Gattex Kit

(Teduglutide)

ApprovedPeptide

Gattex Kit is a peptide that works as a Glucagon-Like Peptide 2 Receptor Agonist.[2] It is being used across 9 indications, with its most advanced program in Approved.[1]

Gattex Kit is one of 250 small molecule programs targeting Crohn's Disease. It is currently in Approved.

Indications

Total Trials

Active Trials

249

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

Crohn's DiseaseApproved

Primary Short Bowel SyndromeActive, not recruiting

Malabsorption SyndromeActive, not recruiting

Liver DiseaseApproved

HyperlipidemiaApproved

Graft Versus Host DiseaseApproved

HIV InfectionApproved

Kidney DiseaseApproved

Short Bowel SyndromeCompleted

Crohn's DiseaseApproved

Approved

Primary Short Bowel SyndromeApproved

Active, not recruiting

Malabsorption SyndromeApproved

Active, not recruiting

Liver DiseaseApproved

Approved

HyperlipidemiaApproved

Approved

Graft Versus Host DiseaseApproved

Approved

HIV InfectionApproved

Approved

Kidney DiseaseApproved

Approved

Short Bowel SyndromeApproved

Completed

Competition

Competitive Landscape

123 competitors in HIV Infection

#DrugCompanyPhaseTrials

Gattex Kit

Takeda

Approved

36 2

Retrovir

BBp Consulting, Inc

Approved

36 3

Epivir

GGlaxo Dba Glaxosmithkline

Approved

16 4

Ziagen

GSK

Approved

4 5

Vemlidy

Gilead

Approved

1 6

Lialda

Takeda

Approved

1 7

Golytely

Hepsera

Zofran

Viread

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

N/ARecruiting

Short Bowel Syndrome

NCT07400783

Q3 2027

Phase 3Active, not recruiting

Short Bowel Syndrome

NCT06973304

Clinical

Trials by Indication[1]

Short Bowel Syndrome18 trials

Long-term Study of Teduglutide in Pediatric Subjects With Short Bowel Syndrome Who Completed the TED-C13-003 Study

Completed· Takeda logo

Takeda·Phase 3·NCT02949362·29 enrolled

A Pharmacokinetic, Safety, and Pharmacodynamic Study of Teduglutide in Pediatric Subjects With Short Bowel Syndrome

Completed· Takeda logo

Takeda·Phase 3·NCT01952080·42 enrolled

Safety, Efficacy and Pharmacokinetic Study of Teduglutide in Infants 4 to 12 Months of Age With Short Bowel Syndrome

Completed· Takeda logo

Takeda·Phase 3·NCT03571516·10 enrolled

Show 15 more trials

Characterization of the Long-term Safety, Efficacy, and Pharmacodynamics Revestive® in the Management of Short Bowel Syndrome Pediatric Patients

Completed·AAssistance Publique - Hôpitaux de Paris·Phase 4·NCT03562130·25 enrolled

Study to Evaluate the Safety, Efficacy and Pharmacokinetics of Teduglutide in Japanese Subjects With PN-dependent Short Bowel Syndrome (SBS)

Completed· Takeda logo

Takeda·Phase 3·NCT02340819·11 enrolled

Short Bowel Syndrome and Teduglutide Versus Placebo

Completed·MMayo Clinic·Phase 4·NCT02099084·8 enrolled

TED_ORG: Study on Short Bowel Syndrome

Recruiting·MMeyer Children's Hospital IRCCS·N/A·NCT07400783·50 enrolled

Quality of Life in Patients With Short Bowel Syndrome Treated Without and With Teduglutide - a Prospective Nested Matched Pair Analysis

Unknown status·—··NCT04733066·40 enrolled

Study in Japanese Pediatric Subjects With Short Bowel Syndrome (SBS) Who Are Dependent on Parenteral Support

Completed· Takeda logo

Takeda·Phase 3·NCT02980666·10 enrolled

Study of Teduglutide Effectiveness in Parenteral Nutrition (PN)-Dependent Short Bowel Syndrome (SBS) Subjects

Completed· Takeda logo

Takeda·Phase 3·NCT00798967·86 enrolled

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

Completed· Takeda logo

Takeda·Phase 3·NCT03596164·11 enrolled

A Study in Japanese Children With Short Bowel Syndrome Who Completed SHP633-302

Completed· Takeda logo

Takeda·Phase 3·NCT03268811·9 enrolled

A Study of Teduglutide in Japanese Children With Short Bowel Syndrome Aged 4 Months or Older

Completed· Takeda logo

Takeda·Phase 3·NCT05027308·3 enrolled

Teduglutide in Short Bowel Syndrome Patients

Completed·MMedical University of Vienna··NCT04857801·17 enrolled

Open-Label Study of Teduglutide for Subjects With PN-Dependent Short Bowel Syndrome (SBS)

Completed· Takeda logo

Takeda·Phase 3·NCT00930644·88 enrolled

Study of Teduglutide in Japanese Participants With Short Bowel Syndrome

Completed· Takeda logo

Takeda·Phase 3·NCT03663582·7 enrolled

An Open-label, Phase 3 Study to Evaluate the Efficacy, Safety and Pharmacokinetics of 0.05 mg/kg/Day Subcutaneous Teduglutide Following Treatment of Short Bowel Syndrome for 24 Weeks in Chinese Adults Who Are Dependent on Parenteral Support

