Clinical Trials

Numerous clinical trials spanning Phase 1 through Phase 4 evaluate roxadustat (FG-4592) primarily for treating anemia associated with chronic kidney disease, hemodialysis, myelodysplastic syndrome, and cardiovascular conditions like heart failure. Sponsored by major industry leaders—including FibroGen, AstraZeneca, and Astellas Pharma Inc—in collaboration with academic medical centers, these studies assess safety, pharmacokinetics, and therapeutic efficacy. Although key studies across these indications are completed, other trials remain active, actively recruiting, terminated, or withdrawn.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07722988 NOT_YET_RECRUITING
Myelodysplastic Syndromes
Kyntra Bio
 2027-04 PHASE3
NCT07045155 RECRUITING
Dialysis; Complications; Chronic Kidney Disease 5D; Renal Anemia of Chronic Kidney Disease; Renal Anaemia; Renal Anemia, Chronic
Chinese PLA General Hospital
 2025-08-01 PHASE4
NCT05970172 RECRUITING
Chronic Kidney Disease; Renal Anemia
Astellas Pharma Global Development, Inc.
 2024-01-16 PHASE3
NCT05810311 NOT_YET_RECRUITING
Diabetes Complications; Diabetes; Nephropathy (Manifestation)
Region Stockholm
 2025-06-01 PHASE2
NCT06772272 ACTIVE_NOT_RECRUITING
Perioperative Anemia
Second Affiliated Hospital, Zhejiang University, School of Medicine
 2024-11-10 PHASE3
NCT07162090 NOT_YET_RECRUITING
Sarcopenia; Anemia Associated With Chronic Kidney Disease (CKD); Dialysis Patients
Tianjin Medical University General Hospital
 2025-09-10 PHASE4
NCT07786168 COMPLETED
Diabetic Nephropathy; Anemia; Chronic Kidney Disease
Hanzla Arshad
 2025-12-20
NCT06903559 RECRUITING
Kidney Failure, Chronic; Malnutrition-Inflammation Syndrome; Anemia in End Stage Renal Disease; Cardiovascular Diseases (CVD)
Mansoura University
 2025-04-15 PHASE1; PHASE2
NCT06917950 RECRUITING
Kidney Failure,Chronic; Anemia in End Stage Renal Disease; Depression Anxiety Disorder
Mansoura University
 2025-04-15 PHASE1; PHASE2
NCT06020833 WITHDRAWN
Myelodysplastic Syndromes
Peking Union Medical College Hospital
 2023-08 PHASE1; PHASE2
NCT05010460 TERMINATED
Coronary Artery Bypass
Peking Union Medical College Hospital
 2021-09-30 PHASE2
NCT06115421 COMPLETED
Anemia in Dialysis-dependent CKD Patients
Alexandria University
 2023-05-24 PHASE4
NCT06006949 UNKNOWN
Myelodysplastic Syndromes
Peking Union Medical College Hospital
 2023-08 PHASE4
NCT04925661 COMPLETED
Chronic Kidney Diseases; Renal Anemia
Sunshine Lake Pharma Co., Ltd.
 2021-11-04 PHASE1
NCT05691257 UNKNOWN
Heart Failure; Chronic Kidney Diseases; Anemia
China-Japan Friendship Hospital
 2023-02-01 PHASE4
NCT05301517 COMPLETED
Chemotherapy Induced Anemia
Kyntra Bio
 2022-03-16 PHASE3
NCT03263091 TERMINATED
Primary MDS (Very Low, Low or Intermediate IPSS-R With <5% Blasts); Anemia
Kyntra Bio
 2018-01-29 PHASE3
NCT03303066 COMPLETED
Anemia; Myelodysplastic Syndrome
Kyntra Bio
 2018-06-06 PHASE2; PHASE3
NCT07359027 COMPLETED
Diabetic Kidney Disease; Anemia
Second Xiangya Hospital of Central South University
 2021-11-02 PHASE4
NCT04803864 UNKNOWN
ST Elevation Myocardial Infarction
Ruijin Hospital
 2021-06-10 PHASE2
NCT05053893 UNKNOWN
Cardio-Renal Syndrome
The Affiliated Hospital of Qingdao University
 2021-09-22
NCT04925011 UNKNOWN
Anemia Associated With Chronic Kidney Disease
Mao Jianhua
 2021-09-01 PHASE3
NCT04621331 WITHDRAWN
Anemia Associated With Chronic Kidney Disease
Kyntra Bio
 2022-05-23 PHASE3
NCT04059913 COMPLETED
CKD Anemia in Dialysis Participants
Kyntra Bio
 2019-06-11 PHASE4
NCT04655027 COMPLETED
Anemia of Chronic Kidney Disease
AstraZeneca
 2021-02-22 PHASE4
NCT04484857 COMPLETED
Anemia Associated With End Stage Renal Disease
Kyntra Bio
 2020-07-22 PHASE3
NCT04410198 COMPLETED
Anemia Associated With End Stage Renal Disease (ESRD)
Kyntra Bio
 2020-05-26 PHASE3
NCT04454879 COMPLETED
Renal Anemia
Peking University First Hospital
 2020-07-01 PHASE4
NCT04076943 COMPLETED
Chemotherapy Induced Anemia
Kyntra Bio
 2019-08-20 PHASE2
NCT01630889 COMPLETED
Chronic Kidney Disease; End Stage Renal Disease; Anemia
Kyntra Bio
 2012-05-18 PHASE2
NCT03960489 COMPLETED
