Givinostat
Duvyzat (givinostat) is a small molecule pharmaceutical. Givinostat was first approved as Duvyzat on 2024-03-21. It is used to treat duchenne muscular dystrophy in the USA.
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Commercial
Therapeutic Areas
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Trade Name
FDA
EMA
Duvyzat
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Givinostat hydrochloride
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| DUVYZAT | Italfarmaco | N-217865 RX | 2024-03-21 | 1 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| duvyzat | New Drug Application | 2024-03-29 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| duchenne muscular dystrophy | EFO_0000429 | D020388 | — |
Agency Specific
FDA
EMA
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Patent Expiration
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ATC Codes
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HCPCS
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Clinical
Clinical Trials
23 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 |
|---|---|---|---|---|---|---|---|---|---|
| Duchenne muscular dystrophy | D020388 | EFO_0000429 | — | 2 | 3 | 3 | — | — | 6 |
| Muscular dystrophies | D009136 | HP_0003560 | G71.0 | 2 | 3 | 3 | — | — | 6 |
| Polycythemia vera | D011087 | — | D45 | 2 | 2 | 1 | — | — | 4 |
| Polycythemia | D011086 | EFO_0005804 | D75.1 | 1 | 2 | 1 | — | — | 3 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Juvenile arthritis | D001171 | EFO_1002007 | M08 | — | 2 | — | — | 1 | 3 |
| Arthritis | D001168 | HP_0001369 | M05-M14 | — | 2 | — | — | 1 | 3 |
| Lymphoma | D008223 | — | C85.9 | 2 | 2 | — | — | — | 2 |
| Hodgkin disease | D006689 | — | C81 | 2 | 2 | — | — | — | 2 |
| Myeloproliferative disorders | D009196 | — | D47.1 | — | 2 | — | — | — | 2 |
| Hereditary autoinflammatory diseases | D056660 | — | — | — | 1 | — | — | — | 1 |
| Syndrome | D013577 | — | — | — | 1 | — | — | — | 1 |
| Schnitzler syndrome | D019873 | EFO_1001165 | — | — | 1 | — | — | — | 1 |
| Multiple myeloma | D009101 | — | C90.0 | — | 1 | — | — | — | 1 |
| Plasma cell neoplasms | D054219 | — | — | — | 1 | — | — | — | 1 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Drug interactions | D004347 | — | — | 3 | — | — | — | — | 3 |
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Givinostat |
| INN | givinostat |
| Description | N-[4-[(hydroxyamino)-oxomethyl]phenyl]carbamic acid [6-(diethylaminomethyl)-2-naphthalenyl]methyl ester is a carbamate ester. |
| Classification | Small molecule |
| Drug class | enzyme inhibitors: histone deacetylase inhibitors; vinca alkaloids |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | CCN(CC)Cc1ccc2cc(COC(=O)Nc3ccc(C(=O)NO)cc3)ccc2c1 |
Identifiers
| PDB | — |
| CAS-ID | 497833-27-9 |
| RxCUI | — |
| ChEMBL ID | CHEMBL1213492 |
| ChEBI ID | — |
| PubChem CID | 9804992 |
| DrugBank | DB12645 |
| UNII ID | 5P60F84FBH (ChemIDplus, GSRS) |
Target
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Trends
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Safety
Black-box Warning
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Adverse Events
0 adverse events reported
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