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

Stem definitionDrug idCAS RN
SMO receptor antagonists 5008 956697-53-3

Description:

MoleculeDescription

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: 5.84
  • LIPINSKI: 1
  • HAC: 6
  • HDO: 1
  • TPSA: 63.69
  • ALOGS: -5.50
  • ROTB: 6

Drug dosage:

None

ADMET properties:

None

Approvals:

DateAgencyCompanyOrphan
June 25, 2015 EMA
July 24, 2015 FDA NOVARTIS PHARMS CORP

FDA Adverse Event Reporting System (Female)

None

FDA Adverse Event Reporting System (Male)

None

Pharmacologic Action:

SourceCodeDescription
ATC L01XX48 ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
ANTINEOPLASTIC AGENTS
OTHER ANTINEOPLASTIC AGENTS
Other antineoplastic agents
FDA EPC N0000184149 Hedgehog Pathway Inhibitor
FDA MoA N0000184148 Smoothened Receptor Antagonists
CHEBI has role CHEBI:35610 antineoplastic agent

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
Basal cell carcinoma of skin indication 254701007

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 9.08 acidic
pKa2 4.97 Basic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
EQ 200MG BASE ODOMZO SUN PHARMA GLOBAL N205266 July 24, 2015 RX CAPSULE ORAL 8178563 Feb. 6, 2029 TREATMENT OF BASAL CELL CARCINOMA

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
EQ 200MG BASE ODOMZO SUN PHARMA GLOBAL N205266 July 24, 2015 RX CAPSULE ORAL July 24, 2020 NEW CHEMICAL ENTITY

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Smoothened homolog GPCR ANTAGONIST Ki 8.22 SCIENTIFIC LITERATURE SCIENTIFIC LITERATURE
Sonic hedgehog protein Enzyme IC50 8.26 CHEMBL

External reference:

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

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Odomzo HUMAN PRESCRIPTION DRUG LABEL 1 47335-303 CAPSULE 200 mg ORAL NDA 18 sections