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Lexicon

FST-344 (Follistatin)

A myostatin antagonist from muscle research - with a big gap between the gene-therapy data and what is actually in the vial.

6 min read 9 sources

FST-344 vial labelled follistatin with the black TPD label on a white podium, next to a large blue 3D model of a ring-shaped folded protein chain in a bright lab
Peptide preclinical · not approved

Summary

At a glance

Sources checked on 26 Oct 2026

Secreted form
315 amino acids

the FS344 variant is secreted as a protein of 315 building blocks and circulates in the blood4

Muscle mass (mice)
~4 -fold

mice without myostatin plus a follistatin gene, compared with normal mice3

Longer walking distance (gene therapy)
4 of 6

Becker patients, +29 to +125 m in the 6-minute walk test, not the peptide5

With the peptide in humans
0 trials

the registry lists only gene therapy with the FS344 gene (as of 26 Oct 2026)9

  • FST-344 is the FS344 variant of the body's own protein follistatin. Follistatin captures myostatin and activin and so releases the natural brake on muscle growth.42
  • In mice with a follistatin gene muscle mass grew strongly. Mice without myostatin reached about four times the muscle mass with extra follistatin.23
  • In humans there is only gene therapy: the FS344 gene was delivered into the thigh by a virus. In four of six patients with Becker muscular dystrophy walking distance got longer.5
  • There is no human study of the injected peptide in the vial. The gene therapy results with continuous production in the muscle cannot simply be transferred.94
  • There is no approval. Everything here is research, not a recommendation.9
Profile

Updated June 2026

Type
Follistatin-344 isoform

myostatin antagonist

Route
Subcutaneous

reconstituted

Vial
1 mg

very small amount

Evidence
Strong in gene therapy

thin for the peptide

Sizes
1 mg

1 size in the shop

Contents 16 sections
  1. At a glance
  2. What is FST-344?
  3. How it works
  4. What you need
  5. Reconstitution
  6. Injection
  7. Dosing
  8. What the research shows
  9. Research status
  10. Side effects
  11. Practice
  12. Storage
  13. Related compounds
  14. FAQ
  15. Glossary
  16. Sources

What is FST-344?

FST-344 is an isoform of the body's own protein follistatin, specifically the alternatively spliced FS344 variant. Follistatin is well known in muscle research because it is a strong antagonist of myostatin (also called GDF-8). Myostatin is the natural brake on muscle growth: without it, muscles grow beyond the normal range. You see this in double-muscled cattle like the Belgian Blue and in mice lacking the myostatin gene.

The idea is simple: if follistatin mops up myostatin, the growth brake should be released. That is why follistatin shows up in a performance context. What matters is cleanly separating where the impressive data come from - and where they do not. More on that below.

This is a freeze-dried peptide in a vial that you dissolve and inject yourself. That is fundamentally different from the gene-therapy studies you are about to read. This information is for research and educational purposes only. No medical recommendations.

Comparison

Ways to release the muscle brake

Follistatin captures the messenger. The description of the other entries comes from the lexicon.

How it works

Follistatin binds and neutralizes myostatin and related molecules from the TGF-beta family, including activin. Myostatin normally signals through the activin type II receptors and keeps muscle growth in check. If that pathway is inhibited, the brake is theoretically off - in preclinical models this led to markedly more muscle mass.

Notably, in mice completely lacking the myostatin gene, an added follistatin transgene still increased muscle mass further - up to four times the normal value. That suggests follistatin captures not only myostatin but also other growth brakes such as activin.

The key catch: all of this comes from permanent expression - either built in genetically (transgene) or delivered into muscle tissue via gene therapy, where the tissue itself continuously produces follistatin. Injected follistatin peptide, by contrast, has a very short half-life in the blood and is rapidly degraded. Whether a subcutaneous peptide injection captures enough myostatin systemically to trigger muscle growth is simply not established.

Where it acts

Where follistatin acts

Tap a point or a card. Colour = target, grey = observed. Almost all from animal studies and gene therapy.

  1. Skeletal muscle

    Larger, stronger muscles with gene therapy, from mice to monkeys7

    MyostatinActivin
  2. Pituitary gland

    Follistatin can suppress the hormone FSH, the FS344 variant was chosen to avoid this4

    Observed in trials
  3. Blood

    The secreted form circulates in the blood instead of sticking to cell surfaces4

    Observed in trials

Known targets2

Compound UniProt P19883 (Follistatin): two described targets, type of action on each card.

Myostatin (GDF-8)
Gene
MSTN
UniProt
O14793
ChEMBL
CHEMBL3407325
Action
Is bound and kept away from the ActRIIB receptor
Activin A (inhibin beta A subunit)
Gene
INHBA
UniProt
P08476
ChEMBL
CHEMBL3588735
Action
Is bound, follistatin counts as an activin-binding protein
Glass model of parallel muscle fibres, next to blue protein ribbons capturing small grey molecules
Symbolic image.

What you need

Before you start, have everything ready:

Supplies

5 things, numbered as in the picture

Tick off what you already have. Vial and BAC water are our real shop photos at the same size.

FST-344 vial and bacteriostatic water at the same size with the black TPD label, next to two U-100 insulin syringes, two alcohol swabs and a sharps container with a blue lid
  1. FST-344 vial

    The FST-344 vial with the freeze-dried powder (usually 1 mg, very little substance)

    In the shop
  2. Bacteriostatic water

    Bacteriostatic water to dissolve it

    In the shop
  3. U-100 insulin syringes

    U-100 insulin syringes for use

  4. Alcohol swabs

    Alcohol swabs for the vial cap and the skin site

  5. Sharps container

    A sealable container for used needles

As an Amazon associate we earn from qualifying purchases. Links open Amazon - no extra cost for you.

Because the vial holds only a tiny amount, careful math matters here especially - small errors in concentration make a large percentage difference.

Reconstitution

The powder is dissolved with bacteriostatic water. How much water you use determines the concentration. That in turn decides how many units you later draw on the insulin syringe for your dose. With a 1 mg vial and the usual doses you are working in a very small unit range, so it is worth using a bit more water to make drawing up more accurate.

Use the peptide calculator for exactly this: pick vial size and water amount to see the concentration and units per dose right away.

Step by step

Dissolving the powder

Four steps, the same for every vial size.

  1. 1Wipe the cap

    Clean the rubber stopper with an alcohol swab.

  2. 2Add BAC water

    Just add it, it does not matter if it hits the powder directly.

  3. 3Swirl or shake

    Until everything has dissolved, both are fine.

  4. 4Draw up

    With the U-100 insulin syringe.

Less water higher concentration fewer units on the syringe Example: 1 mg + 1 ml = 1 mg/ml

Injection

It is injected subcutaneously, into the fat under the skin. Typical sites are the belly (avoiding the area around the navel), the front and the inner side of the thigh, or the back of the upper arm.

Injection

Where and at what angle

Pick a spot or switch the angle. Subcutaneous means: into the fat layer, not the muscle.

Rotate the spot each time, never the same one twice in a row.

90°More fat under the skin

Rule of thumb: where there is more fat under the skin, insert straight at 90 degrees. In lean people with little fat, 45 degrees, so the needle stays in the fat layer. Simplified diagram.

  1. Clean the skin site with an alcohol swab and let it dry

  2. Lift a small fold of skin

  3. Insert the needle: at 90 degrees where there is more fat under the skin, at 45 degrees in lean people with little fat

  4. Inject slowly, wait briefly, withdraw the needle

  5. Needle straight into the sharps container

Rotate the injection site every time.

Dosing

Dosing

Dosing, titration and syringe

Loading the dosing information …

  • Getting started and stepping up, drawn as a staircase
  • Units on the U-100 syringe for every step
  • How long one vial lasts

What the research shows

The follistatin-myostatin axis is exceptionally well studied - but almost always in animal models or via genetic engineering:

  • Cattle and mice: A myostatin mutation produces double-muscled animals (Belgian Blue, Piedmontese). This shows how powerful myostatin is as a growth brake - preclinical, animal genetics.
  • Transgenic mice: Follistatin as a built-in transgene increased muscle mass dramatically. In myostatin-free mice it even rose to four times normal. That is permanent genetic expression, not injection.
  • Gene therapy (mouse to monkey): AAV-packaged FS344 delivered into muscle tissue increased muscle size and strength across several species.
  • Human: In a phase 1/2a gene-therapy trial, six Becker patients received AAV1-FS344 injected directly into the thigh. Some clearly improved their walking distance. Muscle tissue showed hypertrophy. But: this was a viral vector with permanent follistatin production in the muscle - not the injected peptide.

The common thread: everything convincing requires permanent follistatin production at the site of action. For the freeze-dried peptide you inject subcutaneously, there is simply no comparable human efficacy data. Using FST-344 as a peptide means operating in a largely unproven space.

Study results

What the trials measured

Interactive: switch tabs, tap points, show or hide arms. Arms are named relative to each other, no dosing advice.

6-minute walk test after gene therapy5

Change in walking distance in metres, six patients with Becker muscular dystrophy

Patient 15
Gene therapy, lower level 58 m
Patient 25
Gene therapy, lower level 125 m
Patient 35 no change
Gene therapy, lower level 0 m
Patient 45 no improvement
Gene therapy, higher level 0 m
Patient 55
Gene therapy, higher level 108 m
Patient 65
Gene therapy, higher level 29 m

Gene therapy with the FS344 gene (AAV1 virus, injected into both thigh muscles), not the peptide. No comparison group. According to the study there were no side effects. Tissue samples showed less fibrous tissue and larger muscle fibres.

Walking distance per year in inclusion body myositis6

Change in metres per year (median), 6 treated versus 8 untreated

6-minute walk test6 with an exercise programme
Untreated comparison group -25.8 m
Gene therapy, higher level +56.0 m

Gene therapy, not the peptide. Four of the six treated walked 58 to 153 m further, two only 5 to 23 m. In more advanced disease it helped less.

Muscle mass with a follistatin gene3

Compared with normal mice, as a multiple

Muscle mass across the body3 approximate values according to the abstract
Normal mice 1-fold
Without the myostatin gene 2-fold
Without myostatin, plus a follistatin gene 4-fold

Follistatin still worked without myostatin, so it also blocks further growth brakes such as activin. Genetically modified mice with continuous production, not an injected peptide.

Petri dish under a microscope with a frosted glass muscle fibre that gets thicker towards one end, next to a small glass gate
Symbolic image.

Research status

Where the research stands

The registry lists only gene therapy trials with the FS344 gene: a phase 1 trial in Becker muscular dystrophy and inclusion body myositis (15 participants) and a phase 1/2 trial in Duchenne (3 participants). There is none with the peptide in the vial. As of 26 Oct 2026. 9

  1. Preclinical Mouse models, gene therapy up to monkeys
  2. Phase 1 no registered trial
  3. Phase 2 no registered trial
  4. Phase 3 no registered trial
  5. Approval not yet
Not approved. Neither the peptide nor the FS344 gene therapy is approved.9

So far there is no registered trial in humans. 9

Side effects

Because solid human data on the injected peptide is lacking, the side-effect profile is also poorly characterized. What can be inferred from the biology and the gene-therapy data:

  • Follistatin originally derives from the ovary and can suppress follicle-stimulating hormone - so in theory it touches the hormone axis. The FS344 isoform was specifically chosen to bypass such off-target effects.
  • Local reactions at the injection site, as with any subcutaneous injection.
  • Permanently unbraked muscle growth raises long-term safety questions, for example regarding tendons and heart muscle - discussed in a preclinical frame, not studied for the peptide.

Bottom line: the real risk here is not a dramatic acute profile, but that almost nothing is known about longer-term use of this peptide form.

Practice

FST-344 is a prime example of how far a fascinating research mechanism and a sold peptide can diverge. Myostatin inhibition is real and impressively documented - but the strong effects depend on permanent expression via genetic engineering. The injected, short-lived peptide is a different thing. The evidence for it is largely missing.

Anyone looking at this in a research context should keep expectations honestly low and not be dazzled by the gene-therapy numbers. This information is for research and educational purposes only. No medical recommendations.

Storage

The undissolved powder is robust, normal room temperature (around 20 to 25 degrees) is fine, ideally kept in the dark. Once mixed, it keeps for at least 4 to 6 months in the fridge (2 to 8 °C). Bacteriostatic water brings a preservative that keeps the dissolved form stable for longer. Peptides are sensitive to heat and light - so do not leave them sitting out in the open.

Shelf life

How long it keeps

Undissolved (powder) Room temperature, around 20 to 25 degrees, dark

Robust, no fridge needed. Keeps for several months without trouble.

Dissolved (mixed) Fridge, 2 to 8 degrees

Keeps for at least 4 to 6 months. The bacteriostatic water brings a preservative.

  • Keep it dark
  • Dissolved: 2 to 8 degrees
  • Note the mixing date on the vial
Nine vials with white powder and blue caps in the door shelf of a bright fridge
Powder dark at room temperature, once dissolved into the fridge (2 to 8 degrees), stable there for at least 4 to 6 months, protect from heat and light. Symbolic image.

Related

Related compounds

Same targets or a different path: all in the TPD lexicon.

FAQ

Common questions about FST-344 (Follistatin)

Short answers, each backed by the sources below.

Is FST-344 approved or studied in humans?

It is not approved. As of 26 October 2026 ClinicalTrials.gov lists no trial with injected follistatin peptide. There are only gene therapy trials that deliver the FS344 gene into muscle by virus: a phase 1 trial in Becker muscular dystrophy and inclusion body myositis and a phase 1/2 trial in Duchenne.98

What does the 344 mean?

FS344 is one of two splice variants of the follistatin gene. Mendell's group chose it because the secreted protein of 315 building blocks circulates in the blood instead of binding to cell surfaces. That was meant to keep effects outside the muscle, for example on the hormone FSH, small.45

What did gene therapy show in humans?

Six patients with Becker muscular dystrophy received the FS344 gene into both thighs. Four walked 29 to 125 m further in the 6-minute walk test, two did not. According to the study there were no side effects. In inclusion body myositis the treated improved by 56 m per year, eight comparable untreated patients got worse by 25.8 m.56

Does this transfer to the peptide in the vial?

Not easily. All convincing data come from continuous production: mice with a follistatin gene or gene therapy where the muscle itself keeps making follistatin. For an injected peptide there is no study showing an effect in humans.259

Why does follistatin work more strongly than just lacking myostatin?

Because it does not only capture myostatin. Mice entirely without myostatin had about twice the muscle mass of normal mice, with an extra follistatin gene about four times as much. So there must be further brakes that follistatin also releases, such as activin.3

Which risks are discussed?

Follistatin was first found in the ovary and can suppress the hormone FSH. That raises questions about the hormone axis and fertility. In the animal studies with FS344 up to monkeys the researchers found no organ damage and no change in fertility. This has not been studied for the injected peptide.47

Glossary

Terms explained briefly

Dotted words in the text open these explanations directly.

6-minute walk test
Measures how many metres someone can walk in six minutes. A common test in muscle diseases.
AAV
Adeno-associated virus: a disarmed virus used as a carrier for genes.
Activin
Related messenger from the same family as myostatin. It also brakes muscle growth.
Becker muscular dystrophy
Inherited muscle disease with progressive weakness, a milder form of Duchenne muscular dystrophy.
Follistatin
Body's own protein that captures myostatin and activin. That releases the natural brake on muscle growth.
FSH
Follicle-stimulating hormone from the pituitary gland, important for eggs and sperm production.
Gene therapy
A gene is delivered into cells, which then make the protein themselves for a long time. Here via a disarmed virus (AAV) into the muscle.
Isoform
One of several forms of a protein that come from the same gene, depending on how the blueprint is assembled.
Lyophilisate
Freeze-dried powder. Without water a peptide keeps much longer.
Myostatin
Messenger (also GDF-8) that limits skeletal muscle growth.

Evidence

Sources

Show all 9 sourcesHide sources 7 Studies2 Trial registry checked 26 Oct 2026

Studies

  1. Double muscling in cattle from mutations in the myostatin gene

    McPherron und Lee, PNAS, 1997

    Checked 26 Oct 2026 via doi.org, Crossref, PubMed
  2. Follistatin blocks myostatin, more muscle in mice with a follistatin gene

    Lee und McPherron, PNAS, 2001

    Checked 26 Oct 2026 via doi.org, Crossref, PubMed
  3. Four-fold muscle mass in mice without myostatin plus follistatin

    Lee, PLoS ONE, 2007

    Checked 26 Oct 2026 via doi.org, Crossref, PubMed
  4. Review of follistatin FS344 as gene therapy, mice to monkeys

    Rodino-Klapac et al., Muscle & Nerve, 2009

    Checked 26 Oct 2026 via doi.org, Crossref, PubMed
  5. FS344 gene therapy in Becker muscular dystrophy (phase 1/2a)

    Mendell et al., Molecular Therapy, 2015

    Checked 26 Oct 2026 via doi.org, Crossref, PubMed
  6. FS344 gene therapy in inclusion body myositis

    Mendell et al., Molecular Therapy, 2017

    Checked 26 Oct 2026 via doi.org, Crossref, PubMed
  7. Follistatin gene therapy strengthens muscles in monkeys

    Kota et al., Science Translational Medicine, 2009

    Checked 26 Oct 2026 via doi.org, Crossref, PubMed

Trial registry

  1. Gene therapy trial with the FS344 gene on the registry

    ClinicalTrials.gov, NCT01519349

    Checked 26 Oct 2026 via ClinicalTrials.gov API v2
  2. Search on ClinicalTrials.gov (no trial with the peptide)

    ClinicalTrials.gov, U.S. National Library of Medicine

    Checked 26 Oct 2026 via ClinicalTrials.gov API v2

In the shop

FST-344 (Follistatin) in the catalog

Sizes, prices and shipping times are on the product page.

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