Is apraglutide FDA-approved, and what does the research show?

What is apraglutide?

Apraglutide is an investigational peptide drug, a modified, synthetic version of the gut hormone GLP-2 built to last longer in the body ¹, ², ³. GLP-2, glucagon-like peptide-2, is a peptide of 33 amino acids that the small intestine releases ³. The natural hormone is cleared within minutes, so it has little use as a drug on its own ³. Apraglutide was designed so that one injection under the skin lasts a week ¹, ¹¹. Its early trials used the code name FE 203799 ¹¹.

VectivBio AG sponsors its trials, and Ironwood Pharmaceuticals, which bought VectivBio in June 2023, calls it investigational ⁵, ². In these trials, short bowel syndrome followed surgical removal of part of the small intestine ¹². When the bowel that remains cannot absorb enough fluid and nutrients, the condition is called intestinal failure, and patients depend on parenteral support, nutrition and fluids given into a vein ¹.

Is apraglutide FDA-approved?

Apraglutide is not FDA-approved: Drugs@FDA lists no approved apraglutide product as of November 9, 2026 ⁴. It is an investigational drug in a confirmatory phase 3 trial, STARS-2, which began recruiting in 2026 ⁵, ⁶. A phase 3 trial is the large, late-stage trial a company runs to support an application for approval. Because no product is approved, there is no FDA label for apraglutide, and no FDA-reviewed prescribing or safety information exists ⁴.

Ironwood began a rolling new drug application, or NDA, in January 2025: the filing FDA reviews before it approves a drug, submitted in parts ¹³. In April 2025 the company said that, after a discussion with FDA, "a confirmatory Phase 3 trial is needed to seek approval" ¹⁰. The same release said an analysis made while preparing the application found a dosing problem: "the exposure and dose delivered in the STARS Phase 3 trial were lower than planned due to dose preparation and administration" ¹⁰. These are the company's statements; FDA has published nothing on apraglutide in any opened source. The company says the confirmatory trial, STARS-2, started in June 2026, and that it plans to file for approval in 2029 if the results allow ⁶, ¹⁴.

No opened source describes a lawful way to obtain apraglutide outside a clinical trial. FDA's list of substances nominated for pharmacy compounding under section 503A of the drug law, updated May 14, 2026, does not name apraglutide, as read on November 10, 2026. Nor does FDA's 503B list, for outsourcing facilities, updated March 21, 2025.

One GLP-2 analog is FDA-approved: teduglutide, sold as Gattex, approved on December 21, 2012 under new drug application NDA 203441, now held by Takeda ¹⁵. Its label says it is "indicated for the treatment of adults and pediatric patients 1 year of age and older with Short Bowel Syndrome (SBS) who are dependent on parenteral support" ¹⁶. It is a prescription drug given by injection under the skin ¹⁶. Apraglutide is a different molecule, and teduglutide's approval does not extend to it ⁴, ¹⁵. Teduglutide is injected once a day; apraglutide's trials gave it once a week ¹, ³.

See the FDA status of every peptide, updated weekly.

How does apraglutide work?

Apraglutide acts at the GLP-2 receptor as a full agonist, a molecule that switches the receptor on as fully as the natural hormone does ⁵. Its potency is comparable to native GLP-2 in laboratory assays ⁵, ³. FDA's label for teduglutide, the approved GLP-2 analog, describes the hormone's actions: GLP-2 "is known to increase intestinal and portal blood flow and inhibit gastric acid secretion" ¹⁶. Its receptors sit on cells and nerves in the gut wall ¹⁶. The aim of a GLP-2 drug in short bowel syndrome is to make the remaining bowel grow and absorb more, which the trials call intestinal adaptation ¹, ³, ¹⁷.

What sets apraglutide apart is how long it lasts. Compared with native GLP-2 it has "slower absorption, reduced clearance, and higher protein binding, enabling once-weekly dosing" ¹¹. Its elimination half-life, the time for half a dose to leave the blood, was studied in animals ³. In rats it was 159 minutes, against 6.4 minutes for native GLP-2 and 19 for teduglutide ³.

Studied in people: 24 healthy volunteers randomized to six weekly injections of apraglutide at one of three doses, or placebo ¹¹. Plasma citrulline, a marker of the mass of gut-lining cells, rose with dose and stayed raised for 10 to 17 days after the last injection ¹¹. Studied in people: nine adults with short bowel syndrome, whose small bowel length on MRI increased from 29.7 to 40.7 centimeters in a 52-week open-label study ⁷.

