Drugs / Decitabine and Cedazuridine
Decitabine and Cedazuridine
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 2 | NCT05600894 | Jun 2023 → Aug 2026 overdue | chronic myelomonocytic leukemia, myelodysplastic syndrome with excess blasts | National Cancer Institute (NCI) | Active not recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 14
| Date | Issuer | Release |
|---|---|---|
| 2026-06-03 | Taiho Oncology, Inc. | Results Taiho Oncology Announces New England Journal of Medicine Publication of First All-Oral Regimen in Newly Diagnosed Acute Myeloid Leukemia taihooncology.com ↗
Publication highlights positive results for the first all-oral decitabine-cedazuridine plus venetoclax regimen in newly diagnosed acute myeloid leukemia patients who are ineligible for intensive induction chemotherapy. |
| 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 ↗ |
| 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 ↗ |
| 2025-12-08 | Taiho Oncology, Inc. | Results Taiho Oncology Presents Data on All-Oral Regimens Azacitidine and Cedazuridine, and Decitabine and Cedazuridine at the 2025 American Society of Hematology Annual Meeting and Exposition taihooncology.com ↗
A second oral presentation will share findings from the Phase 2 ASTX727-03 trial of low-dose oral decitabine and cedazuridine versus an attenuated course of stand |
| 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 ↗ |
| 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). |
| 2023-12-10 | Taiho Oncology, Inc. | Results Taiho Oncology Announces Presentation of Data From a U.S. Real-World Study of Oral Decitabine and Cedazuridine taihooncology.com ↗
Taiho Oncology, Inc. announced results of a U.S. real-world study of oral decitabine and cedazuridine (DEC-C) in patients with myelodysplastic syndromes (MDS), a rare form of blood cancer. |
| 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 ↗
INAQOVI is the first and only oral hypomethylating agent licensed in the EEA in this patient population. |
| 2022-12-12 | Taiho Oncology, Inc. | Results Taiho Oncology and Astex Pharmaceuticals Present Overall Survival Data for Oral Decitabine and Cedazuridine (INQOVI®, ASTX727) in Patients With MDS and CMML Harboring TP53 Mutations at 64th ASH Annual Meeting taihooncology.com ↗
The median OS (mOS) in patients treated with ASTX727 with biallelic vs. monoallelic mutations was 13.0 months (95% Confidence Interval [CI]: 5.3, 29.1) vs. 29.2 months (95% CI: 19.8, NE). |
| 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. |
| 2021-09-23 | 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. |
| 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. |
| 2020-02-11 | 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 |
All press releases naming this drug 15 releases
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Decitabine and Cedazuridine | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05600894 ↗ |
| Known as | ASTX727 | “ASTX727” NCT05600894 ↗ |
| Known as | C-DEC | “C-DEC” NCT05600894 ↗ |
| Route | Oral | “Given PO” NCT05600894 ↗ |