Drugs / Daprodustat
Daprodustat
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | JESDUVROQ | — | 2023-02-01 | fda.gov ↗ |
Trials 33
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 110 trials | ||||||
| Phase 1 | NCT03239522 | Oct → Nov 2017 | anemia | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT03223337 | Jul 2017 → Aug 2018 | anemia | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT02371603 | Feb → Aug 2015 | anemia | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT02231190 | Jan → Jun 2015 | disease of the tendon | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT02293148 | Nov 2014 → Mar 2015 | anemia | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT02243306 | Oct 2014 → May 2017 | anemia | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT01831804 | Jun 2013 → Feb 2017 | — | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT01673555 | May → Nov 2012 | anemia | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT01406340 | Aug 2011 → Aug 2013 | anemia | GlaxoSmithKline | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT01376232 | Nov → Dec 2010 | anemia | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 212 trials · 2 met primary · 3 missed | ||||||
| Phase 2 | NCT03457701 | Jul 2019 → Jul 2022 | anemia | GlaxoSmithKline | Completed | Missed primary |
| Phase 2 | NCT03446612 | Jan → May 2019 | anemia | GlaxoSmithKline | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT03029247 | Jul 2017 → Jul 2020 | anemia | GlaxoSmithKline | Completed | Missed primary |
| Phase 2 | NCT02689206 | Feb 2016 → Jan 2017 | anemia | GlaxoSmithKline | Completed | Met primary |
| Phase 2 | NCT02075463 | Jun 2014 → Mar 2016 | anemia | GlaxoSmithKline | Terminated | No outcome recorded |
| Phase 2 | NCT02019719 | Nov 2013 → Aug 2014 | anemia | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 2 | NCT01977482 | Nov 2013 → Feb 2015 | anemia | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 2 | NCT01977573 | Oct 2013 → May 2015 | anemia | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 2 | NCT01920594 | Oct 2013 → Oct 2014 | — | GlaxoSmithKline | Completed | Missed primary |
| Phase 2 | NCT01587924 | May 2012 → May 2013 | anemia | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 2 | NCT01587898 | May 2012 → May 2013 | anemia | GlaxoSmithKline | Completed | Met primary |
| Phase 2 | NCT02135848 | Oct 2010 → Nov 2011 | peripheral vascular disease | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 310 trials · 6 met primary | ||||||
| Phase 3 | NCT07300111 | Dec 2025 → May 2027 expected | anemia | Qilu Pharmaceutical Co., Ltd. | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT05682326 | Sep 2023 → Oct 2024 | anemia | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT03400033 | Sep 2018 → Jun 2020 | anemia | GlaxoSmithKline | Completed | Met primary |
| Phase 3 | NCT03409107 | Mar 2018 → Oct 2020 | anemia | GlaxoSmithKline | Completed | Met primary |
| Phase 3 | NCT03029208 | May 2017 → Sep 2020 | anemia | GlaxoSmithKline | Completed | Met primary |
| Phase 3 | NCT02969655 | Nov 2016 → Jul 2018 | anemia | GlaxoSmithKline | Completed | Met primary |
| Phase 3 | NCT02879305 | Sep 2016 → Nov 2020 | allergic bronchopulmonary aspergillosis, anemia | GlaxoSmithKline | Completed | Met primary |
| Phase 3 | NCT02876835 | Sep 2016 → Apr 2021 | anemia | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT02829320 | Aug 2016 → May 2017 | anemia | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT02791763 | Jun 2016 → Oct 2018 | anemia | GlaxoSmithKline | Completed | Met primary |
| Phase 41 trial | ||||||
| Phase 4 | NCT05951192 | Jul 2023 → Feb 2024 | anemia, chronic kidney disease | USRC Kidney Research | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 11
| Date | Issuer | Release |
|---|---|---|
| 2023-06-26 | GlaxoSmithKline | Regulatory GSK receives positive CHMP opinion recommending authorisation of daprodustat for symptomatic anaemia associated with chronic kidney disease in adults on chronic maintenance dialysis gsk.com ↗ |
| 2023-02-01 | GlaxoSmithKline | Regulatory Jesduvroq (daprodustat) approved by US FDA for anaemia of chronic kidney disease in adults on dialysis gsk.com ↗ |
| 2022-10-27 | GlaxoSmithKline | Regulatory GSK reports outcome from US FDA Advisory Committee meeting on daprodustat for anaemia of CKD gsk.com ↗
In adult non-dialysis patients with anaemia of CKD, the CRDAC did not support that the benefit of treatment with daprodustat outweighs the risks with a 5 to 11 vote. |
