Data updated: May 26, 2026
DECITABINE
Nucleic Acid Synthesis Inhibitors
Oncology
Approved 2013-07-11
DECITABINE is indicated for the treatment of Myelodysplastic Syndromes; Refractory Anemia; Refractory Anemia with Ringed Sideroblasts; Refractory Anemia with Excess Blasts; Chronic Myelomonocytic Leukemia.
How DECITABINE Works
Decitabine exerts its antineoplastic effects following phosphorylation and direct incorporation into DNA. It inhibits DNA methyltransferase, resulting in DNA hypomethylation and the formation of covalent adducts between the enzyme and DNA. This process can restore normal function to genes critical for controlling cellular differentiation and proliferation, leading to the death (apoptosis) or normal differentiation of cancer cells. Decitabine specifically targets rapidly dividing cells, while non-proliferating cells are relatively insensitive to its effects.
21
Indications
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Phase 3 Trials
12
Years on Market
Details
- Status
- Prescription
- First Approved
- 2013-07-11
- Routes
- INTRAVENOUS
- Dosage Forms
- INJECTABLE, POWDER
Companies
Novartis SAGENT PHARMS INC EUGIA PHARMA HETERO LABS LTD VI PHARMASCIENCE INC NOVAST LABS GLAND CHEMI SPA Cipla MSN QILU PHARM HAINAN RELIANCE LIFE SCI ACCORD HLTHCARE WOCKHARDT BIO AG Lupin Dr. Reddy's NIVAGEN PHARMS INC JIANGSU HANSOH PHARM Sun Pharma MEITHEAL ZYDUS PHARMS
Active Ingredient: DECITABINE
Website: ↗
DECITABINE Approval History
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
53 FDA actions from 2013 to 2025
Dec 2025 ORIGINAL
Update
Jul 2025 SUPPL
Label · Labeling
Jun 2025 SUPPL
Label · Labeling
Apr 2025 SUPPL
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May 2024 ORIGINAL
Update
Apr 2022 ORIGINAL
Update
Nov 2021 ORIGINAL
Update
Sep 2021 SUPPL
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Sep 2021 ORIGINAL
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Jul 2021 ORIGINAL
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Jun 2021 SUPPL
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Apr 2021 ORIGINAL
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Mar 2021 SUPPL
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Jan 2021 SUPPL
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Dec 2020 ORIGINAL
Update
Nov 2020 ORIGINAL
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Nov 2020 SUPPL
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Nov 2020 SUPPL
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Nov 2020 SUPPL
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Sep 2020 SUPPL
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Oct 2019 SUPPL
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Sep 2019 ORIGINAL
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Aug 2019 ORIGINAL
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Apr 2019 ORIGINAL
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Nov 2018 ORIGINAL
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Mar 2018 ORIGINAL
Update
Nov 2017 ORIGINAL
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Sep 2017 ORIGINAL
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May 2017 ORIGINAL
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May 2017 SUPPL
Label
May 2017 SUPPL
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Feb 2017 ORIGINAL
Update
Mar 2016 SUPPL
Mfg
Aug 2014 SUPPL
Mfg
Jul 2013 ORIGINAL
Update
What DECITABINE Treats
5 indicationsDECITABINE is approved for 5 conditions since its original approval in 2013. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Myelodysplastic Syndromes
- Refractory Anemia
- Refractory Anemia with Ringed Sideroblasts
- Refractory Anemia with Excess Blasts
- Chronic Myelomonocytic Leukemia
Source: FDA Label
DECITABINE Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
1
Same target(s) AND same indication — head-to-head.
Indication competitors
10
Same indication, different mechanism — what else might this patient receive?
