Drugs / Roxadustat
Roxadustat
Regulatory milestones approvals, filings & regulatory actions · 5 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed aregenerative anemia 3 milestones | |||||
| Filed | EU (EMA) | — | aregenerative anemia | 2020-05-21 | “the marketing authorization application (MAA) for roxadustat for the treatment of anemia in adult patients with chronic kidney disease (CKD) has been accepted by the European...” astellas.com ↗ |
| Filed | Japan (PMDA) | Evrenzo | aregenerative anemia | 2020-01-30 | “today announced the submission of a supplemental New Drug Application (sNDA) to Japan’s Ministry of Health, Labour and Welfare” astellas.com ↗ |
| Filed | Japan (PMDA) | — | aregenerative anemia | 2018-10-01 | “Astellas submitted a New Drug Application (NDA) for marketing approval in Japan of roxadustat (generic name, development code: ASP1517/FG-4592)” astellas.com ↗ |
| Rejected anemia due to chronic disorder 1 milestone | |||||
| Rejected (CRL) | US (FDA) | — | anemia due to chronic disorder | 2021-08-11 | “The US Food and Drug Administration (FDA) has issued a complete response letter (CRL) regarding the New Drug Application (NDA) for roxadustat” astrazeneca.com ↗ |
| Approved Indication not stated 1 milestone | |||||
| Approved | EU (EMA) | Evrenzo | — | 2021-08-18 | europa.eu ↗ |
Trials 60
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 111 trials | ||||||
| Phase 1 | NCT03960489 | Jul → Oct 2019 | — | Astellas Pharma Global Development, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT02965040 | Dec 2016 → Dec 2017 | impaired renal function disease, medulloadrenal hyperfunction | Astellas Pharma Europe B.V. | Completed | No outcome recorded |
| Phase 1 | NCT02952040 | Nov → Dec 2016 | — | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 1 | NCT02805374 | Jul → Aug 2016 | — | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 1 | NCT02693613 | Feb → Apr 2016 | — | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 1 | NCT02252731 | Sep → Nov 2013 | — | Astellas Pharma Europe B.V. | Completed | No outcome recorded |
| Phase 1 | NCT02161796 | Sep → Dec 2013 | — | Astellas Pharma Europe B.V. | Completed | No outcome recorded |
| Phase 1 | NCT02161224 | Sep → Dec 2013 | liver disorder | Astellas Pharma Europe B.V. | Completed | No outcome recorded |
| Phase 1 | NCT01376063 | Mar → May 2010 | — | Kyntra Bio | Completed | No outcome recorded |
| Phase 1 | NCT01083888 | Feb → Jun 2010 | anemia, impaired renal function disease | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 1 | NCT00978198 | Sep 2009 → Jun 2010 | — | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 1/23 trials | ||||||
| Phase 1/2 | NCT06903559 | Apr → Oct 2025 overdue | cardiovascular disorder, chronic renal failure syndrome, end stage renal failure, protein-energy malnutrition | Mansoura University | Recruiting | No outcome recorded |
| Phase 1/2 | NCT06917950 | Apr → Oct 2025 overdue | end stage renal failure, mixed anxiety and depressive disorder | Mansoura University | Recruiting | No outcome recorded |
| Phase 1/2 | NCT06020833 | Aug 2023 → Oct 2025 | myelodysplastic syndrome | Peking Union Medical College Hospital | Withdrawn | No outcome recorded |
| Phase 212 trials · 2 met primary · 2 missed | ||||||
| Phase 2 | NCT05010460 | Sep 2021 → May 2025 | — | Peking Union Medical College Hospital | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT04803864 | Jun 2021 → Sep 2022 | ST-elevation myocardial infarction | Ruijin Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT04076943 | Aug 2019 → Mar 2021 | chemotherapy-induced toxicity | Kyntra Bio | Completed | No outcome recorded |
| Phase 2 | NCT01964196 | Sep 2013 → Jul 2015 | — | Astellas Pharma Inc | Completed | Met primary |
| Phase 2 | NCT01888445 | Mar 2013 → Sep 2014 | anemia due to chronic disorder | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 2 | NCT01630889 | May 2012 → Dec 2019 | anemia, end stage renal failure | Kyntra Bio | Completed | No outcome recorded |
