Drugs / Vadadustat
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | VAFSEO | — | 2024-03-27 | fda.gov ↗ |
| Approved | EU (EMA) | Vafseo | — | 2023-04-24 | europa.eu ↗ |
Trials 40 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 111 trials | ||||||
| Phase 1 | NCT04299633 | Jun → Aug 2020 | — | Akebia Therapeutics | Completed | No outcome recorded |
| Phase 1 | NCT03992066 | May 2019 → May 2020 | anemia due to chronic disorder | Akebia Therapeutics | Completed | No outcome recorded |
| Phase 1 | NCT03789032 | Oct → Nov 2018 | — | Akebia Therapeutics | Completed | No outcome recorded |
| Phase 1 | NCT03801746 | Jul → Aug 2018 | — | Akebia Therapeutics | Completed | No outcome recorded |
| Phase 1 | NCT03801759 | Jul → Sep 2018 | — | Akebia Therapeutics | Completed | No outcome recorded |
| Phase 1 | NCT03801733 | Jun → Nov 2018 | — | Akebia Therapeutics | Completed | No outcome recorded |
| Phase 1 | NCT03799848 | Jun → Oct 2018 | — | Akebia Therapeutics | Completed | No outcome recorded |
| Phase 1 | NCT02502500 | Jul 2015 | — | Akebia Therapeutics | Completed | No outcome recorded |
| Phase 1 | NCT02412449 | Apr 2015 | — | Akebia Therapeutics | Completed | No outcome recorded |
| Phase 1 | NCT02327546 | Dec 2014 | — | Akebia Therapeutics | Completed | No outcome recorded |
| Phase 1 | NCT02062203 | Jan → Apr 2014 | — | Akebia Therapeutics | Completed | No outcome recorded |
| Phase 210 trials | ||||||
| Phase 2 | NCT04478071 | Aug 2020 → Mar 2022 | COVID-19, acute respiratory distress syndrome | The University of Texas Health Science Center, Houston | Completed | No outcome recorded |
| Phase 2 | NCT03799627 | Jan 2019 → Jun 2020 | anemia, chronic kidney disease | Akebia Therapeutics | Completed | No outcome recorded |
| Phase 2 | NCT03140722 | May 2017 → Mar 2018 | anemia, chronic kidney disease | Akebia Therapeutics | Terminated | No outcome recorded |
| Phase 2 | NCT03054350 | Dec 2016 → Oct 2017 | anemia, chronic kidney disease | Akebia Therapeutics | Completed | No outcome recorded |
| Phase 2 | NCT03054337 | Oct 2016 → Jul 2017 | anemia, chronic kidney disease | Akebia Therapeutics | Completed | No outcome recorded |
| Phase 2 | NCT02260193 | Sep 2014 → Jul 2015 | anemia, end stage renal failure | Akebia Therapeutics | Completed | No outcome recorded |
| Phase 2 | NCT01906489 | Jul 2013 → Sep 2014 | anemia, chronic kidney disease | Akebia Therapeutics | Completed | No outcome recorded |
| Phase 2 | NCT01381094 | Jun 2011 → Feb 2012 | anemia, kidney disorder | Akebia Therapeutics | Completed | No outcome recorded |
| Phase 2 | NCT01235936 | Oct 2010 → Apr 2011 | anemia, chronic kidney disease | Akebia Therapeutics | Completed | No outcome recorded |
| Phase 2 | NCT04707573 | Jul → Sep 2010 | chronic kidney disease | Akebia Therapeutics | Completed | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT07086755 | Oct 2025 → Jul 2026 overdue | acute lung injury, acute respiratory distress syndrome | Bentley J. Bobrow | Recruiting | No outcome recorded |
| Phase 317 trials | ||||||
| Phase 3 | NCT07565701 | Apr 2026 → Apr 2027 expected | anemia due to chronic disorder | Geoff Block | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT06901505 | Jul 2025 → Aug 2026 overdue | anemia due to chronic disorder | Akebia Therapeutics | Active not recruiting | No outcome recorded |
| Phase 3 | NCT05082584 | Jan 2025 → Jul 2026 | anemia due to chronic disorder | Akebia Therapeutics | Withdrawn | No outcome recorded |
| Phase 3 | NCT05082571 | Jan 2025 → Jul 2026 | anemia due to chronic disorder | Akebia Therapeutics | Withdrawn | No outcome recorded |
