Vial Guide
PreclinicalMyostatin and activin blocker

Follistatin-344

FST344, FS344, follistatin

Common dose
100 mcg daily (community)
Cycle
No set cycle
Vial sizes
1 mg
Typical draw
10 units1 mg with 1 mL, 100 mcg

A protein the body makes that mops up myostatin and activin, two signals that hold muscle growth back. Blocking them builds muscle in animals.

Evidence. No published study has given follistatin protein to a person. Human testing has been gene therapy instead: a Phase 1 trial injected an AAV1 virus carrying the FS344 gene into the thigh muscles of 15 people with Becker muscular dystrophy or inclusion body myositis, and most walked further afterwards. A separate follistatin-based fusion protein, ACE-083, was injected into muscle in two Phase 2 trials (95 and 63 patients) that were both terminated.

Status

Approval
Not approved as a drug in the US or EU, and no follistatin product is approved anywhere. Human testing has been limited to gene therapy trials that ended in 2017 and to a follistatin-based fusion protein, ACE-083, whose Phase 2 trials in facioscapulohumeral muscular dystrophy and Charcot-Marie-Tooth disease were terminated.
US compounding
Never nominated for pharmacy compounding, so it appears on neither FDA’s Category 1 nor Category 2 bulk substance lists (April 2026 snapshot).
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 of every compound.

How it works

Follistatin is a protein the body makes that binds myostatin and activin, two signals that hold back muscle growth, and stops them reaching their receptors. In mice, follistatin made in muscle produced large muscle gains. It was first identified as a protein that lowers FSH, a pituitary hormone needed for fertility. Human trials delivered the FS344 gene, not the protein, into thigh muscle with a virus.

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

About 100 mcg once daily for 10–30 days is the figure that recurs, but public guides range from 50 to 300 mcg a day and none of them cite a study. No dose of the protein has been tested in people.

Trial

Mendell 2015 and 2017

Gene therapy, not protein: a single set of injections of 2 × 10¹¹ to 6 × 10¹¹ vg/kg per thigh of an AAV1 vector carrying FS344.

Frequency
Once daily
Route
Subcutaneous or intramuscular injection (community). The human trials delivered the follistatin gene into muscle with a virus, not the protein.
Cycle
Reports run 10 to 30 days, then 3 to 4 weeks off. No study supports any schedule.

No set cycle, shown over 26 weeks

Common protocols

The ways Follistatin-344 is most often run, each tagged with where it comes from.

Community injection

Community
Dose
100 mcg (guides say 50–300 mcg)
How often
Once daily
How long
10–30 days, then a break of 3–4 weeks

Not tested in any study. The public guides disagree by sixfold and none of them cite a source for the numbers.

Draw 10 units1 mg + 1 mL

Gene therapy, inclusion body myositis

Trial
Dose
6 × 10¹¹ vg/kg per leg of rAAV1.CMV.huFS344
How often
One set of injections into both quadriceps
How long
Single treatment, followed about a year

Six patients, with an exercise program alongside. Walking distance improved against 8 untreated matched people (Mendell 2017).

Gene therapy, Becker muscular dystrophy

Trial
Dose
3 × 10¹¹ or 6 × 10¹¹ vg/kg per leg of AAV1.CMV.FS344
How often
One set of injections into both quadriceps
How long
Single treatment, safety followed 2 years

Six patients in two dose groups. Four walked further, two did not change, and no adverse effects were reported (Mendell 2015).

Taking it

Where it goes

The trials used multiple direct injections into the quadriceps muscle of both legs, in hospital. Community use is subcutaneous injection with rotating sites, or injection into the muscle someone wants to grow, neither of which has been studied.

If you miss a dose

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

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 on the 6-minute walk test and 2 did not change. No adverse effects were reported.

    Trial
  3. 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

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 the protein, which no study has done.

Lower FSH and knock-on effects on reproductive hormones

Expected from blocking activin, which is why the trials chose the FS344 form. 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.

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.

Who should avoid it

No product label covers follistatin-344, 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 first identified 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.

Interactions

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

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.

Tracking and pairing

Worth tracking

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

Often paired with

  • 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 together.

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 and 2 improved 5 to 23 m, with less fibrosis and more regeneration on biopsy.

    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 rAAV1.CMV.huFS344 injected 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 AAV1.CMV.FS344 injected into both quadriceps
    Length
    Single treatment, safety followed 2 years

    Mendell et al., Mol Ther 2015, PMID 25322757

All human studies on Vial Guide

Limits of the evidence

No published study has given follistatin protein itself 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; most walked further. ACE-083, an engineered follistatin-based drug, grew the injected muscle in a placebo-controlled study of 58 healthy women but didn’t make it stronger, and its Phase 2 trials were terminated. Injecting follistatin under the skin is untested for dose, effect and safety.

