Teduglutide

Teduglutide is a recombinant analog of glucagon-like peptide-2 (GLP-2) approved for adults with short bowel syndrome who are dependent on parenteral support. It promotes intestinal adaptation and increases nutrient absorption. Unlike native GLP-2, it has an extended half-life.

PubMed results: 341 · Human studies: 241 · Animal studies: 261

Ranges reflect protocols studied in published research and animal-model extrapolation. Presented for research purposes only, not a recommendation or instruction for human use.

Doses studied in published research. Information presented for research purposes only, not a recommendation for human use.

• Subcutaneous — standard range 0.05 mg/kg, Once daily

1.3 hours (high confidence)

• Intestinal adaptation in short bowel syndrome (Strong clinical): Clinical trials in adults with short bowel syndrome dependent on parenteral support demonstrated that this recombinant GLP-2 analog promotes structural and functional intestinal adaptation and increases absorptive capacity.
• Reduced parenteral nutrition dependence (Strong clinical): Pivotal studies showed reductions in weekly parenteral support volume and days of dependence, consistent with improved nutrient and fluid absorption under GLP-2 pathway stimulation.
• Extended half-life versus native GLP-2 (Strong clinical): Structural modification relative to native glucagon-like peptide-2 extends plasma half-life, enabling clinically practical dosing while retaining intestinotrophic activity.

• Abdominal pain and gastrointestinal symptoms — Mild, Common. Clinical programs reported abdominal pain, nausea, and other GI symptoms as among the more frequent adverse events, consistent with intestinotrophic pharmacology.
• Injection site reactions — Mild, Common. Subcutaneous administration has been associated with local injection-site reactions including erythema, swelling, and discomfort in trial populations.
• Fluid overload / congestive heart failure risk — Serious, Uncommon. Enhanced fluid absorption has been linked to fluid retention and, in susceptible individuals, precipitation or worsening of congestive heart failure; monitoring is emphasized in product labeling contexts.

• Active gastrointestinal malignancy (Established): GLP-2–mediated intestinal growth raises concern about promoting neoplastic tissue; product guidance excludes active GI malignancy and requires appropriate cancer surveillance considerations.
• History of certain GI cancers within five years (Clinical): Prior gastrointestinal malignancy is treated as a high-risk setting for intestinotrophic agents; clinical use is generally restricted based on oncologic history and imaging criteria.

Lyophilized (powder): Refrigerated (2-8°C), Up to 24 months. Light sensitive: yes, store dark

Reconstituted (solution): Refrigerated (2-8°C), Use promptly per product labeling; typically single-use after reconstitution. Solvent: Bacteriostatic water

• NCT03442972 — Glucagon-like Peptide-2 Mediated Secretion of Stored Enteral Lipids (PHASE2 / PHASE3), status: COMPLETED. Indications: Hyperlipidemias
• NCT04733066 — Quality of Life in Patients With Short Bowel Syndrome Treated Without and With Teduglutide - a Prospective Nested Matched Pair Analysis, status: UNKNOWN. Indications: Short Bowel Syndrome, Intestinal Failure
• NCT03422666 — Plasma Lipoprotein Response to Glucagon-like Peptide-2 (PHASE2 / PHASE3), status: COMPLETED. Indications: Hyperlipidemias
• NCT05027308 — A Study of Teduglutide in Japanese Children With Short Bowel Syndrome Aged 4 Months or Older (PHASE3), status: COMPLETED. Indications: Short Bowel Syndrome
• NCT02980666 — Study in Japanese Pediatric Subjects With Short Bowel Syndrome (SBS) Who Are Dependent on Parenteral Support (PHASE3), status: COMPLETED. Indications: Short Bowel Syndrome
• NCT03716115 — Therapeutic Approaches to Malnutrition Enteropathy (PHASE2), status: COMPLETED. Indications: Severe Acute Malnutrition
• NCT02099084 — Short Bowel Syndrome and Teduglutide Versus Placebo (PHASE4), status: COMPLETED. Indications: Short Bowel Syndrome
• NCT02889393 — Teduglutide for Enterocutaneous Fistula (ECF) (PHASE2), status: COMPLETED. Indications: Postoperative Fistula
• NCT03534661 — L-NMMA on GLP-2 Mediated Intestinal Lipoprotein Release (PHASE2 / PHASE3), status: COMPLETED. Indications: Hyperlipidemias
• NCT04290429 — Treatment of Patients With Teduglutide (GLP-2) for GVHD and Analysis of Paneth Cells of GVHD Patients (EARLY_PHASE1), status: COMPLETED. Indications: Graft Versus Host Disease
• NCT05561647 — A Survey to Assess Participants' and Physicians' Knowledge When Using GATTEX (Knowledge Assessment Survey), status: RECRUITING. Indications: Short Bowel Syndrome (SBS)
• NCT01209351 — Effect of Teduglutide on Gastric Emptying in Healthy Subjects (PHASE1), status: COMPLETED. Indications: Healthy Volunteers
• NCT04877431 — A Study of Teduglutide (Revestive®) in Children, Teenagers and Adults With Short Bowel Disease, status: COMPLETED. Indications: Short Bowel Syndrome
• NCT01028924 — Effects of Teduglutide on Cardiac Repolarisation and Conduction in Healthy Male and Female Volunteers (PHASE1), status: COMPLETED. Indications: Healthy
• NCT03268811 — A Study in Japanese Children With Short Bowel Syndrome Who Completed SHP633-302 (PHASE3), status: COMPLETED. Indications: Short Bowel Syndrome
• NCT03596164 — An Extension Study of Teduglutide in Japanese Participants With Short Bowel Syndrome Who Completed 24 Weeks of Treatment in SHP633-306 or TED-C14-004 (PHASE3), status: COMPLETED. Indications: Short Bowel Syndrome
• NCT03663582 — Study of Teduglutide in Japanese Participants With Short Bowel Syndrome (PHASE3), status: COMPLETED. Indications: Short Bowel Syndrome
• NCT05023382 — A Study of Teduglutide in Japanese People With Short Bowel Syndrome, status: RECRUITING. Indications: Short Bowel Syndrome
• NCT04916665 — Bridging Intestinal Failure With Teduglutide - a Case Report, status: COMPLETED. Indications: Short Bowel Syndrome
• NCT04832087 — Pediatric Teduglutide Registry, status: COMPLETED. Indications: Short Bowel Syndrome