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

Stem definition	Drug id	CAS RN
Glucagon-like Peptide (GLP) analogues	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:

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

FDA Adverse Event Reporting System (Female)

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	411.21	29.34	86	3028	4298	50597712
Stoma complication	194.14	29.34	30	3084	249	50601761
Device related sepsis	185.57	29.34	43	3071	3432	50598578
Hospitalisation	140.73	29.34	73	3041	67864	50534146
Device related infection	113.35	29.34	44	3070	20691	50581319
Gastrointestinal stoma output increased	105.48	29.34	17	3097	189	50601821
Abdominal pain	87.71	29.34	89	3025	236139	50365871
Dehydration	74.64	29.34	67	3047	152382	50449628
Weight decreased	74.22	29.34	79	3035	221166	50380844
Abdominal distension	68.19	29.34	47	3067	72856	50529154
Sepsis	58.35	29.34	55	3059	132870	50469140
Device related bacteraemia	57.66	29.34	9	3105	80	50601930
Therapy interrupted	57.53	29.34	27	3087	20125	50581885
Product dose omission issue	56.93	29.34	63	3051	183775	50418235
Product availability issue	51.83	29.34	14	3100	2074	50599936
Intestinal obstruction	42.35	29.34	24	3090	26359	50575651
Bacteraemia	37.10	29.34	18	3096	14415	50587595
Flatulence	32.32	29.34	21	3093	29437	50572573
Gastrointestinal stoma output abnormal	31.97	29.34	5	3109	45	50601965
Weight fluctuation	31.49	29.34	13	3101	7135	50594875
Abnormal faeces	30.55	29.34	11	3103	4185	50597825
Inappropriate schedule of product administration	30.07	29.34	29	3085	71802	50530208
Enterocutaneous fistula	29.67	29.34	8	3106	1176	50600834
Small intestinal obstruction	29.57	29.34	16	3098	16052	50585958

FDA Adverse Event Reporting System (Male)

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	467.62	40.15	88	1841	2417	29570181
Device related infection	158.11	40.15	53	1876	15583	29557015
Device related sepsis	153.46	40.15	35	1894	2460	29570138
Hospitalisation	132.76	40.15	63	1866	45925	29526673
Stoma complication	82.69	40.15	14	1915	202	29572396
Complication associated with device	74.50	40.15	23	1906	5168	29567430
Large intestine polyp	61.46	40.15	21	1908	6488	29566110
Device breakage	58.48	40.15	15	1914	1719	29570879
Gastrointestinal stoma output increased	57.31	40.15	8	1921	27	29572571
Duodenal polyp	51.76	40.15	9	1920	153	29572445
Weight decreased	44.86	40.15	52	1877	150853	29421745
Device related bacteraemia	44.63	40.15	8	1921	163	29572435
Product dose omission issue	44.39	40.15	42	1887	96341	29476257
Nephrolithiasis	42.00	40.15	24	1905	25310	29547288
Abdominal pain	40.80	40.15	47	1882	135310	29437288

FDA Adverse Event Reporting System (Geriatric)

