Overview
Myelodysplastic syndromes (MDS) are a heterogeneous group of hematopoietic neoplasms with variable underlying etiology and presentation, including neutropenia and thrombocytopenia. Further mutations leading to increased proliferation of cancerous cells can eventually lead to secondary acute myeloid leukemia, which has a poor prognosis. Among treatment options, nucleoside analogues such as decitabine and azacitidine integrate into cellular DNA and inhibit the action of DNA methyltransferases, leading to global hypomethylation and related downstream therapeutic benefits. Decitabine was developed by MGI Pharma/SuperGen Inc. and was approved by the FDA for the treatment of MDS on February 5, 2006. It was first marketed under the name Dacogen®. It is also available as an oral combination product together with the cytidine deaminase inhibitor cedazuridine.
Indication
Decitabine is indicated for the treatment of patients with myelodysplastic syndromes (MDS) including all French-American-British subtypes (refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, and chronic myelomonocytic leukemia), as well as for MDS scored as belonging to the intermediate-1, intermediate-2, or high-risk group in the International Prognostic Scoring System.
Associated Conditions
- Chronic Myelomonocytic Leukemia
- Myelodysplastic Syndrome
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/07/17 | Not Applicable | Not yet recruiting | |||
2025/07/11 | Not Applicable | Not yet recruiting | |||
2025/07/04 | Not Applicable | Not yet recruiting | |||
2025/07/01 | Not Applicable | Not yet recruiting | |||
2025/06/10 | Phase 1 | Not yet recruiting | |||
2025/06/06 | Phase 2 | Not yet recruiting | Wuhan Union Hospital, China | ||
2025/06/05 | Phase 1 | Recruiting | |||
2025/05/30 | Phase 1 | Not yet recruiting | |||
2025/05/15 | Phase 2 | Recruiting | |||
2025/04/15 | Phase 1 | Not yet recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| MSN LABORATORIES PRIVATE LIMITED | 69539-115 | INTRAVENOUS | 50 mg in 10 mL | 8/27/2020 | |
| Taiho Pharmaceutical Co., Ltd. | 64842-0727 | ORAL | 35 mg in 1 1 | 3/30/2022 | |
| Sagent Pharmaceuticals | 25021-231 | INTRAVENOUS | 50 mg in 10 mL | 6/14/2023 | |
| Amneal Pharmaceuticals LLC | 70121-1644 | INTRAVENOUS | 50 mg in 20 mL | 11/26/2019 | |
| Meitheal Pharmaceuticals Inc. | 71288-119 | INTRAVENOUS | 50 mg in 20 mL | 7/2/2021 | |
| Nivagen Pharmaceuticals, Inc. | 75834-190 | INTRAVENOUS | 50 mg in 20 mL | 2/28/2022 | |
| Dr.Reddy's Laboratories Limited | 55111-556 | INTRAVENOUS | 50 mg in 10 mL | 8/16/2021 | |
| Cipla USA Inc. | 69097-905 | INTRAVENOUS | 50 mg in 10 mL | 1/17/2023 | |
| Hikma Pharmaceuticals USA Inc. | 0143-9385 | INTRAVENOUS | 50 mg in 1 1 | 2/21/2022 | |
| Mylan Institutional LLC | 67457-316 | INTRAVENOUS | 50 mg in 20 mL | 7/26/2020 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 9/15/2023 | ||
Authorised | 9/20/2012 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Decitabine for Injection | 国药准字H20133080 | 化学药品 | 注射剂 | 10/19/2022 | |
| Decitabine for Injection | 国药准字H20173051 | 化学药品 | 注射剂 | 8/17/2022 | |
| Decitabine for Injection | 国药准字H20163249 | 化学药品 | 注射剂 | 3/11/2021 | |
| Decitabine for Injection | 国药准字H20130067 | 化学药品 | 注射剂 | 5/23/2023 | |
| Decitabine for Injection | 国药准字H20120067 | 化学药品 | 注射剂 | 4/22/2022 | |
| Decitabine for Injection | 国药准字H20120066 | 化学药品 | 注射剂 | 4/22/2022 | |
| Decitabine for Injection | 国药准字HJ20181217 | 化学药品 | 注射剂 | 3/15/2021 | |
| Decitabine for Injection | 国药准字H20173052 | 化学药品 | 注射剂 | 8/17/2022 | |
| Decitabine for Injection | 国药准字H20163271 | 化学药品 | 注射剂 | 3/19/2024 | |
| Decitabine for Injection | 国药准字H20143382 | 化学药品 | 注射剂 | 4/22/2022 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| DECITABINE POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION 50MG | N/A | N/A | N/A | 3/31/2025 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| INQOVI 35/100 decitabine 35 mg and cedazuridine 100 mg tablet blister pack | 375556 | Medicine | A | 12/22/2021 | |
| INQOVI 35/100 decitabine 35 mg and cedazuridine 100 mg tablet bottle | 328904 | Medicine | A | 11/2/2020 |
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