What does the research show?

Studied in people: STARS, a randomized, double-blind, placebo-controlled phase 3 trial, 163 adults with short bowel syndrome and intestinal failure, change in weekly parenteral support volume at 24 weeks ¹. Placebo-controlled means a dummy injection for comparison; double-blind means neither participants nor investigators knew who had which.

Participants needed intravenous support at least three days a week, and two were assigned to apraglutide for every one to placebo ¹, ¹². Weekly support volume fell by 25.5% with apraglutide against 12.5% with placebo ¹. Among the 80 participants with a stoma, a surgical opening of the bowel through the abdominal wall, it fell by 25.6% against 7.8% ¹. More participants on apraglutide cut their support by at least one day a week: 43.0% against 27.5% ¹.

The trial's two other key goals concerned the 83 participants whose colon remained connected, called colon-in-continuity, at 48 weeks ¹. There 51.8% against 44.4% gained a day off support, and 12.5% against 7.4% came off intravenous support entirely, called enteral autonomy ¹. Neither difference was statistically significant, meaning chance could explain it ¹.

Ironwood's release of February 29, 2024 says these two goals "were not achieved" and gives the enteral autonomy counts as seven of 56 against two of 27 ⁹. The trial ran at 68 sites in 18 countries by the company's account and finished in February 2024 by the registry's ⁹, ¹². The paper appeared online on September 3, 2026 ¹.

As the company disclosed in April 2025, the dose delivered in STARS was lower than planned, and FDA asked for a confirmatory trial, by the company's account ¹⁰. STARS-2, the confirmatory trial, is recruiting about 124 adults, assigned one to one to apraglutide or placebo for 24 weeks, with the same primary measure ⁵. Its primary completion is estimated for October 2028 ⁵. The company says more than 100 sites in 22 countries are planned ¹⁴.

Studied in people: STARS Extend, an open-label extension in which 158 participants from the earlier trials receive apraglutide for up to 208 weeks ¹⁸. It is running, with completion estimated for October 2027 ¹⁸. Open-label means everyone knows they are on the drug and there is no placebo group. Ironwood says an analysis of the extension data showed 27 apraglutide-dosed patients reaching enteral autonomy ¹³. That is the company's figure, with no denominator and no published paper behind it in any opened source.

Studied in people: a randomized, double-blind, placebo-controlled crossover phase 2 trial, eight adults with short bowel syndrome and intestinal failure, urine output after four weeks ¹⁹. In a crossover trial each participant has the drug and placebo in turn ¹⁹. Urine output rose by an adjusted mean of 714 and 795 milliliters a day at the two doses tested, against placebo ¹⁹. The authors read this as more fluid absorbed by the bowel ¹⁹.

Studied in people: an open-label phase 1 and 2 trial, eight adults, four with intestinal failure and four with the less severe intestinal insufficiency ¹⁷. Absorption was measured by inpatient balance studies, which weigh what goes in against what comes out ¹⁷. Fluid absorption rose by 741 grams a day and energy absorption by 1,095 kilojoules a day after four weeks ¹⁷.

Studied in people: the same 52-week open-label phase 2 study, nine adults with short bowel syndrome, intestinal failure and colon-in-continuity, with safety as its primary end point ⁷. Parenteral support volume fell by 4,702 milliliters a week, a 52% reduction, and seven of the nine gained at least one day a week off support ⁷.

Phase 1 studies in people were small. Two single-dose studies each compared eight adults with impaired organ function against eight healthy adults, severe kidney impairment in one and moderate liver impairment in the other ²⁰, ²¹. Neither impairment raised exposure to the drug ²⁰, ²¹.

Studied in people: STARGAZE, a randomized, single-blind phase 2 trial, 31 patients aged 12 and over with steroid-refractory acute graft-versus-host disease of the gut, with safety as its primary goal ⁸. Single-blind means participants did not know their dose group; steroid-refractory means not responding to steroids ⁸. Graft-versus-host disease is a complication of donor stem-cell transplants in which donor immune cells attack the recipient's tissues ²². All three groups received apraglutide at different weight-based doses, so the trial had no control group ⁸.

