Is Glepaglutide legal in Australia?

A long-acting GLP-2 analogue for short bowel syndrome with intestinal failure. In a 106 person phase 3, 10 mg twice weekly cut weekly parenteral support volume by 5.13 litres against 2.85 on placebo; the once-weekly arm did not separate from placebo. Not approved anywhere as of September 2026, with a further phase 3 recruiting.

Glepaglutide is a synthetic analogue of glucagon-like peptide 2 (GLP-2), the gut hormone that drives intestinal growth and absorption, engineered by Zealand Pharma for a long enough half-life to be given once or twice a week as a ready-to-use injection. It is a candidate treatment for short bowel syndrome with intestinal failure, in which people who have lost most of their small intestine depend on intravenous parenteral support for fluid and nutrition.

Mechanism: GLP-2 is released by intestinal L cells after meals and acts on the GLP-2 receptor to increase villus height and crypt depth, slow gastric emptying, raise intestinal blood flow and improve absorption of fluid and nutrients. People who have lost their terminal ileum and colon lose most of their GLP-2 producing cells, which is part of why the remaining bowel adapts poorly.

Regulatory history: Not FDA approved. No application in Drugs@FDA and no EMA medicine page as of 11 September 2026. Phase 3 EASE SBS-1 completed; a further confirmatory phase 3 (NCT07197944) recruiting since February 2026.

Registers or lists therapeutic goods on the ARTG and schedules substances in the Poisons Standard. Many peptides are Schedule 4 (prescription only), so possession without a prescription and personal importation are restricted even when no product is registered.

The classification above is the The Longevity Archive reading of Therapeutic Goods Administration listings for Glepaglutide at the reviewed date, not a legal opinion. Rules change, and importing, prescribing and possessing a compound can each be treated differently. Check the regulator directly before acting on anything here.