Drugs / Vadadustat
Regulatory milestones approvals, filings & regulatory actions · 8 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed anemia due to chronic disorder 5 milestones | |||||
| Filed | US (FDA) | — | anemia due to chronic disorder | 2023-09-28 | “has resubmitted its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for vadadustat” akebia.com ↗ |
| Rejected (CRL) | US (FDA) | — | anemia due to chronic disorder | 2022-03-29 | “the FDA issued a complete response letter to Akebia's New Drug Application for vadadustat for the treatment of anemia due to chronic kidney disease (CKD).” akebia.com ↗ “the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) to Akebia's New Drug Application (NDA) for Akebia's vadadustat” otsuka.co.jp ↗ “On March 29, 2022, the FDA issued a complete response letter to Akebia's New Drug Application for vadadustat” akebia.com ↗ “On March 29, 2022, the FDA issued a complete response letter to Akebia's New Drug Application for vadadustat” akebia.com ↗ |
| Filed | US (FDA) | — | anemia due to chronic disorder | 2021-06-01 | “accepted for filing the New Drug Application (NDA) for vadadustat for the treatment of anemia due to chronic kidney disease (CKD)” akebia.com ↗ “In late May, the FDA accepted for filing the NDA for vadadustat for the treatment of anemia due to CKD” akebia.com ↗ |
| Filed | US (FDA) | — | anemia due to chronic disorder | 2021-03-30 | “(Akebia) has submitted a New Drug Application (NDA) to the Food and Drug Administration in the U.S. (FDA) seeking approval for Akebia's investigational drug vadadustat” otsuka-us.com ↗ “(Akebia) has submitted a New Drug Application (NDA) to the Food and Drug Administration in the U.S. (FDA) seeking approval for Akebia’s investigational drug vadadustat” otsuka-us.com ↗ “today announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for vadadustat” akebia.com ↗ |
| Filed | Japan (PMDA) | — | anemia due to chronic disorder | 2019-07-23 | “In July, Mitsubishi Tanabe Pharma Corporation (MTPC), Akebia’s development and commercialization collaboration partner in Japan for vadadustat, submitted a Japanese New Drug...” akebia.com ↗ “has submitted a Japanese New Drug Application (JNDA) to the Ministry of Health, Labor and Welfare in Japan for manufacturing and marketing approval of vadadustat as a treatment...” akebia.com ↗ “In July, MTPC submitted a Japanese New Drug Application (JNDA) to the Ministry of Health, Labor and Welfare in Japan” akebia.com ↗ “MTPC filed a Japanese New Drug Application for vadadustat in July 2019.” akebia.com ↗ |
| Filed aregenerative anemia 1 milestone | |||||
| Filed | EU (EMA) | — | aregenerative anemia | 2021-10-29 | “Otsuka submitted an initial marketing authorization application (MAA) to the European Medicines Agency (EMA) for vadadustat for the treatment of anemia associated with chronic...” akebia.com ↗ “In October 2021, Akebia's collaboration partner, Otsuka Pharmaceutical Co., Ltd. (Otsuka), submitted an initial marketing authorization application (MAA) for vadadustat to the...” akebia.com ↗ “In October 2021, Otsuka, in collaboration with Akebia, submitted an initial marketing authorization application (MAA) to the European Medicines Agency (EMA) for vadadustat” otsuka.co.jp ↗ “Otsuka Pharmaceutical Netherlands B.V. has submitted an initial marketing authorization application to the European Medicines Agency (EMA) for vadadustat” otsuka.co.jp ↗ “Otsuka Pharmaceutical Netherlands B.V. has submitted an initial marketing authorization application (MAA) to the European Medicines Agency for vadadustat” akebia.com ↗ “Akebia announced that Otsuka submitted a marketing authorization application to the European Medicines Agency for vadadustat” akebia.com ↗ |
| Approved Indication not stated 2 milestones | |||||
| Approved | US (FDA) | VAFSEO | — | 2024-03-27 | fda.gov ↗ |
| Approved | EU (EMA) | Vafseo | — | 2023-04-24 | europa.eu ↗ |
Trials 35
| 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 | NCT03801759 | Jul → Sep 2018 | — | Akebia Therapeutics | Completed | No outcome recorded |
