Apraglutide
Apraglutide (FE 203799)
Clinical trials are ongoing or recently completed. Final approval has not been granted.
An investigational once-weekly injection being developed for short bowel syndrome -- a condition where the intestine cannot absorb enough nutrients from food, often requiring nutrition through an IV. A large late-stage clinical trial has been completed and a drug application has been submitted for approval.
This entry is a cited research summary, not an established treatment reference. Dosing language is included as source context, not as medical instruction.
Safety Summary
Across the Phase 1/2 and Phase 2 SBS studies, treatment-related adverse events were usually mild to moderate and were dominated by GI/stoma effects and fluid-balance effects, including decreased stoma output, stoma complications, nausea, flatulence, polyuria, edema, abdominal pain, vomiting, and mild injection-site reactions (PMID 35233802; PMID 34287970; PMID 39461299). No treatment-related serious adverse events were reported in the randomized 4-week Phase 2 crossover trial (PMID 34287970). One treatment-related SAE of abdominal pain was reported in the open-label Phase 1/2 study (PMID 35233802). In the 52-week CiC study, 127 AEs were reported, mostly mild to moderate; one severe treatment-related SAE of acute obstructive cholangitis occurred in a patient with pre-existing asymptomatic cholecystolithiasis, requiring ERCP and cholecystectomy (PMID 39461299). The full text of the CiC study notes that GLP-2 has been linked to gallbladder hypomotility contributing to bile stasis, and that liver function test monitoring is warranted during GLP-2 analog therapy (PMID 39461299). A network meta-analysis found no significant safety difference between apraglutide and control groups; catheter-related bloodstream infection was the most common AE across GLP-2 analogs (PMID 38663565). In Phase 1 studies, apraglutide was generally well tolerated with no serious adverse events or immunogenicity observed.
Clinical check-in
If real-world use or exposure is being considered, review potential interactions, contraindications, and monitoring needs with a licensed clinician rather than relying on summary copy alone.
Sources: [1-16]