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Details:
Inqovi is a combination of decitabine, a nucleoside metabolic inhibitor, and cedazuridine, a cytidine deaminase inhibitor. It is being evaluated in combination with venetoclax for the treatment of higher-risk myelodysplastic syndromes & chronic myelomonocytic leukemia.
Lead Product(s): Decitabine,Cedazuridine,Venetoclax
Therapeutic Area: Oncology Product Name: Inqovi
Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Genentech
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 22, 2024
Details:
Inaqovi (decitabine and cedazuridine) is an orally administered, fixed-dose combination and inhibitor of cytidine deaminase, which is indicated for newly diagnosed acute myeloid leukaemia.
Lead Product(s): Cedazuridine,Decitabine
Therapeutic Area: Oncology Product Name: Inaqovi
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Astex Pharmaceuticals
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 19, 2023
Details:
ASTX727 is an orally administered, fixed dose combination of the approved anti-cancer DNA hypomethylating agent, decitabine, together with cedazuridine, an inhibitor of cytidine deaminase.
Lead Product(s): Decitabine,Cedazuridine
Therapeutic Area: Oncology Product Name: ASTX727
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Astex Pharmaceuticals
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 22, 2022
Details:
ASCERTAIN - AML clinical study of decitabine and cedazuridine, as a fixed-dose combination (ASTX727), in adult patients with AML not candidates for chemotherapy demonstrated decitabine exposure equivalence of total 5-day dosing between oral ASTX727 and intravenous decitabine.
Lead Product(s): Decitabine,Cedazuridine
Therapeutic Area: Oncology Product Name: ASTX727
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 12, 2022
Details:
Orphan Drug Designation from EC was received on the basis of Phase1 and Phase 2 clinical trial results, for the combination of decitabine and ASTX727 (cedazuridine) for the treatment of Acute Myeloid Leukemia.
Lead Product(s): Decitabine,Cedazuridine
Therapeutic Area: Oncology Product Name: ASTX727
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 06, 2022
Details:
Inqovi is oral fixed-dose combination of anti-cancer Deoxyribonucleic acid hypomethylating agent, decitabine, and cytidine deaminase inhibitor, cedazuridine. Updated efficacy data demonstrated overall response rate of 62%, with 22% of patients achieving complete response.
Lead Product(s): Cedazuridine,Decitabine
Therapeutic Area: Oncology Product Name: Inqovi
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 23, 2021
Details:
ASTX727 is a small molecule DNMT inhibitor currently under Phase III trial. Astex and Recro expand partnership for oral solid dose drug product services.
Lead Product(s): Decitabine,Cedazuridine
Therapeutic Area: Oncology Product Name: ASTX727
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Astex Pharmaceuticals
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Partnership May 18, 2021
Details:
FDA approved hypomethylating agent INQOVI® (decitabine and cedazuridine) 35 mg/100 mg tablets, for oral use, has been included in the latest National Comprehensive Cancer Network® Clinical Practice Guidelines in Oncology for Myelodysplastic Syndromes.
Lead Product(s): Cedazuridine,Decitabine
Therapeutic Area: Oncology Product Name: Inqovi
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Astex Pharmaceuticals
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 23, 2020
Details:
The initial focus will be on evaluating Astex’s oral decitabine and cedazuridine hypomethylating agent (INQOVI®) in combinations with other therapies. MD Anderson and Astex will design new clinical studies to be conducted at MD Anderson.
Lead Product(s): Decitabine,Cedazuridine,Undisclosed
Therapeutic Area: Oncology Product Name: INQOVI
Highest Development Status: UndisclosedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Astex Pharmaceuticals
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Collaboration September 08, 2020
Details:
The National Comprehensive Cancer Network® (NCCN®) Oncology Research Program (ORP) plans to develop a program to scientifically evaluate and facilitate clinical trials on the efficacy of decitabine and cedazuridine. Studies will be funded by Taiho Oncology.
Lead Product(s): Decitabine,Cedazuridine
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: UndisclosedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Taiho Oncology
Deal Size: $2.0 million Upfront Cash: Undisclosed
Deal Type: Collaboration September 01, 2020
Details:
INQOVI is the first and only orally administered hypomethylating agent approved in the U.S. and Canada for the treatment of MDS and CMML.
Lead Product(s): Cedazuridine,Decitabine
Therapeutic Area: Oncology Product Name: Inqovi
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 08, 2020
Details:
NDA is supported by data from the phase 3 ASCERTAIN study of oral C-DEC in adults with intermediate- and high-risk myelodysplastic syndromes (MDS) including chronic myelomonocytic leukemia.
Lead Product(s): Cedazuridine,Decitabine
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 11, 2020
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