| Phase 1 | NCT03801746 | Jul → Aug 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 · 4 met primary · 2 missed | ||||||
| Phase 2 | NCT04478071 | Aug 2020 → Mar 2022 | COVID-19, acute respiratory distress syndrome | The University of Texas Health Science Center, Houston | Completed | Missed primary |
| 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 | Met primary |
| Phase 2 | NCT03054337 | Oct 2016 → Jul 2017 | anemia, chronic kidney disease | Akebia Therapeutics | Completed | Met primary |
| Phase 2 | NCT02260193 | Sep 2014 → Jul 2015 | anemia, end stage renal failure | Akebia Therapeutics | Completed | Missed primary |
| Phase 2 | NCT01906489 | Jul 2013 → Sep 2014 | anemia, chronic kidney disease | Akebia Therapeutics | Completed | Met primary |
| Phase 2 | NCT01381094 | Jun 2011 → Feb 2012 | anemia, kidney disorder | Akebia Therapeutics | Completed | Met primary |
| 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 312 trials · 5 met primary | ||||||
| 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 | anemia due to chronic disorder | Akebia Therapeutics | Completed | No outcome recorded |
| Phase 3 | NCT05082571 | Jan 2025 → Jul 2026 | anemia due to chronic disorder | Akebia Therapeutics | Withdrawn | No outcome recorded Stop: Business |
| Phase 3 | NCT05082584 | Jan 2025 → Jul 2026 | anemia due to chronic disorder | Akebia Therapeutics | Withdrawn | No outcome recorded Stop: Business |
| Phase 3 | NCT06520826 | Nov 2024 → Jun 2026 overdue | anemia due to chronic disorder | USRC Kidney Research | Active not recruiting | Met primary |
| Phase 3 | NCT04707768 | Jun 2021 → Jan 2023 | anemia due to chronic disorder | Akebia Therapeutics | Completed | Met primary |
| Phase 3 | NCT04313153 | May 2020 → Nov 2021 | anemia | Akebia Therapeutics | Completed | Mixed |
| 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 | Met primary |
| Phase 3 | NCT02865850 | Jul 2016 → Jan 2020 | anemia, end stage renal failure | Akebia Therapeutics | Completed | Met primary |
| Phase 3 | NCT02680574 | Feb 2016 → Jun 2020 | anemia, chronic kidney disease | Akebia Therapeutics | Completed | Met primary |
| 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 overdue | anemia | Mackay Memorial Hospital | Not yet recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 46
| Date | Issuer | Release |
|---|---|---|
| 2026-06-30 | Akebia Therapeutics | Results U.S. Renal Care and Akebia Announce Interim Analysis of VOICE Trial Demonstrated Overwhelming Statistical Evidence of Improved Safety Outcomes for Patients Treated with Vafseo versus an ESA akebia.com ↗
Vafseo® demonstrated a clinically meaningful safety outcome benefit in U.S. patients with anemia due to CKD on dialysis utilizing TIW dosing regimen |
| 2026-05-04 | Akebia Therapeutics | Results Akebia Therapeutics Announces Vadadustat Post-hoc Win Statistics Analysis Demonstrating Statistically Significant Reduction in Mortality and Hospitalization Composite Endpoint Published in the Journal of American Society of Nephrology akebia.com ↗ |
| 2025-11-06 | Akebia Therapeutics | Results Vafseo® (vadadustat) Dialysis Dependent Patient Post Hoc Data Analysis: Composite of All-Cause Mortality and Hospitalization Outcomes Statistically More Favorable for Patients Receiving Vadadustat vs. ESAs akebia.com ↗
The presentation entitled, “Win-Odds Analysis of Deaths and Hospitalization in Patients taking Vadadustat or Darbepoetin Alfa for CKD-Related Anemia Undergoing Dialysis,” demonstrated favorable and statistically significant effects of Vafseo relative to the erythropoiesis-stimulating agent (ESA) darbepoetin alfa on the composite endpoint of death or hospitalization. |
| 2025-06-04 | Akebia Therapeutics | Results Vadadustat U.S. Patient Data from Global Phase 3 Clinical Program Published in Journal of the American Society of Nephrology akebia.com ↗
Data from the pre-specified analyses for the U.S. patient subgroup demonstrate that among patients with DD-CKD, safety and efficacy of vadadustat and darbepoetin alfa in the U.S. and outside the U.S. were similar. |
| 2024-11-14 | Akebia Therapeutics | Results Vadadustat Alternative Dosing Study Results Published in the American Journal of Kidney Disease akebia.com ↗ |
| 2024-10-10 | Akebia Therapeutics | Regulatory CMS Grants TDAPA Reimbursement for Vafseo® (vadadustat) beginning January 1, 2025 akebia.com ↗ |
| 2024-03-27 | Akebia Therapeutics | Regulatory Akebia Receives FDA Approval of Vafseo® (vadadustat) Tablets for the Treatment of Anemia due to Chronic Kidney Disease in Adult Patients on Dialysis akebia.com ↗
Akebia Therapeutics®, Inc. (Nasdaq: AKBA), a biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease, today announced that the U.S. Food and Drug Administration (FDA) has approved Vafseo® (vadadustat) Tablets for the treatment of anemia due to chronic kidney disease (CKD) in adults who have been receiving dialysis for at least three months. |
| 2023-10-25 | Akebia Therapeutics | Regulatory Akebia Receives FDA Acceptance of Resubmission to NDA of Vadadustat for the Treatment of Anemia due to Chronic Kidney Disease akebia.com ↗
The FDA has classified this as a class 2 response, which results in a six-month review period from the date of resubmission, and the FDA set a user fee goal date ("PDUFA" date) of March 27, 2024. |
| 2023-09-28 | Akebia Therapeutics | Regulatory Akebia Therapeutics Resubmits New Drug Application to the FDA for Vadadustat akebia.com ↗ |
| 2023-09-26 | Akebia Therapeutics | Regulatory Akebia Announces Approval of Vafseo® (vadadustat) in Australia and Provides Commercial Update akebia.com ↗
Akebia Therapeutics®, Inc. (Nasdaq: AKBA) today announced that Australia's Therapeutic Goods Administration (TGA) has granted approval for Vafseo® (vadadustat), an oral hypoxia-inducible factor prolyl hydroxylase inhibitor for the treatment of anemia associated with chronic kidney disease (CKD) in adults on chronic maintenance dialysis. |
| 2023-06-20 | Akebia Therapeutics | Regulatory Akebia Announces Swissmedic Approval of Vafseo® (vadadustat) akebia.com ↗
Akebia Therapeutics®, Inc. (Nasdaq: AKBA) today announced that the Swiss Agency for Therapeutic Products (Swissmedic) has granted marketing authorization for Vafseo® (vadadustat), an oral hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor for the treatment of symptomatic anemia associated with chronic kidney disease (CKD) in adults on chronic maintenance dialysis. |
| 2023-05-30 | Akebia Therapeutics | Regulatory FDA Provides Akebia Therapeutics a Path Forward for Vadadustat akebia.com ↗
FDA denies formal dispute resolution, but outlines path to resubmit NDA for dialysis-dependent patients without new clinical studies |
| 2023-05-22 | Akebia Therapeutics | Regulatory Akebia Announces UK MHRA Approval of Vafseo® (vadadustat) for the Treatment of Symptomatic Anemia Associated with Chronic Kidney Disease in Adults on Chronic Maintenance Dialysis akebia.com ↗ |
| 2023-04-25 | Akebia Therapeutics | Regulatory Akebia Receives European Commission Approval for Vafseo™ (vadadustat) for the Treatment of Symptomatic Anaemia Associated with Chronic Kidney Disease in Adults on Chronic Maintenance Dialysis akebia.com ↗
Akebia Therapeutics®, Inc. (Nasdaq: AKBA) today announced that the European Commission (EC) has granted marketing authorisation for Vafseo™ (vadadustat), an oral hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor for the treatment of symptomatic anaemia associated with chronic kidney disease (CKD) in adults on chronic maintenance dialysis. |
| 2023-04-03 | Akebia Therapeutics | Results Akebia Therapeutics Announces Positive Top-Line Results from Vadadustat Alternative Dosing Study akebia.com ↗
Data demonstrated that vadadustat met the primary and secondary efficacy endpoints and was non-inferior to an ESA as a treatment for anemia due to chronic kidney disease when administered three times a week at the time of dialysis |
| 2023-02-23 | Akebia Therapeutics | Regulatory Akebia Receives Positive CHMP Opinion in Europe for Vafseo™ (vadadustat) for the Treatment of Symptomatic Anaemia Associated with Chronic Kidney Disease in Adults on Chronic Maintenance Dialysis akebia.com ↗