Active, not recruiting· Takeda logo

Takeda·Phase 3·NCT06973304·13 enrolled

Special Drug Use Investigation of Revestive Subcutaneous Injection 3.8 mg (All-case Surveillance)

Completed· Takeda logo

Takeda··NCT05023382·250 enrolled

TED3 trials

Bridging Intestinal Failure With Teduglutide - a Case Report

Completed·MMedical University of Vienna··NCT04916665·1 enrolled

Teduglutide for Enterocutaneous Fistula (ECF)

Completed·DDaniel Dante Yeh·Phase 2·NCT02889393·6 enrolled

A One-Year, Open-Label Study With Teduglutide for Subjects Who Completed Study CL0600-021

Completed· Takeda logo

Takeda·Phase 3·NCT01560403·14 enrolled

Safety and Efficacy2 trials

Safety and Efficacy of ALX-0600 in Subjects With Active Crohn's Disease

Completed· Takeda logo

Takeda·Phase 2·NCT00072839·100 enrolled

Safety and Efficacy of ALX-0600 in Subjects With Active Crohn's Disease Who Completed Protocol CL0600-008

Completed· Takeda logo

Takeda·Phase 2·NCT00308438·67 enrolled

Lip2 trials

Glucagon-like Peptide-2 Mediated Secretion of Stored Enteral Lipids

Completed·UUniversity Health Network, Toronto·Phase 2/3·NCT03442972·21 enrolled

Plasma Lipoprotein Response to Glucagon-like Peptide-2

Completed·UUniversity Health Network, Toronto·Phase 2/3·NCT03422666·10 enrolled

Gastric Emptying1 trial

Effect of Teduglutide on Gastric Emptying in Healthy Subjects

Completed· Takeda logo

Takeda·Phase 1·NCT01209351·36 enrolled

10 more indications

Malnutrition1 trial

Therapeutic Approaches to Malnutrition Enteropathy

Completed·QQueen Mary University of London·Phase 2·NCT03716115·125 enrolled

Complication1 trial

Pilot Study to Investigate the Effect of Teduglutide on Temporary Ileostomy Function and Complications

Withdrawn·—·Phase 3·NCT03953170

Inflammation1 trial

A Study of the Gut Barrier and Blood Vessel Inflammation in Individuals With and Without HIV

Completed·MMassachusetts General Hospital·Phase 2·NCT02431325·32 enrolled

Treatment1 trial

Treatment of Patients With Teduglutide (GLP-2) for GVHD and Analysis of Paneth Cells of GVHD Patients

Completed·UUniversity of Freiburg·Phase 1·NCT04290429·6 enrolled

Renal Impairment1 trial

Pharmacokinetics of 10 mg Teduglutide in Subjects With Renal Impairment Compared to Healthy Subjects With Normal Renal Function

Completed·NNycomed·Phase 1·NCT01028768·36 enrolled

Hepatic Function1 trial

Pharmacokinetics (PK) of 20 mg Teduglutide in Participants With Moderately Impaired Hepatic Function Compared to Healthy Participants

Completed· Takeda logo

Takeda·Phase 1·NCT00819468·24 enrolled

Double-blind1 trial

A Double-Blind Multi-Dose Tolerability and Pharmacokinetic Study of Teduglutide

Completed· Takeda logo

Takeda·Phase 1·NCT00820885·95 enrolled

Cardiac1 trial

Effects of Teduglutide on Cardiac Repolarisation and Conduction in Healthy Male and Female Volunteers

Completed·NNycomed·Phase 1·NCT01028924·72 enrolled

Pediatric1 trial

Pediatric Teduglutide Registry

Completed·—··NCT04832087·142 enrolled

Adult1 trial

A Study to Evaluate the Bioavailability of Teduglutide Administered Subcutaneously by Syringe Injection Versus Pen Injector in Healthy Adult Participants

Completed· Takeda logo

Takeda·Phase 1·NCT04465396·64 enrolled

Regulatory

FDA Approval Timeline[4]

Dec 21, 2012

GATTEX KIT

NDA NDA203441

Sources

References

[1]
ClinicalTrials.gov — 36 trial records for Teduglutide. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Teduglutide compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Teduglutide. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA203441). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Gattex Kit. U.S. Food & Drug Administration.
[6]
SEC EDGAR — Takeda company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Glucagon-Like Peptide 2 Receptor Agonist[2]
Modality: Peptide[2]
Highest Phase: Approved[1]
Company: Takeda

Patent Landscape[5]

Patent #Expires

9060992Nov 1, 2025

7847061Nov 1, 2025

7847061*PEDMay 1, 2026

9060992*PEDMay 1, 2026

Gattex Kit

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q3 2027

Trials by Indication[1]

Short Bowel Syndrome18 trials

TED3 trials

Safety and Efficacy2 trials

Lip2 trials

Gastric Emptying1 trial

Malnutrition1 trial

Complication1 trial

Inflammation1 trial

Treatment1 trial

Renal Impairment1 trial

Hepatic Function1 trial

Double-blind1 trial

Cardiac1 trial

Pediatric1 trial

Adult1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

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