Sonefpeglutide
A long-acting GLP-2 analogue from Hanmi in phase 2 for short bowel syndrome, built to replace daily teduglutide injections.
Sonefpeglutide (HM15912) is a long-acting GLP-2 analogue from Hanmi Pharmaceutical. In rats its half-life was 42.3 hours against 0.6 hours for teduglutide, and once-weekly dosing grew the small intestine and improved absorption in a rat model of short bowel syndrome (PMID 36410792). Two phase 1 studies are completed and a phase 2 trial in short bowel syndrome with intestinal failure is recruiting (NCT04775706). It is not approved.
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Recommended Dosing
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Mechanism of action
Activates the GLP-2 receptor like teduglutide; its in vitro potency is somewhat lower than human GLP-2 or teduglutide, but its longer action gave more small-intestinal growth in rodents, even dosed once a week (PMID 36410792).
Primary uses
- Investigational: short bowel syndrome with intestinal failure (phase 2)
Typical dosing
No human dose published: the phase 1 and phase 2 results are not in a paper found (October 28, 2026).
Regulatory status
Not approved: Drugs@FDA (openFDA) and the EMA medicines list hold no record (October 28, 2026). ClinicalTrials.gov lists two completed phase 1 studies (NCT04076293, NCT05711381) and a recruiting phase 2 trial in short bowel syndrome with intestinal failure (NCT04775706).
Status as of this entry's last review, October 28, 2026. Approvals, compounding rules and sport rules change; the regulatory tracker is checked more often.
What we checked
Sonefpeglutide is a long-acting GLP-2 analogue in mid-stage trials; this section records what can be checked.
Identity, computed
| Structure | a long-acting GLP-2 analogue (PMID 36410792); the full structure is not given in the sources read |
No sequence or formula is published in a source we could find, so none is given.
Regulatory status, read October 29, 2026
Drugs@FDA: 0 records for “sonefpeglutide”. EMA medicines list: 0 records for “sonefpeglutide”. Run for semaglutide, the same queries return 6 and 5 records (and the registry search 81 trials), so a zero here is an absence, not a broken search. Not named on the WADA 2026 and 2027 Prohibited Lists. As a substance with no current approval for human therapeutic use, it falls under section S0 (non-approved substances), which is prohibited at all times; the lists were read on October 28, 2026.
What the studies show
One indexed paper, a 2023 rodent study (PMID 36410792); three registered trials, two phase 1 studies completed and a phase 2 trial recruiting.
What we looked for and did not find
No published human results and no approval anywhere.
| Source | Query | Results, October 29, 2026 | What it was |
|---|---|---|---|
| PubMed | sonefpeglutide OR HM15912 | 1 | the 2023 rodent study |
| ClinicalTrials.gov | sonefpeglutide | 3 | two phase 1 and one phase 2 trial |
| Drugs@FDA (openFDA) | sonefpeglutide | 0 | |
| EMA medicines list | sonefpeglutide | 0 |
What the studies show
Animal · 2023
HM15912, a Novel Long-Acting Glucagon-Like Peptide-2 Analog, Improves Intestinal Growth and Absorption Capacity in a Male Rat Model of Short Bowel Syndrome
In rats HM15912's half-life was 42.3 hours against 0.6 for teduglutide; weekly dosing grew the small intestine and raised D-xylose absorption in rats with short bowel syndrome.
References
- [pubmed] Choi J, et al. "HM15912, a Novel Long-Acting Glucagon-Like Peptide-2 Analog, Improves Intestinal Growth and Absorption Capacity in a Male Rat Model of Short Bowel Syndrome." J Pharmacol Exp Ther, 2023;384(2):277-286. PMID: 36410792.
- [registry] ClinicalTrials.gov API v2, read October 28, 2026: NCT04076293 (phase 1, single ascending doses in healthy Korean subjects, completed November 2020), NCT05711381 (phase 1, pharmacokinetics in normal and severe kidney function, completed August 2023) and NCT04775706 (phase 2, safety, pharmacokinetics and pharmacodynamics in short bowel syndrome with intestinal failure, recruiting); sponsor Hanmi Pharmaceutical.
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This entry is for educational purposes only and does not constitute medical advice. Dosing information reflects published regulatory or research data and is not a recommendation. Many compounds described here are not approved for human use in the United States. Consult a licensed medical professional before considering any peptide therapy.