Healthy Adult Subjects
Astellas Pharma Global Development, Inc.
 2019-07-31 PHASE1
NCT02988973 COMPLETED
Chronic Kidney Disease
Astellas Pharma Inc
 2017-01-12 PHASE3
NCT02174627 COMPLETED
Anemia
AstraZeneca
 2014-06-26 PHASE3
NCT02174731 COMPLETED
Anemia
AstraZeneca
 2014-07-01 PHASE3
NCT01750190 COMPLETED
CKD Anemia
Kyntra Bio
 2012-11-05 PHASE3
NCT02052310 COMPLETED
Anemia in Incident Dialysis Patients
Kyntra Bio
 2014-02-11 PHASE3
NCT02273726 COMPLETED
CKD Anemia in Stable Dialysis Patients
Kyntra Bio
 2015-01-15 PHASE3
NCT02964936 COMPLETED
Chronic Kidney Disease
Astellas Pharma Inc
 2017-01-11 PHASE3
NCT03303066 Completed
Anemia|Myelodysplastic Syndrome
FibroGen|AstraZeneca
 2018-06-06 Phase 2|Phase 3
NCT02021318 COMPLETED
Anemia in Chronic Kidney Disease in Non-dialysis Patients
Astellas Pharma Europe B.V.
 2014-03-12 PHASE3
NCT02952092 COMPLETED
Hemodialysis Chronic Kidney Disease Patients With Anemia
Astellas Pharma Inc
 2016-11-30 PHASE3
NCT02780141 COMPLETED
ESA-naive Hemodialysis Chronic Kidney Disease Patients With Anemia
Astellas Pharma Inc
 2016-06-02 PHASE3
NCT02965040 COMPLETED
Normal Renal Function; Impaired Renal Function
Astellas Pharma Europe B.V.
 2016-12-12 PHASE1
NCT01887600 COMPLETED
Anemia in Chronic Kidney Disease in Non-dialysis Patients
Astellas Pharma Europe B.V.
 2013-09-03 PHASE3
NCT02780726 COMPLETED
Peritoneal Dialysis Chronic Kidney Disease Patients With Anemia
Astellas Pharma Inc
 2016-06-22 PHASE3
NCT02278341 COMPLETED
Anemia; End Stage Renal Disease (ESRD)
Astellas Pharma Europe B.V.
 2014-11-21 PHASE3
NCT02779764 COMPLETED
Hemodialysis Patients With Renal Anemia
Astellas Pharma Inc
 2016-05-16 PHASE3
NCT02652806 COMPLETED
Anemia
Kyntra Bio
 2015-12 PHASE3
NCT02652819 COMPLETED
Anemia
Kyntra Bio
 2015-12 PHASE3
NCT02988973 Completed
Chronic Kidney Disease
Astellas Pharma Inc|FibroGen
 2017-01-12 Phase 3
NCT02964936 Completed
Chronic Kidney Disease
Astellas Pharma Inc|FibroGen
 2017-01-11 Phase 3
NCT02952040 Completed
Healthy Subjects
Astellas Pharma Inc|FibroGen
 2016-11 Phase 1
NCT02952092 Completed
Hemodialysis Chronic Kidney Disease Patients With Anemia
Astellas Pharma Inc|FibroGen
 2016-11-30 Phase 3
NCT02805374 Completed
Healthy Subjects
Astellas Pharma Inc|FibroGen
 2016-07 Phase 1
NCT01888445 COMPLETED
Renal Anemia Associated With Chronic Renal Failure (CRF)
Astellas Pharma Inc
 2013-03-28 PHASE2
NCT02161224 COMPLETED
PK of FG-4592; Hepatic Insufficiency; Healthy Subjects
Astellas Pharma Europe B.V.
 2013-09 PHASE1
NCT02161796 COMPLETED
PK for FG-4592; Healthy Subjects
Astellas Pharma Europe B.V.
 2013-09 PHASE1
NCT02252731 COMPLETED
Pharmacokinetics of FG-4592; Healthy Subjects
Astellas Pharma Europe B.V.
 2013-09 PHASE1
NCT01414075 COMPLETED
Dialysis; Anemia
Kyntra Bio
 2011-07-21 PHASE2
NCT01599507 COMPLETED
Anemia in Chronic Kidney Disease
Kyntra Bio
 2011-12 PHASE2
NCT01596855 COMPLETED
Anemia in End Stage Renal Disease
Kyntra Bio
 2011-09 PHASE2
NCT01147666 COMPLETED
End Stage Renal Disease; Anemia
Kyntra Bio
 2010-05-17 PHASE2
NCT01244763 COMPLETED
Chronic Kidney Disease; Anemia
Kyntra Bio
 2010-10-29 PHASE2
NCT00761657 COMPLETED
Chronic Kidney Disease; Anemia
Kyntra Bio
 2006-11-01 PHASE2
NCT01083888 COMPLETED
Anemia; Hemodialysis; Renal Impairment
Astellas Pharma Inc
 2010-02-15 PHASE1
NCT01376063 COMPLETED
Healthy Adult Subjects
Kyntra Bio
 2010-03 PHASE1

(data from https://clinicaltrials.gov, updated on 2026-07-23)

Check the Roxadustat (FG-4592) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Roxadustat (FG-4592) selectively inhibits hypoxia-inducible factor (HIF) prolyl hydroxylase, thereby preventing the enzymatic degradation of HIF-alpha subunits and allowing their cytosolic accumulation and nuclear translocation. This stabilization promotes the transcriptional activation of downstream target genes involved in erythropoiesis and iron metabolism, which restores endogenous erythropoietin production to effectively treat anemia in patients with chronic kidney disease and myelodysplastic syndrome.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.