-amino-acid chain left after a cell cuts the short signal piece off the 344-amino-acid precursor. It mops up myostatin and activin, two signals that hold muscle growth back.

Evidence. No published study has given follistatin protein to a person, in either of the forms sold. Human testing has been gene therapy instead: a phase 1 trial injected a virus carrying the FS344 gene, which cells turn into this protein, into the thigh muscles of 15 people with Becker muscular dystrophy or inclusion body myositis, and most walked further afterwards. Everything known about the protein itself comes from cells, mice and monkeys.

What it’s used for

None of these uses is approved. Uses tested in people come first, then claims that rest on animal studies or user reports.

Muscle growth
AnimalUnproven in people as a protein: more follistatin in muscle built muscle in mice, and a gene given into monkey thigh muscle raised size and strength. Nobody has been injected with the protein.
Becker muscular dystrophy
TrialGene therapy, not protein: 4 of 6 people walked 29 to 125 m further on a 6-minute walk test after one set of thigh injections, 2 didn’t change, and no adverse effects were reported.
Inclusion body myositis
TrialGene therapy, not protein: in 6 people, walking distance changed by +56.0 m a year against −25.8 m a year in 8 untreated matched people, with an exercise program alongside.
Age-related muscle loss
No studyNo results. A 12-person trial of an AAV follistatin gene in adults 35 and older began recruiting in June 2026, with completion expected in 2028. No study of the protein exists.
Fat loss and body composition
No studyNo study has tested follistatin protein for fat loss in people, and the gene-therapy trials measured walking and muscle, not fat.
Strength and athletic performance
No studyNo study has measured strength or performance after injected follistatin. It is banned in sport at all times, and gene versions count as gene doping.

Trial: tested in people, with the result. Animal: cell or animal studies only. No study: nothing published supports it.

Every compound’s uses, by body system: evidence map, and by condition: conditions A to Z.

Status

Approval
Not approved as a drug in the US or EU, and no follistatin product is approved anywhere. Human testing has been gene therapy: a 15-person trial that ended in 2017, two small open-label studies of a follistatin plasmid run at a clinic abroad in 2023 and 2026, and a 12-person trial of an AAV follistatin gene in age-related muscle loss that began recruiting in June 2026. ACE-083, an engineered follistatin-based protein injected into muscle, had its phase 2 trials terminated in 2020.
US compounding
Never nominated for pharmacy compounding, so follistatin appears on none of FDA’s 503A or 503B bulk substance category lists (503A list updated May 14, 2026).
European Union
No marketing authorization; no follistatin product is approved anywhere, in any form.
United Kingdom
No marketing authorization (MHRA).
Canada
No marketing authorization (Health Canada).
Australia
Prescription only: FOLLISTATIN is in Schedule 4 and in Appendix D of the October 2026 Poisons Standard, so possessing it without authority is illegal.
Sport (WADA 2026)
Banned in sportS4.3 agents preventing activin receptor IIB activation: myostatin-binding proteins, with follistatin named. Banned at all times, as a non-Specified substance. Follistatin gene therapy is separately covered by M3 gene and cell doping.

Category 2 is FDA’s list of bulk substances that may present significant safety risks in compounding. The 503A bulks list adds substances that pharmacies may compound with. Advisory committee votes are advice; FDA makes the final decision. Sport status follows the WADA Prohibited List in force since January 1, 2026; athletes should confirm with their anti-doping organization. Checked October 5, 2026. Status outside the US checked October 7, 2026 against EMA, MHRA, Health Canada and TGA records. By country: EU, UK, Canada, Australia. Status of every compound.

How it works

Follistatin wraps around myostatin and activin, two signals that hold back muscle growth, and stops them reaching their receptors. This 315-amino-acid form is the one that circulates: its tail end lowers how tightly it sticks to heparin-like sugars on cell surfaces, so it travels in blood instead of staying put, which is why the human gene-therapy trials chose the gene that makes it. In mice and monkeys, more follistatin in muscle meant larger, stronger muscle.

AnimalMainly from cell and animal studies; not shown in people.

