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AboutPricing
Drug ReportsSonidegib
Odomzo(sonidegib)
Odomzo (sonidegib) is a small molecule pharmaceutical. Sonidegib was first approved as Odomzo on 2015-07-24. It is used to treat skin neoplasms in the USA. It has been approved in Europe to treat basal cell neoplasms. The pharmaceutical is active against protein smoothened.
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FDA approval date
EMA approval date
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Last update post date
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Results first post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
neoplasmsD009369
skin and connective tissue diseasesD017437
Trade Name
FDA
EMA
Odomzo
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Sonidegib phosphate
Tradename
Company
Number
Date
Products
ODOMZOSun Pharmaceutical IndustriesN-205266 RX2015-07-24
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
odomzoNew Drug Application2024-12-31
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
skin neoplasmsEFO_0004198D012878C44
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent
Expires
Flag
FDA Information
Sonidegib Phosphate, Odomzo, Sun Pharm
102665232036-03-30DS, DP
80630432029-09-15DS, DP
81785632029-07-24DPU-1722
ATC Codes
L: Antineoplastic and immunomodulating agents
— L01: Antineoplastic agents
— L01X: Other antineoplastic agents in atc
— L01XJ: Hedgehog pathway inhibitors
— L01XJ02: Sonidegib
HCPCS
No data
Clinical
Clinical Trials
51 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
CarcinomaD002277—C80.021111519
Basal cell carcinomaD002280——31011519
Basal cell neoplasmsD018295——3811517
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
SyndromeD013577——131—15
Basal cell nevus syndromeD001478EFO_0004136——41—15
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
NeoplasmsD009369—C8071——19
MedulloblastomaD008527——43———6
Pancreatic neoplasmsD010190EFO_0003860C2551———5
AdenocarcinomaD000230——41———4
Skin neoplasmsD012878EFO_0004198C4412——14
LeukemiaD007938—C9521———3
Breast neoplasmsD001943EFO_0003869C5021———3
Myeloproliferative disordersD009196—D47.121———2
Essential thrombocythemiaD013920—D47.321———2
Polycythemia veraD011087—D4521———2
Show 21 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
RecurrenceD012008——2————2
Myeloid leukemiaD007951—C922————2
Prostatic neoplasmsD011471—C612————2
Esophageal neoplasmsD004938—C152————2
Neoplasm metastasisD009362EFO_0009708—2————2
GlioblastomaD005909EFO_0000515—2————2
Ovarian neoplasmsD010051EFO_0003893C562————2
Lung neoplasmsD008175—C34.902————2
Stomach neoplasmsD013274EFO_0003897C162————2
Myelodysplastic syndromesD009190—D461————1
Show 37 more
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Eyelid neoplasmsD005142EFO_1000934—————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameSonidegib
INNsonidegib
Description
Sonidegib is a member of the classo of biphenyls that is the amide obtained by formal condensation of the carboxy group of 2-methyl-4'-(trifluoromethoxy)[1,1'-biphenyl]-3-carboxylic acid with the amino group of 6-(2,6-dimethylmorpholin-4-yl)pyridin-3-amine. Used (as its phosphate salt) for treatment of locally advanced basal cell carcinoma. It has a role as an antineoplastic agent, a SMO receptor antagonist and a Hedgehog signaling pathway inhibitor. It is a member of morpholines, an aminopyridine, a member of biphenyls, a member of benzamides, an aromatic ether, an organofluorine compound and a tertiary amino compound.
Classification
Small molecule
Drug classhedgehog signaling inhibitors
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
Cc1c(C(=O)Nc2ccc(N3C[C@H](C)O[C@H](C)C3)nc2)cccc1-c1ccc(OC(F)(F)F)cc1
Identifiers
PDB—
CAS-ID956697-53-3
RxCUI—
ChEMBL IDCHEMBL2105737
ChEBI ID—
PubChem CID24775005
DrugBankDB09143
UNII ID0RLU3VTK5M (ChemIDplus, GSRS)
Target
Agency Approved
SMO
SMO
Organism
Homo sapiens
Gene name
SMO
Gene synonyms
SMOH
NCBI Gene ID
6608
Protein name
smoothened homolog
Protein synonyms
frizzled family member 11, Protein Gx, seven transmembrane helix receptor, smoothened, frizzled family receptor, smoothened, seven transmembrane spanning receptor
Uniprot ID
Q99835
Mouse ortholog
Smo (319757)
smoothened homolog (P56726)
Alternate
No data
Variants
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Safety
Black-box Warning
Black-box warning for: Odomzo
Adverse Events
Top Adverse Reactions
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1,370 adverse events reported
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