Drugs / Cedazuridine
Cedazuridine
also known as
E7727 · CED · Cedazuridina · cedazuridine (E7727) · CEDAZURIDINE COMPONENT OF ASTX-727 · Cedazuridine component of inqovi
Small molecule targets CDA via inhibition
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| 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” taihooncology.com ↗ |
| Approved Indication not stated 2 milestones | |||||
| Approved | EU (EMA) | Inaqovi | — | 2023-09-15 | europa.eu ↗ |
| Approved | US (FDA) | INQOVI | — | 2020-07-07 | fda.gov ↗ |
Trials 42
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT06802146 | Feb 2025 → Dec 2026 expected | clonal hematopoiesis of indeterminate potential | Lachelle D. Weeks, MD, PhD | Recruiting | No outcome recorded |
| Phase 119 trials | ||||||
| Phase 1 | NCT06802523 | Apr 2026 → Dec 2028 | acute myeloid leukemia | National Cancer Institute (NCI) | Suspended | No outcome recorded |
| Phase 1 | NCT06484062 | Aug 2025 → Jun 2028 expected | acute myeloid leukemia, myelodysplastic syndrome | National Cancer Institute (NCI) | Recruiting | No outcome recorded |
| Phase 1 | NCT05673200 | Sep 2023 → Feb 2027 | female breast carcinoma, triple-negative breast carcinoma | National Cancer Institute (NCI) | Suspended | No outcome recorded |
| Phase 1 | NCT05403450 | Feb 2023 → Dec 2024 | peripheral T-cell lymphoma, not otherwise specified | Taiho Oncology, Inc. | Terminated | No outcome recorded |
| Phase 1 | NCT04953910 | Dec 2022 → Dec 2026 expected | acute myeloid leukemia, myelodysplastic syndrome | Taiho Oncology, Inc. | Recruiting | No outcome recorded |
| Phase 1 | NCT05272384 | Nov 2022 → Jun 2027 expected | Hodgkins lymphoma, diffuse large B-cell lymphoma | National Cancer Institute (NCI) | Recruiting | No outcome recorded |
| Phase 1 | NCT05396859 | Oct 2022 → Jun 2024 overdue | acute myeloid leukemia | OHSU Knight Cancer Institute | Active not recruiting | No outcome recorded |
| Phase 1 | NCT05178693 | Apr 2022 → Jun 2026 overdue | neuroendocrine neoplasm | Imperial College London | Recruiting | No outcome recorded |
| Phase 1 | NCT05037500 | Jan 2022 → Dec 2024 | castration-resistant prostate carcinoma | Roswell Park Cancer Institute | Terminated | No outcome recorded |
| Phase 1 | NCT04953897 | Dec 2021 → Dec 2026 expected | acute myeloid leukemia, myelodysplastic syndrome | Taiho Oncology, Inc. | Recruiting | No outcome recorded |
| Phase 1 | NCT05010772 | Oct 2021 → Dec 2026 expected | acute myeloid leukemia | M.D. Anderson Cancer Center | Recruiting | No outcome recorded |
| Phase 1 | NCT04980404 | Sep 2021 → Aug 2023 overdue | chronic myelomonocytic leukemia, myelodysplastic syndrome | Massachusetts General Hospital | Active not recruiting | No outcome recorded |
| Phase 1 | NCT04953923 | Jul → Nov 2021 | — | Astex Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT04608110 | Oct 2020 → Dec 2025 overdue | myelodysplastic syndrome | Taiho Pharmaceutical Co., Ltd. | Recruiting | No outcome recorded |
| Phase 1 | NCT04155580 | Jun 2020 → Jan 2022 | acute myeloid leukemia | Astex Pharmaceuticals, Inc. | Terminated | No outcome recorded |
| Phase 1 | NCT03875287 | Apr 2019 → Mar 2027 expected | cancer | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Active not recruiting | No outcome recorded |
| Phase 1 | NCT03906695 | Mar 2019 → Jan 2026 overdue | myelodysplastic syndrome | Otsuka Pharmaceutical Co., Ltd. | Active not recruiting | No outcome recorded |
| Phase 1 | NCT03813186 | Nov 2018 → Jun 2019 | acute myeloid leukemia, chronic myelomonocytic leukemia, myelodysplastic syndrome | Astex Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT03613532 | Oct 2018 → May 2026 overdue | acute myeloid leukemia, chronic myelomonocytic leukemia, disease related to hematopoietic stem cell transplant, myelodysplastic syndrome +1 | Jacqueline Garcia, MD | Active not recruiting | No outcome recorded |
| Phase 1/28 trials | ||||||
| Phase 1/2 | NCT05089370 | Jun 2022 → Aug 2026 overdue | melanoma | University of Colorado, Denver | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT04742634 | May 2022 → Nov 2033 expected | myelodysplastic syndrome | Washington University School of Medicine | Recruiting | No outcome recorded |
| Phase 1/2 | NCT04817241 | Feb 2022 → Jun 2025 overdue | acute myeloid leukemia | National Cancer Institute (NCI) | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT05010122 | Jul 2021 → Jan 2028 expected | acute myeloid leukemia, myelodysplastic syndrome | M.D. Anderson Cancer Center | Recruiting | No outcome recorded |
| Phase 1/2 | NCT04774393 | May 2021 → Nov 2027 expected | acute myeloid leukemia | M.D. Anderson Cancer Center | Recruiting | No outcome recorded |
| Phase 1/2 | NCT04013880 | Aug 2019 → Mar 2021 | acute myeloid leukemia, myelodysplastic syndrome | Vanderbilt-Ingram Cancer Center | Withdrawn | No outcome recorded Stop: Business |
| Phase 1/2 | NCT03502668 | Jul 2018 → Jan 2026 | myelodysplastic syndrome | Taiho Oncology, Inc. | Completed | No outcome recorded |
| Phase 1/2 | NCT02103478 | Oct 2014 → Jun 2018 | myelodysplastic syndrome | Astex Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 213 trials | ||||||
| Phase 2 | NCT07867626 | Sep 2026 → Jun 2028 expected | acute myeloid leukemia | Rutgers, The State University of New Jersey | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07507760 | Jun 2026 → Apr 2029 expected | acute myeloid leukemia | PETHEMA Foundation | Recruiting | No outcome recorded |
| Phase 2 | NCT06661915 | Aug 2025 → Dec 2027 expected | acquired polycythemia vera, essential thrombocythemia, leukemia, myeloid, accelerated-phase, myelodysplastic/myeloproliferative neoplasm +3 | National Cancer Institute (NCI) | Recruiting | No outcome recorded |
| Phase 2 | NCT06577441 | Jun 2025 → Mar 2027 expected | myelodysplastic syndrome | National Cancer Institute (NCI) | Recruiting | No outcome recorded |
| Phase 2 | NCT06351306 | Apr 2024 | acute myeloid leukemia | Columbia University | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT05960773 | Jan 2024 → Jul 2028 expected | BAP1-related tumor predisposition syndrome, malignant mesothelioma | National Cancer Institute (NCI) | Recruiting | No outcome recorded |
| Phase 2 | NCT05835011 | Jun → Aug 2023 | myelodysplastic syndrome | Astex Pharmaceuticals, Inc. | Terminated | No outcome recorded |
| Phase 2 | NCT05799079 | Apr 2023 → Sep 2024 | acute myeloid leukemia | Sanjay Mohan | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT05007873 | Oct 2021 → Oct 2028 expected | Philadelphia-positive myelogenous leukemia, chronic myeloid leukemia | M.D. Anderson Cancer Center | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04985656 | Oct 2021 → Jan 2024 | myelodysplastic syndrome | Takeda | Withdrawn | No outcome recorded Stop: Business |
| Phase 2 | NCT04975919 | Sep 2021 → May 2027 expected | mixed phenotype acute leukemia | M.D. Anderson Cancer Center | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04872543 | Apr 2021 → Apr 2027 expected | malignant peripheral nerve sheath tumor | Memorial Sloan Kettering Cancer Center | Recruiting | No outcome recorded |
| Phase 2 | NCT04746235 | Feb 2021 → Oct 2028 expected | acute myeloid leukemia | M.D. Anderson Cancer Center | Active not recruiting | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT04256317 | May 2020 → Nov 2027 expected | acute myeloid leukemia, chronic myelomonocytic leukemia, myelodysplastic syndrome | Taiho Oncology, Inc. | Recruiting | No outcome recorded |
| Comparator or background therapy10 trials | ||||||
| Phase 1 | NCT05456269 Background | Jul 2022 → Aug 2023 | acute myeloid leukemia, chronic myelomonocytic leukemia, myelodysplastic syndrome | Racura Oncology Ltd | Withdrawn | No outcome recorded |
| Phase 1 | NCT03922555 Background | Jul 2019 → Jan 2027 expected | nervous system cancer | Massachusetts General Hospital | Recruiting | No outcome recorded |
| Phase 1/2 | NCT05148234 Background | Nov 2022 → Feb 2023 | myelodysplastic syndrome | National Cancer Institute (NCI) | Terminated | No outcome recorded |
| Phase 1/2 | NCT04061421 Background | Nov 2021 → Aug 2027 expected | myelodysplastic/myeloproliferative neoplasm | Michael Savona | Recruiting | No outcome recorded |
| Phase 1/2 | NCT04655755 Background | Jan 2021 → Jul 2028 expected | chronic myelomonocytic leukemia, myelodysplastic syndrome | M.D. Anderson Cancer Center | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT02649790 Background | Jan 2016 → Aug 2024 | acute myeloid leukemia, castration-resistant prostate carcinoma, colorectal cancer, myelodysplastic syndrome +1 | Karyopharm Therapeutics Inc | Completed | No outcome recorded |
| Phase 2 | NCT07437950 Background | Sep 2026 → Sep 2034 expected | acute myeloid leukemia | National Cancer Institute (NCI) | Recruiting | No outcome recorded |
| Phase 2 | NCT07148947 Background | Mar 2026 → Dec 2028 expected | myeloproliferative neoplasm | University of Washington | Recruiting | No outcome recorded |
| Phase 2 | NCT06672146 Background | May 2025 → Mar 2027 expected | acute myeloid leukemia | National Cancer Institute (NCI) | Recruiting | No outcome recorded |
| Phase 3 | NCT05883956 Comparator | Dec 2023 → Dec 2024 overdue | acute myeloid leukemia, chronic myelomonocytic leukemia, myelodysplastic syndrome | Otsuka Australia Pharmaceutical Pty Ltd | Active not recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 15
| Date | Issuer | Release |
|---|---|---|
| 2026-10-01 | Taiho Oncology, Inc. | Results Taiho Pharmaceutical and Taiho Oncology Announce Positive Topline Results in Phase 3 AZTOUND Trial Evaluating Oral Azacitidine and Cedazuridine in Myelodysplastic Syndromes or Chronic Myelomonocytic Leukemia taiho.co.jp ↗
The safety profile was consistent with parenteral azacitidine. |
| 2026-09-30 | Taiho Oncology, Inc. | Results Taiho Oncology and Taiho Pharmaceutical Announce Positive Topline Results in Phase 3 AZTOUND Trial Evaluating Oral Azacitidine and Cedazuridine in Myelodysplastic Syndromes or Chronic Myelomonocytic Leukemia taihooncology.com ↗
The study met its primary endpoint of total cycle area under the curve (AUC) from 0 to 24 hours (AUC0-24) exposures, measured as the ratio of azacitidine total cycle AUC0-24 exposures following oral azacitidine and cedazuridine compared with subcutaneous azacitidine. |
| 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. |
| 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 ↗ |
| 2024-12-09 | 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. |
| 2024-01-23 | 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). |
| 2023-09-19 | 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. |
| 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. |
| 2020-07-08 | 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. |
| 2020-02-12 | 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 |
| 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). |
All press releases naming this drug 22 releases
Evidence & citations 11 cited values
Every value below carries the sentence it was read from. 54 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Cedazuridine | “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 ↗50“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 ↗ “simultaneous oral administration with the novel CDA inhibitor cedazuridine increases decitabine bioavailability for the treatment of myelodysplastic syndromes.” PMID 30926081 ↗ Apr 2019 “All participants will receive ASTX727 orally (cedazuridine 100mg + 35mg decitabine) Days 0-5 prior to receiving Lutathera Day 8 +/- 2days.” NCT05178693 ↗ “ASTX727 is an oral drug product composed of a fixed-dose combination of cedazuridine (E7727), a CDA inhibitor, and decitabine.” NCT03813186 ↗ “This research study involves the study drug Inqovi, which is a combination of the drugs decitabine and cedazuridine.” NCT04980404 ↗ “35 mg decitabine/100 mg cedazuridine taken by mouth once daily on Days 1, 2, 3 of a 28 day cycle.” NCT04742634 ↗ “Multiple-dose oral administration of once-daily decitabine (35 mg) and cedazuridine (100 mg)” NCT04953910 ↗ “Multiple-dose oral administration of once-daily decitabine (35 mg) and cedazuridine (100 mg)” NCT04953897 ↗ “ASTX727 is a combination drug of 35 mg decitabine and 100 mg cedazuridine.” NCT02649790 ↗ “ASTX727 is made up of the 2 study drugs cedazuridine and decitabine.” NCT03922555 ↗ |
| Known as | CED | “Decitabine/cedazuridine (DEC/CED) (a nucleoside metabolic inhibitor and cytidine deaminase inhibitor).” NCT06802146 ↗ |
| Known as | Cedazuridina | ChEMBL registry synonym — accepted as the source's own label CHEMBL3237547 ↗ |
| Known as | cedazuridine (E7727) | “cedazuridine (E7727)” NCT02103478 ↗ |
| Known as | CEDAZURIDINE COMPONENT OF ASTX-727 | ChEMBL registry synonym — accepted as the source's own label CHEMBL3237547 ↗ |
| Known as | Cedazuridine component of inqovi | ChEMBL registry synonym — accepted as the source's own label CHEMBL3237547 ↗ |
| Known as | E7727 | “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 ↗3“ASTX727 is an oral drug product composed of a fixed-dose combination of cedazuridine (E7727), a CDA inhibitor, and decitabine.” NCT03813186 ↗ “oral decitabine (LD) + cedazuridine (E7727)” NCT03502668 ↗ |
| Action | Inhibit | “simultaneous oral administration with the novel CDA inhibitor cedazuridine increases decitabine bioavailability” PMID 30926081 ↗ Apr 2019 |
| Modality | Small molecule | — CHEMBL3237547 ↗ |
| Route | Oral | “Participants in Part 3 of the study will also have the opportunity to receive venetoclax plus oral decitabine/cedazuridine after transplantation.” NCT03613532 ↗ |
| Target | CDA | “simultaneous oral administration with the novel CDA inhibitor cedazuridine increases decitabine bioavailability” PMID 30926081 ↗ Apr 2019 |