Zealand Pharma has won a CHMP positive opinion recommending EU marketing authorization for Zeydovio, its twice-weekly GLP-2 analog for short bowel syndrome, adopted on 17 September 2026 and announced the following day. The recommendation lands less than two years after FDA sent the same drug back for more evidence — a sequence that puts Europe, not the United States, first to approve what would be only the second GLP-2 analog on the market for the condition.
A molecule Europe said yes to first
Glepaglutide's road to a second regulator
- 1998
Zealand Pharma founded
Established in Copenhagen as a peptide-medicine company focused on gastrointestinal, metabolic and rare diseases.
- 2013 / 2017
First marketed molecule
Lixisenatide, invented by Zealand, launched via Sanofi as Lyxumia in the EU and Adlyxin in the U.S.
- 2021
Zegalogue launched
Zealand's own dasiglucagon autoinjector for severe hypoglycemia reaches the U.S. market.
- 30 September 2022
EASE-1 topline results
Phase 3 trial of glepaglutide in short bowel syndrome meets its primary endpoint.
- December 2023
FDA submission
Zealand files a New Drug Application for glepaglutide in short bowel syndrome.
- 19 December 2024
FDA Complete Response Letter
FDA says EASE-1 alone does not provide substantial evidence of efficacy at a to-be-marketed dose and recommends a further confirmatory trial.
- 2 June 2025
EMA submission
Zealand files a Marketing Authorisation Application for glepaglutide with the European Medicines Agency.
- 17 September 2026
CHMP positive opinion
Europe's medicines committee recommends approval as Zeydovio.
- Within 67 days
European Commission decision
The Commission's binding decision is due under the standard centralized-procedure deadline.
What CHMP recommended, twice a week
CHMP's opinion covers Zeydovio 10 mg, a solution for injection, for “adults with SBS who are clinically stable following a period of postsurgical intestinal adaptation” — the precise wording EMA's own record gives for the indication. In Zealand's EASE-1 trial, the twice-weekly dose that CHMP is recommending was the one that reached statistical significance; a once-weekly arm tested in the same study did not, which is exactly the gap FDA later cited when it declined to approve the drug in the U.S.
“The positive opinion for Zeydovio™ is the first major advancement in short bowel syndrome treatment in Europe in more than a decade… Offering simple dosing twice weekly via a ready-to-use autoinjector, Zeydovio™ holds potential as a transformative therapy for SBS that could meaningfully ease the burden of disease management for thousands of patients.” David Kendall, MD, Chief Medical Officer, Zealand Pharma — 18 September 2026 announcement
The European Commission now has up to 67 days from the CHMP opinion — the standard ceiling under the EU's centralized procedure — to issue a binding marketing-authorization decision. That decision, not today's opinion, is what would actually put Zeydovio on the market.
Zeydovio in four numbers
Figures from the EASE-1 Phase 3 trial (Gastroenterology, 2024) and the 18 September 2026 announcement.
A hormone built to grow the gut back
Glepaglutide is a long-acting analog of GLP-2, a hormone the intestine itself produces to increase blood flow to the gut, slow transit and promote growth of the mucosal lining — the tissue patients with short bowel syndrome have too little of after major intestinal resection. The condition leaves patients dependent on parenteral nutrition or intravenous fluids, sometimes for life, because what remains of the small intestine cannot absorb enough on its own.
Three ways twice-weekly changes the regimen
Twice-weekly, not daily
Teduglutide, the only other approved GLP-2 analog for short bowel syndrome, requires a daily injection. Zeydovio's label, if the EC follows CHMP, would ask patients for two doses a week.
A ready-to-use autoinjector
Zealand designed the pen to be prefilled rather than reconstituted from a vial, the step teduglutide's daily regimen requires each time.
A second attempt, a different regulator
The same trial data that drew an FDA rejection letter in December 2024 supported a CHMP recommendation in September 2026 — Zealand is now running a second confirmatory trial, EASE-5, aimed at satisfying FDA's specific objection.
Short bowel syndrome's crowded next decade
Short bowel syndrome is rare — estimates put U.S. prevalence in the range of 10,000 to 20,000 patients on long-term parenteral support — but the drug class built around GLP-2 analogs is no longer a one-company field. Zealand is one of at least three companies now competing on dosing frequency alone: less-frequent injections are the entire differentiation strategy, since none of the class has yet shown it can end parenteral dependence for most patients rather than reduce it.
Where a second GLP-2 analog fits
$2.80B → $3.74B
Short bowel syndrome and GLP-2 analog market forecasts for 2032, from two publishers measuring overlapping but different scopes.
Sources: IndustryARC, GLP-2 Analogs Market · Fortune Business Insights, Short Bowel Syndrome Treatment Market
Regulatory News outlook
We expect a second approved GLP-2 analog to take a meaningful minority of the class's revenue by the early 2030s if EU approval leads to a broader-label U.S. resubmission, given twice-weekly dosing's convenience edge over a daily injection.
How we got here: Splitting the difference between IndustryARC's $2.80 billion GLP-2-analog forecast and Fortune Business Insights' $3.74 billion whole-SBS-market forecast for 2032 puts the addressable market at roughly $3.3 billion, of which a second approved analog competing against teduglutide's daily regimen could reasonably take a quarter to a third of the class's share.
Zeydovio against the GLP-2 field
| Product | Company | Dosing | Regulatory status |
|---|---|---|---|
| Zeydovio (glepaglutide) | Zealand Pharma | Twice-weekly autoinjector | CHMP positive opinion (Sept 2026); FDA Complete Response Letter (Dec 2024), resubmission pending |
| Gattex / Revestive (teduglutide) | Takeda | Once-daily injection | Approved in the U.S. (2012) and EU (2012) |
| Apraglutide | Ironwood Pharmaceuticals | Once-weekly injection | Phase 3 (STARS) met its primary endpoint; filing pending |
| Sonefpeglutide (HM15912) | Hanmi Pharmaceutical / Eli Lilly | Once-monthly injection (planned) | Phase 2 |
From each company’s labelling and public announcements; not a clinical comparison.
What a December rejection still means
A CHMP opinion is not the same as an approval, and Zealand's own history with this drug is the reason to say so plainly: the same EASE-1 data now recommended for EU authorization was judged insufficient by FDA less than two years ago, for a reason — the once-weekly arm's non-significant result — that has nothing to do with the twice-weekly regimen CHMP is recommending. Whether the European Commission's eventual decision label mirrors CHMP's opinion, and whether Zealand's EASE-5 confirmatory trial satisfies FDA's specific objection, are both still open.
- European Commission decision: due within 67 days of the 17 September 2026 CHMP opinion.
- U.S. path: Zealand has initiated EASE-5, a second Phase 3 confirmatory trial, to support a future FDA resubmission.
- Commercial partner: Zealand has said it is seeking a partner for European and U.S. commercialization of glepaglutide.
What is not yet public: a commercial launch date or price for Zeydovio in any EU market, both of which depend on the European Commission's decision and on Zealand finding a commercialization partner.
Sources & further reading
- Zealand Pharma, “Zealand Pharma Receives Positive CHMP Opinion for Zeydovio (glepaglutide) for the Treatment of Short Bowel Syndrome,” press release, 18 September 2026. globenewswire.com
- European Medicines Agency, Zeydovio (glepaglutide) EPAR. ema.europa.eu
- European Medicines Agency, “Meeting highlights from the Committee for Medicinal Products for Human Use, 14-17 September 2026.” ema.europa.eu
- Medscape, “GLP-2 Analog Wins EMA Backing in Short-Bowel Syndrome.” medscape.com
- Zealand Pharma, pipeline page for glepaglutide. zealandpharma.com
- Zealand Pharma investor relations — stock information. zealandpharma.com
Regulatory News reports on public regulatory documents. It is not legal advice, and the primary sources above govern. If we have made an error, we will say so in public: see corrections.
Frequently asked questions
What did CHMP recommend?
A positive opinion recommending EU marketing authorization for Zeydovio (glepaglutide) in adults with short bowel syndrome who are clinically stable following a period of postsurgical intestinal adaptation. The European Commission has up to 67 days to issue its binding decision.
How is Zeydovio dosed?
Twice weekly, by subcutaneous injection from a prefilled autoinjector — compared with teduglutide (Gattex/Revestive), the only other approved GLP-2 analog for the condition, which is injected once daily.
Did FDA reject this drug before?
Yes. FDA issued a Complete Response Letter in December 2024, saying the pivotal trial's once-weekly and twice-weekly arms did not together provide substantial evidence of efficacy at a to-be-marketed dose, and recommending an additional confirmatory trial. Zealand has since started a second Phase 3 trial, EASE-5, to support a U.S. resubmission.
When will the EU decision be final?
The European Commission has up to 67 days after a CHMP opinion — the standard deadline under the centralized procedure — to issue a binding marketing authorization decision.
