Vidaza(azacitidine)
Azacitidine, Onureg, Vidaza (azacitidine) is a small molecule pharmaceutical. Azacitidine was first approved as Vidaza on 2004-05-19. It is used to treat myelomonocytic leukemia chronic, refractory anemia, and sideroblastic anemia in the USA. It has been approved in Europe to treat myelodysplastic syndromes, myeloid leukemia acute, and myelomonocytic leukemia chronic.
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Commercial
Therapeutic Areas
Trade Name
FDA
EMA
Azacitidine, Onureg, Vidaza (discontinued: Azacitidine)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Azacitidine
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| AZACITIDINE | Allergan | N-208216 RX | 2016-04-29 | 1 products |
| ONUREG | Bristol Myers Squibb | N-214120 RX | 2020-09-01 | 2 products, RLD, RS |
| VIDAZA | Bristol Myers Squibb | N-050794 RX | 2004-05-19 | 1 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| azacitidine | ANDA | 2025-09-16 |
| azacitidine for | ANDA | 2022-09-14 |
| onureg | New Drug Application | 2022-10-26 |
| vidaza | New Drug Application | 2024-01-29 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| myelomonocytic leukemia chronic | — | D015477 | C93.1 |
| sideroblastic anemia | — | D000756 | D64.3 |
| refractory anemia | — | D000753 | D46.4 |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
AZACITIDINE, VIDAZA, BRISTOL-MYERS | |||
| 2029-05-20 | ODE-399 | ||
| 2025-05-20 | I-889 | ||
AZACITIDINE, ONUREG, BRISTOL | |||
| 2027-09-01 | ODE-320 | ||
HCPCS
Code | Description |
|---|---|
| J9025 | Injection, azacitidine, 1 mg |
Clinical
Clinical Trials
1191 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Myelodysplastic syndromes | D009190 | — | D46 | 15 | 26 | 4 | 1 | 5 | 47 |
| Preleukemia | D011289 | — | — | 14 | 23 | 3 | 1 | 3 | 40 |
| Syndrome | D013577 | — | — | 10 | 16 | 2 | 1 | 1 | 28 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Leukemia | D007938 | — | C95 | 23 | 28 | 4 | — | 2 | 49 |
| Myeloid leukemia acute | D015470 | — | C92.0 | 17 | 27 | 4 | — | 2 | 43 |
| Myeloid leukemia | D007951 | — | C92 | 16 | 20 | 4 | — | 2 | 36 |
| Lymphoma | D008223 | — | C85.9 | 11 | 6 | 2 | — | — | 16 |
| T-cell lymphoma | D016399 | — | — | 1 | 1 | 2 | — | — | 4 |
| T-cell lymphoma peripheral | D016411 | — | — | 1 | 1 | 2 | — | — | 4 |
| Immunoblastic lymphadenopathy | D007119 | EFO_1001350 | C86.5 | 1 | — | 2 | — | — | 3 |
| Thrombocytopenia | D013921 | HP_0001873 | D69.6 | — | 1 | 1 | — | — | 2 |
| Pathologic complete response | D000095384 | — | — | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Neoplasms | D009369 | — | C80 | 9 | 5 | — | — | — | 12 |
| Myelomonocytic leukemia chronic | D015477 | — | C93.1 | 4 | 5 | — | — | 1 | 10 |
| Non-hodgkin lymphoma | D008228 | — | C85.9 | 7 | 1 | — | — | — | 7 |
| Myelomonocytic leukemia juvenile | D054429 | — | C93.3 | 2 | 5 | — | — | — | 7 |
| Non-small-cell lung carcinoma | D002289 | — | — | 3 | 3 | — | — | — | 6 |
| Hodgkin disease | D006689 | — | C81 | 5 | 1 | — | — | — | 5 |
| Recurrence | D012008 | — | — | 3 | 2 | — | — | — | 5 |
| Lung neoplasms | D008175 | — | C34.90 | 2 | 2 | — | — | — | 4 |
| Ovarian neoplasms | D010051 | EFO_0003893 | C56 | 3 | 1 | — | — | — | 4 |
| Large b-cell lymphoma diffuse | D016403 | — | C83.3 | 3 | 1 | — | — | — | 3 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Multiple myeloma | D009101 | — | C90.0 | 4 | — | — | — | 1 | 5 |
| Sarcoma | D012509 | — | — | 2 | — | — | — | — | 2 |
| Plasma cell neoplasms | D054219 | — | — | 1 | — | — | — | 1 | 2 |
| Thyroid neoplasms | D013964 | EFO_0003841 | — | 1 | — | — | — | — | 1 |
| Glioblastoma | D005909 | EFO_0000515 | — | 1 | — | — | — | — | 1 |
| Urogenital neoplasms | D014565 | EFO_0003863 | D07 | 1 | — | — | — | — | 1 |
| Osteosarcoma | D012516 | — | — | 1 | — | — | — | — | 1 |
| Small cell lung carcinoma | D055752 | — | — | 1 | — | — | — | — | 1 |
| Urinary bladder neoplasms | D001749 | — | C67 | 1 | — | — | — | — | 1 |
| Fallopian tube neoplasms | D005185 | — | — | 1 | — | — | — | — | 1 |
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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 | Azacitidine |
| INN | azacitidine |
| Description | 5-azacytidine is an N-glycosyl-1,3,5-triazine that is 4-amino-1,3,5-triazin-2(1H)-one substituted by a beta-D-ribofuranosyl residue via an N-glycosidic linkage. An antineoplastic agent, it is used in the treatment of myeloid leukaemia. It has a role as an antineoplastic agent. It is a N-glycosyl-1,3,5-triazine and a nucleoside analogue. It is functionally related to a beta-D-ribose. |
| Classification | Small molecule |
| Drug class | H2-receptor antagonists (cimetidine type) |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | Nc1ncn([C@@H]2O[C@H](CO)[C@@H](O)[C@H]2O)c(=O)n1 |
Identifiers
| PDB | — |
| CAS-ID | 320-67-2 |
| RxCUI | — |
| ChEMBL ID | CHEMBL1489 |
| ChEBI ID | 2038 |
| PubChem CID | 9444 |
| DrugBank | DB00928 |
| UNII ID | M801H13NRU (ChemIDplus, GSRS) |
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Azacitidine – Celgene
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Vidaza – Bristol Myers Squibb
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Vidaza – Celgene
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Onureg – Bristol Myers Squibb
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Trends
PubMed Central
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Additional graphs summarizing 27,052 documents
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Safety
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Adverse Events
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25,347 adverse events reported
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