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Gattex Kit (TEDUGLUTIDE)
Gattex Kit works by binding to and activating the glucagon-like peptide 2 receptor, promoting intestinal growth and absorption.
Gattex Kit (TEDUGLUTIDE) is a GLP-2 Analog developed by NPS PHARMS INC and currently owned by Takeda Pharms Usa. It targets the glucagon-like peptide 2 receptor to treat Short bowel syndrome. Gattex Kit is a small molecule modality, FDA approved in 2012, and remains a branded product with no generic manufacturers. Key safety considerations include the need for regular injections and potential side effects such as abdominal pain and injection site reactions. As a patented product, Gattex Kit is not yet off-patent.
At a glance
| Generic name | TEDUGLUTIDE |
|---|---|
| Sponsor | Takeda |
| Drug class | GLP-2 Analog [EPC] |
| Target | Glucagon-like peptide 2 receptor |
| Modality | Recombinant protein |
| Therapeutic area | Metabolic |
| Phase | FDA-approved |
| First approval | 2012 |
Mechanism of action
Teduglutide is an analog of naturally occurring human glucagon-like peptide-2 (GLP-2), peptide secreted by L-cells of the distal intestine. GLP-2 is known to increase intestinal and portal blood flow and inhibit gastric acid secretion. Teduglutide binds to the glucagon-like peptide-2 receptors located in intestinal subpopulations of enteroendocrine cells, subepithelial myofibroblasts and enteric neurons of the submucosal and myenteric plexus. Activation of these receptors results in the local release of multiple mediators including insulin-like growth factor (IGF)-1, nitric oxide and keratinocyte growth factor (KGF).
Approved indications
- Short bowel syndrome
Common side effects
- Abdominal pain
- Nausea
- Upper respiratory tract infection
- Abdominal distension
- Injection site reaction
- Vomiting
- Fluid Overload
- Hypersensitivity
- Flatulence
- Decreased appetite
- Influenza
- Skin hemorrhage
Key clinical trials
- A Study of Teduglutide in Chinese Children and Teenagers With Short Bowel Syndrome
- TED_ORG: Study on Short Bowel Syndrome (NA)
- A Survey to Assess Participants' and Physicians' Knowledge When Using GATTEX (Knowledge Assessment Survey)
- Registry for Participants With Short Bowel Syndrome
- Characterization of the Long-term Safety, Efficacy, and Pharmacodynamics Revestive® in the Management of Short Bowel Syndrome Pediatric Patients (PHASE4)
- A Study of Teduglutide in Chinese Adults With Short Bowel Syndrome (PHASE3)
- A Study of Teduglutide in Japanese People With Short Bowel Syndrome
- A Study of Teduglutide (Revestive®) in Participants With Short Bowel Syndrome (SBS) in Canada
Patents
| Patent | Expiry | Type |
|---|---|---|
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |