Hormonal · Dosing reference

Teduglutide dosage

Dosing as the FDA label states it, how long trials ran, and the arithmetic for working with vials.

FDA-approvedAHuman trial evidenceFDA label

Full research page Cycle-length evidence Compare Prefer Amiravo on Google

Regulatory status: FDA-approved
Human amounts: 0.05 mg/kg once daily (adults and children 1 year and older); 0.025 mg/kg once daily if eGFR is below 60 mL/min/1.73 m2 (GATTEX label)
Route studied: Subcutaneous injection
Frequency: Once daily
Half-life: About 2 hours (healthy) and 1.3 hours (SBS)
Evidence grade: Grade A · Human trial evidence
Vial sizes on the market: Not recorded
Other forms seen: —

What Teduglutide is

Teduglutide is a 33-amino-acid GLP-2 analog, FDA-approved since 2012 as Gattex for adults and children aged 1 year and older with short bowel syndrome who depend on parenteral support.

Teduglutide is an analog of GLP-2, a peptide secreted by L-cells of the distal intestine that increases intestinal and portal blood flow and inhibits gastric acid secretion ^1. Receptor actions It binds GLP-2 receptors on intestinal enteroendocrine cells, subepithelial myofibroblasts and enteric neurons, leading to local release of IGF-1, nitric oxide and keratinocyte growth factor ^1. Clinical correlate In STEPS,… How it works →

Key evidence

Jeppesen et al., Gastroenterology (STEPS, NCT00798967) · 2012 · Humans (86 adults with SBS and intestinal failure)
Responders 63% versus 30% (P = .002); mean parenteral support reduction 4.4 versus 2.3 L/week; 54% versus 23% gained at least one day off per week ^3. ³
GATTEX prescribing information, Studies 2 and 4 (extensions) · 2025 · Humans (adults with SBS)
Of 30 patients completing 30 months, 93% had at least 20% reduction in parenteral support and 10 were weaned off; in Study 4, 75% of earlier responders sustained response at 1 year ^1. ¹
GATTEX prescribing information, pediatric studies · 2025 · Humans (41 children aged 1 to under 17 with SBS)
Safety profile similar to adults; anti-teduglutide antibodies in 54% at month 12 versus 24% in adults ^1. ¹

All studies on the research page

Dosing as stated on the FDA label

Short bowel syndrome dependent on parenteral support (GATTEX): 0.05 mg/kg subcutaneously once daily for adults and pediatric patients aged 1 year and older ^1.
Moderate or severe renal impairment or end-stage renal disease (eGFR below 60 mL/min/1.73 m2): 0.025 mg/kg once daily ^1.
The label requires baseline colonoscopy and upper GI endoscopy with polyp removal (adults) or fecal occult blood testing (children) within 6 months before starting, plus bilirubin, alkaline phosphatase, lipase and amylase at baseline and every 6 months ^1.
Twice the recommended dose (0.1 mg/kg/day), tested in Study 3, is not a recommended dosage per the label ^1.

How long did human studies run?

No human study durations are recorded for Teduglutide.

Cycle-length evidence for Teduglutide

Side effects reported in studies

Abdominal pain
30% versus 22% placebo · Adults with SBS, Studies 1 and 3 (24 weeks) ¹
Nausea
23% versus 20% · Same ¹
Upper respiratory tract infection
21% versus 12% · Same ¹
Abdominal distension
20% versus 2% · Same ¹
Gastrointestinal stoma complication
42% (13/31) versus 14% (3/22) · Adults with a stoma in placebo-controlled studies ¹
Intestinal obstruction/stenosis
4% (recommended dose) and 9% (twice the recommended dose) versus 0% placebo · Adult placebo-controlled studies ¹
Peripheral edema / congestive heart failure
10% versus 3% / 2 CHF cases on teduglutide · Adult placebo-controlled studies ¹

Full adverse-event data

Supplies and handling

Lyophilized vial
Sealed vial with the freeze-dried cake. Check the label, lot and the certificate of analysis before opening.
Sterile diluent
The diluent named on the product documentation. Bacteriostatic water contains benzyl alcohol; sterile water does not.
Graduated syringes
Sized to the volume being measured. U-100 insulin syringes are graduated in units where 100 units = 1 mL.
Alcohol prep pads
For wiping vial stoppers before each puncture.
Nitrile gloves
Clean gloves for aseptic handling.
Sharps container
Puncture-resistant container for used needles.

Step-by-step reconstitution guide Storage and transport accessories

Storage

Follow the current GATTEX label for kit storage and the reconstituted solution; research material per supplier documentation.

Lyophilized (unmixed) vials: typically stored cold and dry, away from light, as the documentation directs. Many are stable longer frozen.
Reconstituted vials: typically refrigerated (about 2–8 °C), protected from light and not frozen.
Bacteriostatic water contains benzyl alcohol, which inhibits bacterial growth in multi-use vials; sterile water has no preservative.

Handling mistakes and troubleshooting

Added the wrong volume of diluent: The concentration changes, not the amount of compound in the vial. Recalculate with the volume actually added and relabel the vial.
Shook the vial and it foamed: Let it settle in the refrigerator. Foam is a sign of agitation; some peptides aggregate when shaken. Note it on the label.
The solution is cloudy or has particles: Do not use it. Cloudiness can indicate incomplete dissolution, contamination or degradation. Record the lot and contact the supplier with the certificate of analysis.
The powder cake looks melted or shrunken before reconstitution: This can indicate the vial was exposed to heat or moisture. Record the lot and condition on arrival.
Liquid sprayed back when the needle was removed: Pressure built up in the vial. Withdraw a small volume of air while adding diluent to keep pressure neutral.

Regulatory status

Status: FDA-approved as GATTEX (NDA 203441, original approval December 21, 2012) for adults and pediatric patients 1 year of age and older with short bowel syndrome who are dependent on parenteral support; label reviewed from the September 18, 2025 DailyMed version ^1,2.
United States (FDA): FDA-approved under NDA 203441 (GATTEX KIT, Takeda), original approval December 21, 2012 per Drugs@FDA ^2; current indication per the September 2025 label covers adults and children aged 1 year and older with SBS dependent on parenteral support ^1.
Sport (WADA): Teduglutide is not named in the 2026 Prohibited List text reviewed; as an approved drug it is outside S0, but S2.3 covers other growth factors or modulators affecting tissue regenerative capacity, so status should be confirmed with the relevant anti-doping organization ^4.

Status varies by country and changes over time. How we describe regulatory status.

Teduglutide compared with related compounds

Compound	Status	Evidence	Human amounts	Half-life
Teduglutide	FDA-approved	A	FDA label	About 2 hours (healthy) and 1.3 hours (S
Kisspeptin-54	Not approved — research use only	B	None established	About 28 minutes (intravenous, healthy m
Apelin-13	Not approved — research use only	B	None established	Not located as a numeric value in the so
hCG (human chorionic gonadotropin)	FDA-approved	A	FDA label	About 29 hours (recombinant hCG, subcuta
Octreotide	FDA-approved	A	FDA label	1.7-1.9 hours (injection)
Vasopressin	FDA-approved	A	FDA label	10 minutes or less at shock infusion rat

Frequently asked questions

What doses of Teduglutide have been studied in humans?

Teduglutide is FDA-approved, so the label states the dosing for the approved product. This page quotes it, with citations. It does not apply to research-grade material.

Is there an established Teduglutide cycle length?

No. We found no human studies that report treatment duration for Teduglutide.

How much bacteriostatic water should be added to a Teduglutide vial?

There is no compound-specific volume. The diluent volume only sets the concentration: concentration = mass in the vial ÷ volume added (for example, 10 mg in 2 mL gives 5 mg/mL). The calculator on this page shows the arithmetic for any combination.

How many units is a given amount on an insulin syringe?

On a U-100 syringe, 100 units = 1 mL. Units for an amount = amount ÷ (concentration per unit). The calculator converts any amount you enter at the concentration you choose; a unit is a volume mark, not an amount of compound.

What is the half-life of Teduglutide?

About 2 hours (healthy) and 1.3 hours (SBS)

Is Teduglutide FDA-approved?

FDA-approved. FDA-approved as GATTEX (NDA 203441, original approval December 21, 2012) for adults and pediatric patients 1 year of age and older with short bowel syndrome who are dependent on parenteral support; label reviewed from the September 18, 2025 DailyMed version ^1,2.

References

GATTEX (teduglutide) for injection, prescribing information (DailyMed SPL version 20, published Sep 18, 2025) FDA label (DailyMed). 2025
Drugs@FDA application NDA 203441 (GATTEX KIT, Takeda; original approval 2012-12-21) via openFDA FDA (openFDA Drugs@FDA). 2026
Teduglutide reduces need for parenteral support among patients with short bowel syndrome with intestinal failure Gastroenterology. 2012
Tractatenblad 2026 Nr. 25: Anti-doping convention (ETS No. 135), amendment to the appendix - The 2026 Prohibited List, World Anti-Doping Code (English text; entry into force 1 January 2026) Tractatenblad van het Koninkrijk der Nederlanden (official government publication). 2026
PubChem compound record for teduglutide (CID 16139605) PubChem. 2026

Last reviewed October 24, 2026 by the Amiravo editorial team. Editorial policy · Report an error