Cedazuridine
Small molecule targets CDA via inhibition
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Inaqovi | — | 2023-09-15 | europa.eu ↗ |
| Approved | US (FDA) | INQOVI | — | 2020-07-07 | fda.gov ↗ |
Trials 43 · a red edge is where a trial was stopped
Also used as a comparator or background therapy in 9 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 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→ Aug 2023 | acute myeloid leukemia, chronic myelomonocytic leukemia, myelodysplastic syndrome | Racura Oncology Ltd | Withdrawn | No outcome recorded |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 1/24 trials | ||||||
| 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 22 trials | ||||||
| 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 31 trial | ||||||
| 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 |
Press releases naming this drug 2 releases
| Date | Issuer | Release |
|---|---|---|
| 2023-09-19 | Otsuka Pharmaceutical Development & Commercialization, Inc. | 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 ↗ |
| 2022-08-22 | Otsuka Pharmaceutical Development & Commercialization, Inc. | European Medicines Agency commences review of oral fixed-dosecombination of decitabine and cedazuridine for the treatment ofadults with acute myeloid leukemia otsuka.co.jp ↗ |
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)” NCT04953897 ↗ “Multiple-dose oral administration of once-daily decitabine (35 mg) and cedazuridine (100 mg)” NCT04953910 ↗ “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 ↗ “Drug: Cedazuridine Tablets for oral administration” NCT04608110 ↗ “oral decitabine (LD) + cedazuridine (E7727)” NCT03502668 ↗ “oral decitabine 5mg + cedazuridine” NCT03906695 ↗ “Decitabine and Cedazuridine” NCT06802146 ↗ “cedazuridine + decitabine” NCT04155580 ↗ |
| 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 |