Year
DEALS // DEV.
Country
Therapeutic Area
Study Phase
Deal Type
Product Type
Dosage Form
Lead Product
Target
Lead Product(s) : Daprodustat
Therapeutic Area : Hematology
Study Phase : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Jesduvroq (daprodustat) is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) used for the treatment of symptomatic anaemia associated with chronic kidney disease (CKD) in adults on chronic maintenance dialysis.
Product Name : GSK1278863
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
June 26, 2023
Lead Product(s) : Daprodustat
Therapeutic Area : Hematology
Highest Development Status : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Daprodustat
Therapeutic Area : Nephrology
Study Phase : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Jesduvroq (daprodustat), a HIF-PHI, which inhibis of oxygen-sensing prolyl hydroxylase enzymes stabilises hypoxia-inducible factors, which can lead to transcription of erythropoietin and other genes involved in the correction of anaemia.
Product Name : GSK1278863
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
January 02, 2023
Lead Product(s) : Daprodustat
Therapeutic Area : Nephrology
Highest Development Status : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Daprodustat
Therapeutic Area : Hematology
Study Phase : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
GSK Reports Outcome From US FDA Advisory Committee Meeting on Daprodustat for Anaemia of CKD
Details : Duvroq (daprodustat), a HIF-PHI, belongs to a novel class of oral medicines being studied for the treatment of anaemia of CKD in adult patients not on dialysis and on dialysis.
Product Name : GSK1278863
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
October 27, 2022
Lead Product(s) : Daprodustat
Therapeutic Area : Hematology
Highest Development Status : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Daprodustat
Therapeutic Area : Hematology
Study Phase : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
GSK Reports Outcome From US FDA Advisory Committee Meeting On Daprodustat For Anaemia Of CKD
Details : Duvroq (daprodustat), a HIF-PHI, belongs to a novel class of oral medicines being studied for the treatment of anaemia of CKD in adult patients not on dialysis and on dialysis.
Product Name : GSK1278863
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
October 27, 2022
Lead Product(s) : Daprodustat
Therapeutic Area : Hematology
Highest Development Status : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Daprodustat
Therapeutic Area : Hematology
Study Phase : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
GSK Announces Update on US FDA Regulatory Review of Daprodustat in Anaemia of Chronic Kidney Disease
Details : Studies demonstrated that Duvroq (daprodustat) improved or maintained Hb within target level, and primary safety analysis of populations showed that daprodustat achieved non-inferiority of MACE compared to standard of care, both non-dialysis and dialysis...
Product Name : GSK1278863
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
June 09, 2022
Lead Product(s) : Daprodustat
Therapeutic Area : Hematology
Highest Development Status : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Daprodustat
Therapeutic Area : Hematology
Study Phase : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
US Food and Drug Administration Accepts New Drug Application for Daprodustat
Details : Regulatory submission of daprodustat for treatment of anaemia of chronic kidney disease based on ASCEND phase III clinical trial programme, consisting of five trials that all met their primary efficacy and safety endpoints in non-dialysis and dialysis pa...
Product Name : GSK1278863
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
April 19, 2022
Lead Product(s) : Daprodustat
Therapeutic Area : Hematology
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Daprodustat
Therapeutic Area : Hematology
Study Phase : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
European Medicines Agency (EMA) Accepts Marketing Authorisation Application for Daprodustat
Details : The MAA based on positive data from ASCEND Phase III clinical trial programme for GSK1278863 (daprodustat), a HIF-PHI met co-primary efficacy and safety endpoints also, approved in Japan as Duvroq for patients with renal anaemia.
Product Name : GSK1278863
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
January 03, 2022
Lead Product(s) : Daprodustat
Therapeutic Area : Hematology
Highest Development Status : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Daprodustat
Therapeutic Area : Hematology
Study Phase : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : The most commonly reported adverse events in patients receiving daprodustat across the ASCEND programme included hypertension, diarrhoea, dialysis hypotension, peripheral edema, and urinary tract infection.
Product Name : GSK1278863
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
July 16, 2021
Lead Product(s) : Daprodustat
Therapeutic Area : Hematology
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Daprodustat
Therapeutic Area : Hematology
Study Phase : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : GSK1278863 (Daprodustat) is first oral HIF-PHI to clearly show positive efficacy, along with no increased cardiovascular risk as assessed in primary analysis. Daprodustat is currently approved in Japan as Duvroq for patients with renal anaemia.
Product Name : GSK1278863
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
May 11, 2021
Lead Product(s) : Daprodustat
Therapeutic Area : Hematology
Highest Development Status : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable