Name | Teduglutide |
CAS number | 197922-42-2 |
Description | Teduglutide is a recombinant analog of human glucagon-like peptide two, consisting of thirty-three amino acids produced through recombinant DNA technology using a modified strain of Escherichia coli. |
Structural formula |  |
Molecular Formula | C164H252N44O55S |
Molecular Weight | 3752.08000 g/mol |
Appearance | White powder |
Quality Standard | 99% |
Storage Condition | Cool dry place( away from the light) |
Shelf Life | >2 years if stored properly |
Sample package | Aluminium foil bag |
Commercial package | Aluminium Tin, Fiber drum |
Origin | China |
Teduglutide is a recombinant analog of human glucagon-like peptide two, consisting of thirty-three amino acids produced through recombinant DNA technology using a modified strain of Escherichia coli. Its molecular structure differs from endogenous GLP-two by a single amino acid substitution where alanine is replaced by glycine, a subtle but critical modification that confers resistance to degradation by the enzyme dipeptidyl peptidase-four. This structural enhancement significantly prolongs its half-life and biological activity compared to the naturally occurring hormone. It was granted orphan drug designation by the United States Food and Drug Administration in June two thousand and received initial marketing approval for adults in December twenty twelve, with pediatric approval following in May twenty nineteen.
The therapeutic mechanism of teduglutide involves specific binding to glucagon-like peptide-two receptors distributed throughout the intestinal epithelium, including on enteroendocrine cells, subepithelial myofibroblasts, and enteric neurons. Receptor activation triggers the local release of multiple downstream mediators such as insulin-like growth factor one, nitric oxide, and keratinocyte growth factor. This signaling cascade promotes mucosal growth through villus hyperplasia and crypt cell proliferation, fundamentally increasing the absorptive surface area of the remaining intestine. Additionally, it slows gastric emptying and reduces gastric acid secretion, optimizing nutrient absorption while decreasing intestinal fluid losses. A key pharmacodynamic indicator of its effect is the elevation of plasma citrulline levels, which serves as a biomarker reflecting increased enterocyte mass and functional adaptation.
The primary clinical application of teduglutide is the treatment of short bowel syndrome in patients who are dependent on parenteral support. It is indicated for both adults and pediatric patients aged one year and older with this condition. By enhancing intestinal adaptation and absorptive capacity, the therapy enables significant reductions in parenteral nutrition and intravenous fluid requirements. Long-term studies in pediatric populations demonstrate that more than eighty percent of treated patients achieve a clinical response, defined as at least a twenty percent reduction in parenteral support volume, with sustained treatment over extended periods producing substantial mean fluid reductions. The degree of response correlates with factors including duration of exposure, remaining bowel length, and the presence of colon in continuity.
The safety profile of teduglutide requires vigilant monitoring due to its growth factor activity. The Food and Drug Administration mandates a Risk Evaluation and Mitigation Strategy to inform prescribers about risks including possible acceleration of neoplastic growth, enhancement of colon polyp growth, gastrointestinal obstruction, and biliary and pancreatic disorders. Comprehensive meta-analyses reveal that gastrointestinal adverse events occur in approximately half of treated patients. Infections represent another significant concern, with upper respiratory tract infections and central venous catheter-related infections occurring in notable proportions of patients. Other adverse reactions include pyrexia, sepsis, injection site reactions, fluid and electrolyte imbalances, and cardiovascular complications. Real-world pharmacovigilance data have additionally identified previously unreported signals including nephrolithiasis, weight loss, and dehydration that warrant clinical attention.
Beyond its approved indication, emerging research explores teduglutide's potential in other gastrointestinal conditions characterized by mucosal injury or malabsorption. Case reports suggest possible benefit in graft-versus-host disease involving the gastrointestinal tract, primary amyloidosis with intestinal involvement, and refractory microscopic colitis. However, real-world experience has also heightened awareness of the risk for gastrointestinal polyp development, and the cost-effectiveness of long-term therapy remains uncertain, necessitating careful patient selection and ongoing surveillance. The development of newer long-acting GLP-two analogs continues, building upon the foundation established by this first-in-class therapy.
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