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 |
|---|---|---|---|---|---|
2025/08/29 | Not Applicable | Not yet recruiting | |||
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 |
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 |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
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 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| DACOGEN 50 mg polvo para concentrado para solucion para perfusion | 112792001 | POLVO PARA CONCENTRADO PARA SOLUCIÓN PARA PERFUSIÓN | Uso Hospitalario | Commercialized | |
| INAQOVI 35 MG/100 MG COMPRIMIDOS RECUBIERTOS CON PELICULA | 1231756001 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Diagnóstico Hospitalario | 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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