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

Stem definition	Drug id	CAS RN
anthelminthics, tiabendazole derivatives	2734	68786-66-3

Description:

Molecule

Description

Molfile Inchi Smiles

Synonyms:

egaten
triclabendazole
fasinex

Benzimidazole antiplatyhelmintic agent that is used for the treatment of FASCIOLIASIS and PARAGONIMIASIS.

Molecular weight: 359.65
Formula: C14H9Cl3N2OS
CLOGP: 6.14
LIPINSKI: 1
HAC: 3
HDO: 1
TPSA: 37.91
ALOGS: -5.85
ROTB: 3

Status: ONP

Legend:
OFP - off patent
OFM - off market
ONP - on patent

Drug dosage:

None

ADMET properties:

Property	Value	Reference
BDDCS (Biopharmaceutical Drug Disposition Classification System)	2	Benet LZ, Broccatelli F, Oprea TI
S (Water solubility)	0.20 mg/mL	Bocci G, Oprea TI, Benet LZ
EoM (Fraction excreted unchanged in urine)	2 %	Benet LZ, Broccatelli F, Oprea TI

Approvals:

Date	Agency	Company	Orphan
Feb. 13, 2019	FDA	NOVARTIS PHARMS CORP
Jan. 1, 1990	YEAR INTRODUCED

FDA Adverse Event Reporting System (Female)

None

FDA Adverse Event Reporting System (Male)

None

FDA Adverse Event Reporting System (Geriatric)

None

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
ATC	P02BX04	ANTIPARASITIC PRODUCTS, INSECTICIDES AND REPELLENTS ANTHELMINTICS ANTITREMATODALS Other antitrematodal agents
FDA CS	M0001301	Anthelmintics
FDA EPC	N0000175481	Anthelmintic
MeSH PA	D000871	Anthelmintics
MeSH PA	D000890	Anti-Infective Agents
MeSH PA	D000977	Antiparasitic Agents
MeSH PA	D000980	Antiplatyhelmintic Agents
FDA MoA	N0000182137	Cytochrome P450 2D6 Inhibitors
FDA MoA	N0000182138	Cytochrome P450 1A2 Inhibitors
FDA MoA	N0000182139	Cytochrome P450 2B6 Inhibitors
FDA MoA	N0000182140	Cytochrome P450 2C19 Inhibitors
FDA MoA	N0000185504	Cytochrome P450 2C9 Inhibitors
FDA MoA	N0000187062	Cytochrome P450 2C8 Inhibitors
FDA MoA	N0000190114	Cytochrome P450 3A Inhibitors
FDA MoA	N0000193937	Cytochrome P450 2A6 Inhibitors

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

Disease	Relation	SNOMED_ID	DOID
Infection by Fasciola	indication	111922007	DOID:885

🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	10.08	acidic
pKa2	3.81	Basic

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Exclusivity date	Description
250MG	EGATEN	NOVARTIS	N208711	Feb. 13, 2019	RX	TABLET	ORAL	Feb. 13, 2024	NEW CHEMICAL ENTITY
250MG	EGATEN	NOVARTIS	N208711	Feb. 13, 2019	RX	TABLET	ORAL	Feb. 13, 2026	INDICATED FOR THE TREATMENT OF FASCIOLIASIS IN PATIENTS 6 YEARS OF AGE AND OLDER

Bioactivity Summary:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Mechanism action	Bioact source	MoA source
Transthyretin	Secreted	P02766	TTHY_HUMAN		IC50	5.46		CHEMBL
Cruzipain	Enzyme		CYSP_TRYCR		IC50	4.82		CHEMBL

External reference:

ID	Source
D07364	KEGG_DRUG
4038425	VANDF
C0077071	UMLSCUI
CHEBI:94759	CHEBI
JA9	PDB_CHEM_ID
CHEMBL1086440	ChEMBL_ID
DB12245	DRUGBANK_ID
D000077682	MESH_DESCRIPTOR_UI
50248	PUBCHEM_CID
5003	INN_ID
4784C8E03O	UNII
2118525	RXNORM
23285	MMSL
d06607	MMSL
010991	NDDF
713429009	SNOMEDCT_US
714020008	SNOMEDCT_US

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
EGATEN	HUMAN PRESCRIPTION DRUG LABEL	1	0078-0937	TABLET	250 mg	ORAL	NDA	31 sections
EGATEN	HUMAN PRESCRIPTION DRUG LABEL	1	0078-0937	TABLET	250 mg	ORAL	NDA	31 sections
EGATEN	HUMAN PRESCRIPTION DRUG LABEL	1	0078-0937	TABLET	250 mg	ORAL	NDA	31 sections