Akebia Therapeutics®, Inc. (NASDAQ: AKBA) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending the European Commission (EC) to approve Vafseo™ (vadadustat), an oral hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor for the treatment of symptomatic anaemia associated with chronic kidney disease (CKD) in adults on chronic maintenance dialysis. |
| 2023-02-21 | Akebia Therapeutics | Regulatory Akebia Therapeutics Received Interim Response from the FDA to Appeal for Vadadustat for the Treatment of Anemia due to Chronic Kidney Disease akebia.com ↗
today announced that the company received a second interim response from the U.S. Food and Drug Administration to its Formal Dispute Resolution Request regarding the Complete Response Letter for vadadustat received in March 2022. |
| 2022-12-22 | Akebia Therapeutics | Regulatory Akebia Therapeutics Received Interim Response to Appeal for Vadadustat for the Treatment of Anemia due to Chronic Kidney Disease from the FDA akebia.com ↗ |
| 2022-08-04 | Akebia Therapeutics | Results Akebia Therapeutics Reports Second Quarter 2022 Financial Results and Recent Business Highlights akebia.com ↗
Shared initial findings from investigator-sponsored study evaluating vadadustat for the prevention and treatment of acute respiratory distress syndrome (ARDS) in patients with COVID-19 and hypoxemia |
| 2022-08-04 | Akebia Therapeutics | Results Akebia Therapeutics Announces Initial Findings from Investigator-Sponsored Clinical Study Evaluating Vadadustat for the Prevention and Treatment of Acute Respiratory Distress Syndrome (ARDS) in Subjects with COVID-19 and Hypoxemia (VSTAT) akebia.com ↗
Those receiving vadadustat; however, did demonstrate 94% probability for conferring benefit on the NIAID-OS at Day 14. |
| 2022-03-31 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Regulatory 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 ↗ |
| 2022-03-30 | Akebia Therapeutics | Regulatory Akebia Therapeutics Receives Complete Response Letter from the FDA for Vadadustat for the Treatment of Anemia due to Chronic Kidney Disease in Adult Patients akebia.com ↗ |
| 2021-10-29 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Regulatory 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 ↗ |
| 2021-10-29 | Akebia Therapeutics | Regulatory Akebia Announces Otsuka's Submission of Initial Marketing Authorization Application to the European Medicines Agency for Vadadustat for the Treatment of Patients with Anemia due to Chronic Kidney Disease akebia.com ↗
Otsuka Pharmaceutical Netherlands B.V. has submitted an initial marketing authorization application (MAA) to the European Medicines Agency for vadadustat, an investigational oral hypoxia-inducible factor prolyl hydroxylase inhibitor, for the treatment of anemia associated with chronic kidney disease (CKD) in adults. |
| 2021-06-01 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Regulatory 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 ↗
Otsuka Pharmaceutical Co., Ltd. (Otsuka) and Akebia Therapeutics, Inc., announce that the U.S. Food and Drug Administration (FDA) accepted for filing the New Drug Application (NDA) for vadadustat for the treatment of anemia due to chronic kidney disease (CKD) in both adult patients on dialysis and adult patients not on dialysis. |
| 2021-06-01 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Regulatory 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 ↗
The FDA has assigned the application standard review and a Prescription Drug User Fee Act (PDUFA) target action date of March 29, 2022. |
| 2021-06-01 | Akebia Therapeutics | Regulatory 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 akebia.com ↗
The FDA has assigned the application standard review and a Prescription Drug User Fee Act (PDUFA) target action date of March 29, 2022. |
| 2021-04-28 | Akebia Therapeutics | Results New England Journal of Medicine Publishes Results of Global Phase 3 Clinical Program of Vadadustat for the Treatment of Anemia Due to Chronic Kidney Disease akebia.com ↗
Among patients with anemia and CKD who were undergoing dialysis, vadadustat was noninferior to darbepoetin alfa with respect to cardiovascular safety and maintenance of hemoglobin concentrations. |
| 2021-03-30 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Regulatory 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. | Regulatory Otsuka and Akebia Announce Submission of New Drug Application to the FDA for Approval of Akebia’s Vadadustat otsuka-us.com ↗ |
| 2021-03-30 | Akebia Therapeutics | Regulatory Akebia Submits New Drug Application (NDA) to the FDA for Vadadustat for the Treatment of Anemia Due to Chronic Kidney Disease in Adult Patients on Dialysis and Not on Dialysis akebia.com ↗
today announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for vadadustat, Akebia's investigational oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), for the treatment of anemia due to chronic kidney disease (CKD) in both adult patients on dialysis and adult patients not on dialysis. |
| 2020-10-23 | Akebia Therapeutics | Results Akebia Presents Results from its PRO₂TECT Global Phase 3 Program of Vadadustat for the Treatment of Anemia due to Chronic Kidney Disease in Adult Patients Not on Dialysis During Late-Breaking Session at American Society of Nephrology Kidney Week 2020 Reimagined akebia.com ↗
Newly presented pre-specified regional analyses of the PRO2TECT program show vadadustat demonstrated no clinically meaningful increase in cardiovascular risk compared to darbepoetin alfa in analyses of MACE, expanded MACE and all-cause mortality in U.S. patients treated to a target hemoglobin (Hb) range of 10 to 11 g/dL, consistent with U.S. treatment guidelines. |
| 2020-10-22 | Akebia Therapeutics | Results Akebia Presents Results from its INNO2VATE Global Phase 3 Program; Demonstrated Efficacy and Cardiovascular Safety of Vadadustat for the Treatment of Anemia due to Chronic Kidney Disease in Adult Patients on Dialysis akebia.com ↗
More specifically, vadadustat's cardiovascular safety profile in dialysis patients is further reinforced by newly presented data clearly showing vadadustat achieved non-inferiority to darbepoetin alfa on MACE, expanded MACE, cardiovascular MACE, cardiovascular mortality, and all-cause mortality. |
| 2020-09-03 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Results 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 ↗
Vadadustat achieved the primary and key secondary efficacy endpoints in both of the two PROTECT studies, demonstrating non-inferiority to darbepoetin alfa as measured by a mean change in hemoglobin (Hb) between baseline and the primary evaluation period (weeks 24 to 36), and between baseline and the secondary evaluation period (weeks 40 to 52). |
| 2020-09-03 | Akebia Therapeutics | Results Akebia Therapeutics Announces Top-Line Results from its PRO2TECT Global Phase 3 Program of Vadadustat for Treatment of Anemia Due to Chronic Kidney Disease in Adult Patients Not on Dialysis akebia.com ↗
PRO2TECT achieves primary and key secondary efficacy endpoints |
| 2020-06-29 | Akebia Therapeutics | Regulatory Akebia Therapeutics Announces Approval of Vadadustat in Japan for the Treatment of Anemia Due to Chronic Kidney Disease in Dialysis-Dependent and Non-Dialysis Dependent Adult Patients akebia.com ↗
Mitsubishi Tanabe Pharma Corporation (MTPC), Akebia's collaboration partner in Japan for vadadustat, has obtained manufacturing and marketing approval of vadadustat as a treatment for anemia due to CKD in both dialysis-dependent and non-dialysis dependent adult patients by the Ministry of Health, Labour and Welfare in Japan on June 29, 2020. |
| 2020-05-05 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Results 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 ↗
Akebia Therapeutics, Inc. announced positive top-line results from INNOVATE, its global Phase 3 clinical trial program evaluating vadadustat, Akebia Therapeutics' investigational hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) as an oral treatment for adult patients on dialysis with anemia associated with chronic kidney disease (CKD). |