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	759.81	29.81	154	4191	6026	64488361
Device related sepsis	307.67	29.81	71	4274	5084	64489303
Device related infection	241.43	29.81	87	4258	30539	64463848
Stoma complication	196.48	29.81	33	4312	437	64493950
Gastrointestinal stoma output increased	130.15	29.81	21	4324	213	64494174
Abdominal pain	104.11	29.81	116	4229	312259	64182128
Hospitalisation	101.25	29.81	63	4282	75144	64419243
Device related bacteraemia	95.67	29.81	17	4328	318	64494069
Bacteraemia	79.59	29.81	38	4307	26873	64467514
Duodenal polyp	72.52	29.81	13	4332	256	64494131
Sepsis	70.54	29.81	82	4263	230259	64264128
Large intestine polyp	67.70	29.81	26	4319	10811	64483576
Dehydration	66.08	29.81	77	4268	216686	64277701
Complication associated with device	62.66	29.81	27	4318	15053	64479334
Weight decreased	62.50	29.81	86	4259	285653	64208734
Nephrolithiasis	62.30	29.81	38	4307	43645	64450742
Product dose omission issue	60.70	29.81	70	4275	194677	64299710
Abdominal distension	58.95	29.81	50	4295	95944	64398443
Intestinal obstruction	58.07	29.81	34	4311	36252	64458135
Enterocutaneous fistula	49.78	29.81	13	4332	1544	64492843
Gastrointestinal stoma complication	49.68	29.81	14	4331	2212	64492175
Flatulence	48.23	29.81	30	4315	35636	64458751
Abnormal faeces	47.40	29.81	17	4328	5842	64488545
Therapy interrupted	46.48	29.81	24	4321	20012	64474375
Catheter site infection	36.77	29.81	14	4331	5679	64488708
Stoma site haemorrhage	35.34	29.81	10	4335	1603	64492784
Small intestinal obstruction	34.85	29.81	21	4324	23552	64470835
Device breakage	34.15	29.81	15	4330	8740	64485647
COVID-19	34.08	29.81	31	4314	65109	64429278
Gastric polyps	33.31	29.81	11	4334	2954	64491433
Gastrointestinal bacterial overgrowth	32.80	29.81	7	4338	347	64494040
Device dislocation	31.66	29.81	19	4326	21159	64473228
Vascular device occlusion	31.52	29.81	5	4340	45	64494342

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

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
FDA Chemical/Ingredient	N0000175140	Glucagon-Like Peptide 2
FDA Chemical/Ingredient	N0000175452	Analogs/Derivatives
MeSH PA	D005765	Gastrointestinal Agents
MeSH PA	D020011	Protective Agents
MeSH PA	D011837	Radiation-Protective Agents
FDA MoA	N0000190990	Glucagon-like Peptide-2 (GLP-2) Agonists
FDA EPC	N0000190992	GLP-2 Analog
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

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

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	2.81	acidic
pKa2	3.1	acidic
pKa3	3.51	acidic
pKa4	3.79	acidic
pKa5	4.07	acidic
pKa6	4.58	acidic
pKa7	5.16	acidic
pKa8	12.12	acidic
pKa9	12.14	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
pKa19	13.41	acidic
pKa20	13.45	acidic
pKa21	13.46	acidic
pKa22	13.54	acidic
pKa23	13.75	acidic
pKa24	13.8	acidic
pKa25	13.87	acidic
pKa26	13.9	acidic
pKa27	11.08	Basic
pKa28	10.48	Basic
pKa29	7.86	Basic
pKa30	5.98	Basic

Orange Book patent data (new drug applications)

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	7056886	Sept. 18, 2022	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	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
5MG/VIAL	GATTEX KIT	TAKEDA PHARMS USA	N203441	Dec. 21, 2012	RX	POWDER	SUBCUTANEOUS	9539310	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	9545434	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	9545435	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	9555079	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	9572867	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	9592273	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	9592274	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	9968655	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	9968656	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	9968658	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	9974835	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	9974837	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	9981014	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	9981016	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	9987334	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	9987335	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	9993528	Nov. 1, 2025	TREATMENT OF ADULT PATIENTS WITH SHORT BOWEL SYNDROME WHO ARE DEPENDENT ON PARENTERAL SUPPORT

Orange Book exclusivity data (new drug applications)

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

Bioactivity Summary:

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

External reference:

ID	Source
D06053	KEGG_DRUG
4032133	VUID
N0000186572	NUI
4032133	VANDF
CHEBI:72305	CHEBI
CHEMBL2104987	ChEMBL_ID
C494910	MESH_SUPPLEMENTAL_RECORD_UI
C438272	MESH_SUPPLEMENTAL_RECORD_UI
7049	IUPHAR_LIGAND_ID
8444	INN_ID
DB08900	DRUGBANK_ID
7M19191IKG	UNII
16139605	PUBCHEM_CID
1364468	RXNORM
196699	MMSL
29024	MMSL
d07938	MMSL
014819	NDDF
710807004	SNOMEDCT_US
715636000	SNOMEDCT_US
C1530889	UMLSCUI

Pharmaceutical products:

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