Teduglutide

Treats Short Bowel Syndrome (SBS). Sold as Gattex. Every FDA application for this active ingredient.

As of Nov 13, 2026, FDA lists 1 application for Teduglutide (sold as Gattex), first approved Dec 21, 2012, with 3 new uses approved and 0 published complete response letters.

First approved: Dec 21, 2012
Applications: 1
New uses approved: 3
Complete response letters: 0
Medicare spending, 2025: $392M
First approved in Japan: Jun 23, 2021

Medicare Spending

CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name

Product	Part	Spending, 2025	Change	Beneficiaries
Gattex	Part D	$392M	+9%	1,020

Approvals in Japan (PMDA)

First approved in Japan 102 months after the US. PMDA's English list since 2008, matched by ingredient; see all Japanese approvals

Revestive, new ingredientA drug with a new active ingredient indicated for the treatment of short bowel syndrome. · Takeda Pharmaceutical Company Limited · Jun 23, 2021

Clinical Trials

5 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all


Glucagon-like Peptide 2 (GLP-2) in Undernourished Women Improving From Histology-Confirmed Environmental Enteric Dysfunction (EED)Environmental Enteric Dysfunction · International Centre for Diarrhoeal Disease Research, Bangladesh	Phase 2	Not yet recruiting	Apr 17, 2026
TED_ORG: Study on Short Bowel SyndromeShort Bowel Syndrome (SBS) · Meyer Children's Hospital IRCCS	Not applicable	Recruiting	Feb 10, 2026
A Study of Teduglutide in Chinese Children and Teenagers With Short Bowel SyndromeShort Bowel Syndrome (SBS) · Takeda	—	Recruiting	Jan 6, 2026
A Study of Teduglutide in Chinese Adults With Short Bowel SyndromeShort Bowel Syndrome · Takeda	Phase 3	Active, not recruiting	May 15, 2025
Registry for Participants With Short Bowel SyndromeShort Bowel Syndrome · Shire	—	Active, not recruiting	Nov 21, 2013

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history

Approved	Application	Sponsor	Supplements	Marketing
Dec 21, 2012	GattexNDA 203441 · New molecular entity	Takeda Pharms USA	18	Marketed

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA