teduglutide 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definition	Drug id	CAS RN
glucagon-like peptide (GLP) analogues and agonists	4718	197922-42-2

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: revestive teduglutide gattex ALX-0600 teduglutide recombinant	an analogue of human glucagon-like peptide-2 (GLP-2) preserves mucosal integrity by promoting repair and normal growth of the intestine through an increase of villus height and crypt depth Molecular weight: 3752.13 Formula: C164H252N44O55S CLOGP: LIPINSKI: None HAC: 99 HDO: 55 TPSA: 1624.22 ALOGS: ROTB: 125

Molecule

Description

Molfile Inchi Smiles

Synonyms:

revestive
teduglutide
gattex
ALX-0600
teduglutide recombinant

an analogue of human glucagon-like peptide-2 (GLP-2) preserves mucosal integrity by promoting repair and normal growth of the intestine through an increase of villus height and crypt depth

Molecular weight: 3752.13
Formula: C164H252N44O55S
CLOGP:
LIPINSKI: None
HAC: 99
HDO: 55
TPSA: 1624.22
ALOGS:
ROTB: 125

Drug dosage:

Dose	Unit	Route
5	mg	P

ADMET properties:

None

Approvals:

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Date	Agency	Company
Aug. 30, 2012	EMA	NPS Pharma Holdings Limited
Dec. 21, 2012	FDA	NPS PHARMS INC
June 23, 2021	PMDA	TAKEDA PHARMACEUTICAL COMPANY LIMITED

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FDA Adverse Event Reporting System (Female)

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MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Vascular device infection	992.83	24.37	220	7628	7092	63474082
Stoma complication	315.05	24.37	55	7793	480	63480694
Device related sepsis	285.79	24.37	72	7776	4022	63477152
Device related infection	282.97	24.37	107	7741	23285	63457889
Hospitalisation	260.41	24.37	150	7698	84931	63396243
Gastrointestinal stoma output increased	206.60	24.37	36	7812	310	63480864
Weight decreased	173.24	24.37	191	7657	276607	63204567
Device related bacteraemia	161.03	24.37	27	7821	180	63480994
Abdominal distension	159.94	24.37	111	7737	86504	63394670
Product dose omission issue	138.38	24.37	157	7691	234156	63247018

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FDA Adverse Event Reporting System (Male)

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MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Vascular device infection	1150.26	31.82	228	4410	3957	34948336
Device related sepsis	290.68	31.82	70	4568	3023	34949270
Device related infection	266.00	31.82	96	4542	17141	34935152
Hospitalisation	209.75	31.82	116	4522	56786	34895507
Stoma complication	203.80	31.82	36	4602	313	34951980
Gastrointestinal stoma output increased	120.71	31.82	19	4619	73	34952220
Complication associated with device	113.69	31.82	39	4599	5967	34946326
Device related bacteraemia	97.48	31.82	20	4618	406	34951887
Weight decreased	95.70	31.82	117	4521	176184	34776109
Device breakage	89.95	31.82	26	4612	2274	34950019

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FDA Adverse Event Reporting System (Geriatric)

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MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Vascular device infection	1822.51	22.82	387	9795	9889	79724317
Device related sepsis	554.43	22.82	134	10048	6106	79728100
Device related infection	513.56	22.82	185	9997	34109	79700097
Stoma complication	385.79	22.82	70	10112	749	79733457
Gastrointestinal stoma output increased	245.61	22.82	43	10139	368	79733838
Device related bacteraemia	222.63	22.82	43	10139	659	79733547
Hospitalisation	163.99	22.82	118	10064	94118	79640088
Abdominal pain	149.34	22.82	214	9968	389355	79344851
Weight decreased	137.35	22.82	196	9986	355002	79379204
Abdominal distension	134.94	22.82	116	10066	119534	79614672

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FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

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Source	Code	Description
ATC	A16AX08	ALIMENTARY TRACT AND METABOLISM OTHER ALIMENTARY TRACT AND METABOLISM PRODUCTS OTHER ALIMENTARY TRACT AND METABOLISM PRODUCTS Various alimentary tract and metabolism products
CHEBI has role	CHEBI:22586	antioxidants
CHEBI has role	CHEBI:25212	metabolites
CHEBI has role	CHEBI:50267	protective agents
CHEBI has role	CHEBI:72311	glucagon-like peptide-2 receptor agonists
FDA Chemical/Ingredient	N0000175140	Glucagon-Like Peptide 2
FDA Chemical/Ingredient	N0000175452	Analogs/Derivatives
FDA EPC	N0000190992	GLP-2 Analog
FDA MoA	N0000190990	Glucagon-like Peptide-2 (GLP-2) Agonists
MeSH PA	D005765	Gastrointestinal Agents

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Drug Use | Suggest Off label Use Form| |View source of the data|

Disease	Relation	SNOMED_ID	DOID
Short bowel syndrome	indication	26629001	DOID:10605

🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

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Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	2.81	acidic
pKa10	12.47	acidic
pKa11	12.53	acidic
pKa12	12.69	acidic
pKa13	12.83	acidic
pKa14	12.86	acidic
pKa15	12.87	acidic
pKa16	13.05	acidic
pKa17	13.1	acidic
pKa18	13.22	acidic

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Orange Book patent data (new drug applications)

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Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Patent number	Patent expiration date	Patent use
5MG/VIAL	GATTEX KIT	TAKEDA PHARMS USA	N203441	Dec. 21, 2012	RX	POWDER	SUBCUTANEOUS	7847061	Nov. 1, 2025	TREATMENT OF ADULT PATIENTS WITH SHORT BOWEL SYNDROME WHO ARE DEPENDENT ON PARENTERAL SUPPORT
5MG/VIAL	GATTEX KIT	TAKEDA PHARMS USA	N203441	Dec. 21, 2012	RX	POWDER	SUBCUTANEOUS	9060992	Nov. 1, 2025	TREATMENT OF ADULT PATIENTS WITH SHORT BOWEL SYNDROME WHO ARE DEPENDENT ON PARENTERAL SUPPORT

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Orange Book exclusivity data (new drug applications)

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Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Exclusivity date	Description
5MG/VIAL	GATTEX KIT	TAKEDA PHARMS USA	N203441	Dec. 21, 2012	RX	POWDER	SUBCUTANEOUS	May 16, 2026	TREATMENT OF PEDIATRIC PATIENTS 1 YEAR OF AGE AND OLDER WITH SHORT BOWEL SYNDROME (SBS) WHO ARE DEPENDENT ON PARENTERAL SUPPORT

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Bioactivity Summary:

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Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Mechanism action	Bioact source	MoA source
Glucagon-like peptide 2 receptor	GPCR	O95838	GLP2R_HUMAN	AGONIST	EC50	10.05		CHEMBL	CHEMBL
Glucagon-like peptide 2 receptor	GPCR		GLP2R_RAT		EC50	10.10		CHEMBL

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External reference:

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ID	Source
014819	NDDF
1364468	RXNORM
16139605	PUBCHEM_CID
196699	MMSL
29024	MMSL
4032133	VUID
4032133	VANDF
7049	IUPHAR_LIGAND_ID
710807004	SNOMEDCT_US
715636000	SNOMEDCT_US

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Pharmaceutical products:

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Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Gattex	HUMAN PRESCRIPTION DRUG LABEL	1	68875-0101	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	5 mg	SUBCUTANEOUS	NDA	30 sections
Gattex	HUMAN PRESCRIPTION DRUG LABEL	1	68875-0101	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	5 mg	SUBCUTANEOUS	NDA	30 sections

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