Cedazuridine

Generic Name: Cedazuridine

Brand Names: Inqovi 5 Tablet Pack

Drug Type: Small Molecule

Chemical Formula: C_₉H_₁₄F_₂N_₂O_₅

CAS Number: 1141397-80-9

Unique Ingredient Identifier: 39IS23Q1EW

Background: Myelodysplastic syndromes (MDS) are a group of hematopoietic neoplasms that give rise to variable cytopenias progressing to secondary acute myeloid leukemia (sAML), which is invariably fatal if untreated. Hypomethylating agents such as decitabine and azacitidine are used to treat MDS through inducing DNA hypomethylation and apoptosis of cancerous cells. Although effective, these compounds are rapidly metabolized by cytidine deaminase (CDA) prior to reaching systemic circulation when administered orally, necessitating intramuscular or intravenous administration routes. Cedazuridine is a fluorinated tetrahydrouridine derivative specifically designed to inhibit CDA and facilitate oral administration of hypomethylating agents.

Cedazuridine was first reported in 2014, and was subsequently approved by the FDA on July 7, 2020, in combination with decitabine for sale by Astex Pharmaceuticals Inc under the name INQOVI®.

Indication: Cedazuridine, in combination with decitabine, is indicated for the treatment of myelodysplastic syndromes (MDS), including MDS with refractory anemia, MDS with refractory anemia and ringed sideroblasts, MDS with refractory anemia and excess blasts, MDS scoring intermediate-1, intermediate-2, or high-risk on the International Prognostic Scoring System (IPSS), and chronic myelomonocytic leukemia (CMML).

Associated Conditions: Chronic Myelomonocytic Leukemia, Myelodysplastic Syndrome

Clinical Trials

A Study of Pevonedistat Combined With Decitabine and Cedazuridine in Adults With Higher-risk Myelodysplastic Syndromes

Phase 2

Withdrawn

Conditions: Myelodysplastic Syndromes (MDS)

Interventions: Drug: Pevonedistat
Drug: Decitabine
Drug: Cedazuridine

First Posted Date: 2021-08-02

Last Posted Date: 2021-09-29

Lead Sponsor: Takeda

Registration Number: NCT04985656

Inqovi Maintenance Therapy in Myeloid Neoplasms

Phase 1

Recruiting

Conditions: Chronic Myelomonocytic Leukemia
Myelodysplastic Syndromes
Stem Cell Leukemia

Interventions: Drug: Inqovi

First Posted Date: 2021-07-28

Last Posted Date: 2024-03-08

Lead Sponsor: Massachusetts General Hospital

Target Recruit Count: 22

Registration Number: NCT04980404

Locations: 🇺🇸
Massachusetts General Hospital, Boston, Massachusetts, United States

Study to Evaluate the Pharmacokinetics and Safety of Oral Decitabine and Cedazuridine in Cancer Patients With Hepatic Impairment

Phase 1

Recruiting

Conditions: Acute Myeloid Leukemia
Myelodysplastic Syndromes

Interventions: Drug: ASTX727

First Posted Date: 2021-07-08

Last Posted Date: 2025-04-02

Lead Sponsor: Taiho Oncology, Inc.

Target Recruit Count: 27

Registration Number: NCT04953910

Locations: 🇺🇸
MD Anderson, Houston, Texas, United States
🇦🇲
Erebuni Medical Center, Yerevan, Armenia
🇦🇲
Hematology Center After Prof. R. Yeolyan (Adult Blood Disorders), Yerevan, Armenia

and more 15 locations

Study to Evaluate the Pharmacokinetics and Safety of Oral Decitabine and Cedazuridine in Cancer Patients With Renal Impairment

Phase 1

Recruiting

Conditions: Acute Myeloid Leukemia
Myelodysplastic Syndromes

Interventions: Drug: ASTX727

First Posted Date: 2021-07-08

Last Posted Date: 2025-04-02

Lead Sponsor: Taiho Oncology, Inc.

Target Recruit Count: 18

Registration Number: NCT04953897

Locations: 🇺🇸
MD Anderson, Houston, Texas, United States
🇦🇲
Erebuni Medical Center, Yerevan, Armenia
🇷🇴
Institutul Oncologic Prof. Dr. Ion Chiricuta, Cluj-Napoca, Romania

and more 14 locations

Thorough QT Assessment of Cedazuridine in Healthy Subjects

Phase 1

Completed

Conditions: Healthy Volunteers

Interventions: Drug: Cedazuridine
Drug: Placebo
Drug: Moxifloxacin

First Posted Date: 2021-07-08

Last Posted Date: 2024-08-02

Lead Sponsor: Astex Pharmaceuticals, Inc.

