Drugs / ASTX727

Regulatory milestones approvals, filings & regulatory actions · 1 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Approved US (FDA) INQOVI 2020-07-07 fda.gov

Trials 15 · a red edge is where a trial was stopped

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 15 trials
Phase 1 NCT06357858 Jun 2024 → Feb 2025 head and neck squamous cell carcinoma, metastatic squamous cell carcinoma Case Comprehensive Cancer Center Withdrawn No outcome recorded
Phase 1 NCT06191978 Mar 2024 → Dec 2028 expected acute myeloid leukemia M.D. Anderson Cancer Center Recruiting No outcome recorded
Phase 1 NCT06177171 Feb 2024 → Jan 2028 expected ATM-related cancer predisposition, BRCA1-related cancer predisposition, BRCA2-related cancer predisposition, CHEK2-related cancer predisposition +1 Varun Monga, MBBS Recruiting No outcome recorded
Phase 1 NCT04134884 Apr 2020 → Jan 2024 hormone receptor-positive breast cancer, metastatic malignant neoplasm, triple-negative breast carcinoma Kathy Miller Completed No outcome recorded
Phase 1 NCT02998567 Jan 2017 → Sep 2026 expected non-small cell lung carcinoma Royal Marsden NHS Foundation Trust Active not recruiting No outcome recorded
Phase 1/24 trials
Phase 1/2 NCT07472322 Jul 2026 → May 2031 expected cutaneous neuroendocrine carcinoma University of Wisconsin, Madison Not yet recruiting No outcome recorded
Phase 1/2 NCT06284460 Jan → Dec 2025 myelodysplastic syndrome, myeloproliferative neoplasm M.D. Anderson Cancer Center Withdrawn No outcome recorded
Phase 1/2 NCT06113289 Feb 2024 → Mar 2025 acute myeloid leukemia M.D. Anderson Cancer Center Withdrawn No outcome recorded
Phase 1/2 NCT06091267 Oct 2023 → May 2026 overdue myelodysplastic syndrome Otsuka Beijing Research Institute Active not recruiting No outcome recorded
Phase 25 trials
Phase 2 NCT07710534 Sep 2026 → Sep 2031 expected acute myeloid leukemia, myelodysplastic syndrome Virginia Commonwealth University Not yet recruiting No outcome recorded
Phase 2 NCT06297629 Jul 2024 disease related to hematopoietic stem cell transplant M.D. Anderson Cancer Center Withdrawn No outcome recorded
Phase 2 NCT05201066 Feb 2023 → Feb 2028 expected chronic myelomonocytic leukemia, myelodysplastic syndrome Novartis Pharmaceuticals Active not recruiting No outcome recorded
Phase 2 NCT04857645 Jun 2021 → Apr 2024 acute myeloid leukemia, myelodysplastic syndrome Groupe Francophone des Myelodysplasies Completed No outcome recorded
Phase 2 NCT04093570 Sep 2019 → Dec 2027 expected acute myeloid leukemia, chronic myelomonocytic leukemia, myelodysplastic syndrome Taiho Oncology, Inc. Enrolling by invitation No outcome recorded
Phase 31 trial
Phase 3 NCT03306264 Feb 2018 → Sep 2021 acute myeloid leukemia, chronic myelomonocytic leukemia, myelodysplastic syndrome Astex Pharmaceuticals, Inc. Completed No outcome recorded
Also used as a comparator or background therapy in 3 trials
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 1/22 trials
Phase 1/2 NCT05918055 Background Nov 2023 → Mar 2025 myelodysplastic syndrome National Cancer Institute (NCI) Terminated No outcome recorded
Phase 1/2 NCT05360160 Background Oct 2022 → Dec 2026 expected acute myeloid leukemia M.D. Anderson Cancer Center Recruiting No outcome recorded
Phase 21 trial
Phase 2 NCT04878432 Background Mar 2022 → Oct 2023 myelodysplastic syndrome Novartis Pharmaceuticals Terminated No outcome recorded

Press releases naming this drug 3 releases

DateIssuerRelease
2020-07-08 Otsuka Pharmaceutical Development & Commercialization, Inc. 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
2020-02-12 Otsuka Pharmaceutical Development & Commercialization, Inc. 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
2019-06-07 Otsuka Pharmaceutical Development & Commercialization, Inc. Otsuka and its Subsidiary Astex Pharmaceuticals, Inc. Announce Positive Results from a Phase III Clinical Trial of Anticancer Candidate ASTX727 otsuka.co.jp

Evidence & citations 6 cited values

Every value below carries the sentence it was read from. 18 sources stand behind the page.

FieldValueCited text
Known as ASTX727 “subjects will receive treatment with ASTX727, 1 tablet/day for 5 consecutive days, in 28-day cycles.” NCT06091267
12

NCT04857645

NCT04134884

NCT04093570

NCT06297629

NCT06177171

NCT06191978

NCT07472322

NCT06113289

NCT02998567

NCT05360160

NCT03306264

NCT06284460

Known as DEC-C “Decitabine-cedazuridine (DEC-C) dosage per protocol taken by mouth once weekly” NCT07710534
Known as decitabine-cedazuridine “Inqovi (decitabine-cedazuridine) is an oral formulation of decitabine plus cytidine deaminase inhibitor that was recently Food and Drug Administration (FDA)-approved for MDS,...” NCT05918055
1

NCT07710534

Known as Inqovi ClinicalTrials.gov intervention name — accepted as the source's own label NCT05918055
3

NCT06357858

NCT05201066

NCT04878432

Action Inhibit “(DNMT) inhibitor ASTX727” NCT06177171
Route Oral “ASTX727 (replacement of guadecitabine to an oral dose tablet)” NCT02998567