Not known

Whether injected follistatin protein reaches muscle at all is unknown: in rats, injected follistatin left the blood within hours, mostly taken up by the liver. Its effects on human reproductive hormones are also unmeasured.

Protocol

Community

No dose has been tested in any person. One public guide quotes 50 to 200 mcg a day under the skin for this form; others give no figure, and the numbers circulating for follistatin-344 run from 50 to 300 mcg. None cites a study.

Trial

Mendell 2015 and 2017

Gene therapy, not protein: one set of injections into both thighs of 3 × 10¹¹ to 6 × 10¹¹ vg/kg per leg of an AAV1 virus carrying the FS344 gene, which cells then turn into this protein.

Frequency
Not established
Route
Subcutaneous or intramuscular injection (community). No study has injected the protein into a person.
Cycle
No established cycle. Reports for either form run 10 to 30 days, then a break of 3 to 4 weeks, with nothing behind the figures.

No set cycle, shown over 26 weeks

Common protocols

The ways Follistatin-315 is most often run, each tagged with where it comes from.

Community injection

Community
Dose
No tested dose; one guide quotes 50–200 mcg
How often
Usually described as once daily
How long
Reports mention 10–30 days

Not tested in any study. The figures quoted under this name and under follistatin-344 disagree, and none of the guides cites a source.

Gene therapy, inclusion body myositis

Trial
Dose
6 × 10¹¹ vg/kg per leg of a virus carrying the FS344 gene
How often
One set of injections into both thigh muscles
How long
Single treatment, followed about a year

Six patients, with an exercise program alongside. The gene makes this protein inside muscle; nobody was injected with the protein itself.

Gene therapy, Becker muscular dystrophy

Trial
Dose
3 × 10¹¹ or 6 × 10¹¹ vg/kg per leg
How often
One set of injections into both thigh muscles
How long
Single treatment, safety followed 2 years

Six patients in two dose groups. Four walked 29 to 125 m further on a 6-minute walk test, two didn’t change, and no adverse effects were reported.

Taking it

Where it goes

The trials injected a gene, not the protein, into the quadriceps of both legs in hospital. Community use is injection under the skin with rotating sites, or into the muscle someone wants to grow; neither has been studied.

If you miss a dose

No published guidance. Skip the missed day and carry on; don’t double up.

Missed doses for every compound

What to expect

  1. About a year after one set of gene-therapy injections

    In inclusion body myositis, walking distance changed by +56.0 m a year against −25.8 m a year in 8 untreated matched people (p=0.01).

    Trial
  2. Up to 2 years after gene therapy in Becker muscular dystrophy

    Four of 6 people walked 29 to 125 m further and 2 did not change. No adverse effects were reported.

    Trial
  3. Months after gene delivery into monkey thigh muscle

    Muscle size and strength rose and stayed up, with no abnormal changes in major organs. The 2009 report carries an erratum published in August 2026.

    Animal
  4. With the injected protein

    Nothing is known. No published study has given follistatin protein to a person, so there are no timelines and no outcomes to report.

    Community

Side effects and what to do

Unknown in people: the protein has never been injected in a published study

The gene-therapy trials say nothing about injecting the protein, which leaves the blood of rats within hours.

Lower FSH and knock-on effects on reproductive hormones

Expected from blocking activin: follistatin was discovered as an FSH-lowering protein. Blood tests can check FSH, LH and sex hormones.

Immune reaction to a protein grown in cells

Cell-grown proteins can carry other cell proteins and unfamiliar sugar patterns. Stop at hives, swelling or wheeze and get help.

Injection-site pain, redness or infection (unregulated vials)

Use sterile technique. Spreading redness, heat or pus needs medical care.

No adverse effects were reported in the gene-therapy trials (15 people, safety followed 2 years)

That is about a virus delivering a gene into muscle, not about injecting this protein.

Stop and get medical help

Hives, swelling of the face or throat, or trouble breathing after an injection: stop and get medical help. A hot, spreading red injection site with fever needs urgent care.

Can it cause …?

The side effects people ask about most, answered one by one. Each answer says where it comes from.

