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Identification
- Summary
Teduglutide is a glucagon-like peptide-2 (GLP-2) analog used to treat patients with Short Bowel Syndrome (SBS) who require parenteral nutritional support.
- Brand Names
- Gattex, Revestive
- Generic Name
- Teduglutide
- DrugBank Accession Number
- DB08900
- Background
Teduglutide is a glucagon-like peptide-2 (GLP-2) analogue. It is made up of 33 amino acids and is manufactured using a strain of Escherichia coli modified by recombinant DNA technology. Teduglutide differs from GLP-2 by one amino acid (alanine is substituted by glycine). The significance of this substitution is that teduglutide is longer acting than endogenous GLP-2 as it is more resistant to proteolysis from dipeptidyl peptidase-4. FDA approved on December 21, 2012.
- Type
- Biotech
- Groups
- Approved
- Biologic Classification
- Protein Based Therapies
Other protein based therapies - Protein Chemical Formula
- C164H252N44O55S
- Protein Average Weight
- 3752.0 Da
- Sequences
>Protein sequence for teduglutide HGDGSFSDEMNTILDNLAARDFINWLIQTKITD
Download FASTA Format- Synonyms
- (Gly2)GLP-2
- Glucagon-like peptide II (2-glycine) (human)
- Gly(2)-GLP-2
- Teduglutida
- Teduglutide
- Teduglutide [rDNA origin]
- Teduglutide Recombinant
- External IDs
- ALX 0600
- ALX-0600
Pharmacology
- Indication
Teduglutide is indicated for the treatment of adults and pediatric patients 1 year of age and older with Short Bowel Syndrome (SBS) who are dependent on parenteral support.4
Reduce drug development failure ratesBuild, train, & validate machine-learning modelswith evidence-based and structured datasets.Build, train, & validate predictive machine-learning models with structured datasets.- Associated Conditions
Indication Type Indication Combined Product Details Approval Level Age Group Patient Characteristics Dose Form Management of Short bowel syndrome •••••••••••• •••••• ••••••••• •••••••••• ••••••••• ••••••••• - Contraindications & Blackbox Warnings
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An enhancement of gastrointestinal fluid absorption (750-1000 mL/day) was observed following daily administrations of teduglutide. An increase in villus height and crypt depth of the intestinal mucosa was also noted. A decrease in fecal weight has also been observed. Teduglutide does not prolong the QTc interval.
- Mechanism of action
Teduglutide is an analog of naturally occurring human glucagon-like peptide-2 (GLP-2), a peptide secreted by L-cells of the distal intestine in response to meals. GLP-2 increases intestinal and portal blood flow and inhibit gastric acid secretion. Teduglutide binds to the glucagon-like peptide-2 receptors located in enteroendocrine cells, subepithelial myofibroblasts and enteric neurons of the submucosal and myenteric plexus. This causes the release of insulin-like growth factor (IGF)-1, nitric oxide and keratinocyte growth factor (KGF). These growth factors may contribute to the increase in crypt cell growth and surface area of the gastric mucosa. Ultimately, absorption through the intestine is enhanced.
Target Actions Organism AGlucagon-like peptide 2 receptor agonistHumans - Absorption
The pharmacokinetic profile of teduglutide (when administered subcutaneously) is described by a one-compartment model with first order absorption in the abdomen, arm, and thigh. With escalating doses, teduglutide demonstrates linear pharmacokinetics. Absolute bioavailability, SubQ = 88%; Tmax, SubQ = 3-5 hours;
Cmax, 0.05 mg/kg SubQ, SBS patients = 36 ng/mL; AUC, 0.05 mg/kg SubQ, SBS patients = 0.15 µg•hr/mL; Teduglutide does not accumulate following multiple subcutaneous administrations.- Volume of distribution
Vd, healthy subjects = 103 mL/kg
- Protein binding
Not Available
- Metabolism
Although a formal investigation has not been conducted, it is expected because teduglutide is a peptide-based drug, it will be degraded into smaller peptides and amino acids via catabolic pathways. The cytochrome P450 enzyme system is not involved in the metabolism of this drug.
- Route of elimination
Urine
- Half-life
Terminal half-life, healthy subjects = 2 hours; Terminal half-life, SBS patients = 1.3 hours
- Clearance
Plasma clearance, healthy subjects = 123 mL/hr/kg; This value indicates that teduglutide is primarily cleared by the kidney.
- Adverse Effects
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The most common adverse reactions (≥ 10%) across all studies with GATTEX are abdominal pain, injection site reactions, nausea, headaches, abdominal distension, upper respiratory tract infection. In addition, vomiting and fluid overload were reported in the SBS studies (1 and 3) at rates ≥ 10%.
