cedazuridine
Trade name: Inqovi
Small moleculeapprovedOrphan Drug FDA
Approved
Jul 7, 2020
Clinical trial activity
66 trials · 44 clinical orgs · 2 marketing orgs
Phase 1
44
Phase 2
38
Phase 3
3
Phase 4
0
Earliest trial started May 1, 2014 (NCT02103478)
Timeline
2010s
2020s
- Jul 7, 2020
Otsuka — Earliest FDA Approval
- Jul 7, 2020
Otsuka — NDA Secondary Org
- Jul 7, 2020
Otsuka — NDA Organization
- Jul 7, 2020
Taiho Pharmaceutical — NDA Secondary Org
Indications
Approved for
Studied for
- BRCA1 Protein · Phase 1
- Breast Neoplasms · Phase 1
- Carcinoma, Squamous Cell · Phase 1
- Clonal Hematopoiesis · Early Phase 1
- Fusion Proteins, bcr-abl · Phase 2
- Healthy Volunteers · Phase 1
- Hematopoietic Stem Cell Transplantation · Phase 2
- Hodgkin Disease · Phase 1
- Isocitrate Dehydrogenase · Phase 2
- Leukemia · Phase 2
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive · Phase 2/Phase 3
- Leukemia, Myeloid, Acute · Phase 3
- Leukemia, Myeloid, Chronic-Phase · Phase 2
- Leukemia, Myelomonocytic, Chronic · Phase 3
- Lymphoma, Large B-Cell, Diffuse · Phase 1
- Lymphoma, Non-Hodgkin · Phase 1
- Lymphoma, T-Cell · Phase 1/Phase 2
- Mastocytosis · Phase 1
- Melanoma · Phase 1/Phase 2
- Mesothelioma · Phase 2
- Mutation · Phase 2
- Myelodysplastic Syndromes · Phase 3
- Myeloproliferative Disorders · Phase 2
- Neoplasms · Phase 2
- Nerve Sheath Neoplasms · Phase 2
- Neuroendocrine Tumors · Phase 1
- Patient Preference · Phase 3
- Polycythemia Vera · Phase 2
- Primary Myelofibrosis · Phase 2
- Prostatic Neoplasms, Castration-Resistant · Phase 1
- Squamous Cell Carcinoma of Head and Neck · Phase 1
- Thrombocythemia, Essential · Phase 2
- Thrombocytopenia · Early Phase 1
- Triple Negative Breast Neoplasms · Phase 1
Mechanism of action
- Cytidine deaminaseANTAGONIST
CDA antagonist
- Cytidine deaminaseINHIBITOR
Cytidine deaminase inhibitor
Inhibits cytidine deaminase (an enzyme that degrades decitabine) and increases decitabine exposure.
Combination products
inqovi
with decitabine
Also known as decitabine and cedazuridine
Approval history
- approvedPriority reviewJul 7, 2020
Chemistry & pharmacology
Loading structure…
SMILES
O=C1N[C@H](O)CCN1[C@@H]1O[C@H](CO)[C@@H](O)C1(F)F- Mol. weight
- 268.22 g/mol
- Lipinski Ro5
- Pass
- Rule of 3
- No
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Delivery
- Oral
- Availability
- Prescription Only
Oral
Yes
Parenteral
No
Topical
No
Sources
- ChEMBLCHEMBL3237547 ↗
Also known as
- astx727
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT07153497 | Phase 2 | Feb 26, 2026 | National Cancer Institute (NCI) |
| NCT07148947 | Phase 2 | Feb 1, 2026 | Swedish Orphan Biovitrum, University of Washington |
| NCT07012044 | Phase 1 | Oct 31, 2025 | National Cancer Institute (NCI) |
| NCT06802523 | Phase 1 | Apr 30, 2025 | National Cancer Institute (NCI), Yale University |
| NCT06597734 | Phase 2 | Mar 11, 2025 | Rigel Pharmaceuticals, University of Texas at Houston |
| NCT06802146 | Early Phase 1 (Phase 1) | Feb 7, 2025 | Astex Pharmaceuticals, Inc., Breakthrough Cancer Research, Harvard University |
| NCT06672146 | Phase 2 | Feb 3, 2025 | National Cancer Institute (NCI), SWOG Cancer Research Network |
| NCT06661915 | Phase 2 | Jan 31, 2025 | City of Hope National Medical Center, National Cancer Institute (NCI) |
| NCT06284460 | Phase 1/Phase 2 (Phase 2) | Jan 31, 2025 | University of Texas at Houston |
| NCT06577441 | Phase 2 | Jan 17, 2025 | National Cancer Institute (NCI) |
| NCT06484062 | Phase 1 | Dec 6, 2024 | Harvard University, National Cancer Institute (NCI) |
| NCT06297629 | Phase 2 | Jul 1, 2024 | Astex Pharmaceuticals, Inc., University of Texas at Houston |
| NCT06357858 | Phase 1 | Jun 1, 2024 | Case Western Reserve University |
| NCT06113289 | Phase 1/Phase 2 (Phase 2) | Apr 1, 2024 | University of Texas at Houston |
| NCT06177171 | Phase 1 | Apr 1, 2024 | National Cancer Institute (NCI), University of California, San Francisco |
| NCT06327685 | Phase 1 | Mar 13, 2024 | Blueprint Medicines Corporation, University of South Florida |
| NCT06191978 | Phase 1 | Mar 7, 2024 | Astex Pharmaceuticals, Inc., University of Texas at Houston |
| NCT06351306 | Phase 2 | Jan 30, 2024 | Columbia University |
| NCT05960773 | Phase 2 | Jan 3, 2024 | National Cancer Institute (NCI) |
| NCT05799079 | Phase 2 | Dec 31, 2023 | National Comprehensive Cancer Network, Otsuka, Vanderbilt University |
Showing 20 of 66 trials
Page 1 / 4
Organizations
Research & Development (44)
44 organizations
Page 1 / 3
Marketing (3)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Otsuka | For profit | NDA2 | Jul 7, 2020 |
| Otsuka | For profit | NDA | Jul 7, 2020 |
| Taiho Pharmaceutical | For profit | NDA2 | Jul 7, 2020 |