Mixing your vial

VialWaterCommon doseDrawStrengthAction
1 mg1 mL100 mcg10 units (0.10 mL)1 mg/mL

Vials are usually 1 mg. With 1 mL of bacteriostatic water, 100 mcg is 10 units on a U-100 syringe. This is a glycoprotein, not a short peptide: research-grade follistatin is made up with a carrier protein such as albumin, because without it the protein sticks to the glass and is lost.

Dose chart

1 mg vial

Syringe units for common doses at different water volumes. Select a cell to open it in the calculator.

DoseWater added
1 mL2 mL3 mL
50 mcg
60 mcg
75 mcg
100 mcg
150 mcg
200 mcg
250 mcg
300 mcg

U-100 insulin syringe: 100 units is 1 mL. Draws over 100 units show in mL. Faded values are under 2 units, which is hard to measure. Check that your vial holds the larger volumes.

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.
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. The gel range comes from a datasheet for recombinant human follistatin (amino acids 30–344) made in hamster ovary cells, predicted 34.7 kDa
  • 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.

Cautions

  • What is sold as follistatin-344 is a protein grown in living cells. Vials rarely say which cells made it, and nothing checks the identity, the sugar coating or the amount.
  • Injecting follistatin has never been tested in people. The trials put the gene into muscle with a virus, which then makes the protein in place.
  • Follistatin also blocks activin, which can lower follicle-stimulating hormone (FSH) and shift reproductive hormones. Trials used the FS344 form partly because it binds activin less tightly.
  • Banned in sport at all times: WADA names follistatin as a myostatin-binding protein (S4.3).

Questions

What is follistatin-344?

A protein the body makes that mops up myostatin and activin, two signals that hold muscle growth back. Blocking them builds muscle in animals.

How does follistatin-344 work?

Follistatin is a protein the body makes that binds myostatin and activin, two signals that hold back muscle growth, and stops them reaching their receptors. In mice, follistatin made in muscle produced large muscle gains. It was first identified as a protein that lowers FSH, a pituitary hormone needed for fertility. Human trials delivered the FS344 gene, not the protein, into thigh muscle with a virus. 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-344 FDA-approved?

Not approved as a drug in the US or EU, and no follistatin product is approved anywhere. Human testing has been limited to gene therapy trials that ended in 2017 and to a follistatin-based fusion protein, ACE-083, whose Phase 2 trials in facioscapulohumeral muscular dystrophy and Charcot-Marie-Tooth disease were terminated. Never nominated for pharmacy compounding, so it appears on neither FDA’s Category 1 nor Category 2 bulk substance lists (April 2026 snapshot).

What is the usual follistatin-344 dose?

From community reports, not established: About 100 mcg once daily for 10–30 days is the figure that recurs, but public guides range from 50 to 300 mcg a day and none of them cite a study. No dose of the protein has been tested in people. From human studies (Mendell 2015 and 2017): Gene therapy, not protein: a single set of injections of 2 × 10¹¹ to 6 × 10¹¹ vg/kg per thigh of an AAV1 vector carrying FS344. These are the amounts sources reference, not recommendations.

How much water do I mix follistatin-344 with?

There’s no single right amount, because the water only sets the strength. With 1 mL of bacteriostatic water in a 1 mg vial, the strength is 1 mg/mL, so 100 mcg is 10 units on a U-100 insulin syringe. More water makes small doses easier to measure. The dose chart above shows other volumes.

Who should avoid follistatin-344?

No product label covers follistatin-344, 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 first identified 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.

What is the half-life of follistatin-344?

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.

How should follistatin-344 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-344 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-344 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 and 2 improved 5 to 23 m, with less fibrosis and more regeneration on biopsy.

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
  • UniProt P19883, follistatin precursor (344 amino acids)

For the protocol details

  • Al-Zaidy et al., review of follistatin gene therapy in Becker muscular dystrophy (J Neuromuscul Dis 2015) PMID 27858738
  • 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
  • Esch et al., follistatin identified as an FSH-lowering protein (Mol Endocrinol 1987) PMID 3153465
  • Kogure et al., IV follistatin taken up mainly by the liver in rats (Hepatology 1996) PMID 8690405
  • Glasser et al., ACE-083 injected into muscle in healthy women, Phase 1 (Muscle Nerve 2018) PMID 29486514

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.