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

Glepaglutide (ZP1848, Zeydovio): what the evidence says

Name: Glepaglutide (ZP1848, Zeydovio)
Published: 2026-10-27

At a glance

What it is: a long-acting GLP-2 analogue from Zealand Pharma for short bowel syndrome. ^R1

What the evidence says: in phase 3 EASE-1 (106 patients), twice-weekly dosing cut IV nutrition needs more than placebo; once-weekly did not reach significance. ^{R2, R3} FDA issued a Complete Response Letter on Dec 19, 2024 asking for another trial. ^R4 Europe's CHMP recommended approval on Sep 18, 2026. ^R5

Biggest risks: stomach and stoma complications; class risks of GLP-2 drugs. ^R1

Rating


Human Human evidence	Moderate: phase 2 (n = 18) ^R1; phase 3 EASE-1 (n = 106) ^R2
Animal Animal / lab evidence	Not reviewed
Regulatory	Not FDA-approved (CRL 2024) ^R4 · positive EU CHMP opinion 2026 ^R5 · not on FDA's 503A or 503B bulk-substance category lists and not on FDA's compounding safety-risk page ^{R6, R7, R8} · not named by WADA ^R9
Established human dose	None in the US

Evidence verdict: Short bowel syndrome: Moderate (one phase 3; twice-weekly dose positive, once-weekly not) · US status: FDA declined approval (2024) · Other uses: 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: one phase 3 trial with mixed results by dose. The confirmatory EASE-5 trial is recruiting; primary completion is listed for Oct 2028. ^R10

What is it?

Related pages: Teduglutide, Apraglutide, BPC-157.

Does it work?

Human Phase 2: better intestinal absorption at the two higher doses, not the lowest. ^R1
Human EASE-1: twice-weekly dosing significantly reduced IV support; 5 patients (14%) came off IV support entirely vs none on placebo. ^R2
Unknown Gut healing or other uses in healthy people: no data.

Is it safe?

Human Phase 2 related serious events included abdominal pain, stoma obstruction and catheter infections. ^R1 EASE-1 found it well tolerated. ^R2
UNVERIFIED GLP-2 class warnings (polyp/tumor growth) as they apply to glepaglutide; check against teduglutide's label.

Gray-market 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; Complete Response Letter in 2024. ^R4 Expected readout: EASE-5, primary completion Oct 2028. ^R10
EU: positive CHMP opinion; European Commission decision pending. ^R5 UNVERIFIED whether the EC decision has been issued.
Compounding: not on FDA's 503A or 503B bulk-substance category lists and not on FDA's compounding safety-risk page. ^{R6, R7, R8}
Sport: not named on WADA's 2026 Prohibited List. ^R9

Study details

These are amounts researchers used, not recommendations.

Study	People / model	Route	Amount used	Follow-up	Reported	Citation
Phase 2 2019	18 adults, SBS	SC daily	0.1, 1 or 10 mg	3 weeks per dose	Absorption up at 1 and 10 mg	PMID 30880176
EASE-1 2025	106 adults, SBS-IF	SC	10 mg once or twice weekly	24 weeks	Twice weekly: PS volume down	PMID 39708985

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

^R1 Naimi RM, et al. Lancet Gastroenterol Hepatol. 2019. PMID 30880176
^R2 Jeppesen PB, et al. Gastroenterology. 2025. PMID 39708985
^R3 ClinicalTrials.gov NCT03690206, EASE-1 phase 3, completed (CT.gov API v2, checked Oct 26, 2026). https://clinicaltrials.gov/study/NCT03690206
^R4 Zealand Pharma press release, FDA Complete Response Letter for glepaglutide NDA, Dec 19, 2024. https://www.globenewswire.com/news-release/2024/12/19/3000220/0/en/u-s-food-and-drug-administration-issues-complete-response-letter-for-the-glepaglutide-new-drug-application-for-the-treatment-of-short-bowel-syndrome.html
^R5 Zealand Pharma press release No. 16/2026, positive CHMP opinion for Zeydovio (glepaglutide), Sep 18, 2026. https://investor.wedbush.com/wedbush/article/gnwcq-2026-9-18-zealand-pharma-receives-positive-chmp-opinion-for-zeydovio-glepaglutide-for-the-treatment-of-short-bowel-syndrome
^R6 FDA, 503A bulk drug substances categories list (updated May 14, 2026). https://www.fda.gov/media/94155/download
^R7 FDA, 503B bulk drug substances categories list (updated Mar 21, 2025). https://www.fda.gov/media/94164/download
^R8 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
^R9 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
^R10 ClinicalTrials.gov NCT07197944, EASE-5 confirmatory phase 3, recruiting, primary completion Oct 2028 (CT.gov API v2, checked Oct 26, 2026). https://clinicaltrials.gov/study/NCT07197944

Disclaimer

This page is for education and harm reduction, not medical advice or a recommendation to use Glepaglutide (ZP1848, Zeydovio). This is an investigational drug. Outside a registered clinical trial, any product sold under this name is unregulated. Report problems to FDA MedWatch (https://www.fda.gov/safety/medwatch).