| 2022-09-06 | GlaxoSmithKline | Regulatory GSK announces update on US FDA regulatory review of daprodustat in anaemia of chronic kidney disease gsk.com ↗
A date for the Advisory Committee meeting is set for 26 October 2022. |
| 2022-04-19 | GlaxoSmithKline | Regulatory US Food and Drug Administration accepts New Drug Application for daprodustat gsk.com ↗
GlaxoSmithKline plc (LSE/NYSE: GSK) today announced that the US Food and Drug Administration (FDA) accepted the New Drug Application (NDA) for daprodustat, an oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), for the potential treatment of patients with anaemia of chronic kidney disease (CKD). |
| 2022-03-01 | GlaxoSmithKline | Regulatory European Medicines Agency (EMA) accepts marketing authorisation application for daprodustat gsk.com ↗
GlaxoSmithKline plc (LSE/NYSE: GSK) today announced that the European Medicines Agency (EMA) validated the marketing authorisation application (MAA) for daprodustat, an investigational oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), for the treatment of patients with anaemia of chronic kidney disease (CKD). |
| 2021-11-05 | GlaxoSmithKline | Results GSK announces positive Phase III efficacy and safety data for daprodustat in patients with anaemia due to chronic kidney disease gsk.com ↗
Results showed daprodustat improved and/or maintained Hb within target level (10-11.5 g/dL) for these patients, and the primary safety analysis of the ITT population showed that daprodustat achieved non-inferiority compared to ESA control. |
| 2021-07-16 | GlaxoSmithKline | Results GSK announces positive headline results from five Phase 3 studies of daprodustat for patients with anaemia due to chronic kidney disease gsk.com ↗
In addition, the key cardiovascular outcomes studies for non-dialysis (ASCEND-ND) and dialysis patients (ASCEND-D) demonstrated that daprodustat was non-inferior when compared to an ESA in the risk of Major Adverse Cardiovascular Events (MACE), the co-primary endpoint of both studies. |
| 2020-06-29 | GlaxoSmithKline | Regulatory GSK receives first regulatory approval for Duvroq (daprodustat) in Japan for patients with anaemia due to chronic kidney disease gsk.com ↗
GlaxoSmithKline plc (LSE/NYSE: GSK) today announced the approval of a Japanese New Drug Application (JNDA) by the Ministry of Health, Labour and Welfare for Duvroq (daprodustat) tablets, an oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), for the treatment of patients with anaemia due to chronic kidney disease (CKD). |
| 2019-08-21 | GlaxoSmithKline | Regulatory GSK submits first regulatory application for daprodustat in Japan for patients with renal anaemia due to chronic kidney disease gsk.com ↗
GlaxoSmithKline plc (LSE/NYSE: GSK) today announced the submission of a Japanese New Drug Application (JNDA) to the Ministry of Health, Labour and Welfare seeking marketing approval for daprodustat, an oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), for the treatment of patients with renal anaemia due to chronic kidney disease (CKD). |
| 2018-10-29 | GlaxoSmithKline | Results GSK announces positive phase 3 results for daprodustat in patients with anaemia associated with chronic kidney disease gsk.com ↗
Results from the 52-week study of 271 haemodialysis-dependent patients, showed that oral daprodustat met its primary endpoint of non-inferiority to darbepoetin alfa IV injection, as measured by mean haemoglobin levels over Weeks 40 to 52. |
All press releases naming this drug 13 releases
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 35 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Daprodustat | “Daprodustat is an oral agent that stimulates erythropoiesis by inhibiting the prolyl hydroxylases which mark hypoxia-inducible factor for degradation through hydroxylation.” PMID 33561857 ↗ Feb 2021 |
| Known as | GSK1278863 | “Absorption, metabolism and excretion of daprodustat (GSK1278863) have been studied in previous clinical trials” NCT03239522 ↗20“Daprodustat (GSK1278863) 6 mg tablet will be given to all subjects as a single dose via oral route.” NCT03223337 ↗ “Daprodustat (GSK1278863)” NCT03409107 ↗ |
| Known as | Jesduvroq | ChEMBL registry synonym — accepted as the source's own label CHEMBL3544988 ↗ |
| Action | Inhibit | “the hypoxia-inducible factor-prolyl hydroxylase inhibitor GSK1278863” PMID 26494831 ↗ Oct 2015 |
| Modality | Small molecule | “novel small molecule agent” NCT02243306 ↗ |
| Route | Oral | “a single oral dose of GSK1278863” NCT01376232 ↗ |