Apraglutide_Dosage, benefits & legal status
Also known as FE 203799, FE203799, FE-203799, apraglutide sodium
GLP-2 with four changed amino acids that stretch it to a weekly shot, with no fatty chain or PEG. In phase 3 it cut intravenous support by 25.5% against 12.5% on placebo, but not significantly in people whose colon is still connected.
Common vial size is what vendors typically sell, not a recommendation. Enter your own vial in the calculator.
What is Apraglutide?
Plain language first. The technical label stays, but it never stands alone.Overview
People with short bowel syndrome often rely on nutrition and fluids through a vein several days a week, and a weekly injection would mean far fewer shots than the daily treatment approved now. In the STARS phase 3 (164 enrolled, 163 dosed), weekly intravenous support volume fell 25.5% against 12.5% on placebo at 24 weeks (p=0.001), with the clearest effect in people with a stoma. In people whose colon is still connected the difference was not significant (p=0.179), the trial delivered less drug than planned, and the FDA asked for a confirmatory trial with primary completion estimated for October 2028.
Apraglutide is human GLP-2(1-33) with glycine at 2 (as in teduglutide), norleucine at 10, D-phenylalanine at 11 and leucine at 16, and an amidated C-terminus, with no lipid, PEG or other conjugate. Slower absorption, reduced clearance and higher protein binding than native GLP-2 extend its action; the half-life was about 30 hours in healthy volunteers against about 2 hours for teduglutide, supporting once-weekly dosing against daily for teduglutide and twice weekly for glepaglutide. It was discovered at Ferring Research Institute, developed by Therachon and then VectivBio, and has belonged to Ironwood Pharmaceuticals since 2023.
What it's used for
An experimental once-weekly injection for adults with short bowel syndrome who need intravenous nutrition or fluids. It is not approved anywhere.
How does Apraglutide work?
What it does in the body, and where.Apraglutide copies GLP-2, the gut hormone that tells the intestine to grow its lining and absorb more, and is changed to last a week.
- 01Built to lastGlycine at position 2 resists cutting by the enzyme DPP-4, as in teduglutide, and the swaps at 10, 11 and 16 slow breakdown further. It binds blood proteins more than native GLP-2 and is cleared slowly (16.5 to 20.7 L a day in healthy volunteers), without a fatty chain or PEG.
- 02
- 03More absorptionOver weeks the absorptive lining grows: blood citrulline stayed raised 10 to 17 days after the last dose in healthy volunteers. The remaining bowel absorbs more fluid and nutrients, so less intravenous support is needed.
A schematic of the compound's mechanism, not a diagnostic image.
What else is it used for?
Each group carries its own evidence level.Approved means regulators have cleared it for that purpose. Investigational means it is in trials. Early research means it is being studied and is not established.
Phase 3 STARS, all patients
Investigational- Human trialWeekly support volume fell 25.5% against 12.5% on placebo at 24 weeks (p=0.001), the primary endpoint.
- Human trial43.0% against 27.5% gained at least one day a week off support at week 24 (p=0.040), the first key secondary endpoint.
Stoma versus colon in continuity
Investigational- Human trialStoma: support volume fell 25.6% against 7.8% (p<0.001).
- No dataColon in continuity: 25.2% against 17.6% (p=0.179), not significant.
Under-dosing and the FDA
Investigational- No dataAnalysis for the US application found the exposure and dose delivered in STARS were lower than planned, attributed to dose preparation and administration.
- RegulatoryThe FDA indicated a confirmatory phase 3 is needed to seek approval; Ironwood expects the STARS data to remain part of an eventual application.
Phase 2, stoma
Investigational- human-earlyPlacebo-controlled crossover in 8 people: urine output rose 714 mL a day on 5 mg and 795 mL a day on 10 mg weekly against placebo, with no difference between doses.
Phase 2, colon in continuity (STARSnutrition)
Investigational- human-early9 people, open label: weekly support volume fell 4,702 mL (52%) at week 52 (p<0.001), and 7 of 9 gained at least one day off support.
- human-earlyEnergy absorption rose 1,134 kJ a day at week 48 (p=0.041) and wet weight absorption 316 g a day (p=0.039).
