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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 carcinoma. The pharmaceutical is active against smoothened homolog.
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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
ODOMZOsparcN-205266 RX2015-07-24
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
odomzoNew Drug Application2020-07-31
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
44 clinical trials
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Mock data
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Indications Phases 4
No data
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Basal cell neoplasmsD018295251—310
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
MedulloblastomaD00852743———6
Basal cell nevus syndromeD001478EFO_0004136—3——14
Breast neoplasmsD001943EFO_0003869C5021———3
Skin neoplasmsD012878EFO_0004198C44—2——13
Essential thrombocythemiaD013920D47.321———2
Polycythemia veraD011087D4521———2
Primary myelofibrosisD055728D47.421———2
Multiple myelomaD009101C90.0—2———2
NeuroblastomaD009447EFO_000062121———2
GliomaD005910EFO_000052021———2
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Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
NeoplasmsD009369C806———17
Pancreatic neoplasmsD010190EFO_0003860C254————4
Prostatic neoplasmsD011471C612————2
GlioblastomaD005909EFO_00005152————2
Ovarian neoplasmsD010051EFO_0003893C562————2
Liver neoplasmsD008113EFO_1001513C22.02————2
Lung neoplasmsD008175C34.902————2
Stomach neoplasmsD013274EFO_0003897C162————2
Myelodysplastic syndromesD009190D461————1
Myeloid leukemia acuteD015470C92.01————1
Show 24 more
Indications Without Phase
No data
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)
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
RxCUI1659191
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
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
Mock data
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Additional graphs summarizing 1,236 documents
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Safety
Black-box Warning
Black-box warning for: Odomzo
Adverse Events
Top Adverse Reactions
Mock data
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42,631 adverse events reported
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