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What's emerging in DECITABINE's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications DECITABINE treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to DECITABINE
3 of 8FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
INQOVI
CEDAZURIDINE
TAIHO ONCOLOGY
Shared indications:
Myelodysplastic SyndromesRefractory AnemiaRefractory Anemia with Ringed Sideroblasts +2 more
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Clinical Trial Registry
202 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT07012044 | NCI-2025-03946 NCI-2025-03946, PEPN2413 | Ph 1 | recruiting | A Study to Find the Highest Dose of Cedazuridine and Decitabine Combination With Filgrastim as a Treatment Option After Hematopoietic Stem Cell Transplant in Children With High-Risk Acute Myeloid Leukemia |
| NCT03041688 | NCI-2017-00128 NCI-2017-00128, PHI-92 | Ph 1 | active not recruiting | Testing a New Chemotherapy Drug, KRT-232 (AMG-232) in Combination With Decitabine and Venetoclax in Patients With Acute Myeloid Leukemia |
| NCT05829226 | LYT-200-2022-02 | Ph 1 | completed | A Phase 1 Study With LYT-200 in Patients With Relapsed/Refractory Acute Myeloid Leukemia (AML), or With Relapsed/Refractory, High-risk Myelodysplastic Syndrome (MDS) |
| NCT06930651 | 2024-1967 NCI-2025-02697 | Ph 1, Ph 2 | recruiting | A Phase I/II Study of CAR.70-Engineered IL15-Transduced Cord Blood-Derived NK Cells With TGF-beta Receptor 2 (TGFBR2) Knock Out in Conjunction With Lymphodepleting Chemotherapy for the Management of Relapsed/Refractory Myeloid Malignancies |
| NCT07374029 | 25-593 | Ph 1 | recruiting | Adoptive T Cell Therapy With DC/AML Fusion Vaccine Plus Decitabine and Venetoclax in AML |
| NCT02890329 results posted | NCI-2016-01326 NCI-2016-01326, 17-718 | Ph 1 | active not recruiting | Ipilimumab and Decitabine in Treating Patients With Relapsed or Refractory Myelodysplastic Syndrome or Acute Myeloid Leukemia |
| NCT07555405 | IIT2026008 | Ph 4 | not yet recruiting | Evaluating the Safety and Efficacy of Decitabine in the Treatment of XMEN Patients |
| NCT05586074 | HEC73543-AML-301 | Ph 3 | recruiting | HEC73543 Versus Salvage Chemotherapy in R/R FLT3-ITD AML |
| NCT01627041 | NCI-2012-01959 NCI-2012-01959, 1106011736 | Ph 2 | active not recruiting | Decitabine, Cytarabine, and Daunorubicin Hydrochloride in Treating Patients With Acute Myeloid Leukemia |
| NCT06129734 | CASE2923 | Ph 1, Ph 2 | recruiting | Decitabine and Venetoclax Treatment as Maintenance Therapy in Patients Post Allograft Stem Cell Transplant |
| NCT06401603 | 2024-0032 NCI-2024-03867 | Ph 1 | recruiting | A Phase I Study of Decitabine, Lisaftoclax, and Olverembatinib in Patients With Advanced Chronic Myeloid Leukemia and Philadelphia Chromosome-Positive Acute Myeloid Leukemia |
| NCT06923488 | 2502109808 | Ph 1, Ph 2 | recruiting | Leflunomide in Combination With Decitabine for Treatment of Relapsed or Refractory Myelodysplastic Syndromes |
| NCT03164057 | AML16 NCI-2017-00928 | Ph 2 | active not recruiting | A Trial of Epigenetic Priming in Patients With Newly Diagnosed Acute Myeloid Leukemia |
| NCT03184935 | SCLnow-IMIMH-03 | Ph 1, Ph 2 | suspended | Research for Human Umbilical Cord Mesenchymal Stem Cells (19#iSCLife®-MDS) in the Treatment of Myelodysplastic Syndrome (MDS) |
| NCT03009240 | 16270 NCI-2016-02044, 16270 | Ph 1 | completed | Pevonedistat and Decitabine in Treating Patients With High Risk Acute Myeloid Leukemia |
| NCT02957968 results posted | MCC-15-11083 NCI-2016-01980, P30CA016059 | Ph 2 | active not recruiting | Neoadjuvant Pembrolizumab + Decitabine Followed by Std Neoadj Chemo for Locally Advanced HER2- Breast Ca |