| Phase 2 | NCT01599507 | Dec 2011 → Jan 2013 | anemia due to chronic disorder | Kyntra Bio | Completed | No outcome recorded |
| Phase 2 | NCT01596855 | Sep 2011 → Jan 2013 | aregenerative anemia | Kyntra Bio | Completed | No outcome recorded |
| Phase 2 | NCT01414075 | Jul 2011 → Jan 2013 | anemia | Kyntra Bio | Completed | Missed primary |
| Phase 2 | NCT01244763 | Oct 2010 → Jun 2012 | anemia, chronic kidney disease | Kyntra Bio | Completed | No outcome recorded |
| Phase 2 | NCT01147666 | May 2010 → Oct 2012 | anemia, end stage renal failure | Kyntra Bio | Completed | Missed primary |
| Phase 2 | NCT00761657 | Nov 2006 → Jun 2010 | anemia, chronic kidney disease | Kyntra Bio | Completed | Met primary |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT03303066 | Jun 2018 → Jan 2023 | anemia, myelodysplastic syndrome | Kyntra Bio | Completed | No outcome recorded |
| Phase 324 trials · 12 met primary · 1 missed | ||||||
| Phase 3 | NCT06772272 | Nov 2024 → Nov 2026 expected | anemia | Second Affiliated Hospital, School of Medicine, Zhejiang University | Active not recruiting | No outcome recorded |
| Phase 3 | NCT05970172 | Jan 2024 → Oct 2027 expected | anemia, chronic kidney disease | Astellas Pharma Global Development, Inc. | Recruiting | No outcome recorded |
| Phase 3 | NCT04621331 | May 2022 | anemia due to chronic disorder | Kyntra Bio | Withdrawn | No outcome recorded |
| Phase 3 | NCT05301517 | Mar 2022 → Apr 2023 | aregenerative anemia | Kyntra Bio | Completed | Met primary |
| Phase 3 | NCT04925011 | Sep 2021 → Jun 2022 | anemia due to chronic disorder | Mao Jianhua | Unknown | No outcome recorded |
| Phase 3 | NCT04484857 | Jul 2020 → Jul 2021 | end stage renal failure | Kyntra Bio | Completed | No outcome recorded |
| Phase 3 | NCT04410198 | May 2020 → Jun 2021 | end stage renal failure | Kyntra Bio | Completed | No outcome recorded |
| Phase 3 | NCT03263091 | Jan 2018 → Mar 2023 | anemia, myelodysplastic syndrome | Kyntra Bio | Terminated | Missed primary |
| Phase 3 | NCT02988973 | Jan 2017 → Sep 2019 | chronic kidney disease | Astellas Pharma Inc | Completed | Met primary |
| Phase 3 | NCT02964936 | Jan 2017 → Aug 2018 | chronic kidney disease | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 3 | NCT02952092 | Nov 2016 → Mar 2018 | chronic kidney disease | Astellas Pharma Inc | Completed | Met primary |
| Phase 3 | NCT02780726 | Jun 2016 → Aug 2017 | chronic kidney disease | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 3 | NCT02780141 | Jun 2016 → Dec 2017 | — | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 3 | NCT02779764 | May 2016 → May 2017 | aregenerative anemia | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 3 | NCT02652806 | Dec 2015 → Jan 2017 | anemia | Kyntra Bio | Completed | Met primary |
| Phase 3 | NCT02652819 | Dec 2015 → Jan 2017 | anemia | Kyntra Bio | Completed | Met primary |
| Phase 3 | NCT02273726 | Jan 2015 → Sep 2018 | — | Kyntra Bio | Completed | Met primary |
| Phase 3 | NCT02278341 | Nov 2014 → Jun 2017 | anemia, end stage renal failure | Astellas Pharma Europe B.V. | Completed | Met primary |
| Phase 3 | NCT02174731 | Jul 2014 → Sep 2018 | anemia | AstraZeneca | Completed | Met primary |
| Phase 3 | NCT02174627 | Jun 2014 → Oct 2018 | anemia | AstraZeneca | Completed | Met primary |
| Phase 3 | NCT02021318 | Mar 2014 → Mar 2018 | aregenerative anemia | Astellas Pharma Europe B.V. | Completed | Met primary |
| Phase 3 | NCT02052310 | Feb 2014 → Sep 2018 | anemia | Kyntra Bio | Completed | No outcome recorded |
| Phase 3 | NCT01887600 | Sep 2013 → Nov 2017 | — | Astellas Pharma Europe B.V. | Completed | Met primary |
| Phase 3 | NCT01750190 | Nov 2012 → Sep 2018 | chronic kidney disease | Kyntra Bio | Completed | Met primary |
| Phase 48 trials · 2 missed | ||||||
| Phase 4 | NCT07162090 | Sep 2025 → Sep 2026 overdue | anemia due to chronic disorder, muscular atrophy | Tianjin Medical University General Hospital | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT06006949 | Aug 2023 → Aug 2024 | myelodysplastic syndrome | Peking Union Medical College Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT06115421 | May 2023 → Aug 2024 | aregenerative anemia | Alexandria University | Completed | No outcome recorded |
| Phase 4 | NCT05691257 | Feb → Aug 2023 | anemia, chronic kidney disease, heart failure | China-Japan Friendship Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT07359027 | Nov 2021 → Dec 2022 | anemia, diabetic kidney disease | Second Xiangya Hospital of Central South University | Completed | No outcome recorded |
| Phase 4 | NCT04655027 | Feb → Oct 2021 | anemia due to chronic disorder | AstraZeneca | Completed | Missed primary |
| Phase 4 | NCT04454879 | Jul 2020 → Apr 2021 | anemia | Peking University First Hospital | Completed | Missed primary |
| Phase 4 | NCT04059913 | Jun 2019 → Nov 2021 | — | Kyntra Bio | Completed | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT05053893 | Sep 2021 → Jul 2022 | cardio-renal syndrome | The Affiliated Hospital of Qingdao University | Unknown | No outcome recorded |
| Comparator or background therapy3 trials | ||||||
| Phase 1 | NCT04925661 Comparator | Nov 2021 → Aug 2023 | anemia, chronic kidney disease | Sunshine Lake Pharma Co., Ltd. | Completed | No outcome recorded |
| Phase 2 | NCT05810311 Comparator | Jun 2025 → Jan 2027 expected | diabetic kidney disease | Region Stockholm | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07045155 Comparator | Aug 2025 → Dec 2027 expected | anemia due to chronic disorder, end stage renal failure | Chinese PLA General Hospital | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 23
| Date | Issuer | Release |
|---|---|---|
| 2022-05-19 | Astellas Pharma Inc | Results Astellas Analysis Shows No Evidence of Increased Risk of Cardiovascular Events or Mortality with Roxadustat Compared with Erythropoiesis-Stimulating Agents (ESAs) at 59th ERA Congress 2022 astellas.com ↗
Hazard ratios for MACE, MACE+ and ACM vs ESA were 0.79, 0.78 and 0.78, respectively, favoring roxadustat. |
| 2021-08-20 | Astellas Pharma Inc | Regulatory Astellas Receives European Commission Approval for First-in-Class EVRENZO™ (roxadustat) for Adult Patients with Symptomatic Anemia of Chronic Kidney Disease astellas.com ↗
Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") and FibroGen, Inc. (Nasdaq: FGEN, CEO: Enrique Conterno, "FibroGen") today announced that the European Commission (EC) has approved EVRENZO ™ (roxadustat) for the treatment of adult patients with symptomatic anemia associated with chronic kidney disease (CKD). |
| 2021-08-11 | AstraZeneca | Regulatory Update on US regulatory review of roxadustat in anaemia of chronic kidney disease astrazeneca.com ↗
The US Food and Drug Administration (FDA) has issued a complete response letter (CRL) regarding the New Drug Application (NDA) for roxadustat for the treatment of anaemia of chronic kidney disease (CKD), in both non-dialysis dependent (NDD) and dialysis-dependent (DD) adult patients. |
| 2021-07-16 | AstraZeneca | Regulatory Status on FDA Advisory Committee vote on roxadustat in anaemia of chronic kidney disease astrazeneca.com ↗
The Food and Drug Administration’s (FDA) Cardiovascular and Renal Drugs Advisory Committee (CRDAC) has voted 13 to 1 that the benefit-risk profile of roxadustat does not support approval |
| 2021-06-25 | Astellas Pharma Inc | Regulatory Astellas Receives Positive CHMP Opinion for EVRENZO™ (roxadustat) for Adult Patients with Symptomatic Anemia of Chronic Kidney Disease astellas.com ↗ |
| 2021-03-01 | AstraZeneca | Regulatory Further update on US regulatory review of roxadustat in anaemia of chronic kidney disease astrazeneca.com ↗
AstraZeneca and FibroGen, Inc. (FibroGen) today announced that the US Food and Drug Administration (FDA) informed FibroGen that it will convene a meeting of the Cardiovascular and Renal Drugs Advisory Committee to review the new drug application for roxadustat. |
| 2020-12-18 | AstraZeneca | Regulatory Update on US regulatory review of roxadustat in anaemia of chronic kidney disease astrazeneca.com ↗ |
| 2020-11-27 | Astellas Pharma Inc | Regulatory Astellas Receives Approval of EVRENZO® (roxadustat) in Japan for the Treatment of Anemia of Chronic Kidney Disease in Adult Patients Not on Dialysis astellas.com ↗
Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) and FibroGen, Inc. (Nasdaq: FGEN, CEO: Enrique Conterno, “FibroGen”) today announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) approved EVRENZO ® (roxadustat) for the treatment of anemia of chronic kidney disease (CKD) in adult patients not on dialysis. |
| 2020-06-08 | Astellas Pharma Inc | Results Roxadustat Demonstrates Non-Inferiority to Darbepoetin in Phase 3 DOLOMITES Study of Anemia in Non-Dialysis-Dependent Adult Patients with Chronic Kidney Disease astellas.com ↗
Roxadustat Demonstrates Non-Inferiority to Darbepoetin in Phase 3 DOLOMITES Study of Anemia in Non-Dialysis-Dependent Adult Patients with Chronic Kidney Disease |
| 2020-05-21 | Astellas Pharma Inc | Regulatory European Medicines Agency Accepts Astellas’ Marketing Authorization Application for Roxadustat astellas.com ↗
European Medicines Agency Accepts Astellas’ Marketing Authorization Application for Roxadustat |
| 2020-01-30 | Astellas Pharma Inc | Regulatory Astellas Submits Supplemental New Drug Application for Approval of Evrenzo® (roxadustat) for the Treatment of Anemia Associated with Chronic Kidney Disease in Non-Dialysis Dependent Patients in Japan astellas.com ↗
today announced the submission of a supplemental New Drug Application (sNDA) to Japan’s Ministry of Health, Labour and Welfare |
| 2019-11-08 | AstraZeneca | Results Roxadustat Phase III programme pooled analyses showed positive efficacy and no increased cardiovascular risk in patients with anaemia from chronic kidney disease astrazeneca.com ↗
AstraZeneca and FibroGen Inc. (FibroGen) today presented pooled efficacy and cardiovascular (CV) safety analyses from the pivotal Phase III programme assessing roxadustat for the treatment of patients with anaemia from chronic kidney disease (CKD). |
| 2019-11-07 | AstraZeneca | Results Roxadustat significantly increased haemoglobin levels for chronic kidney disease patients with anaemia in Phase III OLYMPUS and ROCKIES trials astrazeneca.com ↗
AstraZeneca today presented detailed results from the Phase III OLYMPUS and ROCKIES trials showing that roxadustat significantly increased haemoglobin (Hb) levels in non-dialysis-dependent (NDD) and dialysis-dependent (DD) patients with anaemia from chronic kidney disease (CKD), respectively. |
| 2019-09-20 | Astellas Pharma Inc | Regulatory Evrenzo® (roxadustat) Tablets Approved in Japan for the Treatment of Anemia Associated with Chronic Kidney Disease in Dialysis Patients astellas.com ↗
Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) and FibroGen, Inc. (Nasdaq: FGEN, Interim CEO: James A Schoeneck., “FibroGen”) today announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) approved Evrenzo® (generic name: roxadustat) for the treatment of anemia associated with chronic kidney disease (CKD) in dialysis patients. |
| 2019-08-22 | AstraZeneca | Regulatory Roxadustat approved in China for the treatment of anaemia in non-dialysis-dependent patients with chronic kidney disease astrazeneca.com ↗
AstraZeneca today announced that its partner FibroGen (China) Medical Technology Development Co., Ltd. (FibroGen China) has received marketing authorisation for roxadustat in China for the treatment of anaemia caused by chronic kidney disease (CKD) in non-dialysis-dependent (NDD) patients. |
| 2019-05-10 | AstraZeneca | Results Pooled analyses of the roxadustat global Phase III programme confirmed cardiovascular safety astrazeneca.com ↗
In the pooled analysis of over 4,300 patients, and based on the totality of the adjudicated evidence, the MACE/MACE+ analyses between roxadustat and placebo showed no clinically-meaningful difference. |
| 2018-12-20 | AstraZeneca | Results Phase III OLYMPUS and ROCKIES trials for roxadustat met their primary endpoints in chronic kidney disease patients with anaemia astrazeneca.com ↗
