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 · a red edge is where a trial was stopped
| 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 |
| Phase 1 | NCT01376232 | Nov → Dec 2010 | anemia | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 212 trials | ||||||
| Phase 2 | NCT03457701 | Jul 2019 → Jul 2022 | anemia | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 2 | NCT03446612 | Jan → May 2019 | anemia | GlaxoSmithKline | Terminated | No outcome recorded |
| Phase 2 | NCT03029247 | Jul 2017 → Jul 2020 | anemia | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 2 | NCT02689206 | Feb 2016 → Jan 2017 | anemia | GlaxoSmithKline | Completed | No outcome recorded |
| 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 | No outcome recorded |
| Phase 2 | NCT01587924 | May 2012 → May 2013 | anemia | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 2 | NCT01587898 | May 2012 → May 2013 | anemia | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 2 | NCT02135848 | Oct 2010 → Nov 2011 | peripheral vascular disease | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 310 trials | ||||||
| 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 | No outcome recorded |
| Phase 3 | NCT03409107 | Mar 2018 → Oct 2020 | anemia | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT03029208 | May 2017 → Sep 2020 | anemia | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT02969655 | Nov 2016 → Jul 2018 | anemia | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT02879305 | Sep 2016 → Nov 2020 | allergic bronchopulmonary aspergillosis, anemia | GlaxoSmithKline | Completed | No outcome recorded |
| 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 | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT05951192 | Jul 2023 → Feb 2024 | anemia, chronic kidney disease | USRC Kidney Research | Completed | No outcome recorded |
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 ↗ |