Hair loss
No dataNo human data: hair wasn’t reported in the gene-therapy trials.
Acne, rash or skin changes
No dataNo human data beyond injection-site care; skin effects weren’t reported in the gene-therapy trials.
Water retention or swelling
No dataNo human data: swelling wasn’t reported in the gene-therapy trials.
Joint or muscle pain
TrialPain and bruising were reported after the thigh injections in a Duchenne gene-therapy study, which has no publication and only registry results.
Anxiety, low mood or irritability
TrialInsomnia, anxiety, agitation or behavior change were each recorded once in a 3-boy Duchenne gene-therapy study; the illness itself may explain them.
Low or high blood sugar
No dataNo human data on blood sugar after follistatin of any form.
Fast heartbeat or blood pressure changes
No dataNo human data on heart rate or blood pressure.
More hunger
No dataNo human data: appetite wasn’t measured in the gene-therapy trials.
Liver strain
AnimalNo human data. In rats, follistatin injected into a vein was taken up mainly by the liver, which is where most of it ended up within hours.
Kidney problems
No dataNo human data: kidney tests weren’t reported in the gene-therapy trials.
Cancer risk
PrecautionUnknown. It removes brakes on tissue growth, and no study has looked at cancer risk after follistatin, in animals or people.
TirednessHeadacheNausea or vomitingDiarrhea or constipationDizzinessTrouble sleeping
No dataNo human data: nobody has received follistatin protein in a published study.

Trial: reported in human studies. Precaution: a concern that follows from how it works or from a related drug, not measured. Animal: seen only in animal studies. No data: no human safety data. A side effect that hasn’t been reported can still happen, especially with long or high-dose use. Any of these across every compound: the side-effect finder.

Who should avoid it

No product label covers follistatin-315, so these come from human studies and from precautions based on how it works. Most important first.

Pregnancy, breastfeeding or trying to conceive
PrecautionIt blocks activin and was discovered as a protein that lowers FSH, a hormone needed for egg and sperm production. No human safety data exist.
Anyone relying on product quality
PrecautionIt is a protein grown in living cells; vials rarely say which cells made it, and nothing checks its identity, sugar coating or amount. Cell-grown proteins can trigger immune reactions.
Anyone with active or past cancer
PrecautionIt blocks signals that limit tissue growth. No study has tested whether follistatin affects cancer.
Anyone expecting the gene-therapy results
TrialThose trials put a gene into thigh muscle, which then made the protein in place for months. Injecting the protein is a different thing and has never been studied.

Interactions

No interaction studies have been published, and no product label lists any.

Trial: seen in human studies, or a group those studies left out. Precaution: follows from how it works or from a related drug, and hasn’t been tested. This isn’t a complete list: a pharmacist or doctor can check a specific medicine or condition. Every documented interaction, by medicine: drug interactions.

Special situations

What’s known about pregnancy, breastfeeding, kidney and liver problems, age and surgery. Where nothing has been studied, the row says so.

Pregnancy
PrecautionNo human safety data. It blocks activin and lowers FSH, hormones needed for fertility and pregnancy, so this is a reasoned concern rather than a measured one.
Breastfeeding
PrecautionNo human data; it isn’t known whether it passes into breast milk.
Kidney problems
PrecautionNot studied in kidney disease. In rats the protein was cleared mainly by the liver, not the kidneys, but nothing was measured in people.
Liver problems
PrecautionNot studied in liver disease, and in rats the liver takes up most of an injected dose.
Older adults
PrecautionNot studied as a protein at any age. A gene-therapy trial in adults 35 and older with age-related muscle loss started recruiting in 2026.
Children and teens
TrialNot approved at any age. A follistatin gene-therapy study injected 3 boys aged 7 and older with Duchenne muscular dystrophy; Vial Guide doesn’t publish children’s doses.
Surgery and anesthesia
PrecautionNo data; tell the surgical team about any injected compound.

Trial: from human studies. Precaution: not studied, so the caution follows from how it works or from a related drug. Ages are given as approved or studied; this site never gives doses for children. Across every compound: pregnancy, breastfeeding, kidney disease, liver disease, older adults and surgery.