Target Recruit Count: 36

Registration Number: NCT04953923

Locations: 🇳🇱
PRA Health Sciences, Groningen, Netherlands

A Study of ASTX727 in People With Malignant Peripheral Nerve Sheath Tumors (MPNST)

Phase 2

Recruiting

Conditions: Malignant Peripheral Nerve Sheath Tumors (MPNST)

Interventions: Drug: ASTX727

First Posted Date: 2021-05-04

Last Posted Date: 2025-01-08

Lead Sponsor: Memorial Sloan Kettering Cancer Center

Target Recruit Count: 25

Registration Number: NCT04872543

Locations: 🇺🇸
Memorial Sloan Kettering Monmouth (Limited Protocol Activities), Middletown, New Jersey, United States
🇺🇸
Memorial Sloan Kettering Bergen (Limited Protocol Activities), Montvale, New Jersey, United States
🇺🇸
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities), Basking Ridge, New Jersey, United States

and more 4 locations

ASTX727 and Donor Lymphocyte Infusions After Allogenic Stem Cell Transplantation in Very High Risk MDS or AML Patients

Phase 2

Completed

Conditions: MDS
AML

Interventions: Drug: ASTX727
Other: Donor Lymphocyte Infusions

First Posted Date: 2021-04-23

Last Posted Date: 2025-05-14

Lead Sponsor: Groupe Francophone des Myelodysplasies

Target Recruit Count: 57

Registration Number: NCT04857645

Locations: 🇫🇷
CHU d'Angers - Service des maladies du sang, Angers, France
🇫🇷
CHU de Grenoble - Clinique Universitaire d'hématologie, Grenoble, France
🇫🇷
CHU d'Amiens Picardie - Site sud - Service hématologie clinique et thérapie cellulaire, Amiens, France

and more 9 locations

A Study of ASTX030 (Cedazuridine in Combination With Azacitidine) in MDS, CMML, or AML

Phase 2

Recruiting

Conditions: Acute Myeloid Leukemia
Myelodysplastic Syndromes
Myelodysplastic Syndrome/Neoplasm
Chronic Myelomonocytic Leukemia

Interventions: Drug: Azacitidine
Drug: ASTX030 (cedazuridine + azacitidine)
Drug: Cedazuridine

First Posted Date: 2020-02-05

Last Posted Date: 2025-05-02

Lead Sponsor: Taiho Oncology, Inc.

Target Recruit Count: 235

Registration Number: NCT04256317

Locations: 🇺🇸
Keck School of Medicine of USC, Los Angeles, California, United States
🇺🇸
UCI Health - Chao Family Comprehensive Cancer Center, Orange, California, United States
🇺🇸
Yale University, New Haven, Connecticut, United States

and more 21 locations

A Study of ASTX660 as a Single Agent and in Combination With ASTX727 in Subjects With Relapsed/Refractory Acute Myeloid Leukemia (AML)

Phase 1

Terminated

Conditions: Acute Myeloid Leukemia

Interventions: Drug: ASTX660
Drug: ASTX727

First Posted Date: 2019-11-07

Last Posted Date: 2024-08-02

Lead Sponsor: Astex Pharmaceuticals, Inc.

Target Recruit Count: 68

Registration Number: NCT04155580

Locations: 🇺🇸
The University of Chicago Medical Center, Chicago, Illinois, United States
🇺🇸
Franciscan Health Indianapolis (Blood and Marrow Transplantation), Indianapolis, Indiana, United States
🇺🇸
Ohio State University Comprehensive Cancer Center, Columbus, Ohio, United States

and more 12 locations

Study of ASTX727 Plus Talazoparib in Patients With Triple Negative or Hormone Resistant/HER2-negative Metastatic Breast Cancer

Phase 1

Completed

Conditions: Metastatic Breast Cancer
Hormone Receptor Positive Tumor
Triple Negative Breast Cancer

Interventions: Drug: Talazoparib
Drug: ASTX727

First Posted Date: 2019-10-22

Last Posted Date: 2024-03-22

Lead Sponsor: Kathy Miller

Target Recruit Count: 34

Registration Number: NCT04134884

Locations: 🇺🇸
Wake Forest Baptist Comprehensive Cancer Center, Winston-Salem, North Carolina, United States
🇺🇸
Indiana University Melvin & Bren Simon Cancer Center, Indianapolis, Indiana, United States

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