- Pathways
- Not Available
- Pharmacogenomic Effects/ADRs
- Not Available
Interactions
- Drug Interactions
- This information should not be interpreted without the help of a healthcare provider. If you believe you are experiencing an interaction, contact a healthcare provider immediately. The absence of an interaction does not necessarily mean no interactions exist.
Drug Interaction Integrate drug-drug
interactions in your software1,2-Benzodiazepine The serum concentration of 1,2-Benzodiazepine can be increased when it is combined with Teduglutide. Abacavir Abacavir may decrease the excretion rate of Teduglutide which could result in a higher serum level. Aceclofenac Aceclofenac may decrease the excretion rate of Teduglutide which could result in a higher serum level. Acemetacin Acemetacin may decrease the excretion rate of Teduglutide which could result in a higher serum level. Acetaminophen Acetaminophen may decrease the excretion rate of Teduglutide which could result in a higher serum level. - Food Interactions
- No interactions found.
Products
Drug product information from 10+ global regionsOur datasets provide approved product information including:dosage, form, labeller, route of administration, and marketing period.Access drug product information from over 10 global regions.- Brand Name Prescription Products
Name Dosage Strength Route Labeller Marketing Start Marketing End Region Image Gattex Injection, powder, lyophilized, for solution 5 mg/0.5mL Subcutaneous Takeda Pharmaceuticals America, Inc. 2012-12-21 Not applicable US 
Revestive Injection, powder, for solution 1.25 mg Subcutaneous Takeda Pharmaceuticals International Ag Ireland Branch 2020-12-22 Not applicable EU 
Revestive Kit; Powder, for solution 5 mg / vial Subcutaneous Takeda 2015-10-28 Not applicable Canada 
Revestive Injection, powder, for solution 5 mg Subcutaneous Takeda Pharmaceuticals International Ag Ireland Branch 2020-12-22 Not applicable EU Revestive Injection, powder, for solution 5 mg Subcutaneous Takeda Pharmaceuticals International Ag Ireland Branch 2016-09-08 Not applicable EU - Mixture Products
Name Ingredients Dosage Route Labeller Marketing Start Marketing End Region Image Gattex Teduglutide (5 mg/0.5mL) + Ethanol (0.7 mL/1mL) Injection, powder, lyophilized, for solution; Kit Subcutaneous; Topical Takeda Pharmaceuticals America, Inc. 2012-12-21 Not applicable US Gattex Teduglutide (5 mg/0.5mL) + Ethanol (0.7 mL/1mL) Injection, powder, lyophilized, for solution; Kit Subcutaneous; Topical Takeda Pharmaceuticals America, Inc. 2012-12-21 Not applicable US
Categories
- ATC Codes
- A16AX08 — Teduglutide
- Drug Categories
- Alimentary Tract and Metabolism
- Amino Acids, Peptides, and Proteins
- Analogs/Derivatives
- Compounds used in a research, industrial, or household setting
- Drugs that are Mainly Renally Excreted
- Gastrointestinal Agents
- Gastrointestinal Hormones
- GLP-2 Analog
- Glucagon-Like Peptide 2
- Glucagon-like Peptide-2 (GLP-2) Agonists
- Glucagon-Like Peptides
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Miscellaneous GI Drugs
- Proglucagon
- Protective Agents
- Radiation-Protective Agents
- Various Alimentary Tract and Metabolism Products
- Chemical TaxonomyProvided by Classyfire
- Description
- Not Available
- Kingdom
- Organic Compounds
- Super Class
- Organic Acids
- Class
- Carboxylic Acids and Derivatives
- Sub Class
- Amino Acids, Peptides, and Analogues
- Direct Parent
- Peptides
- Alternative Parents
- Not Available
- Substituents
- Not Available
- Molecular Framework
- Not Available
- External Descriptors
- Not Available
- Affected organisms
- Humans and other mammals
Chemical Identifiers
- UNII
- 7M19191IKG
- CAS number
- 197922-42-2
References
- General References
- Burness CB, McCormack PL: Teduglutide: a review of its use in the treatment of patients with short bowel syndrome. Drugs. 2013 Jun;73(9):935-47. doi: 10.1007/s40265-013-0070-y. [Article]
