X
API Suppliers
US DMFs Filed
CEP/COS Certifications
0
JDMFs Filed
0
Other Certificates
Other Suppliers
USA (Orange Book)
Europe
Canada
Australia
0
South Africa
Uploaded Dossiers
U.S. Medicaid
Annual Reports
0
Details:
The trial is expected to provide further clinical proof-of-concept of Kiadis’ K-NK003 product.
Lead Product(s): K-NK003,Cytarabine,Decitabine
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: Phase IProduct Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 26, 2020
Iran Expo
Not Confirmed
Contact SupplierDetails:
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:
BP1002 is a Bcl-2 inhibitor that targets the BH3 domain of the Bcl-2 protein. It is being evaluated in combination with decitabine for the treatment of refractory/relapsed acute myeloid leukemia.
Lead Product(s): BP1002,Decitabine
Therapeutic Area: Oncology Product Name: BP1002
Highest Development Status: Phase IProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 14, 2023
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:
BP1001 (prexigebersen) is a neutral liposome incorporated with nuclease-resistant, hydrophobic P-ethoxy antisense oligodeoxynucleotides targeted to Grb2 mRNA, which is investigated for the treatment of acute myeloid leukemia.
Lead Product(s): Prexigebersen,Decitabine,Ventoclax
Therapeutic Area: Oncology Product Name: BP1001
Highest Development Status: Phase IIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 01, 2023
Details:
BP1002 targets the protein Bcl-2, which is responsible for driving cell survival in up to 60% of all cancers. By targeting Bcl-2 at the mRNA level rather than the protein, BP1002 may overcome and prevent some of the mechanisms of resistance that affect venetoclax treatment.
Lead Product(s): BP1002,Decitabine
Therapeutic Area: Oncology Product Name: BP1002
Highest Development Status: Phase IProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 24, 2022
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:
United States Patent and Trademark Office has granted U.S. Patent titled, "P-ethoxy nucleic acids for liposomal formulation." The new patent builds on earlier patents granted that protect the platform technology for DNAbilize®, the Company’s novel RNAi nanoparticle drugs.
Lead Product(s): Prexigebersen,Decitabine
Therapeutic Area: Oncology Product Name: BP1001
Highest Development Status: Phase IIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 10, 2021
Details:
The presentation highlighted the safety, tolerability and anti-leukemic activity of onvansertib in combination with decitabine in patients with difficult-to-treat relapsed/refractory AML.
Lead Product(s): Onvansertib,Decitabine
Therapeutic Area: Oncology Product Name: PCM-075
Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 06, 2020
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:
Study aims to determine the safety and maximum tolerated dose of dubermatinib in combination with decitabine and evaluate the composite complete response rate.
Lead Product(s): Dubermatinib,Decitabine
Therapeutic Area: Oncology Product Name: TP-0903
Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 23, 2020
Details:
The U.S Patent and Trademark Office has issued a notice of allowance for claims related to the Company’s lead product candidate, prexigebersen, in combination with either a cytidine analogue, like decitabine, or the Bcr-Abl tyrosine kinase inhibitors dasatinib and nilotinib.
Lead Product(s): Prexigebersen,Decitabine,Venetoclax
Therapeutic Area: Oncology Product Name: BP1001
Highest Development Status: Phase IIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 22, 2020
Details:
The Phase 1 portion of the trial will determine the maximum tolerated dose of MB-102 for the Phase 2 portion of the trial. Safety will be assessed at each dose level before proceeding to the next.
Lead Product(s): Relmapirazin,Decitabine,Fludarabine Phosphate
Therapeutic Area: Oncology Product Name: MB-102
Highest Development Status: Phase I/ Phase IIProduct Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 01, 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:
First patient in the amended Stage 2 of the Phase 2 clinical study of prexigebersen (BP1001), for the treatment of acute myeloid leukemia (AML), in combination with frontline therapy decitabine and venetoclax, has been enrolled.
Lead Product(s): Prexigebersen,Decitabine,Venetoclax
Therapeutic Area: Oncology Product Name: BP1001
Highest Development Status: Phase IIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 13, 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:
Data highlighted the efficacy, durability of response, favorable safety and tolerability profile, as well as correlative biomarker data. Anti-leukemic activity was observed at a wide range of onvansertib doses (27 to 90 mg/m2), indicating a large therapeutic window.
Lead Product(s): Onvansertib,Decitabine
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 15, 2020
Details:
The poster describes the Phase 2 study design of BP1001 (liposomal Grb2 antisense), the Company’s lead drug candidate, in combination with decitabine as a potential treatment for patients diagnosed with acute myeloid leukemia (AML) or high-risk myelodysplastic syndrome.
Lead Product(s): Prexigebersen,Decitabine
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: Phase IIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 29, 2020
Details:
First patient has been dosed with a one-hour dosing schedule for investigational agent alvocidib, a potent CDK9 inhibitor, administered in sequence after azacitidine, in the expansion of the Phase 1b/2 Zella 102 study in patients with myelodysplastic syndromes (MDS).
Lead Product(s): Alvocidib,Decitabine
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 14, 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
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results] 
Market Place
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