| NCT05222984 | 22178 NCI-2021-05552, 20398 | Ph 1 | active not recruiting | Navitoclax, Venetoclax, and Decitabine for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia Previously Treated With Venetoclax |
| NCT03418038 | LS1781 P50CA097274, NCI-2018-00057 | Ph 2 | recruiting | Ascorbic Acid and Chemotherapy for the Treatment of Relapsed or Refractory Lymphoma, CCUS, and Chronic Myelomonocytic Leukemia |
| NCT03132454 | 2016-0772 NCI-2018-01194, 2016-0772 | Ph 1 | active not recruiting | Palbociclib and Sorafenib, Decitabine, or Dexamethasone in Treating Patients With Recurrent or Refractory Leukemia |
| NCT05038592 | 2020-0895 NCI-2021-04293, 2020-0895 | Ph 1, Ph 2 | active not recruiting | Phase I/II Study of Tagraxofusp in Combination With Decitabine for Patients With Myelomonocytic/Myeloproliferative Neoplasm and High Risk Myelodysplastic Syndromes |
| NCT01861314 | NCI-2013-00999 NCI-2013-00999, OSU-11186 | Ph 1 | active not recruiting | Bortezomib, Sorafenib Tosylate, and Decitabine in Treating Patients With Acute Myeloid Leukemia |
| NCT07177079 | 202506290 | Ph 1 | recruiting | High-dose Ascorbate (HDA) in Combination With Standard of Care Azacitidine and Venetoclax in Acute Myeloid Leukemia (AML) |
| NCT06445959 | 2024-0180 NCI-2024-04807 | Ph 1, Ph 2 | recruiting | Phase 1b/2 Study of Decitabine and Venetoclax in Combination With the Targeted Mutant IDH1 Inhibitor Olutasidenib |
| NCT03240211 | PTCL-002 | Ph 1 | active not recruiting | Study of Pembrolizumab Combined With Decitabine and Pralatrexate in PTCL and CTCL |
| NCT07511062 | NSH 1436 | Ph 1 | not yet recruiting | Axatilimab Combined With Decitabine/Venetoclax for the Treatment of TP53-mutated AML |
| NCT03017131 | i 283616 NCI-2016-01477, i 283616 | Ph 1 | active not recruiting | Genetically Modified T Cells and Decitabine in Treating Patients With Recurrent or Refractory Ovarian, Primary Peritoneal, or Fallopian Tube Cancer |
| NCT06327685 | MCC-22318 | Ph 1 | recruiting | Avapritinib With Decitabine in Patients With SM-AHN |
| NCT07505160 | 2026-0140 | Ph 2 | not yet recruiting | Efficacy and Safety of Lisafotoclax Plus Decitabine and Homoharringtonine in Venetoclax/Azacitidine Pretreated AML Patients |
| NCT05796570 MORE | 22-569 | Ph 2 | recruiting | A Pilot Study to Evaluate the Feasibility of Post-Hematopoietic Stem Cell Transplant Prophylaxis With Decitabine Combined With Filgrastim for Children and Young Adults With AML, MDS and Related Myeloid Malignancies |
| NCT04282187 | RG1006644 NCI-2020-00749, 10419 | Ph 2 | recruiting | Decitabine With Ruxolitinib, Fedratinib or Pacritinib for the Treatment of Accelerated/Blast Phase Myeloproliferative Neoplasms |
| NCT06561074 | 2022-0416 NCI-2024-06907 | Ph 2 | recruiting | A Phase 2 Study to Evaluate Efficacy of Calaspargase Pegol-mknl and Decitabine Combined With Venetoclax in Pediatric, Adolescent, and Young Adult Patients With Relapsed/Refractory T-cell Acute Lymphoblastic Leukemia (T-ALL) and T- Cell Lymphoblastic Lymphoma (T-LLy) |
| NCT03404193 | 2017-0912 NCI-2018-00752, 2017-0912 | Ph 2 | terminated | Venetoclax and Decitabine in Treating Participants With Relapsed/Refractory Acute Myeloid Leukemia or Relapsed High-Risk Myelodysplastic Syndrome |
| NCT03226418 results posted | 0179-17-FB NCI-2017-01285, P30CA036727 | Ph 2 | completed | Geriatric Assessment & Genetic Profiling to Personalize Therapy in Older Adults With Acute Myeloid Leukemia |
| NCT03969446 | 19107 NCI-2019-03153, 19107 | Ph 1 | recruiting | Pembrolizumab and Decitabine With or Without Venetoclax in Treating Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome That Is Newly-Diagnosed, Recurrent, or Refractory |
