Evidence review: Open Peptide Project (verified against primary PubMed, ClinicalTrials.gov & FDA records) · Last checked 2026-10-27. ← Back to Evidence Library

Apraglutide: what the evidence says

Name: Apraglutide
Published: 2026-10-27

At a glance

What it is: a once-weekly, long-acting GLP-2 analogue peptide that helps the remaining gut absorb more. ^R1 CT.gov lists VectivBio AG as sponsor. UNVERIFIED current parent company.

What the evidence says: in the phase 3 STARS trial, it cut weekly IV (parenteral) support by 25.5% vs 12.5% on placebo at 24 weeks. ^{R2, R3} A second phase 3 (STARS-2) is now recruiting. ^R4

Biggest risks: reported as well tolerated in trials; GLP-2 drugs as a class carry growth-related cautions. UNVERIFIED class warnings for apraglutide specifically.

Rating


Human Human evidence	Moderate: small phase 1/2 balance trials ^{R5, R6}; one phase 3 RCT ^R2
Animal Animal / lab evidence	Pharmacology ^R1
Regulatory	Investigational, not FDA-approved · not on FDA's 503A or 503B bulk-substance category lists and not on FDA's compounding safety-risk page · not named on WADA's 2026 list ^{R7, R8, R9, R10}
Established human dose	None approved. Study details lists what trials used

Evidence verdict: Short bowel syndrome (cutting IV nutrition): Moderate (one phase 3 RCT met primary endpoint; second phase 3 recruiting) · Gut healing in healthy people: No human data

This page reports what studies used. It is not dosing advice.

Legend: HUMAN data · ANIMAL / LAB data · UNKNOWN · UNVERIFIED: not yet confirmed against a primary source

About the evidence: only people with short bowel syndrome have been studied for benefit. Some secondary outcomes at 48 weeks did not reach significance. ^R2

What is it?

GLP-2 is a gut hormone that thickens and grows the intestinal lining. Apraglutide lasts long enough for weekly shots. ^{R1, R11} Related pages: Teduglutide, Larazotide, BPC-157.

Does it work?

Human Phase 1/2 balance studies (n = 8 each): more fluid and energy absorbed. ^{R5, R6}
Human STARS phase 3 (n = 164): PS volume −25.5% vs −12.5% (P = .001); more patients gained ≥1 day off PS at week 24 (43.0% vs 27.5%). ^R2
Caution At week 48 in colon-in-continuity patients, days-off and enteral-autonomy differences were not significant. ^R2
Unknown A second phase 3 trial (STARS-2) is recruiting, with primary completion listed for Oct 2028. ^R4 UNVERIFIED the reason FDA asked for it.

Is it safe?

Human Described as well tolerated in STARS. ^R2
Unknown No long-term published data; the extension study is ongoing. ^R12

"Research" vials: extra risks

A gray-market vial has no quality control and no guarantee of identity, strength or sterility. We test retail vials blind under the Open Peptide Standard; see /tests/. A passing test covers one batch on one date and does not mean the compound is safe.

Is it legal?

US: investigational only; not on FDA's 503A or 503B bulk-substance category lists and not on FDA's compounding safety-risk page. ^{R8, R9, R10}
Sport: not named on WADA's 2026 list. ^R7

Study details

These are amounts researchers used, not recommendations.

Study	People / model	Route	Amount used	Follow-up	Reported	Citation
Phase 1/2 metabolic balance 2022	8 adults with SBS	SC weekly	5 mg	4 weeks	More fluid and energy absorbed	PMID 35233802
STARS phase 3 2026	164 adults with SBS-IF	SC weekly	Per protocol	24 to 48 weeks	PS volume −25.5% vs −12.5%	PMID 42692160

Full reference list (PubMed, CT.gov, FDA and WADA checked Oct 26, 2026)

^R1 Hargrove DM, et al. J Pharmacol Exp Ther. 2020. PMID 32075870
^R2 Joly F, et al. Clin Gastroenterol Hepatol. 2026. PMID 42692160
^R3 ClinicalTrials.gov NCT04627025, VectivBio, STARS phase 3 in SBS-IF, completed, n = 164 (CT.gov API v2, checked Oct 26, 2026). https://clinicaltrials.gov/study/NCT04627025
^R4 ClinicalTrials.gov NCT07742735, VectivBio, STARS-2 phase 3 in SBS-IF, recruiting, n = 124, primary completion Oct 2028 (CT.gov API v2, checked Oct 26, 2026). https://clinicaltrials.gov/study/NCT07742735
^R5 Eliasson J, et al. JPEN J Parenter Enteral Nutr. 2022. PMID 35233802
^R6 Eliasson J, et al. JPEN J Parenter Enteral Nutr. 2022. PMID 34287970
^R7 WADA. The 2026 Prohibited List, full list checked; compound not named. https://www.wada-ama.org/sites/default/files/2025-09/2026list_en_final_clean_september_2025.pdf
^R8 FDA, 503A bulk drug substances categories list (updated May 14, 2026). https://www.fda.gov/media/94155/download
^R9 FDA, 503B bulk drug substances categories list (updated Mar 21, 2025). https://www.fda.gov/media/94164/download
^R10 FDA, Certain bulk drug substances for use in compounding that may present significant safety risks (content current Apr 22, 2026). https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks
^R11 Bolognani F, et al. J Pharmacol Exp Ther. 2023. PMID 37316329
^R12 ClinicalTrials.gov NCT05018286, VectivBio, STARS Extend open-label extension, active not recruiting, primary completion Oct 2027 (CT.gov API v2, checked Oct 26, 2026). https://clinicaltrials.gov/study/NCT05018286

Disclaimer

This page is for education and harm reduction, not medical advice or a recommendation to use Apraglutide. Apraglutide is only available in clinical trials. People with short bowel syndrome should talk to their gut-failure team about approved options such as teduglutide. Report problems to FDA MedWatch (https://www.fda.gov/safety/medwatch).