Drugs / Decitabine
Decitabine
also known as
DAC · 5-aza-2'-deoxycytidine · Dacogen · DEC · DACOGEN (Decitabine) · 5-aza-2\'deoxycytidine · decitabine (DAC) · Decitabine (Dacogen, 5-aza-2-deoxycytidine) · +3 more
Small molecule targets DNMT1, TUSC3 via activation
Regulatory milestones approvals, filings & regulatory actions · 11 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Withdrawn myelodysplastic syndrome 5 milestones | |||||
| Filed | US (FDA) | Dacogen | myelodysplastic syndrome | 2009-07-08 | “FDA has accepted for review the Company’s supplemental new drug application (sNDA) for an alternative five-day dosing regimen of Dacogen® (decitabine) for Injection” eisai.com ↗ |
| Withdrawn | EU (EMA) | Dacogen | myelodysplastic syndrome | 2005-11-15 | “the Companies have withdrawn the Marketing Authorization Application for Dacogen injection.” astx.com ↗ |
| Filed | US (FDA) | Dacogen | myelodysplastic syndrome | 2005-11-15 | “FDA has accepted the Companies' resubmission as of November 15, 2005 as a complete response to the Approvable Letter for Dacogen ™ (decitabine) injection for myelodysplastic...” astx.com ↗ |
| Filed | US (FDA) | Dacogen | myelodysplastic syndrome | 2004-11-01 | “Submission of Dacogen(TM) NDA to U.S. FDA” astx.com ↗ |
| Filed | EU (EMA) | Dacogen | myelodysplastic syndrome | 2004-10-01 | “Marketing Authorization Application (MAA) seeking approval of Dacogen ™ (decitabine) for injection has been submitted to the European Agency for the Evaluation of Medicinal...” astx.com ↗ “SuperGen continues to achieve its planned strategic milestones, with the European regulatory submissions in June 2004 for Orathecin and in early October 2004 for Dacogen” astx.com ↗ |
| Filed acute megakaryoblastic leukemia in adult 2 milestones | |||||
| Filed | US (FDA) | INQOVI | acute megakaryoblastic leukemia in adult | 2025-07-09 | “accepted their supplemental new drug application (sNDA) for INQOVI (decitabine and cedazuridine) plus venetoclax as a treatment for adults with newly diagnosed acute myeloid leukemia” taihooncology.com ↗ |
| Filed | EU (EMA) | — | acute megakaryoblastic leukemia in adult | 2022-08-22 | “EMA has accepted the Marketing Authorisation Application (MAA) for the oral fixed-dose combination of decitabine and cedazuridine (ASTX727)” otsuka.co.jp ↗ |
| Filed chronic myelomonocytic leukemia 1 milestone | |||||
| Filed | US (FDA) | — | chronic myelomonocytic leukemia | 2020-02-11 | “FDA acceptance for review of an NDA for the combination oral hypomethylating agent cedazuridine and decitabine (ASTX727 or oral C-DEC)” taihooncology.com ↗ |
| Approved Indication not stated 3 milestones | |||||
| Approved | EU (EMA) | Dacogen | — | 2012-09-20 | europa.eu ↗ |
| Label expansion | US (FDA) | DACOGEN | — | 2010-03-11 | fda.gov ↗ |
| Approved | US (FDA) | DACOGEN | — | 2006-05-02 | fda.gov ↗ |
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News releases announcing trial results or a regulatory action · 78
| Date | Issuer | Release |
|---|---|---|
| 2026-06-11 | Syndax Pharmaceuticals | Results Syndax Showcases Revuforj® (revumenib) Clinical Activity in Multiple Acute Leukemia Subtypes and Settings at EHA 2026 syndax.com ↗
Ph 2 SAVE trial of revumenib with venetoclax and decitabine/cedazuridine in R/R NPM1m, KMT2Ar, or NUP98r AML shows 88% (37/42) ORR, 68% (25/37) MRD negativity among responders, and 45% (19/42) transplant rate |
| 2026-06-11 | Syndax Pharmaceuticals | Results Syndax Announces Publication of SAVE Data on Revuforj® (revumenib) in Combination with Decitabine/Cedazuridine and Venetoclax in Relapsed/Refractory NPM1m, KMT2Ar, and NUP98r AML in the Journal of Clinical Oncology syndax.com ↗ |
| 2026-05-14 | Taiho Oncology, Inc. | Regulatory U.S. FDA Approves INQOVI® in Combination with Venetoclax, the First All-Oral Combination Treatment for Patients with Acute Myeloid Leukemia Who Are Ineligible for Intensive Induction Chemotherapy taiho.co.jp ↗
INQOVI in combination with venetoclax is the first and only all-oral combination treatment regimen approved for this patient population, offering an alternative to parenteral hypomethylating agent–based regimens that require frequent clinic visits. |
| 2026-05-13 | Taiho Oncology, Inc. | Regulatory U.S. FDA Approves INQOVI® in Combination with Venetoclax, the First All-Oral Combination Treatment for Patients with Acute Myeloid Leukemia Who Are Ineligible for Intensive Induction Chemotherapy taihooncology.com ↗
INQOVI in combination with venetoclax is the first and only all-oral combination treatment regimen approved for this patient population, offering an alternative to parenteral hypomethylating agent–based regimens that require frequent clinic visits. |
| 2026-05-12 | Syndax Pharmaceuticals | Results Syndax Highlights 12 Revuforj® (revumenib) Abstracts Accepted for EHA 2026, Advancing Leadership in Menin Inhibition syndax.com ↗
We also look forward to sharing additional frontline and R/R combination data showing high rates of MRD negativity, transplant, and favorable tolerability, supporting physician decision making and our ongoing pivotal trials. |
| 2025-12-08 | Syndax Pharmaceuticals | Results Syndax Highlights Leadership in Menin Inhibition at ASH 2025 with Multiple Revuforj® (revumenib) Presentations Spanning the Acute Leukemia Treatment Continuum syndax.com ↗
Ph 2 SAVE trial of revumenib with venetoclax/HMA in newly diagnosed NPM1m and KMT2Ar AML shows 86% ORR (18/21), 76% CR (16/21), and 100% (18/18) MRD negativity among responders |
| 2025-07-09 | Taiho Oncology, Inc. | Regulatory Taiho Oncology and Taiho Pharmaceutical Announce U.S. FDA Acceptance of Supplemental New Drug Application for INQOVI® in Combination with Venetoclax to Treat Patients with Acute Myeloid Leukemia taihooncology.com ↗ |
| 2025-02-13 | Bio-Path Holdings, Inc. | Results Bio-Path Holdings Provides Key Clinical Updates biopathholdings.com ↗
We are pleased to report that each of these patients remain in complete remission after two years of treatment. |
| 2024-12-16 | Foghorn Therapeutics Inc. | Results Foghorn Therapeutics Provides Update on FHD-286 Clinical Development Program and Strategic Priorities foghorntx.com ↗
In the Phase 1 dose escalation trial of FHD-286 in combination with decitabine in relapsed and/or refractory AML, objective clinical responses were observed by standard response criteria. |
| 2024-12-09 | Taiho Oncology, Inc. | Results Taiho Oncology Data at ASH Annual Meeting Highlight Progress in Oral Therapies for Patients with Blood Cancers taihooncology.com ↗
In addition, results of a real-world study comparing clinical outcomes with INQOVI® (decitabine and cedazuridine) tablets, an oral hypomethylating agent (HMA), versus intravenous (IV) or subcutaneous (SC) decitabine and azacitidine, respectively, were shared in a poster presentation. |
| 2024-12-07 | Syndax Pharmaceuticals | Results Syndax Presents Positive Revuforj® (revumenib) Data in Acute Leukemias from Multiple Trials, Including the SAVE Combination and AUGMENT-101 Trials, at 66th ASH Annual Meeting syndax.com ↗
82% ORR (27 of 33 pts) and 48% CR/CRh (16 of 33 pts) in SAVE trial studying revumenib in combination with venetoclax and decitabine/cedazuridine in R/R AML |
| 2024-11-05 | Syndax Pharmaceuticals | Results Syndax Announces Revumenib Abstracts to Be Presented at the 66th ASH Annual Meeting syndax.com ↗
The most common (>20%) Grade ≥3 TEAEs were febrile neutropenia (46%) and lung infection (42%), while Grade ≥3 TRAEs (any agent) were thrombocytopenia (12%), neutropenia (8%), QT prolongation (8%), and DS (4%). |
| 2024-08-21 | Bio-Path Holdings, Inc. | Results Bio-Path Holdings Reports Solid Tumor Patient Response Supporting BP1001-A’s Compelling Potential as Treatment for Advanced Solid Tumors biopathholdings.com ↗ |
| 2024-06-03 | Bio-Path Holdings, Inc. | Results Bio-Path Holdings Presents Data from Ongoing Phase 2 Combination Study of Prexigebersen for Treatment of Acute Myeloid Leukemia at American Society of Clinical Oncology (ASCO) Annual Meeting biopathholdings.com ↗
Positive Results from Interim Analysis Demonstrate Significant Clinical Improvement and Tolerable Safety Profile for Prexigebersen Combination in High-Risk Patients |
| 2024-05-23 | Bio-Path Holdings, Inc. | Results Bio-Path Holdings to Present Data at American Society of Clinical Oncology (ASCO) Annual Meeting biopathholdings.com ↗
The data show prexigebersen continues to be well -tolerated and has now demonstrated compelling efficacy results in two reporting cohorts including evaluable newly diagnosed AML patients and evaluable refractory/relapsed AML patients, both of which exceeded outcomes with frontline therapy. |
| 2024-01-23 | Taiho Oncology, Inc. | Results Taiho Oncology Announces Publication of Final Results of the Phase 3 ASCERTAIN Clinical Trial of Oral Decitabine and Cedazuridine Fixed Dose Combination (INQOVI®) in Patients With MDS and CMML taihooncology.com ↗
Taiho Oncology, Inc. announces publication of the final results from the pivotal ASCERTAIN clinical trial of fixed-dose oral decitabine and cedazuridine (INQOVI®) compared to intravenous decitabine in adults with intermediate and high-risk myelodysplastic syndromes (MDS) including chronic myelomonocytic leukemia (CMML). |
| 2023-12-11 | Syndax Pharmaceuticals | Results Syndax Announces Positive Data for Revumenib in Patients with Acute Leukemias from the BEAT AML, SAVE AML and AUGMENT-102 Phase 1 Combination Trials syndax.com ↗
78% CRc observed in SAVE AML trial, an all-oral combination of revumenib , venetoclax and decitabine/cedazuridine in R/R mNPM1, NUP98r and KMT2Ar AML |
| 2023-11-02 | Syndax Pharmaceuticals | Results Syndax Announces Updated Data Supporting Impressive Clinical Profile of Revumenib in Genetically-Defined Acute Leukemias to Be Presented at the 65th ASH Annual Meeting syndax.com ↗
Seven of eight patients were response-evaluable, and all seven attained a morphologic remission (overall response rate of 100%). |
| 2023-09-19 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Regulatory Otsuka and Astex announce that the European Commission has approved INAQOVI (oral decitabine and cedazuridine) for the treatment of adults with newly diagnosed acute myeloid leukaemia ® otsuka.co.jp ↗
Otsuka Pharmaceutical Europe Ltd. (Otsuka) and Astex Pharmaceuticals, Inc. (Astex) today announce that the European Commission (EC) has approved INAQOVI (oral decitabine and cedazuridine) as monotherapy for the treatment of adult patients with newly diagnosed acute myeloid leukaemia (AML) who are ineligible for standard induction chemotherapy. |
| 2023-08-01 | Bio-Path Holdings, Inc. | Results Bio-Path Holdings Announces Positive Results from Interim Analysis of Phase 2 Clinical Trial of Prexigebersen in Acute Myeloid Leukemia biopathholdings.com ↗
today reports interim data from Stage 2 of the Company’s Phase 2 study of prexigebersen in combination with decitabine and venetoclax for the treatment of acute myeloid leukemia (AML). |
| 2022-08-22 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Regulatory European Medicines Agency commences review of oral fixed-dosecombination of decitabine and cedazuridine for the treatment ofadults with acute myeloid leukemia otsuka.co.jp ↗
Otsuka Pharmaceutical Europe Ltd. (Otsuka) and Astex Pharmaceuticals, Inc. (Astex) today announce that the European Medicines Agency (EMA) has accepted the Marketing Authorisation Application (MAA) for the oral fixed-dose combination of decitabine and cedazuridine (ASTX727) for the initial treatment of adults with acute myeloid leukaemia (AML) who are not candidates for standard induction chemotherapy. |
| 2021-12-13 | Bio-Path Holdings, Inc. | Results Bio-Path Holdings Presents Data from Ongoing Phase 2 Study of Prexigebersen at 2021 American Society of Hematology Annual Meeting biopathholdings.com ↗
The poster described the safety and preliminary efficacy of Bio-Path’s lead drug candidate, prexigebersen (liposomal Grb2 antisense), from a Phase 2 study in combination with decitabine or decitabine plus venetoclax as a potential treatment for patients diagnosed with AML. |
| 2021-09-23 | Taiho Oncology, Inc. | Results Astex Pharmaceuticals Presents Overall Survival Data From ASCERTAIN Phase 3 Study of Oral Hypomethylating Agent INQOVI® (decitabine and cedazuridine) in MDS and CMML at International Congress on Myelodysplastic Syndromes taihooncology.com ↗
mOS was 31.7 months. |
| 2021-05-25 | Hoffmann-La Roche | Regulatory European Commission approves Venclyxto-based combinations for adults with newly diagnosed acute myeloid leukaemia who are ineligible for intensive chemotherapy roche.com ↗
Basel, 25 May 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the European Commission has approved Venclyxto® (venetoclax) in combination with hypomethylating agents, azacitidine and decitabine, for the treatment of adult patients with newly diagnosed acute myeloid leukaemia (AML) who are ineligible for intensive chemotherapy. |
| 2021-05-25 | AbbVie | Regulatory AbbVie Receives European Commission Approval of VENCLYXTO® (venetoclax) in Combination with a Hypomethylating Agent for Patients with Newly Diagnosed Acute Myeloid Leukemia Who Are Ineligible for Intensive Chemotherapy abbvie.com ↗ |
| 2021-04-23 | AbbVie | Regulatory AbbVie Receives Positive CHMP Opinion for VENCLYXTO® (venetoclax) as a Combination Regimen for Adult Patients with Newly Diagnosed Acute Myeloid Leukemia Who Are Ineligible for Intensive Chemotherapy abbvie.com ↗
AbbVie (NYSE: ABBV) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion for VENCLYXTO® (venetoclax) in combination with hypomethylating agents for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) who are ineligible for intensive chemotherapy. |
| 2021-04-05 | Bio-Path Holdings, Inc. | Results Bio-Path Holdings Announces Successful Completion of Safety Cohort of Triple Combination of Prexigebersen, Decitabine and Venetoclax in Stage 2 of Phase 2 Clinical Trial in Acute Myeloid Leukemia biopathholdings.com ↗
We are also very encouraged by the efficacy signals shown in this dataset, with five of six evaluable relapsed, refractory and newly diagnosed AML patients demonstrating clinical activity. |
| 2020-12-06 | Cardiff Oncology | Results Cardiff Oncology Presents Data at ASH Demonstrating the Safety and Anti-Leukemic Activity of Onvansertib in Patients with Relapsed/Refractory AML cardiffoncology.com ↗
The presentation highlighted the safety, tolerability and anti-leukemic activity of onvansertib in combination with decitabine in patients with difficult-to-treat relapsed/refractory AML. |
| 2020-10-16 | Genentech, Inc. | Regulatory Genentech Announces Full FDA Approval for Venclexta Combinations for Acute Myeloid Leukemia gene.com ↗
Today’s FDA approval converts Venclexta’s accelerated approval in this setting to a full approval. |
| 2020-10-16 | AbbVie | Regulatory VENCLEXTA® (venetoclax) Receives FDA Full Approval for Acute Myeloid Leukemia (AML) abbvie.com ↗ |
| 2020-07-08 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Regulatory Otsuka announces simultaneous regulatory approvals by U.S. FDA and Health Canada of INQOVI, an oral hypomethylating agent (HMA) therapy for MDS and CMML® otsuka.co.jp ↗
INQOVI is the first and only orally administered hypomethylating agent approved in the U.S. and Canada for the treatment of MDS and CMML. |
| 2020-07-07 | Taiho Oncology, Inc. | Regulatory Astex Pharmaceuticals, Taiho Oncology, and Otsuka Pharmaceutical announce FDA and Health Canada approval of INQOVI® (decitabine and cedazuridine) tablets, oral hypomethylating agent (HMA) therapy for intermediate and high-risk MDS and CMML taihooncology.com ↗
Astex Pharmaceuticals, Inc.; Taiho Oncology, Inc.; and Otsuka Pharmaceutical Co., Ltd. today announce that the U.S. Food and Drug Administration (FDA) and Health Canada have approved INQOVI® (decitabine and cedazuridine) tablets. |
| 2020-06-15 | Cardiff Oncology | Results Cardiff Oncology Data Continues to Demonstrate Efficacy, Durability and Safety of Onvansertib in Patients with Difficult-to-Treat Relapsed/Refractory AML cardiffoncology.com ↗
Onvansertib in combination with decitabine continues to be a safe and well-tolerated treatment regimen |
| 2020-02-12 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Regulatory Otsuka announces that subsidiary Astex Pharmaceuticals' NDA for ASTX727 (oral C-DEC), for the treatment of MDS and CMML, has been accepted for priority review by the U.S. FDA otsuka.co.jp ↗ |
| 2020-02-11 | Taiho Oncology, Inc. | Regulatory Astex Pharmaceuticals announces U.S. Food and Drug Administration (FDA) acceptance for review of an NDA for the combination oral hypomethylating agent cedazuridine and decitabine (ASTX727 or oral C-DEC), for the treatment of MDS and CMML taihooncology.com ↗
Astex Pharmaceuticals announces U.S. Food and Drug Administration (FDA) acceptance for review of an NDA for the combination oral hypomethylating agent cedazuridine and decitabine (ASTX727 or oral C-DEC), for the treatment of MDS and CMML |
| 2019-11-26 | Bio-Path Holdings, Inc. | Results BIO-PATH HOLDINGS ANNOUNCES SUCCESSFUL COMPLETION OF SAFETY TESTING IN STAGE 2 OF PHASE 2 CLINICAL TRIAL IN ACUTE MYELOID LEUKEMIA biopathholdings.com ↗
Combination of Prexigebersen and Decitabine Showed Encouraging Safety and Efficacy Results |
| 2019-04-10 | Wockhardt | Regulatory WOCKHARDT RECEIVES US FDA APPROVAL FOR CANCER DRUG wockhardt.com ↗
Pharmaceutical and biotechnology major Wockhardt has received approval from the United States Food & Drug Administration (US FDA) for an ANDA for 50mg injection of Decitabine, which is used to treat certain forms of cancer. |
| 2018-12-04 | Hoffmann-La Roche | Results New Venclexta/Venclyxto data demonstrate deep responses in two of the most common types of leukaemia roche.com ↗
The M14-358 study showed high rates of complete remission (with at least partial blood count recovery, CR+CRh) of 67% for those who received Venclexta/Venclyxto plus azacitidine and 71% for those who received Venclexta/Venclyxto plus decitabine. |
| 2018-12-04 | Lupin Limited | Regulatory Lupin receives FDA approval for Decitabine for Injection, 50 mg/vial, Single-Dose Vial lupin.com ↗
Pharma major Lupin announced that it has received approval for its Decitabine for Injection, 50 mg/vial, Single-Dose Vial from the United States Food and Drug Administration (FDA) to market a generic version of Otsuka Pharmaceutical Co. Ltd.’s (Otsuka) Dacogen for Injection, 50 mg/vial, Single-Dose Vial. |
| 2018-12-03 | Genentech, Inc. | Results New Venclexta® Data Demonstrate Deep Responses in Two of the Most Common Types of Leukemia gene.com ↗
The M14-358 study showed high rates of complete remission (with at least partial blood count recovery, CR+CRh) of 67 percent for those who received Venclexta plus azacitidine and 71 percent for those who received Venclexta plus decitabine. |
| 2018-11-21 | Hoffmann-La Roche | Regulatory Roche announces FDA grants Venclexta accelerated approval for people with newly-diagnosed acute myeloid leukaemia or those who are ineligible for intensive induction chemotherapy roche.com ↗
Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the US Food and Drug Administration (FDA) has granted accelerated approval to Venclexta® (venetoclax), in combination with a hypomethylating agent (azacitidine or decitabine), or low-dose cytarabine (LDAC), for the treatment of people with newly-diagnosed acute myeloid leukaemia (AML), who are age 75 years or older, or for those ineligible for intensive induction chemotherapy due to coexisting medical conditions. |
| 2018-11-21 | Genentech, Inc. | Regulatory Genentech Announces FDA Grants Venclexta Accelerated Approval for People With Newly-Diagnosed Acute Myeloid Leukemia or Those Who Are Ineligible For Intensive Induction Chemotherapy gene.com ↗