| Phase 3 | NCT06520826 | Nov 2024 → Jun 2026 overdue | anemia due to chronic disorder | USRC Kidney Research | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04707768 | Jun 2021 → Jan 2023 | anemia due to chronic disorder | Akebia Therapeutics | Completed | No outcome recorded |
| Phase 3 | NCT04313153 | May 2020 → Nov 2021 | anemia | Akebia Therapeutics | Completed | No outcome recorded |
| Phase 3 | NCT03645863 | Aug → Sep 2018 | — | Tanabe Pharma Corporation | Completed | No outcome recorded |
| Phase 3 | NCT03461146 | Mar → Dec 2018 | anemia | Tanabe Pharma Corporation | Completed | No outcome recorded |
| Phase 3 | NCT03439137 | Feb → Dec 2018 | anemia due to chronic disorder | Tanabe Pharma Corporation | Completed | No outcome recorded |
| Phase 3 | NCT03402386 | Jan → Nov 2018 | anemia due to chronic disorder | Tanabe Pharma Corporation | Completed | No outcome recorded |
| Phase 3 | NCT03329196 | Oct 2017 → Jan 2019 | anemia | Tanabe Pharma Corporation | Completed | No outcome recorded |
| Phase 3 | NCT03242967 | Aug 2017 → Feb 2018 | anemia, chronic kidney disease | Akebia Therapeutics | Withdrawn | No outcome recorded |
| Phase 3 | NCT02892149 | Aug 2016 → Jan 2020 | anemia, chronic kidney disease | Akebia Therapeutics | Completed | No outcome recorded |
| Phase 3 | NCT02865850 | Jul 2016 → Jan 2020 | anemia, end stage renal failure | Akebia Therapeutics | Completed | No outcome recorded |
| Phase 3 | NCT02680574 | Feb 2016 → Jun 2020 | anemia, chronic kidney disease | Akebia Therapeutics | Completed | No outcome recorded |
| Phase 3 | NCT02648347 | Dec 2015 → Jun 2020 | anemia, chronic kidney disease | Akebia Therapeutics | Completed | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT07537816 | Apr → Sep 2026 expected | anemia | Mackay Memorial Hospital | Not yet recruiting | No outcome recorded |
Press releases naming this drug 14 releases
| Date | Issuer | Release |
|---|---|---|
| 2024-03-28 | CSL Behring | Vafseo® approved by the U.S. FDA for the treatment of anemia due to chronic kidney disease in dialysis-dependent adult patients csl.com ↗ |
| 2022-03-31 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Akebia Therapeutics Receives Complete Response Letter from U.S. FDAfor Vadadustat for the Treatment of Anemia associated with Chronic Kidney Diseasein Adult Patients otsuka.co.jp ↗ |
| 2021-10-29 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Otsuka submits initial marketing authorization application to the European Medicines Agency for vadadustat for the treatment of adults with anemia associated with chronic kidney disease otsuka.co.jp ↗ |
| 2021-06-01 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Otsuka and Akebia Announce U.S. FDA Acceptance for Filing of New Drug Application for Vadadustat for the Treatment of Anemia Due to Chronic Kidney Disease otsuka.co.jp ↗ |
| 2021-06-01 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Akebia and Otsuka Announce FDA Acceptance for Filing of New Drug Application for Vadadustat for the Treatment of Anemia Due to Chronic Kidney Disease in Adult Patients on Dialysis and Not on Dialysis otsuka-us.com ↗ |
| 2021-03-30 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Otsuka and Akebia Announce Submission of New Drug Application to the FDA for Approval of Akebia's Vadadustat otsuka.co.jp ↗ |
| 2021-03-30 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Otsuka and Akebia Announce Submission of New Drug Application to the FDA for Approval of Akebia’s Vadadustat otsuka-us.com ↗ |
| 2020-09-03 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Top-line Results from Global Phase 3 Program of Vadadustat, a Drug Candidate for Treatment of Renal Anemia due to Chronic Kidney Disease in Non-Dialysis Patients otsuka.co.jp ↗ |
| 2020-05-05 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Positive Top-Line Results from Global Phase 3 Program of Vadadustat for Treatment of Anemia Due to Chronic Kidney Disease in Adult Patients on Dialysis otsuka.co.jp ↗ |
| 2020-05-05 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Positive Top-Line Results from Global Phase 3 Program of Vadadustat for Treatment of Anemia Due to Chronic Kidney Disease in Adult Patients on Dialysis otsuka-us.com ↗ |
| 2017-04-26 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Otsuka and Akebia Concludes Licensing Agreement for Akebia's Renal Anemia Drug Vadadustat - Development and marketing territories include Europe, China, etc. - otsuka.co.jp ↗ |
| 2017-04-25 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Akebia and Otsuka Expand Relationship with Collaboration to Develop and Commercialize Vadadustat in Europe, China and Other Territories otsuka-us.com ↗ |
| 2016-12-20 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Akebia Therapeutics and Otsuka Pharmaceutical Announce Collaboration to Develop and Commercialize Vadadustat in the U.S. otsuka.co.jp ↗ |
| 2016-12-20 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Akebia and Otsuka Pharmaceutical Announce Collaboration to Develop and Commercialize Vadadustat in the U.S. otsuka-us.com ↗ |
Evidence & citations 12 cited values
Every value below carries the sentence it was read from. 41 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Vadadustat | “Vadadustat (AKB-6548), a novel, titratable, oral hypoxia-inducible factor prolyl hydroxylase inhibitor induces endogenous erythropoietin synthesis and enhances iron mobilization.” PMID 27650732 ↗ Sep 201628“Vadadustat (AKB-6548) is an oral hypoxia-inducible factor prolyl-hydroxylase domain (HIF-PHD) inhibitor that is being investigated for the treatment of anemia secondary to CKD.” PMID 28343225 ↗ Mar 2017 |
| Known as | AKB-6548 | “Vadadustat (AKB-6548), a novel, titratable, oral hypoxia-inducible factor prolyl hydroxylase inhibitor induces endogenous erythropoietin synthesis and enhances iron mobilization.” PMID 27650732 ↗ Sep 20168“Vadadustat (AKB-6548) is an oral hypoxia-inducible factor prolyl-hydroxylase domain (HIF-PHD) inhibitor that is being investigated for the treatment of anemia secondary to CKD.” PMID 28343225 ↗ Mar 2017 “AKB-6548” NCT03054350 ↗ |
| Known as | B-506 | ChEMBL registry synonym — accepted as the source's own label CHEMBL3646221 ↗ |
| Known as | MT-6548 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03645863 ↗ |
| Known as | PG-1016548 | ChEMBL registry synonym — accepted as the source's own label CHEMBL3646221 ↗ |
| Known as | Vafseo | ChEMBL registry synonym — accepted as the source's own label CHEMBL3646221 ↗ |
| Action | Inhibit | “Hypoxia-inducible factor prolyl hydroxylase 1 inhibitor” CHEMBL3646221 ↗3“Egl nine homolog 3 inhibitor” CHEMBL3646221 ↗ “Egl nine homolog 1 inhibitor” CHEMBL3646221 ↗ “HIF-PHD inhibitor” PMID 28343225 ↗ Mar 2017 |
| Modality | Small molecule | “A synthetic, orally bioavailable, small molecule” NCT06520826 ↗ |
| Route | Oral | “orally administered AKB-6548” NCT01235936 ↗ |
| Target | EGLN1 | “Egl nine homolog 1 inhibitor” CHEMBL3646221 ↗ |
| Target | EGLN2 | “Hypoxia-inducible factor prolyl hydroxylase 1 inhibitor” CHEMBL3646221 ↗ |
| Target | EGLN3 | “Egl nine homolog 3 inhibitor” CHEMBL3646221 ↗ |