Overview
Azacitidine is a pyrimidine nucleoside analogue with anti-neoplastic activity. It differs from cytosine by the presence of nitrogen in the C5-position, key in its hypomethylating activity. Two main mechanisms of action have been proposed for azacitidine. One of them is the induction of cytotoxicity. As an analogue of cytidine, it is able to incorporate into RNA and DNA, disrupting RNA metabolism and inhibiting protein and DNA synthesis. The other one is through the inhibition of DNA methyltransferase, impairing DNA methylation. Due to its anti-neoplastic activity and its ability to inhibit methylation in replicating DNA, azacytidine has been used mainly used in the treatment of myelodysplastic syndromes (MDS) and acute myeloid leukemia (AML), two types of cancer characterized by the presence of aberrant DNA methylation. In May 2004, the FDA approved the use of azacitidine administered subcutaneously for the treatment of MDS of all French-American-British (FAB) subtypes. In January 2007, the FDA approved the intravenous administration of azacitidine. The use of oral azacitidine for the treatment of AML in patients in complete remission was approved by the FDA in September 2020.
Indication
Azacitidine (for subcutaneous or intravenous use) is indicated for the treatment of adult patients with the following French-American-British (FAB) myelodysplastic syndrome (MDS) subtypes: refractory anemia (RA) or refractory anemia with ringed sideroblasts (RARS) (if accompanied by neutropenia or thrombocytopenia or requiring transfusions), refractory anemia with excess blasts (RAEB), refractory anemia with excess blasts in transformation (RAEB-T), and chronic myelomonocytic leukemia (CMMoL). Azacitidine is also indicated for the treatment of pediatric patients aged 1 month and older with newly diagnosed Juvenile Myelomonocytic Leukemia (JMML). Azacitidine (for oral use) is indicated for continued treatment of adult patients with acute myeloid leukemia (AML) who achieved first complete remission or complete remission with incomplete blood count recovery following intensive induction chemotherapy and are not able to complete intensive curative therapy.
Associated Conditions
- Acute Myeloid Leukemia
- Chronic Myelomonocytic Leukemia
- Refractory Anemia
- Refractory Anemia With Excess Blasts in Transformation
- Refractory Anemia With Excess of Blasts (RAEB)
- Refractory Anemia With Ringed Sideroblasts
- Newly diagnosed Juvenile Myelomonocytic Leukaemias (JMML)
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/08/20 | Not Applicable | Not yet recruiting | |||
2025/08/20 | Not Applicable | Recruiting | |||
2025/07/24 | Not Applicable | Not yet recruiting | |||
2025/07/22 | Not Applicable | Recruiting | Beijing 302 Hospital | ||
2025/07/17 | Not Applicable | Not yet recruiting | |||
2025/07/11 | Not Applicable | Not yet recruiting | |||
2025/07/01 | Not Applicable | Recruiting | |||
2025/06/12 | Phase 1 | Not yet recruiting | The Lymphoma Academic Research Organisation | ||
2025/06/10 | Phase 2 | Recruiting | yuejun Liu | ||
2025/06/05 | Phase 3 | Not yet recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Sandoz Inc | 0781-3253 | SUBCUTANEOUS, INTRAVENOUS | 100 mg in 1 1 | 6/9/2022 | |
| Celgene Corporation | 59572-730 | ORAL | 200 mg in 1 1 | 10/26/2022 | |
| Dr. Reddy's Laboratories Inc. | 43598-143 | SUBCUTANEOUS, INTRAVENOUS | 100 mg in 50 mL | 8/30/2018 | |
| NorthStar RxLLC | 16714-927 | SUBCUTANEOUS, INTRAVENOUS | 100 mg in 1 1 | 12/26/2023 | |
| CELLTRION USA, INC. | 72606-558 | INTRAVENOUS, SUBCUTANEOUS | 100 mg in 1 1 | 1/7/2020 | |
| Sandoz Inc | 0781-9253 | SUBCUTANEOUS, INTRAVENOUS | 100 mg in 1 1 | 9/23/2022 | |
| Fresenius Kabi USA, LLC | 63323-771 | INTRAVENOUS, SUBCUTANEOUS | 100 mg in 30 mL | 9/30/2018 | |
| Camber Pharmaceuticals, Inc. | 31722-365 | INTRAVENOUS, SUBCUTANEOUS | 100 mg in 1 1 | 4/8/2025 | |
| Armas Pharmaceuticals Inc. | 72485-201 | INTRAVENOUS, SUBCUTANEOUS | 100 mg in 1 1 | 12/22/2020 | |
| Accord Healthcare Inc. | 16729-306 | INTRAVENOUS, SUBCUTANEOUS | 100 mg in 1 1 | 1/4/2024 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 2/13/2020 | ||
Authorised | 3/24/2020 | ||
Authorised | 12/17/2008 | ||
Authorised | 3/27/2020 | ||
Authorised | 1/5/2024 | ||
Authorised | 6/17/2021 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| ONUREG FILM-COATED TABLETS 300 MG | SIN16573P | TABLET, FILM COATED | 300.0 mg | 8/19/2022 | |
| AZACITIDINE ADVAGEN POWDER FOR SUSPENSION FOR INJECTION 100MG/VIAL | SIN16285P | INJECTION, POWDER, FOR SUSPENSION | 100mg/vial | 7/23/2021 | |
| Vidaza powder for suspension for injection 100mg/vial | SIN13801P | INJECTION, POWDER, FOR SUSPENSION | 100mg/vial | 5/18/2010 | |
| XPREZA 100 INJECTION 100 MG/VIAL | SIN15118P | INJECTION | 100mg | 11/23/2016 | |
| AVOXRED POWDER FOR SUSPENSION FOR INJECTION 100MG/VIAL | SIN15875P | INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION | 100 mg/ml | 1/16/2020 | |
| ONUREG FILM-COATED TABLETS 200 MG | SIN16572P | TABLET, FILM COATED | 200.0 mg | 8/19/2022 | |
| AZADINE POWDER FOR SUSPENSION FOR INJECTION 100MG/VIAL | SIN15304P | INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION | 100 mg | 7/25/2017 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| AZACITIDINE SANDOZ POWDER FOR SUSPENSION FOR INJECTION 100MG | N/A | N/A | N/A | 12/13/2024 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| AZACITIDINE-TEVA azacitidine 100 mg powder for injection vial | 299040 | Medicine | A | 7/23/2019 | |
| AZACITIDINE EPSL azacitidine 100 mg powder for injection vial | 407492 | Medicine | A | 2/23/2024 | |
| REDDAZA azacitidine 100 mg powder for injection vial | 231946 | Medicine | A | 2/10/2016 | |
| AZACITIDINE ANS azacitidine 100 mg powder for injection vial | 395836 | Medicine | A | 12/22/2023 | |
| ONUREG azacitidine 300 mg film-coated tablet blister pack | 370372 | Medicine | A | 4/8/2022 | |
| AZACCORD azacitidine 100mg powder for injection vial | 265773 | Medicine | A | 5/8/2017 | |
| AZACITIDINE INTAS azacitidine 100mg powder for injection vial | 265775 | Medicine | A | 5/8/2017 | |
| Azacitidine APOTEX azacitidine100 mg powder for injection vial | 231497 | Medicine | A | 9/23/2015 | |
| AZACITIDINE SANDOZ azacitidine 100 mg powder for injection vial | 338376 | Medicine | A | 10/21/2021 | |
| ONUREG azacitidine 200 mg film-coated tablet blister pack | 370367 | Medicine | A | 4/8/2022 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| AZACITIDINE FOR INJECTION | 02529599 | Powder For Suspension - Subcutaneous | 100 MG / VIAL | 4/17/2023 | |
| AZACITIDINE FOR INJECTION | dr reddy's laboratories ltd | 02462826 | Powder For Suspension - Subcutaneous | 100 MG / VIAL | 10/25/2017 |
| NAT-AZACITIDINE | natco pharma (canada) inc | 02480220 | Powder For Suspension - Subcutaneous | 100 MG / VIAL | N/A |
| AZACITIDINE FOR INJECTION | Sterimax Inc | 02534029 | Powder For Suspension - Subcutaneous | 100 MG / VIAL | N/A |
| AZACITIDINE FOR INJECTION | fresenius kabi canada ltd | 02505177 | Powder For Suspension - Subcutaneous | 100 MG / VIAL | 10/15/2024 |
| AZACITIDINE FOR INJECTION | Sterimax Inc | 02534037 | Powder For Suspension - Subcutaneous | 150 MG / VIAL | N/A |
| ONUREG | bristol-myers squibb canada | 02510197 | Tablet - Oral | 200 MG | 3/10/2021 |
| PMS-AZACITIDINE FOR INJECTION | 02532085 | Powder For Suspension - Subcutaneous | 100 MG / VIAL | N/A | |
| ONUREG | bristol-myers squibb canada | 02510200 | Tablet - Oral | 300 MG | 3/10/2021 |
| AZACITIDINE FOR INJECTION | hikma canada limited | 02507668 | Powder For Suspension - Subcutaneous | 100 MG / VIAL | 2/24/2022 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| AZACITIDINA ACCORD 25 MG/ML POLVO PARA SUSPENSION INYECTABLE EFG | 1191413 | POLVO PARA SUSPENSIÓN INYECTABLE | Uso Hospitalario | Commercialized | |
| AZACITIDINA SANDOZ 25 MG/ML POLVO PARA SOLUCION INYECTABLE EFG | Sandoz Farmaceutica S.A. | 85133 | POLVO PARA SUSPENSIÓN INYECTABLE | Uso Hospitalario | Commercialized |
| ONUREG 200 mg COMPRIMIDOS RECUBIERTOS CON PELICULA | 1211556001 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Diagnóstico Hospitalario | Commercialized | |
| ONUREG 300 mg COMPRIMIDOS RECUBIERTOS CON PELICULA | 1211556003 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Diagnóstico Hospitalario | Commercialized | |
| AZACITIDINA EVER PHARMA 25 MG/ML POLVO PARA SUSPENSION INYECTABLE EFG | Ever Valinject Gmbh | 85786 | POLVO PARA SUSPENSIÓN INYECTABLE | Uso Hospitalario | Not Commercialized |
| AZACITIDINA BETAPHARM 25 MG/ML POLVO PARA SUSPENSION INYECTABLE EFG | 1191416001 | POLVO PARA SUSPENSIÓN INYECTABLE | Uso Hospitalario | Commercialized | |
| AZACITIDINA KABI 25 MG/ML POLVO PARA SUSPENSION INYECTABLE EFG | 1231777001 | POLVO PARA SUSPENSIÓN INYECTABLE | Uso Hospitalario | Not Commercialized | |
| AZACITIDINA GLENMARK 25 MG/ML POLVO PARA SUSPENSION INYECTABLE EFG | 86332 | POLVO PARA SUSPENSIÓN INYECTABLE | Uso Hospitalario | Not Commercialized | |
| AZACITIDINA MYLAN 25 MG/ML POLVO PARA SUSPENSION INYECTABLE EFG | 1201426001 | POLVO PARA SUSPENSIÓN INYECTABLE | Uso Hospitalario | Commercialized | |
| AZACITIDINA LORIEN 25 MG/ML POLVO PARA SUSPENSION INYECTABLE EFG | Laboratorios Lorien S.L. | 87622 | POLVO PARA SUSPENSIÓN INYECTABLE | Uso Hospitalario | Not Commercialized |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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