The headline 25.5% against 12.5% is often quoted without two facts: in people with the colon still connected the difference was not significant (25.2% against 17.6%, p=0.179), and Ironwood disclosed that STARS delivered less drug than planned. STARS is reported as both 163 and 164 patients; 164 were enrolled and 163 dosed. It is sometimes described as filed or close to approval, but after a rolling US application began in January 2025 the FDA asked for a confirmatory phase 3, and STARS-2 is not expected to reach primary completion before October 2028. Ironwood reported that STARS-2 started in June 2026, while the registry lists an estimated August 2026 start. The publication is indexed with a date of September 1, 2026; a September 3, 2026, online date could not be confirmed. The 30-hour half-life comes from single doses in healthy volunteers, not from people with short bowel syndrome, and animal figures in minutes (159 in rats, 474 in monkeys, 782 in minipigs) are not human values. Among GLP-2 drugs, teduglutide is daily (about 2 hours), glepaglutide twice weekly (about 88 hours effective) and apraglutide weekly. It is sometimes called the first once-weekly GLP-2; it is the most advanced in development, and no once-weekly GLP-2 is approved anywhere. The acquisition is quoted as $1 billion (net of VectivBio's cash and debt) and $1.2 billion (aggregate consideration); both are right. Enteral autonomy in the open-label extension is given as 27 and 34 patients; Ironwood's figure is 34 as of January 2025, separate from the blinded STARS rate. GSRS lists an estimated 3760.0 Da and formula C172H264O48N46 that do not match the sequence; about 3.8 kDa is the safe figure.
The published record
Papers and trials about Apraglutide
34 papers tagged human · 13 not reviews or lab · 7 clinical trial publications
12 registered trials · 4 with posted results
Furthest stage reached: Phase 3, completed, no results posted
Counted from Europe PMC indexing, not read by a person; a human tag can land on reviews, commentary or lab papers; clinical trial publications is the narrower count.
At a glance
Four things to know about Apraglutide
Evidence
Investigational
Category
Healing and recovery
Common vial
Varies
Half-life
About 30 hours (healthy volunteers, single dose)
How much, and do you cycle it?
The range, and whether you take breaks.2.5 or 5 mg once weekly, by body weight (phase 3 trial), once weekly. Continuous in the trials Trial dose
Given weekly for 24 weeks in STARS, for 48 weeks in people with the colon connected, and longer in the open-label STARS Extend, with no planned breaks.
How long does it stay in the body?
The half-life, and where the figure comes from.About 30 hours (healthy volunteers, single dose)Trial protocol
From a single-ascending-dose study in 40 healthy volunteers; no half-life in people with short bowel syndrome is established. In a multiple-dose study, clearance was 16.5 to 20.7 L a day and citrulline stayed raised 10 to 17 days after the last dose. Teduglutide lasts about 2 hours (1.3 hours in short bowel syndrome) and glepaglutide about 88 hours effective. Animal half-lives (159 minutes in rats, about 474 in monkeys and 782 in minipigs) are not human figures.
Source: Bolognani F et al., CIRTA 2019 phase 1 abstract (40 healthy volunteers)
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How do I dose and price it?
Enter your vial and your dose. Pick a mix. We show the draw and the cost.The vial holds a fixed amount of drug. Adding more water does not make more drug, it just spreads it thinner, so you draw a bigger number on the syringe for the same dose.
Choose your mix
Measuring the water1 mL = one full 100-unit syringe.
How do you store it?
Before mixing, and after.Dry powder in the freezer or fridge. Once mixed, fridge, and use within about a month.
Unmixed lyophilized Apraglutide keeps for a long time cold. Once you add water the clock starts: most reconstituted vials hold up for roughly 28 to 30 days at fridge temperature. Keep it out of light, and do not freeze it after mixing.
What are the side effects and cautions?
Known cautions and warnings for this compound.Solubility, computed: 30% charged residues, 45% hydrophobic. Water usually sufficient.
A first-pass rule from peptide manufacturers' guidance. It does not account for disulfide bridges, salt form or how the powder was dried, and it predicts what should be easy rather than what will happen in your vial.