- Semrad CE: The long road to a new short-bowel therapy: teduglutide for clinical use. Clin Gastroenterol Hepatol. 2013 Jul;11(7):824-5. doi: 10.1016/j.cgh.2013.03.030. Epub 2013 Apr 13. [Article]
- Jeppesen PB: Teduglutide, a novel glucagon-like peptide 2 analog, in the treatment of patients with short bowel syndrome. Therap Adv Gastroenterol. 2012 May;5(3):159-71. doi: 10.1177/1756283X11436318. [Article]
- FDA Approved Drug Products: Gattex (teduglutide) for subcutaneous injection [Link]
- External Links
- KEGG Drug
- D06053
- KEGG Compound
- C16049
- PubChem Substance
- 347910383
- 1364468
- ChEBI
- 72305
- ChEMBL
- CHEMBL2104987
- RxList
- RxList Drug Page
- Drugs.com
- Drugs.com Drug Page
- Wikipedia
- Teduglutide
- FDA label
- Download (410 KB)
Clinical Trials
- Clinical Trials
Clinical Trial & Rare Diseases Add-on Data Package
Explore 4,000+ rare diseases, orphan drugs & condition pairs, clinical trial why stopped data, & more. Preview package Phase Status Purpose Conditions Count Start Date Why Stopped 100+ additional columns Unlock 175K+ rows when you subscribe.View sample data4 Completed Treatment Short Bowel Syndrome (SBS) 2 somestatus stop reason just information to hide 3 Completed Treatment Short Bowel Syndrome (SBS) 16 somestatus stop reason just information to hide 3 Withdrawn Treatment Stoma Ileostomy 1 somestatus stop reason just information to hide 2 Completed Treatment Acute Malnutrition, Severe Acute Malnutrition 1 somestatus stop reason just information to hide 2 Completed Treatment Crohn's Disease (CD) 2 somestatus stop reason just information to hide
Pharmacoeconomics
- Manufacturers
- Not Available
- Packagers
- Not Available
- Dosage Forms
Form Route Strength Injection, powder, lyophilized, for solution Subcutaneous 5 mg/0.5mL Injection, powder, lyophilized, for solution; kit Subcutaneous; Topical Injection, powder, for solution Parenteral; Subcutaneous 1.25 MG Injection, powder, for solution Parenteral; Subcutaneous 5 MG Injection, powder, for solution Subcutaneous 1.25 mg Kit; powder, for solution Subcutaneous 5 mg / vial Injection, powder, for solution Subcutaneous 5 mg - Prices
- Not Available
- Patents
Patent Number Pediatric Extension Approved Expires (estimated) Region US5789379 Yes 1998-08-04 2020-10-14 US US7056886 Yes 2006-06-06 2023-03-18 US US7847061 Yes 2010-12-07 2026-05-01 US US9060992 Yes 2015-06-23 2026-05-01 US US9555079 Yes 2017-01-31 2026-05-01 US US9545434 Yes 2017-01-17 2026-05-01 US US9539310 Yes 2017-01-10 2026-05-01 US US9545435 Yes 2017-01-17 2026-05-01 US US9592273 Yes 2017-03-14 2026-05-01 US US9592274 Yes 2017-03-14 2026-05-01 US US9572867 Yes 2017-02-21 2026-05-01 US US9987334 Yes 2018-06-05 2026-05-01 US US9968658 Yes 2018-05-15 2026-05-01 US US9981016 Yes 2018-05-29 2026-05-01 US US9974837 Yes 2018-05-22 2026-05-01 US US9974835 Yes 2018-05-22 2026-05-01 US US9981014 Yes 2018-05-29 2026-05-01 US US9968656 Yes 2018-05-15 2026-05-01 US US9968655 Yes 2018-05-15 2026-05-01 US US9987335 Yes 2018-06-05 2026-05-01 US US9993528 Yes 2018-06-12 2026-05-01 US
Properties
- State
- Liquid
- Experimental Properties
- Not Available
Targets
- Kind
- Protein
- Organism
- Humans
- Pharmacological action
- Yes
- Actions
- Agonist
- General Function
- This is a receptor for glucagon-like peptide 2. The activity of this receptor is mediated by G proteins which activate adenylyl cyclase
- Specific Function
- G protein-coupled receptor activity
- Gene Name
- GLP2R
- Uniprot ID
- O95838
- Uniprot Name
- Glucagon-like peptide 2 receptor
- Molecular Weight
- 63000.84 Da
References
- Burness CB, McCormack PL: Teduglutide: a review of its use in the treatment of patients with short bowel syndrome. Drugs. 2013 Jun;73(9):935-47. doi: 10.1007/s40265-013-0070-y. [Article]
Drug created at June 06, 2013 05:11 / Updated at June 03, 2022 07:24