Drugs / INQOVI

Regulatory milestones approvals, filings & regulatory actions · 1 recorded

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

Trials 2

20212022202320242025202620272028
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 11 trial
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→ Feb 2025 head and neck squamous cell carcinoma, metastatic squamous cell carcinoma Case Comprehensive Cancer Center Withdrawn No outcome recorded Stop: Business
Phase 21 trial
Phase 2 NCT05201066 Feb 2023 → Feb 2028 expected chronic myelomonocytic leukemia, myelodysplastic syndrome Novartis Pharmaceuticals Active not recruiting No outcome recorded
Comparator or background therapy2 trials
Phase 1/2 NCT05918055 Background Nov 2023 → Mar 2025 myelodysplastic syndrome National Cancer Institute (NCI) Terminated No outcome recorded
Phase 2 NCT04878432 Background Mar 2022 → Oct 2023 myelodysplastic syndrome Novartis Pharmaceuticals Terminated No outcome recorded

Evidence & citations 3 cited values

Every value below carries the sentence it was read from. 4 sources stand behind the page.

FieldValueCited text
Known as INQOVI ClinicalTrials.gov intervention name — accepted as the source's own label NCT06357858 ↗
3

NCT04878432 ↗

NCT05201066 ↗

NCT05918055 ↗

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 ↗
Route Oral “Tablet for oral administration” NCT04878432 ↗