Genentech Announces FDA Grants Venclexta Accelerated Approval for People With Newly-Diagnosed Acute Myeloid Leukemia or Those Who Are Ineligible For Intensive Induction Chemotherapy |
| 2018-11-21 | AbbVie | Regulatory AbbVie Receives US FDA Accelerated Approval for VENCLEXTA® (venetoclax) for Treatment of Newly-Diagnosed Acute Myeloid Leukemia Patients Ineligible for Intensive Chemotherapy abbvie.com ↗
AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval to VENCLEXTA ® (venetoclax tablets) in combination with azacitidine, or decitabine, or low-dose cytarabine (LDAC) for the treatment of newly-diagnosed acute myeloid leukemia (AML) in adults who are age 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy. |
| 2016-12-04 | Karyopharm Therapeutics Inc | Results Karyopharm Presents Updated Phase 2 SAIL Relapsed/Refractory AML Clinical Data at the American Society of Hematology 2016 Annual Meeting karyopharm.com ↗
In this study, the combination of selinexor and decitabine produced a CR/CRi/mCR (marrow CR) rate of 80% in older untreated patients and 26.3% in relapsed/refractory AML (RRAML) patients. |
| 2016-11-29 | Astex Pharmaceuticals, Inc. | Results Astex to Showcase Its Next-Generation Hypomethylating Agents Being Developed for Treatment of AML/MDS at the 2016 Annual Meeting of the American Society of Hematology astx.com ↗
Successful Emulation of IV Decitabine Pharmacokinetics with an Oral Fixed-Dose Combination of the Oral Cytidine Deaminase Inhibitor (CDAi) E7727 with Oral Decitabine, in Subjects with Myelodysplastic Syndromes (MDS): Final Data of Phase 1 Study (Abstract #114). |
| 2012-09-28 | Astex Pharmaceuticals, Inc. | Regulatory DACOGEN ® Approved in the European Union for the Treatment of Acute Myeloid Leukemia astx.com ↗ |
| 2012-07-20 | Astex Pharmaceuticals, Inc. | Regulatory DACOGEN ® Receives a Positive Regulatory Recommendation in the European Union for Treatment of Acute Myeloid Leukemia astx.com ↗ |
| 2012-03-07 | Eisai Inc. | Regulatory EISAI RECEIVES COMPLETE RESPONSE LETTER FROM U.S. FDA FOR DNA METHYLATION INHIBITOR DACOGEN® FOR INJECTION sNDA IN ACUTE MYELOID LEUKEMIA eisai.com ↗
FDA declined to approve the application because it said that the primary study (DACO-016) did not provide convincing evidence of the safety and effectiveness of DACOGEN for the proposed AML indication. |
| 2012-03-06 | Astex Pharmaceuticals, Inc. | Regulatory Eisai Inc. Receives Complete Response Letter from the U.S. Food and Drug Administration for Dacogen ® (decitabine) for Injection sNDA in Acute Myeloid Leukemia astx.com ↗
Astex Pharmaceuticals, Inc. (NASDAQ: ASTX) today announced that the U.S. Food and Drug Administration has issued a Complete Response Letter to partner Eisai for their supplemental New Drug Application (sNDA) for Dacogen® (decitabine) for Injection for patients with acute myeloid leukemia (AML) in adults 65 years of age or older who are not considered candidates for induction therapy. |
| 2012-02-09 | Astex Pharmaceuticals, Inc. | Regulatory FDA’s Oncologic Drugs Advisory Committee (ODAC) Votes to not Support Benefit/Risk Profile of DACOGEN ® (decitabine) in Acute Myeloid Leukemia astx.com ↗ |
| 2011-07-14 | Eisai Inc. | Regulatory EISAI ANNOUNCES FDA ACCEPTANCE OF sNDA SUBMISSION FOR DACOGEN® IN ACUTE MYELOID LEUKEMIA eisai.com ↗
Eisai Co., Ltd. (Headquarters: Tokyo, President & CEO: Haruo Naito, “Eisai”) announced today that the U.S. Food and Drug Administration (FDA) has accepted for review its supplemental New Drug Application (sNDA) seeking approval of DACOGEN® (decitabine) for injection in the treatment of acute myeloid leukemia. |
| 2011-07-13 | Astex Pharmaceuticals, Inc. | Regulatory FDA Accepts DACOGEN ® (Decitabine) sNDA Submission in Acute Myeloid Leukemia astx.com ↗ |
| 2011-06-07 | Eisai Inc. | Results PHASE Ⅲ STUDY OF DNA METHYLATION INHIBITOR DACOGEN® FOR INJECTION IN ACUTE MYELOID LEUKEMIA PRESENTED AT ASCO eisai.com ↗
The results of the analysis showed that at the protocol-defined clinical cutoff, with 396 (81.6%) deaths, Dacogen® demonstrated an overall survival advantage but did not demonstrate statistically significant superiority over the control arm. |
| 2011-06-06 | Astex Pharmaceuticals, Inc. | Results Eisai and Janssen Announce the Presentation of DACOGEN ® (decitabine) Data at ASCO from a Phase III Study in Patients with Acute Myeloid Leukemia astx.com ↗
The data demonstrate a clinical improvement in overall survival in older patients with newly diagnosed de novo or secondary acute myeloid leukemia (AML) as defined by the World Health Organization (WHO). |
| 2010-06-30 | Astex Pharmaceuticals, Inc. | Results Dacogen® (Decitabine) for Injection Phase III AML Results Announced astx.com ↗
While Dacogen did not achieve statistically significant superiority over the control arm, a trend was evident. |
| 2010-03-12 | Eisai Inc. | Regulatory FDA Approves Five-Day Dosing Regimen for Dacogen® New Regimen Offers a New Outpatient Dosing Option for Myelodysplastic Syndromes eisai.com ↗
