FDA Approved Metabolic & Weight Loss

Teduglutide

also known as: Gattex, Revestive, ALX-0600

FDA-approved GLP-2 analog (Gattex/Revestive, 2012) for short-bowel syndrome — the first disease-modifying treatment for SBS, reducing parenteral nutrition dependence by promoting intestinal mucosal growth.

A DPP-4-resistant analog of GLP-2 (alanine-2 → glycine substitution) with a half-life extended from ~7 minutes for native GLP-2 to approximately 2 hours — FDA-approved 2012 as Gattex (Takeda, US) and Revestive (EU) for adult and pediatric short-bowel syndrome (SBS) patients dependent on parenteral nutrition. Mechanism is direct intestinotrophic: enterocyte proliferation, villous height increase, and crypt depth expansion, which together improve nutrient absorption and reduce PN requirements.

Mechanism of action

GLP-2 receptor agonism on intestinal enteroendocrine L-cells, subepithelial myofibroblasts, and enteric neurons. Drives epithelial proliferation, villous height increase, crypt depth expansion, and enhanced intestinal blood flow. In SBS this translates into improved nutrient absorption and reduced parenteral nutrition volume requirements.

Primary uses

  • Short-bowel syndrome (adults and pediatric ≥1 year) — FDA-approved

Typical dosing

0.05 mg/kg once daily (subcutaneous)

Labeled dose 0.05 mg/kg SC once daily. Dose adjustment in renal impairment.

Regulatory status

FDA-approved December 2012 as Gattex (NPS Pharmaceuticals, acquired by Shire, now Takeda) for adult SBS. Pediatric SBS (1+ years) approved 2019. EMA-approved 2012 as Revestive.

References

  1. [fda-pi] FDA. Gattex (teduglutide) prescribing information. Takeda Pharmaceuticals, updated 2024.
  2. [pubmed] Jeppesen PB, et al. "Teduglutide reduces need for parenteral support among patients with short bowel syndrome with intestinal failure." Gastroenterology, 2012;143:1473-1481.

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Disclaimer

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.