Dacogen(decitabine)
Dacogen, Decitabine, Inaqovi, Inqovi (decitabine) is a small molecule pharmaceutical. Decitabine was first approved as Dacogen on 2006-05-02. It is used to treat myelodysplastic syndromes in the USA. It has been approved in Europe to treat myeloid leukemia. It is known to target cytidine deaminase.
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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| neoplasms | D009369 |
| hemic and lymphatic diseases | D006425 |
Trade Name
FDA
EMA
Decitabine (discontinued: Dacogen, Decitabine)
CombinationsInqovi
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Decitabine
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| DECITABINE | Sun Pharmaceutical Industries | N-205582 RX | 2014-01-28 | 1 products, RLD, RS |
Show 1 discontinued
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| 2-oak mix, red/white pollen 3-oak mix, black/blackjack/post pollen 3-ragweed mix, giant/short/western pollen 4-pine mix, austrian/loblolly/scotch/w... | Biologic Licensing Application | 2011-03-11 |
| center-al - acacia longifolia pollen center-al - acer negundo pollen center-al - acer saccharum pollen center-al - agrostis gigantea center-al - al... | Biologic Licensing Application | 2009-06-12 |
| coditussin dac | OTC monograph final | 2016-05-10 |
| dacarbazine | ANDA | 2024-05-02 |
| dactinomycin | ANDA | 2024-06-18 |
| decitabine | ANDA | 2024-10-18 |
| inqovi | New Drug Application | 2024-11-29 |
| standardized bermuda grass pollen standardized kentucky bluegrass pollen standardized meadow fescue grass pollen standardized orchard grass pollen ... | Biologic Licensing Application | 2010-03-27 |
| standardized bermuda grass standardized kentucky blue (june) grass standardized meadow fescue grass standardized orchard grass standardized perenni... | Biologic Licensing Application | 2024-09-11 |
| vizimpro | New Drug Application | 2023-10-13 |
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Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| myelodysplastic syndromes | — | D009190 | D46 |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
CEDAZURIDINE / DECITABINE, INQOVI, OTSUKA | |||
| 2027-07-07 | ODE-316 | ||
| 2025-07-07 | NCE | ||
Clinical
Clinical Trials
558 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Leukemia | D007938 | — | C95 | 112 | 144 | 40 | 2 | 12 | 260 |
| Myeloid leukemia acute | D015470 | — | C92.0 | 110 | 125 | 37 | 2 | 11 | 239 |
| Myeloid leukemia | D007951 | — | C92 | 100 | 118 | 34 | 2 | 10 | 223 |
| Myelodysplastic syndromes | D009190 | — | D46 | 69 | 101 | 17 | 3 | 11 | 167 |
| Preleukemia | D011289 | — | — | 60 | 82 | 13 | 3 | 9 | 138 |
| Syndrome | D013577 | — | — | 50 | 65 | 10 | 3 | 9 | 113 |
| Lymphoma | D008223 | — | C85.9 | 17 | 27 | 3 | 2 | 1 | 39 |
| Precursor cell lymphoblastic leukemia-lymphoma | D054198 | — | — | 10 | 10 | 1 | 1 | 1 | 21 |
| B-cell lymphoma | D016393 | — | — | 8 | 11 | 1 | 1 | — | 16 |
| Large b-cell lymphoma diffuse | D016403 | — | C83.3 | 6 | 9 | 1 | 1 | — | 15 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Neoplasms | D009369 | — | C80 | 37 | 24 | 3 | — | 2 | 52 |
| Recurrence | D012008 | — | — | 25 | 18 | 5 | — | 2 | 43 |
| Myelomonocytic leukemia chronic | D015477 | — | C93.1 | 15 | 20 | 4 | — | 1 | 37 |
| Myelomonocytic leukemia juvenile | D054429 | — | C93.3 | 15 | 19 | 4 | — | 2 | 37 |
| Myeloproliferative disorders | D009196 | — | D47.1 | 14 | 14 | 1 | — | 1 | 25 |
| Myelomonocytic leukemia acute | D015479 | — | C92.5 | 4 | 13 | 2 | — | — | 17 |
| Hematopoietic stem cell transplantation | D018380 | — | — | 2 | 12 | 9 | — | — | 14 |
| Myelodysplastic-myeloproliferative diseases | D054437 | — | — | 7 | 8 | 1 | — | — | 13 |
| Anemia | D000740 | HP_0001903 | D64.9 | 3 | 3 | 2 | — | 1 | 8 |
