GATTEX KIT (teduglutide)
Gattex helps patients with Short Bowel Syndrome who rely on parenteral support for their nutritional needs. This medication is used for both adults and children at least one year of age. It works as a supplemental version of a natural hormone to help the body manage the effects of the condition.
How GATTEX KIT Works
The drug works by binding to glucagon-like peptide-2 receptors found in the cells and neurons of the intestinal tract. This activation increases blood flow to the intestines and triggers the release of local mediators such as nitric oxide and growth factors, while also slowing the secretion of gastric acid.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2012-12-21
- Patent Cliff
- 2026
- Routes
- SUBCUTANEOUS
- Dosage Forms
- POWDER
GATTEX KIT Approval History
What GATTEX KIT Treats
1 indicationsGATTEX KIT is approved for 1 conditions since its original approval in 2012. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Short Bowel Syndrome
Clinical Trial Registry
25 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT03562130 REVE | P171002J 2017-001405-32 | Ph 4 | completed | Characterization of the Long-term Safety, Efficacy, and Pharmacodynamics Revestive® in the Management of Short Bowel Syndrome Pediatric Patients |
| NCT06973304 | TAK-633-3009 | Ph 3 | recruiting | A Study of Teduglutide in Chinese Adults With Short Bowel Syndrome |
| NCT02949362 results posted | SHP633-303 2016-000863-17 | Ph 3 | completed | Long-term Study of Teduglutide in Pediatric Subjects With Short Bowel Syndrome Who Completed the TED-C13-003 Study |
| NCT05027308 results posted | TAK-633-3008 U1111-1267-3327, jRCT2021210035 | Ph 3 | completed | A Study of Teduglutide in Japanese Children With Short Bowel Syndrome Aged 4 Months or Older |
| NCT02431325 results posted | 2013P002669 1R01HL123351-01 | Ph 2 | completed | A Study of the Gut Barrier and Blood Vessel Inflammation in Individuals With and Without HIV |
| NCT03596164 results posted | SHP633-307 | Ph 3 | completed | 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 |
| NCT03953170 | Teduglutide | Ph 3 | withdrawn | Pilot Study to Investigate the Effect of Teduglutide on Temporary Ileostomy Function and Complications |
| NCT04465396 results posted | TAK-633-1001 | Ph 1 | completed | A Study to Evaluate the Bioavailability of Teduglutide Administered Subcutaneously by Syringe Injection Versus Pen Injector in Healthy Adult Participants |
| NCT03422666 GLP-2 Plasma | 16-6368.1 | Ph 2, Ph 3 | completed | Plasma Lipoprotein Response to Glucagon-like Peptide-2 |
| NCT03442972 GLP-2 Biopsy | 16-6368.2 | Ph 2, Ph 3 | completed | Glucagon-like Peptide-2 Mediated Secretion of Stored Enteral Lipids |
| NCT03268811 results posted | SHP633-305 2021-005404-36 | Ph 3 | completed | A Study in Japanese Children With Short Bowel Syndrome Who Completed SHP633-302 |
| NCT02980666 results posted | SHP633-302 2020-005791-35 | Ph 3 | completed | Study in Japanese Pediatric Subjects With Short Bowel Syndrome (SBS) Who Are Dependent on Parenteral Support |
| NCT02889393 results posted | 20170189 | Ph 2 | completed | Teduglutide for Enterocutaneous Fistula (ECF) |
| NCT03716115 TAME | 011724 QM | Ph 2 | completed | Therapeutic Approaches to Malnutrition Enteropathy |
| NCT00930644 results posted | CL0600-021 2009-011679-65 | Ph 3 | completed | Open-Label Study of Teduglutide for Subjects With PN-Dependent Short Bowel Syndrome (SBS) |
| NCT01560403 STEPS3 results posted | TED-C11-001 | Ph 3 | completed | A One-Year, Open-Label Study With Teduglutide for Subjects Who Completed Study CL0600-021 |
| NCT02340819 results posted | TED-C14-004 | Ph 3 | completed | Study to Evaluate the Safety, Efficacy and Pharmacokinetics of Teduglutide in Japanese Subjects With PN-dependent Short Bowel Syndrome (SBS) |
| NCT01952080 results posted | TED-C13-003 | Ph 3 | completed | A Pharmacokinetic, Safety, and Pharmacodynamic Study of Teduglutide in Pediatric Subjects With Short Bowel Syndrome |
| NCT01209351 | C10-003 | Ph 1 | completed | Effect of Teduglutide on Gastric Emptying in Healthy Subjects |
| NCT00798967 STEPS results posted | CL0600-020 2008-006193-15 | Ph 3 | completed | Study of Teduglutide Effectiveness in Parenteral Nutrition (PN)-Dependent Short Bowel Syndrome (SBS) Subjects |
| NCT03571516 results posted | SHP633-301 2017-003606-40 | Ph 3 | completed | Safety, Efficacy and Pharmacokinetic Study of Teduglutide in Infants 4 to 12 Months of Age With Short Bowel Syndrome |
| NCT03663582 results posted | SHP633-306 | Ph 3 | completed | Study of Teduglutide in Japanese Participants With Short Bowel Syndrome |
| NCT02099084 results posted | 13-004866 UL1TR000135 | Ph 4 | completed | Short Bowel Syndrome and Teduglutide Versus Placebo |
| NCT01028768 | TE-1777-101-EC | Ph 1 | completed | Pharmacokinetics of 10 mg Teduglutide in Subjects With Renal Impairment Compared to Healthy Subjects With Normal Renal Function |
| NCT01028924 | TE-1777-102-EC | Ph 1 | completed | Effects of Teduglutide on Cardiac Repolarisation and Conduction in Healthy Male and Female Volunteers |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
GATTEX KIT FDA Label Details
Indications & Usage
FDA Label (PDF)GATTEX KIT is indicated for the treatment of Short Bowel Syndrome.
GATTEX KIT Patents & Exclusivity
Patents (2 active)
Exclusivity
Pro Intelligence Preview
Deep insights for GATTEX KIT
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2026
- • 2 active patents
Trial Analysis
- • 25 total trials
- • Stage: Declining
Competitive Landscape
- • Competitor tracking
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment