Azacitidine

Generic Name
Azacitidine
Brand Names
Onureg, Vidaza, Azacitidine Accord, Azacitidine betapharm, Azacitidine Mylan, Azacitidine Kabi
Drug Type
Small Molecule
Chemical Formula
C8H12N4O5
CAS Number
320-67-2
Unique Ingredient Identifier
M801H13NRU
Background

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)
Associated Therapies
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VIDAZA-DLI Pre-emptive Azacitidine and Donor Lymphocyte Infusions Following Allogeneic Hematopoietic Stem Cell Transplantation for High Risk Acute Myeloid Leukemia and Myelodysplastic Syndrome

First Posted Date
2012-02-29
Last Posted Date
2016-03-18
Lead Sponsor
Nantes University Hospital
Target Recruit Count
30
Registration Number
NCT01541280
Locations
🇫🇷

University Hospital of Nantes, Nantes, France

Azacitidine With or Without Lenalidomide or Vorinostat in Treating Patients With Higher-Risk Myelodysplastic Syndromes or Chronic Myelomonocytic Leukemia

First Posted Date
2012-02-01
Last Posted Date
2024-11-13
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
282
Registration Number
NCT01522976
Locations
🇺🇸

Rose Medical Center, Denver, Colorado, United States

🇺🇸

Western States Cancer Research NCORP, Denver, Colorado, United States

🇺🇸

Mercy Medical Center, Durango, Colorado, United States

and more 291 locations

Treatment of Patients With Myelodysplastic Syndrome or Acute Myelocytic Leukemia With an Impending Hematological Relapse With Azacitidine (Vidaza)

First Posted Date
2011-10-31
Last Posted Date
2021-11-15
Lead Sponsor
Technische Universität Dresden
Target Recruit Count
93
Registration Number
NCT01462578
Locations
🇩🇪

Klinikum Chemnitz (Küchwald), Chemnitz, Germany

🇩🇪

Universitätsklinikum Bonn, Bonn, Germany

🇩🇪

Universitätsklinikum Heidelberg, Medizinische Klinik, Abt. Innere Medizin V, Heidelberg, Germany

and more 8 locations

Azacitidine (AZA) in Minimal Residual Disease (MRD) Chronic Myeloid Leukemia (CML)

First Posted Date
2011-10-27
Last Posted Date
2020-03-05
Lead Sponsor
M.D. Anderson Cancer Center
Target Recruit Count
3
Registration Number
NCT01460498
Locations
🇺🇸

University of Texas MD Anderson Cancer Center, Houston, Texas, United States

Azacitidine + Lenalidomide Combo in the Elderly With Previously Treated AML & High-Risk MDS

First Posted Date
2011-09-28
Last Posted Date
2018-01-03
Lead Sponsor
Stanford University
Target Recruit Count
33
Registration Number
NCT01442714
Locations
🇺🇸

Stanford University School of Medicine, Stanford, California, United States

Azacitidine After Chemotherapy and Donor Lymphocyte Infusion in Patients With Relapsed Acute Myeloid Leukemia or Myelodysplastic Syndrome Previously Treated With Donor Stem Cell Transplant

First Posted Date
2011-07-11
Last Posted Date
2015-04-27
Lead Sponsor
Washington University School of Medicine
Target Recruit Count
14
Registration Number
NCT01390311
Locations
🇺🇸

Washington University School of Medicine, Saint Louis, Missouri, United States

Epigenetic Priming Using Azacitidine With Neoadjuvant Chemotherapy for Resectable Esophageal Cancer

First Posted Date
2011-07-01
Last Posted Date
2018-12-12
Lead Sponsor
Weill Medical College of Cornell University
Target Recruit Count
12
Registration Number
NCT01386346
Locations
🇺🇸

Weill Cornell Medical College, New York, New York, United States

A Study Being Conducted at Multiple Locations to Compare Safety and Efficacy of Three Different Regimens; (1) High-Dose Lenalidomide; (2) Lenalidomide + Azacitidine; or (3) Azacitidine in Subjects ≥ 65 Years With Newly-Diagnosed Acute Myeloid Leukemia

First Posted Date
2011-05-24
Last Posted Date
2019-06-25
Lead Sponsor
Celgene
Target Recruit Count
88
Registration Number
NCT01358734
Locations
🇺🇸

(240) Cedars-Sinai Medical Center, Los Angeles, California, United States

🇺🇸

(160) The Western Pennsylvania Hospital- Cancer Institute, Pittsburgh, Pennsylvania, United States

🇺🇸

(200) Coastal Integrative Cancer Care, San Luis Obispo, California, United States

and more 27 locations

Azacitidine and Entinostat in Treating Patients With Advanced Breast Cancer

First Posted Date
2011-05-09
Last Posted Date
2024-07-23
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
58
Registration Number
NCT01349959
Locations
🇺🇸

Johns Hopkins University/Sidney Kimmel Cancer Center, Baltimore, Maryland, United States

🇺🇸

Metro Minnesota Community Oncology Research Consortium, Saint Louis Park, Minnesota, United States

🇺🇸

USC / Norris Comprehensive Cancer Center, Los Angeles, California, United States

and more 4 locations

Best Promising Drug Association With Azacitidine in Higher Risk Myelodysplastic Syndromes

First Posted Date
2011-04-27
Last Posted Date
2019-02-19
Lead Sponsor
Assistance Publique - Hôpitaux de Paris
Target Recruit Count
320
Registration Number
NCT01342692
Locations
🇫🇷

Avicenne hospital, Bobigny, France

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