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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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| neoplasms | D009369 |
| skin and connective tissue diseases | D017437 |
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 |
|---|---|---|---|---|
| ODOMZO | Sun Pharmaceutical Industries | N-205266 RX | 2015-07-24 | 1 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| odomzo | New Drug Application | 2023-08-29 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| skin neoplasms | EFO_0004198 | D012878 | C44 |
| basal cell neoplasms | — | D018295 | — |
Agency Specific
FDA
EMA
No data
HCPCS
No data
Clinical
Clinical Trials
48 clinical trials
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Indications Phases 4
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Carcinoma | D002277 | — | C80.0 | 3 | 10 | 1 | — | 4 | 17 |
| Basal cell carcinoma | D002280 | — | — | 2 | 10 | 1 | — | 4 | 16 |
| Basal cell neoplasms | D018295 | — | — | 2 | 8 | 1 | — | 4 | 14 |
| Syndrome | D013577 | — | — | 1 | 3 | 1 | — | 1 | 5 |
| Basal cell nevus syndrome | D001478 | EFO_0004136 | — | — | 4 | 1 | — | 1 | 5 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Neoplasms | D009369 | — | C80 | 7 | 1 | — | — | 1 | 9 |
| Medulloblastoma | D008527 | — | — | 4 | 3 | — | — | — | 6 |
| Pancreatic neoplasms | D010190 | EFO_0003860 | C25 | 5 | 1 | — | — | — | 5 |
| Adenocarcinoma | D000230 | — | — | 4 | 1 | — | — | — | 4 |
| Skin neoplasms | D012878 | EFO_0004198 | C44 | 1 | 2 | — | — | 1 | 4 |
| Leukemia | D007938 | — | C95 | 2 | 1 | — | — | — | 3 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 2 | 1 | — | — | — | 3 |
| Myeloproliferative disorders | D009196 | — | D47.1 | 2 | 1 | — | — | — | 2 |
| Essential thrombocythemia | D013920 | — | D47.3 | 2 | 1 | — | — | — | 2 |
| Polycythemia vera | D011087 | — | D45 | 2 | 1 | — | — | — | 2 |
Show 19 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Recurrence | D012008 | — | — | 3 | — | — | — | — | 3 |
| Myeloid leukemia | D007951 | — | C92 | 2 | — | — | — | — | 2 |
| Prostatic neoplasms | D011471 | — | C61 | 2 | — | — | — | — | 2 |
| Esophageal neoplasms | D004938 | — | C15 | 2 | — | — | — | — | 2 |
| Glioblastoma | D005909 | EFO_0000515 | — | 2 | — | — | — | — | 2 |
| Ovarian neoplasms | D010051 | EFO_0003893 | C56 | 2 | — | — | — | — | 2 |
| Hepatocellular carcinoma | D006528 | — | C22.0 | 2 | — | — | — | — | 2 |
| Liver neoplasms | D008113 | EFO_1001513 | C22.0 | 2 | — | — | — | — | 2 |
| Lung neoplasms | D008175 | HP_0100526 | C34.90 | 2 | — | — | — | — | 2 |
| Stomach neoplasms | D013274 | EFO_0003897 | C16 | 2 | — | — | — | — | 2 |
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Indications Without Phase
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Sonidegib |
| INN | sonidegib |
| 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 class | hedgehog 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-ID | 956697-53-3 |
| RxCUI | — |
| ChEMBL ID | CHEMBL2105737 |
| ChEBI ID | — |
| PubChem CID | 24775005 |
| DrugBank | DB09143 |
| UNII ID | 0RLU3VTK5M (ChemIDplus, GSRS) |
Target
Agency Approved
SMO
SMO
Organism
Homo sapiens
Gene name
SMO
Gene synonyms
SMOH
NCBI Gene ID
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
Mouse ortholog
Smo (319757)
smoothened homolog (P56726)
Alternate
No data
Variants
No data
Financial
No data
Trends
PubMed Central
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Safety
Black-box Warning
Black-box warning for: Odomzo
Adverse Events
Top Adverse Reactions
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768 adverse events reported
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