AstraZeneca today announced that the Phase III OLYMPUS and ROCKIES trials for roxadustat each met their primary efficacy endpoints for the treatment of patients with anaemia in chronic kidney disease (CKD) that are either non-dialysis-dependent or dialysis-dependent, respectively. |
| 2018-12-18 | AstraZeneca | Regulatory Roxadustat approved in China for the treatment of anaemia in chronic kidney disease patients on dialysis astrazeneca.com ↗ |
| 2018-10-30 | Astellas Pharma Inc | Results ASN Kidney Week 2018: Data Presented from Two Japanese Phase 3 Studies on Roxadustat in the Treatment of Anemia Associated with Chronic Kidney Disease in Patients on Dialysis astellas.com ↗
In this study, roxadustat effectively maintained Hb within the range of 10-12 g/dL in HD patients, and its efficacy was non-inferior to darbepoetin alfa. |
| 2018-10-01 | Astellas Pharma Inc | Regulatory Astellas Submits New Drug Application in Japan of Roxadustat for The Treatment of Anemia Associated with Chronic Kidney Disease in Patients on Dialysis astellas.com ↗
today announced that Astellas submitted a New Drug Application (NDA) for marketing approval in Japan of roxadustat (generic name, development code: ASP1517/FG-4592) for the treatment of anemia associated with Chronic Kidney Disease (CKD) in patients on dialysis. |
| 2018-09-20 | Astellas Pharma Inc | Results Astellas Announces Positive Topline Results for Global Phase 3 Trial of Roxadustat in Chronic Kidney Disease (CKD) Patients with Anemia not on Dialysis astellas.com ↗ |
| 2018-05-31 | Astellas Pharma Inc | Results Astellas and FibroGen Announce Topline Results from Double-Blind Japan Phase 3 Study for Roxadustat in Hemodialysis Chronic Kidney Disease Patients with Anemia astellas.com ↗
Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) and FibroGen, Inc. (Nasdaq: FGEN, CEO: Thomas B. Neff, “FibroGen”) today announced that the fourth Japan Phase 3 study for roxadustat met its primary endpoint. |
| 2017-10-31 | Astellas Pharma Inc | Results Astellas and FibroGen Announce Positive Topline Results from First Japan Phase 3 Trial for Roxadustat in Chronic Kidney Disease Patients with Anemia astellas.com ↗
The Hb maintenance rate, measured as the proportion of subjects with average Hb levels within the target Hb range of 10.0 to 12.0 g/dL for Weeks 18 to 24, was 92.3% in ESA-naïve and 74.4% in ESA-conversion patients. |
All press releases naming this drug 30 releases
Evidence & citations 8 cited values
Every value below carries the sentence it was read from. 65 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Roxadustat | “Roxadustat is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor that stimulates erythropoiesis and regulates iron metabolism.” PMID 31340116 ↗ Jul 201950“Roxadustat (FG-4592) is an oral inhibitor” PMID 31340089 ↗ Jul 2019 |
| Known as | ASP1517 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01964196 ↗ |
| Known as | Evernzo | “Intervention Group (n=23): Patients will receive oral Roxadustat (Evernzo) according to prescribing guidelines, in addition to their standard care (excluding other ESAs).” NCT06917950 ↗ |
| Known as | Evrenzo | “The group will receive Roxadustat (Evrenzo) three times weekly at an initial dose of 70mg (for body weight \<100.0 kg) or 100 mg (for body weight weight ≥100.0 kg).” NCT05810311 ↗ |
| Known as | FG-4592 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02252731 ↗ |
| Action | Inhibit | “Roxadustat (FG-4592) is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor that stimulates erythropoiesis.” PMID 26238121 ↗ Aug 2015 |
| Modality | Small molecule | “Roxadustat capsules, an oral medication, represent the world's first small - molecule hypoxia - inducible factor prolyl hydroxylase inhibitor (HIF - PHI)” NCT07162090 ↗ |
| Route | Oral | “Participants will receive roxadustat 0.7 mg/kg BIW orally with doses administered at least 68 hours apart for 29 days.” NCT00761657 ↗ |