| Neoplasm metastasis | D009362 | EFO_0009708 | — | 6 | 3 | 1 | — | — | 8 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Bcr-abl positive chronic myelogenous leukemia | D015464 | EFO_0000340 | — | 9 | 9 | — | — | — | 16 |
| Lymphoid leukemia | D007945 | — | C91 | 8 | 7 | — | — | 1 | 14 |
| Carcinoma | D002277 | — | C80.0 | 8 | 9 | — | — | — | 13 |
| Hematologic neoplasms | D019337 | — | — | 7 | 5 | — | — | 1 | 11 |
| Primary myelofibrosis | D055728 | — | D47.4 | 4 | 5 | — | — | 1 | 10 |
| Blast crisis | D001752 | — | — | 4 | 7 | — | — | — | 10 |
| Lung neoplasms | D008175 | HP_0100526 | C34.90 | 8 | 3 | — | — | — | 9 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 6 | 4 | — | — | — | 9 |
| Melanoma | D008545 | — | — | 8 | 4 | — | — | — | 8 |
| Non-small-cell lung carcinoma | D002289 | — | — | 6 | 3 | — | — | — | 7 |
Show 79 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| B-cell chronic lymphocytic leukemia | D015451 | — | C91.1 | 3 | — | — | — | — | 3 |
| Neuroblastoma | D009447 | EFO_0000621 | — | 3 | — | — | — | — | 3 |
| Promyelocytic leukemia acute | D015473 | — | C92.4 | 2 | — | — | — | — | 2 |
| Mantle-cell lymphoma | D020522 | — | — | 2 | — | — | — | — | 2 |
| Burkitt lymphoma | D002051 | — | C83.7 | 2 | — | — | — | — | 2 |
| Leukemia myeloid chronic atypical bcr-abl negative | D054438 | — | C92.2 | 2 | — | — | — | — | 2 |
| Small cell lung carcinoma | D055752 | — | — | 2 | — | — | — | — | 2 |
| Pancreatic ductal carcinoma | D021441 | — | — | 1 | — | — | — | 1 | 2 |
| Ependymoma | D004806 | — | — | 1 | — | — | — | — | 1 |
| Bone marrow diseases | D001855 | — | — | 1 | — | — | — | — | 1 |
Show 25 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Infections | D007239 | EFO_0000544 | — | — | — | — | — | 2 | 2 |
| Frailty | D000073496 | — | R53.1 | — | — | — | — | 1 | 1 |
| Liver transplantation | D016031 | EFO_0010682 | — | — | — | — | — | 1 | 1 |
| Colonic neoplasms | D003110 | — | C18 | — | — | — | — | 1 | 1 |
| Pulmonary hypertension | D006976 | EFO_0001361 | I27.20 | — | — | — | — | 1 | 1 |
| Osteoporosis | D010024 | HP_0000939 | M81.0 | — | — | — | — | 1 | 1 |
| Iron overload | D019190 | — | — | — | — | — | — | 1 | 1 |
| Hiv infections | D015658 | EFO_0000764 | B20 | — | — | — | — | 1 | 1 |
| Coinfection | D060085 | — | — | — | — | — | — | 1 | 1 |
| Communicable diseases | D003141 | — | — | — | — | — | — | 1 | 1 |
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Decitabine |
| INN | decitabine |
| Description | 5-aza-2'-deoxycytidine is a 2'-deoxyribonucleoside. |
| Classification | Small molecule |
| Drug class | nucleoside antiviral or antineoplastic agents, cytarabine or azarabine derivatives |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | Nc1ncn([C@H]2C[C@H](O)[C@@H](CO)O2)c(=O)n1 |
Identifiers
| PDB | — |
| CAS-ID | 2353-33-5 |
| RxCUI | — |
| ChEMBL ID | CHEMBL1201129 |
| ChEBI ID | 50131 |
| PubChem CID | 451668 |
| DrugBank | DB01262 |
| UNII ID | 776B62CQ27 (ChemIDplus, GSRS) |
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Safety
Black-box Warning
Black-box warning for: 2-oak mix, red/white pollen 3-oak mix, black/blackjack/post pollen 3-ragweed mix, giant/short/western pollen 4-pine mix, austrian/loblolly/scotch/w..., Center-al - acacia longifolia pollen center-al - acer negundo pollen center-al - acer saccharum pollen center-al - agrostis gigantea center-al - al..., Dacarbazine, Standardized bermuda grass pollen standardized kentucky bluegrass pollen standardized meadow fescue grass pollen standardized orchard grass pollen ..., Standardized bermuda grass standardized kentucky blue (june) grass standardized meadow fescue grass standardized orchard grass standardized perenni...
Adverse Events
Top Adverse Reactions
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94,890 adverse events reported
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