Tracking and pairing

Worth tracking

  • FSH
  • LH and testosterone (men) or estradiol (women)
  • Injection sites

Often paired with

  • Follistatin-344

    Not a stack: the 344-amino-acid chain is the precursor of this 315-amino-acid protein, so genuine vials of either hold the same mature protein. Nothing has been tested together.

  • IGF-1 LR3

    Commonly talked about together as muscle-growth compounds. Neither has been injected in a published human study, and the pair has never been tested.

Human studies

2 key published human studies, with how many people took part. Animal studies aren’t listed here.

  1. 20176 people

    Walking distance changed by +56.0 m a year against −25.8 m a year in 8 untreated matched people (p=0.01); 4 of 6 improved 58 to 153 m, with less fibrosis and more regeneration on biopsy. The protein itself was not injected.

    Design
    Open-label gene-therapy trial with an untreated comparison group matched for age, sex and baseline (randomization not described)
    Dose
    6 × 10¹¹ vg/kg per leg of a virus carrying the FS344 gene, into both quadriceps, with an exercise program
    Length
    Followed to a median of 1 year

    Mendell et al., Mol Ther 2017, PMID 28279643

  2. 20156 people

    On the 6-minute walk test two people gained 58 m and 125 m in the lower-dose group and two gained 108 m and 29 m in the higher-dose group, while 2 showed no change. No adverse effects were encountered.

    Design
    Phase 1/2a open-label gene-therapy trial in two dose groups, no placebo
    Dose
    3 × 10¹¹ or 6 × 10¹¹ vg/kg per leg of a virus carrying the FS344 gene, into both quadriceps
    Length
    Single treatment, safety followed 2 years

    Mendell et al., Mol Ther 2015, PMID 25322757

All human studies on Vial Guide

Trials under way

Registered trials that are still running, or that finished without published results, most important first. Checked on ClinicalTrials.gov, October 7, 2026.

  1. Phase 1/2NCT07443826

    A virus carrying the follistatin gene, with a second gene, in 12 adults 35 and older with age-related muscle loss

    Recruiting from June 2026; completion expected June 2028

  2. Early phase 1NCT07285629

    A follistatin plus klotho gene plasmid in 14 adults, run at a clinic abroad

    Completed April 2026; no results posted and no publication

Every compound’s registered trials: trials under way.

Limits of the evidence

No published study has given follistatin protein, in this or any form, to a person. The human data are gene-therapy trials in 15 people with Becker muscular dystrophy or inclusion body myositis, with no placebo group, where most walked further. The protein evidence is cells, mice and monkeys. Dose, effect, safety and purity for injected follistatin are all untested.

How it’s supplied

No vial size or dose has been established for Follistatin-315, so there’s no mixing math to show.

Sold as powder vials of a protein grown in living cells, usually 1 mg, with no regulated label. Vial Guide gives no mixing or dose figures here, because no person has received follistatin protein in a published study and the amounts quoted for the two forms don’t agree. Research-grade follistatin is made up with a carrier protein such as albumin, or it sticks to the glass and is lost.

Datasheet

Half-life
about 4 minutes, then about 2 hours, in rats AnimalAfter 1 mcg of radioiodine-labeled follistatin into a vein in rats: initial half-life 4.0 minutes and terminal half-life 130.8 minutes, measured as radioactivity, with most of it taken up by the liver. No human measurement exists for injected follistatin of any form.
Type
Protein, 315 amino acids
Molecular weight
about 34,700 g/mol (the mature 315-amino-acid chain, before sugars; the 344-amino-acid precursor is 38,007, and the glycosylated protein runs at 39,000–56,000 on a gel)
Storage before use
Freezer (−20 °C or colder) for long-term storage, kept dry and dark.
After mixing or opening
Fridge (2–8 °C) for a few weeks, or frozen in single-use portions. Research-grade follistatin is made up with a carrier protein such as albumin.
  • Half-life: Kogure et al., Hepatology 1996, PMID 8690405
  • Molecule: UniProt P19883 (FST_HUMAN): 344-residue precursor, 38,007 Da, signal peptide 1–29, mature chain 30–344, sugars attached at residues 124 and 288. A second splice form gives the 288-residue protein that sticks to cell surfaces. FDA substance record UNII 506IY26H2I (follistatin)
  • Storage: Community Common research-protein practice; no approved label exists for follistatin

Every compound side by side: the half-life chart and the storage chart.

