Drugs / Roxadustat
last change Nov 2025 re-read 2 minutes ago

Roxadustat

also known as FG-4592 · ASP1517 · Evernzo · Evrenzo

Small molecule

Developed for
anemia · chronic kidney disease · end stage renal failure · anemia due to chronic disorder · aregenerative anemia · myelodysplastic syndrome · cardio-renal syndrome · cardiovascular disorder
+5 more · chemotherapy-induced toxicity · diabetic kidney disease · muscular atrophy · protein-energy malnutrition · ST-elevation myocardial infarction
Investigated by
Kyntra Bio · Astellas Pharma Inc · AstraZeneca · Astellas Pharma Europe B.V. · Peking Union Medical College Hospital · Astellas Pharma Global Development, Inc.
+22 more · Mansoura University · Peking University First Hospital · Ruijin Hospital · Alexandria University · Beijing Haidian Hospital · Beijing Hospital · Beijing Hospital of Traditional Chinese Medicine · Chang Zheng Hospital · China-Japan Friendship Hospital · First Affiliated Hospital of Zhejiang University · First Affiliated Hospital, Sun Yat-Sen University · Mao Jianhua · Parexel · RenJi Hospital · Second Affiliated Hospital, School of Medicine, Zhejiang University · Second Xiangya Hospital of Central South University · Shenzhen People's Hospital · The Affiliated Hospital of Qingdao University · The Third Xiangya Hospital of Central South University · Tianjin Medical University General Hospital · Xiangya Hospital of Central South University · Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Regulatory milestones approvals, filings & regulatory actions · 1 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Approved EU (EMA) Evrenzo 2021-08-18 europa.eu

Trials 60 · a red edge is where a trial was stopped

PhaseRegistry idDatesIndicationSponsorStatusOutcome
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 NCT02161224 Sep → Dec 2013 liver disorder Astellas Pharma Europe B.V. 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 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 1/23 trials
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 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 NCT06020833 Aug 2023 → Oct 2025 myelodysplastic syndrome Peking Union Medical College Hospital Withdrawn No outcome recorded
Phase 212 trials
Phase 2 NCT05010460 Sep 2021 → May 2025 Peking Union Medical College Hospital Terminated No outcome recorded
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 No outcome recorded
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 No outcome recorded
Phase 2 NCT01244763 Oct 2010 → Jun 2012 anemia, chronic kidney disease Kyntra Bio Completed No outcome recorded
Phase 2/31 trial
Phase 2/3 NCT03303066 Jun 2018 → Jan 2023 anemia, myelodysplastic syndrome Kyntra Bio Completed No outcome recorded
Phase 324 trials
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 No outcome recorded
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 No outcome recorded
Phase 3 NCT02988973 Jan 2017 → Sep 2019 chronic kidney disease Astellas Pharma Inc Completed No outcome recorded
Phase 3 NCT02964936 Jan 2017 → Aug 2018 chronic kidney disease Astellas Pharma Inc Completed No outcome recorded
Phase 48 trials
Phase 4 NCT07162090 Sep 2025 → Sep 2026 expected 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 No outcome recorded
Phase 4 NCT04454879 Jul 2020 → Apr 2021 anemia Peking University First Hospital Completed No outcome recorded
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
Also used as a comparator or background therapy in 3 trials
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 11 trial
Phase 1 NCT04925661 Comparator Nov 2021 → Aug 2023 anemia, chronic kidney disease Sunshine Lake Pharma Co., Ltd. Completed No outcome recorded
Phase 21 trial
Phase 2 NCT05810311 Comparator Jun 2025 → Jan 2027 expected diabetic kidney disease Region Stockholm Not yet recruiting No outcome recorded
Phase 41 trial
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

Evidence & citations 8 cited values

Every value below carries the sentence it was read from. 65 sources stand behind the page.

FieldValueCited text
Known as Roxadustat Roxadustat is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor that stimulates erythropoiesis and regulates iron metabolism.” PMID 31340116 Jul 2019
50

Roxadustat (FG-4592) is an oral inhibitor” PMID 31340089 Jul 2019

NCT01414075

NCT05301517

NCT02780726

NCT04621331

NCT04410198

NCT04803864

NCT02965040

NCT02278341

NCT07162090

NCT03263091

NCT02021318

NCT04655027

NCT06772272

NCT06115421

NCT04076943

NCT02273726

NCT05970172

NCT05010460

NCT04925011

NCT02988973

NCT05053893

NCT06020833

NCT04484857

NCT02952092

NCT07045155

NCT05810311

NCT01630889

NCT02174627

NCT01244763

NCT03960489

NCT01888445

NCT06006949

NCT06917950

NCT01887600

NCT02174731

NCT01750190

NCT02052310

NCT07359027

NCT02964936

NCT02779764

NCT06903559

NCT04454879

NCT04925661

NCT01147666

NCT04059913

NCT05691257

NCT01083888

NCT02780141

NCT00761657

Known as ASP1517 ClinicalTrials.gov intervention name — accepted as the source's own label NCT02952040
4

NCT02693613

NCT01964196

NCT00978198

NCT02805374

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 NCT02161224
7

NCT03303066

NCT01599507

NCT02652819

NCT01376063

NCT02252731

NCT01596855

NCT02161796

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