| NCT07044544 | IRB-300014728 (UAB 2469) Robert Award | Ph 1 | recruiting | Trial of Novel Anti-leukemia Agents in Flu/Mel RIC Transplant for Myeloid Malignancies |
| NCT07148947 | RG1125470 NCI-2025-05720, FHIRB0021044 | Ph 2 | recruiting | Pacritinib With Standard of Care Azacitidine or Decitabine as a Bridge to Allogeneic Hematopoietic Stem Cell Transplant for Patients With Accelerated and Blast Phase Myeloproliferative Neoplasms |
| NCT03844815 | IRB18-1498 | Ph 1 | active not recruiting | Study of Venetoclax in Combination With Decitabine in Subjects With Acute Myeloid Leukemia |
| NCT07283094 FHD-286 | 2025-16661 2516661-FHD-286 | Ph 1 | recruiting | FHD-286 With Low-Dose Weekly Decitabine/Venetoclax in Patients With Acute Myeloid Leukemia |
| NCT06511882 | MCC-22191 | Ph 2 | recruiting | Discontinuation of Hypomethylating Agent and Venetoclax in Patients With AML MRD |
| NCT03358719 results posted | I 49217 NCI-2017-02012, I 49217 | Ph 1 | completed | DEC-205/NY-ESO-1 Fusion Protein CDX-1401, Poly ICLC, Decitabine, and Nivolumab in Treating Patients With Myelodysplastic Syndrome or Acute Myeloid Leukemia |
| NCT03974217 | 19-152 | Ph 1 | active not recruiting | Talazoparib for Cohesin-Mutated AML and MDS With Excess Blasts |
| NCT07389239 | IRB25-1721 | Ph 1, Ph 2 | not yet recruiting | A Study Evaluating the Immunotherapy Treatment for Ovarian Cancer and Other Advanced Malignancies. |
| NCT04854889 LODACA | IIT2021016 | Ph 2 | terminated | Efficacy and Safety of Low-dose Decitabine in Refractory Aplastic Anemia |
| NCT01515527 | 2011-0987 NCI-2012-00145 | Ph 2 | recruiting | Cladribine Plus Low Dose Cytarabine (LDAC) Alternating With Decitabine in Patients With Acute Myeloid Leukemia (AML) or High-Risk Myelodysplastic Syndrome (MDS) |
| NCT05455294 | 22-263 | Ph 1 | active not recruiting | Combination Navitoclax, Venetoclax and Decitabine for Advanced Myeloid Neoplasms |
| NCT06997094 | MC240706 NCI-2025-03537, 24-012507 | Ph 1 | recruiting | Decitabine in Combination With Standard of Care Therapy for the Treatment of Surgically Resectable HPV-Negative Head and Neck Cancer |
| NCT03926624 | D18-11141 | Ph 3 | terminated | Trial of DFP-10917 vs Non-Intensive or Intensive Reinduction for AML Patients in 2nd/3rd/4th Salvage |
| NCT02961101 | CHN-PLAGH-BT-019 | Ph 1, Ph 2 | recruiting | Anti-PD-1 Antibody Alone or in Combination With Decitabine/Chemotherapy in Relapsed or Refractory Malignancies |
| NCT07006025 | 2024-00001 | Ph 1 | recruiting | A Study of Oral Tetrahydrouridine-Decitabine in Relapsed or Refractory Myelodysplastic Syndromes (MDS) |
| NCT03875287 | J18115 IRB00182038, ASTX727 | Ph 1 | active not recruiting | Dose-Escalation Study of E7727, an Oral Cytidine Deaminase Inhibitor With Oral Decitabine in Subjects With Solid Tumors |
Showing 50 of 202 trials
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Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
Full development history with FDA approval milestones
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Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
DECITABINE FDA Label Details
Indications & Usage
FDA Label (PDF)DECITABINE is indicated for the treatment of Myelodysplastic Syndromes; Refractory Anemia; Refractory Anemia with Ringed Sideroblasts; Refractory Anemia with Excess Blasts; Chronic Myelomonocytic Leukemia.
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Data Sources
FDA Approval: ANDA202969 → Label: DailyMed → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →
Data sourced from official FDA and NIH databases. Click links to verify on original sources.