Identifiers

UNII (FDA)
506IY26H2I (follistatin)
ATC code
None assigned
Development codes
FST-315, FS315; the gene used in trials is called FS344
Brand names
None; no product is approved anywhere
First described
Follistatin was described in 1987 as an FSH-release-inhibiting protein from ovarian fluid (Esch et al.).

Every compound’s numbers: the identifiers table.

Product form and quality

Vials hold a protein grown in living cells, usually 1 mg, and rarely say which cells. Public references print weights from 3,470 to 34,998 for a chain that weighs about 34,700 before sugars, so labels may not match the contents.

Cautions

  • Never given to a person as a protein in any published study, so there is no tested dose, schedule or safety record.
  • Follistatin-315 and follistatin-344 are not rival products: the 344-amino-acid chain is the precursor, and cells cut it down to this 315-amino-acid protein. Sellers price and describe them as different things.
  • It blocks activin as well as myostatin. Follistatin was discovered as a protein that lowers follicle-stimulating hormone (FSH), which is needed for egg and sperm production.
  • What is sold is a protein grown in living cells. Vials rarely say which cells made it, and nothing checks its identity, sugar coating or amount; cell-grown proteins can set off immune reactions.
  • Banned in sport at all times: WADA names follistatin as a myostatin-binding protein under S4.3, and follistatin gene therapy separately as gene doping.

Questions

What is follistatin-315?

The form of follistatin that circulates in blood, and the one a genuine vial of either “follistatin-315” or “follistatin-344” holds: the 315-amino-acid chain left after a cell cuts the short signal piece off the 344-amino-acid precursor. It mops up myostatin and activin, two signals that hold muscle growth back.

How does follistatin-315 work?

Follistatin wraps around myostatin and activin, two signals that hold back muscle growth, and stops them reaching their receptors. This 315-amino-acid form is the one that circulates: its tail end lowers how tightly it sticks to heparin-like sugars on cell surfaces, so it travels in blood instead of staying put, which is why the human gene-therapy trials chose the gene that makes it. In mice and monkeys, more follistatin in muscle meant larger, stronger muscle. Whether injected follistatin protein reaches muscle at all is unknown: in rats, injected follistatin left the blood within hours, mostly taken up by the liver. Its effects on human reproductive hormones are also unmeasured.

Is follistatin-315 FDA-approved?

Not approved as a drug in the US or EU, and no follistatin product is approved anywhere. Human testing has been gene therapy: a 15-person trial that ended in 2017, two small open-label studies of a follistatin plasmid run at a clinic abroad in 2023 and 2026, and a 12-person trial of an AAV follistatin gene in age-related muscle loss that began recruiting in June 2026. ACE-083, an engineered follistatin-based protein injected into muscle, had its phase 2 trials terminated in 2020. Never nominated for pharmacy compounding, so follistatin appears on none of FDA’s 503A or 503B bulk substance category lists (503A list updated May 14, 2026).

What is the usual follistatin-315 dose?

From community reports, not established: No dose has been tested in any person. One public guide quotes 50 to 200 mcg a day under the skin for this form; others give no figure, and the numbers circulating for follistatin-344 run from 50 to 300 mcg. None cites a study. From human studies (Mendell 2015 and 2017): Gene therapy, not protein: one set of injections into both thighs of 3 × 10¹¹ to 6 × 10¹¹ vg/kg per leg of an AAV1 virus carrying the FS344 gene, which cells then turn into this protein. These are the amounts sources reference, not recommendations.

Who should avoid follistatin-315?

No product label covers follistatin-315, so these come from human studies and from precautions based on how it works. Pregnancy, breastfeeding or trying to conceive: It blocks activin and was discovered as a protein that lowers FSH, a hormone needed for egg and sperm production. No human safety data exist. Anyone relying on product quality: It is a protein grown in living cells; vials rarely say which cells made it, and nothing checks its identity, sugar coating or amount. Cell-grown proteins can trigger immune reactions. Anyone with active or past cancer: It blocks signals that limit tissue growth. No study has tested whether follistatin affects cancer. The “Who should avoid it” section lists 1 more group.