Who should avoid it
- Not studied in children: STARS enrolled adults 18 and over
- Not studied in pregnancy or breastfeeding
- Not studied in anyone with cancer, including colon cancer, within the past 5 years
- Not studied in active inflammatory gut disease, major abdominal surgery in the past 6 months, decompensated heart failure, or severe kidney or liver impairment
- Use outside a clinical trial: it is not approved anywhere
Stop and get help
- Swelling of the legs, breathlessness or rapid weight gain, possible fluid overload
- Severe abdominal pain, bloating or vomiting with little or no stool or stoma output, a possible bowel or stoma blockage
- Blood in the stool: the approved GLP-2 drug teduglutide carries a warning that it can speed the growth of tumors
Common effects
- In STARS, 3.6% stopped for side effects against 1.9% on placebo; the trial described it as generally well tolerated, with a safety profile consistent with earlier studies
- In a phase 2 stoma study of 8 people, treatment-related effects were mild to moderate: more urine, less stoma output, stoma problems, less thirst and swelling
- In a 52-week phase 2 in 9 people with the colon connected, 127 side effects were recorded, mostly mild to moderate
- In healthy volunteers, no serious side effects and four moderate ones at single doses of 11.4 and 28.4 mg, with no effect on heart rhythm
Where this page says nothing is established, that means nobody has studied it, not that a compound is safe.
Is Apraglutide approved?
And where the numbers on this page come from.No. Apraglutide is not approved anywhere and is currently in company-run clinical trials. There is no legal route to obtain it outside a trial.
- Approval statusInvestigational
- RouteUnder the skin (subcutaneous)
- Checked17 October 2026
- DoseFrom published clinical trials. Not approved by a regulator for this dose.
- Vial sizeFrom what vendors typically list; not a recommendation.
- SourcesFDA GSRS substance record, apraglutide (UNII CVQ1IAY2G6)Hargrove et al., Journal of Pharmacology and Experimental Therapeutics 2020;373(2):193-203Ironwood, STARS topline results (Business Wire, February 29, 2024)Joly F et al., Clinical Gastroenterology and Hepatology 2026 (STARS)Medicom, STARS results at DDW 2024Ironwood, clinical and regulatory update (April 14, 2025)Fierce Biotech, Ironwood after the FDA request (April 14, 2025)Ironwood, second-quarter 2026 results (Business Wire, August 6, 2026)ClinicalTrials.gov, STARS-2 (NCT07742735)Ironwood, second-quarter 2023 results (SEC filing, August 8, 2023)Bolognani F et al., Journal of Pharmacology and Experimental Therapeutics 2023;386(2):129-137Bolognani F et al., CIRTA 2019 phase 1 abstractVerbiest et al., Clinical Nutrition 2024;43(12):158-166 (STARSnutrition)Gattex (teduglutide) US label, DailyMed
What has happened recently
Not approved anywhere, and no application has been accepted. Discovered at Ferring Research Institute in San Diego (code FE 203799), it was in development at Therachon of Basel when it received EU orphan designation for short bowel syndrome on November 19, 2018, and FDA orphan drug designation on December 20, 2018. When Pfizer bought Therachon in 2019, apraglutide was spun out into VectivBio, launched with $35 million in January 2020. The FDA added an orphan designation for preventing acute graft-versus-host disease on May 25, 2021. Ironwood Pharmaceuticals announced a deal to buy VectivBio on May 22, 2023, for about $1 billion net of cash and debt and completed the deal on June 29, 2023; Asahi Kasei Pharma holds Japanese rights. Ironwood began a rolling US application in January 2025, but on April 14, 2025, it said the FDA had indicated a confirmatory phase 3 is needed, and disclosed that drug exposure in STARS was lower than planned. That trial, STARS-2 (NCT07742735, 24 weeks, about 124 people), is recruiting: Ironwood reported a June 2026 start, while the registry lists an estimated August 2026 start and primary completion in October 2028. No filing date has been given.
You can compare this against the whole library, or read how to check a seller.
What else is like Apraglutide?
Others in Healing and recovery, side by side.If you're weighing Apraglutide, it's worth reading Bivalirudin (Angiomax), Calcitonin (salmon), and Canvuparatide in the same class.
GLP-2 with four changed amino acids that stretch it to a weekly shot, with no fatty chain or PEG. In phase 3 it cut intravenous support by 25.5% against 12.5% on placebo, but not significantly in people whose colon is still connected.
- Dose
- 2.5 or 5 mg once weekly, by body weight (phase 3 trial)
- How often
- Once weekly
A short-acting synthetic anticoagulant that grips thrombin at two sites. FDA-approved since 2000; it wears off within about an hour.
- Dose
- 0.75 mg/kg bolus, then 1.75 mg/kg/h during the procedure (label)
- How often
- Infusion for the procedure, sometimes up to 4 hours after
A bone hormone borrowed from salmon, and the weakest option in its own category.
- Dose
- Set by the label
- How often
- Daily, by spray or injection
Parathyroid hormone fitted with fatty tails and a self-releasing cap so one injection lasts a week. Phase 3 started in August 2026.
- Dose
- 400 to 1,600 mcg once weekly (phase 3 range; 600 mcg for the first 4 weeks)
- How often
- Once weekly
Guides for this compound
- How to Reconstitute a Peptide
Mix peptide powder with bacteriostatic water, step by step.
- How to Read an Insulin Syringe
Read the units, convert to millilitres, and draw the exact dose.
- mcg vs mg: The Peptide Dosing Mistake to Avoid
Your vial says mg and your protocol says mcg. Here is the conversion and how to check it.
- How to Read a Peptide COA
What the purity number does and does not tell you, and how to spot an edited report.
- How to Vet a Peptide Vendor
Independent COAs, HPLC purity, and the red flags that mean walk away.
Sources
- FDA GSRS substance record, apraglutide (UNII CVQ1IAY2G6)(2026)33-residue sequence with norleucine 10, D-phenylalanine 11 and a C-terminal amide; CAS 1295353-98-8; FDA and EU orphan codes.
- Hargrove et al., Journal of Pharmacology and Experimental Therapeutics 2020;373(2):193-203(2020)[Gly2, Nle10, D-Phe11, Leu16]hGLP-2(1-33)-NH2 from Ferring Research Institute; about 2-fold more potent than GLP-2 and teduglutide; selectivity over 33,000; long animal half-lives.
- Ironwood, STARS topline results (Business Wire, February 29, 2024)(2024)164 enrolled, 163 dosed: support volume down 25.5% against 12.5% (p=0.001); key secondary results; generally well tolerated.
- Joly F et al., Clinical Gastroenterology and Hepatology 2026 (STARS)(2026)Peer-reviewed STARS publication: 80 stoma and 83 colon-in-continuity patients; once-weekly apraglutide reduced parenteral support.
- Medicom, STARS results at DDW 2024(2024)Weight-based 2.5 or 5 mg weekly; colon-in-continuity subgroup 25.2% against 17.6% (p=0.179); stopping for side effects 3.6% against 1.9%.
- Ironwood, clinical and regulatory update (April 14, 2025)(2025)FDA indicated a confirmatory phase 3 is needed; exposure and dose delivered in STARS were lower than planned.
- Fierce Biotech, Ironwood after the FDA request (April 14, 2025)(2025)Rolling US application begun in January 2025; Ironwood exploring strategic alternatives.
- Ironwood, second-quarter 2026 results (Business Wire, August 6, 2026)(2026)STARS-2 (NCT07742735) initiated and actively recruiting, a 24-week global trial with week-24 endpoints; the June 2026 start is from Ironwood's July 14, 2026, release.
- ClinicalTrials.gov, STARS-2 (NCT07742735)(2026)About 124 people, 1 to 1; estimated start August 2026; primary completion estimated October 2028.
- Ironwood, second-quarter 2023 results (SEC filing, August 8, 2023)(2023)Tender offer for VectivBio completed June 29, 2023, at $17 a share in cash, about $1.2 billion aggregate consideration.
- Bolognani F et al., Journal of Pharmacology and Experimental Therapeutics 2023;386(2):129-137(2023)Healthy volunteers, six weekly doses: clearance 16.5 to 20.7 L a day; 5 mg weekly gave the maximal citrulline response.
- Bolognani F et al., CIRTA 2019 phase 1 abstract(2019)40 healthy volunteers, single doses of 2.8 to 56 mg: half-life about 30 hours; no serious side effects.
- Verbiest et al., Clinical Nutrition 2024;43(12):158-166 (STARSnutrition)(2024)9 people with the colon connected, 52 weeks: support volume down 52%; better energy and fluid absorption.
- Gattex (teduglutide) US label, DailyMed(2025)Teduglutide comparison: 0.05 mg/kg once daily; half-life about 2 hours in healthy adults and 1.3 hours in short bowel syndrome; class warnings.
Beyond these, 40 records are indexed. Browse the records