The registry records it as terminated, "Company decision," with primary completion in December 2024 ⁸. Ironwood said in January 2025 it was winding the study down "to further focus its resources and investments" ¹³. Ironwood's release of March 28, 2024 said most patients had responded by day 28 and day 56; those are the company's words about an exploratory trial ²².

No opened source reports a trial of apraglutide in children with short bowel syndrome, a head-to-head trial against teduglutide, or any published result from the extension study.

What are the side effects?

STARS, the phase 3 trial, is the largest safety record, and its abstract says only that apraglutide "was well-tolerated with a favorable safety profile" ¹. Ironwood's release says the safety results "were generally consistent with the safety profile demonstrated in apraglutide studies to date" ⁹.

The smaller trials give the detail. In the crossover trial of eight adults with intestinal failure, the common treatment-related events were mild to moderate ¹⁹. They were passing more urine, reduced stoma output, stoma complications, less thirst, and swelling from retained fluid, called edema ¹⁹. No serious event in that trial was judged related to apraglutide ¹⁹.

The open-label trial of eight adults recorded reduced stoma output and stoma complications in six each, nausea in five, flatulence in four and abdominal pain in three ¹⁷. The one related serious event was abdominal pain in one patient ¹⁷. In the 52-week study of nine adults, 127 adverse events were recorded, "mostly mild to moderate" ⁷. Adverse events in the single-dose studies in people with kidney or liver impairment were mild or moderate ²⁰, ²¹.

Of STARGAZE's 31 patients with acute graft-versus-host disease after a transplant, 10 died and 22 had a serious adverse event, by the registry's posted results ⁸. Sepsis, pneumonia and low platelet counts are among the serious events listed ⁸.

Two patients had a perforation of the large intestine, and seven had an event in the category the registry calls "Gastrointestinal Obstructions," one of its adverse events of special interest ⁸. The registry counts one serious event and no death as related to the drug, and the trial had no comparison group ⁸. Every patient entered it on steroids and ruxolitinib, a drug for graft-versus-host disease, for a life-threatening condition ⁸, ²². The same record notes that the doses given "were lower than protocol specified doses" because of dilution and volume lost in preparing the injections ⁸.

FDA has written no safety words on apraglutide, since no product is approved ⁴. Its label for teduglutide, the approved GLP-2 analog, warns of "Acceleration of Neoplastic Growth," intestinal obstruction, biliary and pancreatic disease, fluid overload including congestive heart failure, and increased absorption of oral medicines ¹⁶. That label lists abdominal pain, nausea, upper respiratory tract infection, abdominal distension, injection-site reaction, vomiting, fluid overload and hypersensitivity as its most common reactions ¹⁶.

A 2026 review of GLP-2 agonists in short bowel syndrome reports "gastrointestinal symptoms, fluid balance issues, gallbladder events and injection-site reactions" as the class's most frequent effects ²³. Whether teduglutide's warnings apply to apraglutide has not been established in any opened source; the two are different molecules ¹⁶, ³.

In sport

Apraglutide is not named on the 2026 Prohibited List of WADA, the World Anti-Doping Agency ²⁴. Neither its peptide-hormone section S2 nor its hormone and metabolic modulator section S4 names apraglutide, and the list mentions neither GLP-2 nor any GLP-2 analog ²⁴. Section S0 of the list prohibits at all times "any pharmacological substance which is not addressed by any of the subsequent sections of the List and with no current approval by any governmental regulatory health authority for human therapeutic use (e.g. drugs under pre-clinical or clinical development or discontinued, designer drugs, substances approved only for veterinary use)" ²⁴. FDA is the only regulator whose record was read, and it lists no approved apraglutide product ⁴. Whether S0 applies to apraglutide is a question for anti-doping bodies, and no conclusion is drawn here.

What JumpstartMD offers

JumpstartMD does not prescribe apraglutide. Our peptide library covers it so you have the facts on its FDA status and the evidence, current as of November 10, 2026.

Ready to talk?

Book FREE Consultation

Share your details and a JumpstartMD team member will reach out shortly. Or call 408.478.3496 for your free, no-obligation consultation.

Share your details and a JumpstartMD team member will reach out when we open.

Disclaimer

Compounded medications are not FDA-approved, and FDA does not review their safety, effectiveness, or quality before they are marketed. A licensed clinician decides after an evaluation whether a peptide is appropriate for you, and not every patient will qualify.