Dacogen(decitabine)
Dacogen, 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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FDA Novel Drug Approvals 2020
SARS-CoV-2 Interaction
Commercial
Trade Name
FDA
EMA
Combinations
Inqovi
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| dacogen | New Drug Application | 2020-06-24 |
| decitabine | ANDA | 2023-05-26 |
| inqovi | New Drug Application | 2021-04-26 |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
CEDAZURIDINE / DECITABINE, INQOVI, OTSUKA | |||
| 2027-07-07 | ODE-316 | ||
| 2025-07-07 | NCE | ||
HCPCS
Code | Description |
|---|---|
| J0894 | Injection, decitabine, 1 mg |
Clinical
Clinical Trials
371 clinical trials
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Myelomonocytic leukemia chronic | D015477 | C93.1 | 14 | 16 | 1 | — | 1 | 28 | |
| Leukemia | D007938 | C95 | 14 | 17 | 3 | — | — | 26 | |
| Neoplasms | D009369 | C80 | 16 | 6 | 3 | — | 1 | 20 | |
| Myeloid leukemia | D007951 | C92 | 2 | 2 | 1 | — | — | 5 | |
| Hodgkin disease | D006689 | C81 | 1 | 4 | 1 | — | — | 5 | |
| Monocytic leukemia acute | D007948 | — | 3 | 1 | — | — | 4 | ||
| Myelomonocytic leukemia acute | D015479 | C92.5 | — | 3 | 1 | — | — | 4 | |
| Hematologic diseases | D006402 | EFO_0005803 | D75.9 | 1 | — | 1 | — | 1 | 3 |
| Thrombocytopenia | D013921 | HP_0001873 | D69.6 | 1 | 2 | 1 | — | — | 3 |
| Megakaryoblastic leukemia acute | D007947 | C94.2 | — | 2 | 1 | — | — | 3 |
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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 | 1 | 7 | — | — | — | 8 | |
| Melanoma | D008545 | 8 | 4 | — | — | — | 8 | ||
| Primary myelofibrosis | D055728 | D47.4 | 4 | 2 | — | — | — | 6 | |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 4 | 3 | — | — | — | 6 |
| Non-hodgkin lymphoma | D008228 | C85.9 | 5 | 2 | — | — | — | 5 | |
| Non-small-cell lung carcinoma | D002289 | 4 | 3 | — | — | — | 5 | ||
| Anemia | D000740 | EFO_0004272 | D64.9 | 3 | 2 | — | — | — | 4 |
| Ovarian neoplasms | D010051 | EFO_0003893 | C56 | 3 | 3 | — | — | — | 4 |
| Fallopian tube neoplasms | D005185 | 3 | 2 | — | — | — | 4 | ||
| Sickle cell anemia | D000755 | EFO_0000697 | D57 | 1 | 2 | — | — | — | 3 |
Show 39 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 | 2 | — | — | — | — | 2 | |
| Mantle-cell lymphoma | D020522 | C83.1 | 2 | — | — | — | — | 2 | |
| Burkitt lymphoma | D002051 | C83.7 | 2 | — | — | — | — | 2 | |
| Leukemia myeloid chronic atypical bcr-abl negative | D054438 | C92.2 | 2 | — | — | — | — | 2 | |
| Sarcoma | D012509 | 2 | — | — | — | — | 2 | ||
| Gata2 deficiency | D000077428 | 1 | — | — | — | — | 1 | ||
| Hematopoietic stem cell transplantation | D018380 | 1 | — | — | — | — | 1 | ||
| Ependymoma | D004806 | 1 | — | — | — | — | 1 | ||
| Preleukemia | D011289 | 1 | — | — | — | — | 1 | ||
| Bone marrow diseases | D001855 | 1 | — | — | — | — | 1 |
Show 16 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Colonic neoplasms | D003110 | C18 | — | — | — | — | 1 | 1 | |
| Pulmonary hypertension | D006976 | EFO_0001361 | I27.20 | — | — | — | — | 1 | 1 |
| Osteoporosis | D010024 | EFO_0003882 | M81.0 | — | — | — | — | 1 | 1 |
| Beta-thalassemia | D017086 | Orphanet_848 | D56.1 | — | — | — | — | 1 | 1 |
| Iron overload | D019190 | — | — | — | — | 1 | 1 |
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 | 15657 |
| ChEMBL ID | CHEMBL1201129 |
| ChEBI ID | 50131 |
| PubChem CID | 451668 |
| DrugBank | DB01262 |
| UNII ID | 776B62CQ27 (ChemIDplus, GSRS) |
Target
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
0 adverse events reported
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