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

Stem definition	Drug id	CAS RN
SMO receptor antagonists	5008	956697-53-3

Description:

Molecule

Description

Molfile Inchi Smiles

Synonyms:

sonidegib diphosphate
sonidegib
odomzo
LDE225
erismodegib
LDE-225
NPV-LDE-225
sonidegib phosphate

specific Smoothened/Smo antagonist

Molecular weight: 485.51
Formula: C26H26F3N3O3
CLOGP: 6.09
LIPINSKI: 1
HAC: 6
HDO: 1
TPSA: 63.69
ALOGS: -5.50
ROTB: 6

Status: ONP

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

Drug dosage:

None

ADMET properties:

None

Approvals:

Date	Agency	Company	Orphan
June 25, 2015	EMA
July 24, 2015	FDA	NOVARTIS PHARMS CORP

FDA Adverse Event Reporting System (Female)

None

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
Muscle spasms	100.69	46.14	36	367	74965	34881563
Blood creatine phosphokinase increased	77.20	46.14	26	377	44831	34911697
Dysgeusia	47.95	46.14	16	387	26481	34930047

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
Muscle spasms	124.20	45.19	46	509	174684	79569149
Blood creatine phosphokinase increased	88.20	45.19	28	527	66062	79677771
Dysgeusia	59.09	45.19	20	535	57157	79686676

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
ATC	L01XJ02	ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS ANTINEOPLASTIC AGENTS OTHER ANTINEOPLASTIC AGENTS Hedgehog pathway inhibitors
FDA MoA	N0000184148	Smoothened Receptor Antagonists
FDA EPC	N0000184149	Hedgehog Pathway Inhibitor
CHEBI has role	CHEBI:35610	antineoplastic agents
CHEBI has role	CHEBI:66908	SMO receptor antagonists
CHEBI has role	CHEBI:140921	Hedgehog pathway inhibitors

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

Disease	Relation	SNOMED_ID	DOID
Basal cell carcinoma of skin	indication	254701007

🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	9.08	acidic
pKa2	4.97	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
EQ 200MG BASE	ODOMZO	SUN PHARM	N205266	July 24, 2015	RX	CAPSULE	ORAL	8178563	July 24, 2029	TREATMENT OF BASAL CELL CARCINOMA

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Mechanism action	Bioact source	MoA source
Smoothened homolog	GPCR	Q99835	SMO_HUMAN	ANTAGONIST	Ki	8.22		SCIENTIFIC LITERATURE	SCIENTIFIC LITERATURE
Sonic hedgehog protein	Enzyme		SHH_MOUSE		IC50	8.26		CHEMBL

External reference:

ID	Source
D10119	KEGG_DRUG
4034879	VANDF
CHEBI:90863	CHEBI
CHEMBL2105737	ChEMBL_ID
CHEMBL3137317	ChEMBL_ID
C561435	MESH_SUPPLEMENTAL_RECORD_UI
8199	IUPHAR_LIGAND_ID
1218778-77-8	SECONDARY_CAS_RN
DB09143	DRUGBANK_ID
1659191	RXNORM
235134	MMSL
31130	MMSL
39901	MMSL
d08375	MMSL
016361	NDDF
016362	NDDF
715187001	SNOMEDCT_US
781303007	SNOMEDCT_US
895600009	SNOMEDCT_US
C3886731	UMLSCUI
9394	INN_ID
24775005	PUBCHEM_CID
0RLU3VTK5M	UNII

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Odomzo	HUMAN PRESCRIPTION DRUG LABEL	1	47335-303	CAPSULE	200 mg	ORAL	NDA	29 sections
Odomzo	HUMAN PRESCRIPTION DRUG LABEL	1	47335-303	CAPSULE	200 mg	ORAL	NDA	29 sections
Odomzo	HUMAN PRESCRIPTION DRUG LABEL	1	47335-303	CAPSULE	200 mg	ORAL	NDA	29 sections