| 2020-05-05 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Results 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 ↗
Akebia Therapeutics announced that its vadadustat achieved the primary efficacy and cardiovascular safety endpoints in the study |
| 2020-05-05 | Akebia Therapeutics | Results Akebia Therapeutics Announces 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 akebia.com ↗ |
| 2020-05-05 | Akebia Therapeutics | Results Akebia Announced 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; Reports First Quarter 2020 Financial Results akebia.com ↗
Vadadustat achieves primary efficacy and cardiovascular safety endpoints |
| 2019-11-11 | Tanabe Pharma Corporation | Results HIF-PH Inhibitor Vadadustat (MT-6548) Japan Phase 3 results for the treatment of renal anemia at American Society of Nephrology, Kidney Week 2019 tanabe-pharma.com ↗ |
| 2019-11-09 | Akebia Therapeutics | Results Akebia Announces Positive 52-week Efficacy and Safety Data for Vadadustat from Two Pivotal Phase 3 Studies in Japanese Patients with Anemia Due to Chronic Kidney Disease akebia.com ↗
Each study met its primary endpoint based on mean hemoglobin level at weeks 20 and 24, and showed vadadustat’s effect on hemoglobin was sustained through to 52 weeks in each study. |
| 2019-07-23 | Akebia Therapeutics | Regulatory Akebia Therapeutics Announces Submission of Vadadustat New Drug Application in Japan for Anemia Due to Chronic Kidney Disease by Collaboration Partner, MTPC akebia.com ↗
Akebia Therapeutics, Inc. (Nasdaq: AKBA), today announced that Mitsubishi Tanabe Pharma Corporation (MTPC), its development and commercialization collaboration partner in Japan for vadadustat, Akebia’s investigational oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), has submitted a Japanese New Drug Application (JNDA) to the Ministry of Health, Labor and Welfare in Japan for manufacturing and marketing approval of vadadustat as a treatment for anemia due to chronic kidney disease (CKD). |
| 2019-03-12 | Akebia Therapeutics | Results Akebia Therapeutics Announces Positive Top-Line Results from Two Pivotal Phase 3 Studies of Vadadustat in Japanese Patients with Anemia Due to Chronic Kidney Disease akebia.com ↗
Akebia Therapeutics, Inc. (Nasdaq:AKBA) today announced positive top-line results from two phase 3 active-controlled pivotal studies evaluating vadadustat, an investigational oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), in Japanese subjects with anemia due to chronic kidney disease (CKD). |
| 2018-01-04 | Akebia Therapeutics | Results Akebia Therapeutics Announces Positive Top-Line Results from Phase 2 Study of Vadadustat in Japanese Patients with Anemia Associated with Dialysis-Dependent Chronic Kidney Disease akebia.com ↗
Akebia Therapeutics, Inc. (NASDAQ:AKBA), a biopharmaceutical company focused on delivering innovative therapies to patients with kidney disease through the biology of hypoxia-inducible factor (HIF), today announced positive top-line results from its Phase 2 study of vadadustat in patients with anemia associated with dialysis-dependent chronic kidney disease (DD-CKD) in Japan. |
| 2017-09-26 | Akebia Therapeutics | Results Akebia Announces Positive Top-Line Results from Phase 2 Study of Vadadustat in Japanese Patients with Non-Dialysis-Dependent Chronic Kidney Disease akebia.com ↗
Akebia Therapeutics, Inc. (NASDAQ:AKBA), a biopharmaceutical company focused on delivering innovative therapies to patients with kidney disease through the biology of hypoxia-inducible factor (HIF), today announced positive top-line results from its Phase 2 study of vadadustat in Japanese patients with anemia associated with non-dialysis-dependent chronic kidney disease (NDD-CKD). |
All press releases naming this drug 75 releases
Evidence & citations 11 cited values
Every value below carries the sentence it was read from. 36 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 | 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 ↗ |