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Teduglutide
Identification
- Name
- Teduglutide
- Accession Number
- DB08900
- Description
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
Treatment of short bowel syndrome (SBS), malabsorption associated with the removal of the intestine, in adults patients who are dependent on parenteral support.
- Associated Conditions
- Contraindications & Blackbox Warnings
Learn about our commercial Contraindications & Blackbox Warnings data.
Learn More- Pharmacodynamics
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
Learn about our commercial Adverse Effects data.
Learn More- Toxicity
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%.
- Affected organisms
- Humans and other mammals
- 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 Unlock Additional DataAbacavir Abacavir may decrease the excretion rate of Teduglutide which could result in a higher serum level. Acarbose Acarbose 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. Acetazolamide Acetazolamide may increase the excretion rate of Teduglutide which could result in a lower serum level and potentially a reduction in efficacy. Acetylsalicylic acid Acetylsalicylic acid may decrease the excretion rate of Teduglutide which could result in a higher serum level. Aclidinium Aclidinium may decrease the excretion rate of Teduglutide which could result in a higher serum level. Acrivastine Teduglutide may decrease the excretion rate of Acrivastine which could result in a higher serum level. Acyclovir Acyclovir may decrease the excretion rate of Teduglutide which could result in a higher serum level. Additional Data Available- Extended DescriptionExtended Description
Extended description of the mechanism of action and particular properties of each drug interaction.
Learn more - Severity
- Evidence Level
- ActionAction
An effect category for each drug interaction. Know how this interaction affects the subject drug.
Learn more
- Food Interactions
- Not Available
Products
- Brand Name Prescription Products
Name Dosage Strength Route Labeller Marketing Start Marketing End Region Image Unlock Additional DataGattex Injection, powder, lyophilized, for solution 5 mg/0.5mL Subcutaneous Shire-NPS Pharmaceuticals, Inc. 2012-12-21 Not applicable US 
Revestive Injection, powder, for solution 5 mg Subcutaneous Shire 2012-08-30 Not applicable EU 
Revestive Kit; Powder, for solution Subcutaneous Shire Pharmaceuticals Ireland Limited 2015-10-28 Not applicable Canada 
Additional Data Available- Application NumberApplication Number
A unique ID assigned by the FDA when a product is submitted for approval by the labeller.
Learn more - Product CodeProduct Code
A governmentally-recognized ID which uniquely identifies the product within its regulatory market.
Learn more
- Mixture Products
Name Ingredients Dosage Route Labeller Marketing Start Marketing End Region Image Gattex Teduglutide (5 mg/0.5mL) + Ethanol (0.7 mL/1mL) Subcutaneous; Topical Shire-NPS Pharmaceuticals, Inc. 2012-12-21 Not applicable US Gattex Teduglutide (5 mg/0.5mL) + Ethanol (0.7 mL/1mL) Subcutaneous; Topical Shire-NPS Pharmaceuticals, 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
- Pancreatic Hormones
- Peptide Hormones
- Peptides
- Proglucagon
- Protective Agents
- Protein Precursors
- Proteins
- 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
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. [PubMed:23729002]
- 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. [PubMed:23591284]
- 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. [PubMed:22570676]
- 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
- AHFS Codes
- 56:92.00 — Miscellaneous GI Drugs
- FDA label
- Download (410 KB)
Clinical Trials
- Clinical Trials
Phase Status Purpose Conditions Count 4 Completed Treatment Short bowel condition / Short Bowel Syndrome (SBS) 1 4 Recruiting Treatment Short bowel condition / Short Bowel Syndrome (SBS) 1 3 Active Not Recruiting Treatment Short bowel condition / Short Bowel Syndrome (SBS) 5 3 Completed Treatment Short bowel condition / Short Bowel Syndrome (SBS) 10 3 Not Yet Recruiting Treatment Ileostomy - Stoma 1 2 Completed Treatment Crohn's Disease (CD) 2 2 Not Yet Recruiting Treatment Severe Acute Malnutrition 1 2 Recruiting Treatment Human Immunodeficiency Virus (HIV) Infections 1 2, 3 Completed Basic Science Hyperlipidemias 1 2, 3 Recruiting Basic Science Hyperlipidemias 3
Pharmacoeconomics
- Manufacturers
- Not Available
- Packagers
- Not Available
- Dosage Forms
Form Route Strength Injection, powder, lyophilized, for solution Subcutaneous 5 mg/0.5mL Injection, powder, for solution Subcutaneous 5 mg Kit; powder, for solution Subcutaneous - Prices
- Not Available
- Patents
Patent Number Pediatric Extension Approved Expires (estimated) Region Unlock Additional DataUS5789379 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 Additional Data Available- Filed On
Properties
- State
- Liquid
- Experimental Properties
- Not Available
Targets
- Kind
- Protein
- Organism
- Humans
- Pharmacological action
- Yes
- Actions
- Agonist
- General Function
- Glucagon receptor activity
- Specific Function
- This is a receptor for glucagon-like peptide 2. The activity of this receptor is mediated by G proteins which activate adenylyl cyclase.
- 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. [PubMed:23729002]
Drug created on June 05, 2013 23:11 / Updated on August 10, 2020 08:11
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