The approval of the new five-day dosing regimen offers patients with MDS and healthcare professionals the flexibility of choosing the appropriate dosing regimen. |
| 2009-07-08 | Eisai Inc. | Regulatory FDA Accepts sNDA for Alternative Dosing of Dacogen® to Treat Patients with Myelodysplastic Syndromes (MDS) eisai.com ↗
Eisai Corporation of North America (Headquarters: New Jersey, Chairman and CEO: Hajime Shimizu), a US subsidiary of Eisai Co., Ltd. (Headquarters: Tokyo, President and CEO: Haruo Naito), announced today that the US Food and Drug Administration (FDA) has accepted for review the Company’s supplemental new drug application (sNDA) for an alternative five-day dosing regimen of Dacogen® (decitabine) for Injection to treat patients with myelodysplastic syndromes (MDS). |
| 2008-07-01 | Eisai Inc. | Results EISAI PROVIDES PRELIMINARY EFFICACY UPDATE ON EORTC PHASE Ⅲ TRIAL OF DACOGEN® VERSUS SUPPORTIVE CARE IN PATIENTS WITH MYELODYSPLASTIC SYNDROMES Submission of Five Day Dosing Regimen sNDA Targeted for Fiscal Year-end 2008 eisai.com ↗
The data did not demonstrate a statistically significant advantage of Dacogen treatment on median survival. |
| 2008-07-01 | Astex Pharmaceuticals, Inc. | Results SuperGen Comments on Preliminary Efficacy Update on EORTC Phase 3 Trial of Dacogen® Versus Supportive Care in Patients With Myelodysplastic Syndromes astx.com ↗
The data did not demonstrate a statistically significant advantage of Dacogen treatment on median survival compared to BSC, the primary endpoint of the study. |
| 2008-03-14 | Astex Pharmaceuticals, Inc. | Results SuperGen’s DNA Methyltransferase Inhibitor, S-110, Improves In Vivo Efficacy Profile of Decitabine astx.com ↗
today announced as part of a series of presentations at the 2008 AACR Annual Meeting that S -110, its DNA methyltransferase inhibitor, improves in vivo efficacy of decitabine (Abstract No. 2613). |
| 2006-05-03 | Astex Pharmaceuticals, Inc. | Regulatory U.S. FDA Approves Dacogen™ (Decitabine) For Injection astx.com ↗
MGI PHARMA, INC. (Nasdaq: MOGN) and SuperGen, Inc. (Nasdaq: SUPG) today announced that the U.S. Food and Drug Administration (FDA) has approved Dacogen ™ (decitabine) for Injection. |
| 2005-12-15 | Astex Pharmaceuticals, Inc. | Regulatory Dacogen™ (Decitabine) Injection Complete Response Accepted for Review by U.S. FDA astx.com ↗ |
| 2005-12-12 | Astex Pharmaceuticals, Inc. | Results Dacogen™ (Decitabine) Injection Data Presented at American Society of Hematology (ASH) Annual Meeting astx.com ↗
Updated results from an alternative dosing study of Dacogen injection in patients with myelodysplastic syndromes (MDS) and initial data from a phase 2 trial of Dacogen injection in elderly acute myeloid leukemia (AML) patients were among the data presented. |
| 2005-11-15 | Astex Pharmaceuticals, Inc. | Regulatory MGI PHARMA and SuperGen Provide Regulatory Status Updates for Dacogen™ (decitabine) Injection for MDS astx.com ↗
MGI PHARMA and SuperGen have submitted their response to the Approvable Letter received for Dacogen injection to the U.S. Food and Drug Administration (FDA). |
| 2005-09-01 | Astex Pharmaceuticals, Inc. | Regulatory Approvable Letter Received from the FDA for Dacogen™ (Decitabine) Injection for the Treatment of MDS astx.com ↗
MGI PHARMA, INC. (Nasdaq:MOGN) and SuperGen, Inc. (Nasdaq:SUPG) today announced they have received an approvable letter from the U.S. Food and Drug Administration (FDA) for Dacogen ™ (decitabine) injection for the treatment of myelodysplastic syndromes (MDS). |
| 2005-01-03 | Astex Pharmaceuticals, Inc. | Regulatory Dacogen™ NDA Accepted for Filing by FDA astx.com ↗
SuperGen, Inc. (Nasdaq: SUPG) and MGI PHARMA, INC. (Nasdaq: MOGN) today announced that the New Drug Application (NDA) for Dacogen ™ (decitabine) for injection was accepted for filing by the United States Food and Drug Administration (FDA). |
| 2004-11-01 | Astex Pharmaceuticals, Inc. | Regulatory SuperGen and MGI PHARMA Announce Submission of Dacogen™ NDA to U.S. FDA astx.com ↗
the full New Drug Application (NDA) seeking approval of Dacogen™ (decitabine) for injection has been submitted to the U.S. Food and Drug Administration (FDA) for its review. |
| 2004-10-25 | Astex Pharmaceuticals, Inc. | Regulatory SuperGen and MGI PHARMA Announce Acceptance of Dacogen™ MAA for Review by EMEA astx.com ↗ |
| 2004-10-01 | Astex Pharmaceuticals, Inc. | Regulatory SuperGen and MGI PHARMA Announce Submission of MAA for Approval of Dacogen™ in Europe astx.com ↗ |
| 2004-07-09 | Astex Pharmaceuticals, Inc. | Results SuperGen Announces Publication of Phase II Studies of Dacogen™ in Advanced MDS Patients astx.com ↗
SuperGen, Inc. (Nasdaq: SUPG) announced publication of results from three consecutive Phase II clinical trials of Dacogen ™ (decitabine) for injection in patients with myelodysplastic syndromes (MDS). |