What is the half-life of follistatin-315?

About 4 minutes, then about 2 hours, in rats, measured in animals, not people. After 1 mcg of radioiodine-labeled follistatin into a vein in rats: initial half-life 4.0 minutes and terminal half-life 130.8 minutes, measured as radioactivity, with most of it taken up by the liver. No human measurement exists for injected follistatin of any form.

How should follistatin-315 be stored?

Before mixing: Freezer (−20 °C or colder) for long-term storage, kept dry and dark. After mixing: Fridge (2–8 °C) for a few weeks, or frozen in single-use portions. Research-grade follistatin is made up with a carrier protein such as albumin. This is common practice; no product label covers it.

Is follistatin-315 banned in sport?

Yes. S4.3 agents preventing activin receptor IIB activation: myostatin-binding proteins, with follistatin named. Banned at all times, as a non-Specified substance. Follistatin gene therapy is separately covered by M3 gene and cell doping.

Has follistatin-315 been studied in people?

Yes. The human studies section lists 2 published studies. The largest, from 2017, included 6 people. Walking distance changed by +56.0 m a year against −25.8 m a year in 8 untreated matched people (p=0.01); 4 of 6 improved 58 to 153 m, with less fibrosis and more regeneration on biopsy. The protein itself was not injected.

How long has follistatin-315 been studied in people?

Trial No human studies of the protein. The gene-therapy trials followed 15 people for up to 2 years after a single treatment.

Does follistatin-315 come in other forms, like a pill or nasal spray?

Trial Never given to people as a protein by any route. The human trials injected a gene into thigh muscle; community use is injection under the skin or into muscle. No oral or nasal form exists.

Can you drink alcohol while taking follistatin-315?

No study No data. No study has looked at follistatin and alcohol together.

Can follistatin-315 be taken with semaglutide or tirzepatide?

Precaution No study has combined them. GLP-1 drugs cause some muscle loss alongside fat loss, which is why myostatin blockers are being trialed with them, but not this protein.

What happens if you take too much follistatin-315?

No data There’s no label, no overdose data and no human dosing study of the protein. Call Poison Help (1-800-222-1222), or emergency services for severe symptoms.

Sources

  • Mendell et al., phase 1/2a follistatin gene therapy trial for Becker muscular dystrophy (Mol Ther 2015) PMID 25322757
  • Mendell et al., follistatin gene therapy for sporadic inclusion body myositis (Mol Ther 2017) PMID 28279643
  • Lerch et al., structure of the FS315-activin complex and heparin binding by the two follistatin isoforms (J Biol Chem 2007) PMID 17409095
  • Esch et al., structural characterization of follistatin, an FSH-release-inhibiting protein (Mol Endocrinol 1987) PMID 3153465
  • UniProt P19883, follistatin: 344-amino-acid precursor, signal peptide 1–29, mature chain 30–344
  • WADA 2026 Prohibited List, S4.3 myostatin-binding proteins (follistatin named) and M3 gene doping

For the protocol details

  • Kota et al., AAV1-FS344 gene delivery in cynomolgus macaques (Sci Transl Med 2009; erratum August 2026) PMID 20368179
  • Kogure et al., IV follistatin taken up mainly by the liver in rats (Hepatology 1996) PMID 8690405
  • ClinicalTrials.gov record NCT01519349, phase 1 follistatin gene transfer, 15 patients, completed October 2017

For how it works, who should avoid it and the limits of the evidence

  • Lee and McPherron, follistatin blocks myostatin and builds muscle in mice (PNAS 2001) PMID 11459935

For uses, the side-effect questions, special situations, trials, identifiers and status outside the US

  • ClinicalTrials.gov records NCT01519349, NCT02354781, NCT06411366, NCT07285629, NCT07443826 (checked October 9, 2026)
  • UniProt P19883; FDA substance record UNII 506IY26H2I; Australian Poisons Standard, October 2026

Doses tagged Community come from public dosing guides and user reports, checked against at least two of them. Those sites aren’t named here because many of them sell peptides or earn commissions on them.