| 2004-06-09 | Astex Pharmaceuticals, Inc. | Results SuperGen Reports Promising Results from Phase I Study of Dacogen™ and Carboplatin for Treatment of Advanced Solid Tumors astx.com ↗
SuperGen, Inc. (Nasdaq: SUPG) today announced that a Phase I study of Dacogen™ (decitabine) for injection, the company's investigational cancer treatment for myelodysplastic syndromes (MDS), demonstrated positive clinical results in patients with advanced solid tumors. |
| 2004-06-01 | Astex Pharmaceuticals, Inc. | Regulatory SuperGen Submits CMC to FDA as First Component of Rolling New Drug Application for Dacogen™ astx.com ↗ |
| 2004-05-24 | Astex Pharmaceuticals, Inc. | Results SuperGen Provides Additional Analysis of Response Data from Phase III Study of Dacogen in MDS astx.com ↗
The presentation, which included new additional subset analysis of investigators' evaluation of clinical responses, indicated an average patient objective response rate (partial and complete) of 25 percent. |
| 2004-04-22 | Astex Pharmaceuticals, Inc. | Regulatory SuperGen Announces FDA Acceptance of Rolling NDA Request for Dacogen™ astx.com ↗
SuperGen Inc. (Nasdaq: SUPG) announced today that the Food and Drug Administration has granted its request for a rolling NDA submission for Dacogen ™ (decitabine) for injection. |
| 2004-03-31 | Astex Pharmaceuticals, Inc. | Results SuperGen Reports Results from Dacogen™ Phase III Study in Myelodysplastic Syndromes (MDS) astx.com ↗
Patients randomized to the Dacogen arm had an increased time to progression to AML or death (p=0.042 Wilcoxon test, p=0.198 log-rank test), compared to patients randomized to supportive care only. |
| 2004-03-10 | Astex Pharmaceuticals, Inc. | Results SuperGen Releases Interim Data Clarification From Dacogen™ Phase III Clinical Study in Myelodysplastic Syndrome Following Analyst/Investigator Conference Call astx.com ↗ |
| 2004-03-02 | Astex Pharmaceuticals, Inc. | Results Published Study Results Show Low-Dose Outpatient Dosing Schedule of Dacogen™ Useful in Patients With Hematological Malignancies astx.com ↗
SuperGen, Inc. (Nasdaq: SUPG - ) announced today that results from a clinical study of a low-dose outpatient dosing schedule of the investigational anticancer drug Dacogen ™ (decitabine) for injection showed impressive activity in patients with a variety of hematological malignancies. |
| 2004-02-13 | Astex Pharmaceuticals, Inc. | Results SuperGen Announces Interim Data from Dacogen™ Phase III Clinical Study in Myelodysplastic Syndrome astx.com ↗
SuperGen Inc. (Nasdaq: SUPG - ) today announced that it has released and will discuss a preplanned interim analysis of the Dacogen ™ (decitabine for injection) Phase III clinical study in patients with myelodysplastic syndrome (MDS). |
All press releases naming this drug 95 releases
Evidence & citations 16 cited values
Every value below carries the sentence it was read from. 492 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Decitabine | “ABNL MARRO 001 (AM-001) is an Open label, phase 1/2 study within the framework of the ABNL-MARRO that will test novel treatment combinations in MDS/MPN. Each Arm of AM-001 will...” NCT04061421 ↗480“In the control arm, patients received other physician-directed regimen including fludarabine, cytarabine with/without granulocyte stimulating factor(FLA±G) regimen,cytarabine...” NCT02937662 ↗ “Participants will receive standard low-intensity therapy (LIT) regimens for newly diagnosed AML, which may include venetoclax combined with either azacitidine, decitabine, or...” NCT07014462 ↗ “ASTX727 is a combination of two drugs (cedazuridine and decitabine) that have been designed to target cancer cells with a PCR2 mutation and to disrupt the cells' ability to...” NCT04872543 ↗ “Chidamide, decitabine, cytarabine, aclarubicin, and granulocyte colony-stimulating factor (CDCAG) in patients with relapsed/refractory acute myeloid leukemia: a single-arm,...” PMID 32873343 ↗ Sep 2020 “Decitabine (not allowed as a single agent with the exception of patients with documented TP53 mutations who have not previously received 10-day regimens of single agent decitabine)” NCT02665065 ↗ “HMA: Decitabine was administered at 20mg/m2/day for five consecutive days or Ara-C was administered at 75mg/m2/day for seven consecutive days.” NCT03662087 ↗ “All participants will receive ASTX727 orally (cedazuridine 100mg + 35mg decitabine) Days 0-5 prior to receiving Lutathera Day 8 +/- 2days.” NCT05178693 ↗ “A large number of studies have confirmed that demethylated drug decitabine can effectively induce tumor-specific antigen expression.” NCT04672473 ↗ “The choice of HMA agent (e.g. azacitidine or decitabine) will be the HMA the patient has received prior to enrollment on study.” NCT01893372 ↗ “ASTX727 is an oral drug product composed of a fixed-dose combination of cedazuridine (E7727), a CDA inhibitor, and decitabine.” NCT03813186 ↗ |
| Known as | 5-aza-2'-deoxycytidine | “The goal of this clinical research study is to learn if giving 5-aza-2 deoxycytidine (decitabine) in combination with Mylotarg (gemtuzumab ozogamicin) can help to control AML...” NCT00968071 ↗9“Phase I clinical trial of decitabine (5-aza-2'-deoxycytidine) administered by hepatic arterial infusion in patients with unresectable liver-predominant metastases.” PMID 30962963 ↗ Mar 2019 “There are mechanistic reasons to believe that the DNA methyltransferase inhibitor 5-aza-2 -deoxycytidine (decitabine) can more potently increase HbF.” NCT01375608 ↗ “Decitabine (5 aza-2'deoxycytidine), a drug that produces marked DNA hypomethylator, has demonstrated antileukemic activity at low doses.” NCT00075010 ↗ “Inhibition of DNA Methylation by 1-hr Infusion of 5-aza-2'-Deoxycytidine (Decitabine) x 10 Days” NCT00886457 ↗ “5-Aza-2'-deoxycytidine (decitabine; DAC) is a DNA hypomethylating agent” PMID 10694544 ↗ Mar 2000 “decitabine (5-aza-2'deoxycytidine)” NCT00043381 ↗ “decitabine (5-aza-2'deoxycytidine)” NCT00042016 ↗ “decitabine (5-aza-2'deoxycytidine)” NCT00042003 ↗ “decitabine (5-aza-2'deoxycytidine)” NCT00041990 ↗ |
| Known as | 5-aza-2\'deoxycytidine | “The investigators have shown that the DNA methylation inhibitor 5-aza-2\'deoxycytidine (Decitabine), but not 5-azacytidine, induced HIV expression in vitro.” NCT05230368 ↗ |
| Known as | DAC | “A phase I study utilizing decitabine (DAC) followed by the mammalian target of rapamycin (mTOR) inhibitor, rapamycin, in patients with relapsed/refractory adult AML was...” PMID 24138944 ↗ Sep 201322“Decitabine (DAC), one major DNA demethylating agent, has been approved for treatment of preleukemic hematological disease myelodysplastic syndrome (MDS) by the Food and Drug...” NCT02159820 ↗ “Although decitabine (DAC) shows activity against myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML), patient responses are limited, and prognoses remain poor.” PMID 40453133 ↗ Jan 2025 “Approval of decitabine (DAC) in the European Union (EU) in 2012 for the treatment of patients with AML ≥65 years” PMID 26008690 ↗ May 2015 “Decitabine (DAC), a demethylating agent, is known to promote cell differentiation and maturation at low doses.” PMID 25566808 ↗ Jan 2015 “Patients will receive best supportive care (BSC): azacitidine (AZA) and/or decitabine (DAC) are permitted.” NCT02562443 ↗ “Decitabine (DAC) will be administered at 20 mg/m2 intravenously daily for 5 days every 28 days.” NCT02214407 ↗ “We conducted a phase 2 trial of decitabine (DAC) in 39 patients with advanced CMML.” PMID 21828134 ↗ Aug 2011 “5-Aza-2'-deoxycytidine (decitabine; DAC) is a DNA hypomethylating agent” PMID 10694544 ↗ Mar 2000 “Decitabine (DAC) was administered at 20mg/m2/day on days -10 to -8.” NCT07052422 ↗ “Decitabine (DAC): 20mg/m2 intravenous for 1 hour daily (d1 to d5);” NCT05264883 ↗ |
| Known as | Dacogen | “A Study of Decitabine (DACOGEN) in Sequential Administration With Cytarabine in Children With Relapsed or Refractory Acute Myeloid Leukemia” NCT01853228 ↗6“Dacogen™ (decitabine) is a FDA approved drug (NDA - 021790) for the treatment of myelodysplastic syndromes (MDS)” NCT00879385 ↗ “Decitabine (trade name Dacogen®) is a cytidine deoxynucleoside analogue” NCT03080766 ↗ “Decitabine (Dacogen)” NCT01378416 ↗ |
| Known as | DACOGEN (Decitabine) | “DACOGEN (Decitabine)” NCT01876641 ↗1“Dacogen (decitabine)” NCT01011283 ↗ |
| Known as | DEC | “1.2 AZA (DEC) + DLI For patients with TP53 mutations or those who do not respond to VEN, subcutaneous injection of azacitidine at 32 mg/m² per day for 5 consecutive days, with...” NCT06612944 ↗6“The goal of this clinical trial is to learn about the safety and effectiveness of the combination drug Tetrahydrouridine (THU) and decitabine (DEC) to treat patients with...” NCT07006025 ↗ “Decitabine/cedazuridine (DEC/CED) (a nucleoside metabolic inhibitor and cytidine deaminase inhibitor).” NCT06802146 ↗ “Phase II Study on Venetoclax (VEN) Plus Decitabine (DEC) (VEN-DEC) for Elderly” NCT04476199 ↗ “decitabine (Dec) (2.5 mg) and tetrahydrouridine (THU) (125 mg) minitablets” NCT07435636 ↗ “decitabine (DEC), a DNA methyltransferase 1 inhibitor” PMID 41161613 ↗ Oct 2025 “Decitabine (DEC):20mg/m²/day, Day 2-4” NCT07117422 ↗ |
| Known as | decitabine (DAC) | “decitabine (DAC)” NCT01707004 ↗ |
| Known as | Decitabine (Dacogen, 5-aza-2-deoxycytidine) | “Decitabine (Dacogen, 5-aza-2-deoxycytidine)” NCT05362942 ↗ |
| Known as | Decitabine (trade name Dacogen or 5-aza-2'-deoxycytidine/DAC | “Decitabine (trade name Dacogen or 5-aza-2'-deoxycytidine/DAC” NCT01241162 ↗ |
| Known as | Decitabine (trade name Dacogen) | “Decitabine (trade name Dacogen)” NCT03771222 ↗ |
| Known as | VTD-101 | “Self-administration of VTD-101 ointment (Decitabine ointment)” NCT05717621 ↗ |
| Action | Inhibit | “Decitabine is a new drug that blocks DNA methylation.” NCT00398983 ↗ |
| Modality | Small molecule | “the cytosine analog decitabine” PMID 21700776 ↗ Jun 2011 |
| Route | Intravenous | “IV over 4 hours on days -8 and -7” NCT00002831 ↗ |
| Target | DNMT1 | “deplete DNA methyltransferase 1 (DNMT1)” PMID 21700776 ↗ Jun 2011 |